Download Response to the FDA 2010-07

FROM:
Mr. James H. Brown
President
Caird Technology Inc.
205 Camden Chase
Columbia, South Carolina 29223
Tel: +803-237-8175
Fax: N/A
E-mail: [email protected]
TO:
James Cheng
Senior Regulatory Reviewer
Office of Device Evaluation
Center for Devices and Radiological Health
FDA
10903 New Hampshire Avenue
WO66-1326
Silver Spring, MD 20993-0002
Tel: 301-796-6306
Fax: 301-847-8116
Email: [email protected]
RE: K101016/S001 Caird Technology HRV System
July 19, 2010
Dear Mr. Cheng,
My response to your concerns is as follows:
1.
You have provided documents with the changes previously recommended that indicate that
the device represents a test limited to measurement of Heart Rate Variability. However there
remain some references to the autonomic nervous system and autonomic neuropathy,
including the abbreviation “ANS”, that imply the capability to diagnose autonomic dysfunction.
Since these references would be misleading we recommend that they be changed to a
term/abbreviation reflecting measurement of Heart Rate Variability.
a. The items listed below have been updated.
b.
There are many documents submitted that still reference the letters ANS. This is because the Caird
internal numbering system calls for a three letter suffix for the document number. All documents
commonly available to the public have had this suffix changed from ANS to HRV (i.e. Caird HRV
Operators manual). There still remain some documents with the ANS suffix. These documents are only
for Caird internal operations only and are not generally available to the public. An example of this is the
document ANS-001-003-00140-A ANS Test Software - Application Information Storage TEST.
The intention was to modify these documents when they were normally updated. If the FDA feels this
may still pose a potential problem all documents will be modified per the request. Please advise how you
wish us to proceed.
Based upon your response to the above I will delay the hard copy submission until I receive your
response.
2.
You have included in Section 11 brochures regarding Conditions of the autonomic nervous
system and Autonomic Neuropathy. These could be misleading in implying diagnosis of
autonomic dysfunction. Therefore we recommend that they be removed.
a. I have included the document: HRV Software Brochure
b. The following documents will be removed from the distribution:
Conditions of the autonomic nervous system Brochure
Conditions of the autonomic nervous system
3.
The Executive Summary (Section 6) still refers to “Autonomic Nervous System Software” in the
first paragraph and under “components” and in the “HRV Read Me” under “Documentation.”
Please remove the references to “Autonomic Nervous System Software” in these documents.
The executive summary reference to “Autonomic Nervous System Software” has
be changed to “Heart Rate Variability Software”
The document ANS-002-004-00002-B ANS Read Me has been changed to HRV-002-00400002-B HRV Read Me
I have included the above with this response.
4.
Several documents contains a “Statement of Intended Use” which still refer to the evaluation of
the autonomic nervous system as well as uses which are not supported by the submission
such as Type II Controlled Diabetes, Type I Controlled Diabetes, Type II Uncontrolled
Diabetes, Type I Uncontrolled Diabetes, Impotence of organic origin, Toxic Neuropathy,
Parkinson's Disease, other degenerative diseases of the basal ganglia: Shy-Drager Syndrome,
Parkinson's with orthostatic hypotension. Please remove these indications from the
“Statement of Intended Use” (HRV Test Specification – Risk analysis), “Indications for Use”
(Substantial Equivalence Discussion Section 8), and “Diagnosis” (HRV Operators Manual
Appendix A).
The document ANS-001-004-00016-B ANS Risk Analysis has been updated to
ANS-001-004-00016-C ANS Risk Analysis.
The Caird HRV Operators Manual has been updated to remove the ICD-9 codes.
Note: These have been removed but these specific codes have been developed by
International Statistical Classification of Diseases and Related Health Problems (most
commonly known by the abbreviation ICD). This provides codes to classify diseases and a
wide variety of signs, symptoms, abnormal findings, complaints, social circumstances,
and external causes of injury or disease. Under this system, every health condition can be
assigned to a unique category and given a code, up to six characters long. Such
categories can include a set of similar diseases. The Health Care Financing Adminstration
(HCFA) has approved these codes to be used as diagnosis to qualify for the testing of
Heart Rate Variability (CPT Code – 58521 The Testing of Heart Rate Variability function:
two or more of the following: heart rate response to deep breathing with recorded R-R
interval and/or valsalva ratio and/or 30:15 ratio (posture test).
5. The Caird HRV Operators Manual contains a discussion of the diagnostic utility of heart rate
variability. Please remove these statements under “Clinical Implications.”
The Caird HRV Operators Manual has been updated as follows:
The paragraph “The American Heart Association and the American Association of Clinical
Endocrinologists both recently declared heart rate variability as a recommended test for detecting
autonomic dysfunction in diabetes. Heart rate variability testing has previously been limited to the
research lab setting due to the fact that it called for customized and computerized analysis of
electrocardiograms, but today physicians nationwide can incorporate a heart rate variability test,
into a single office visit.” has been removed.
These paragraphs were updated:
Assessment of HRV function is clinically important because studies have demonstrated that heart
rate variability expressed as diminished variability of an evoked end-organ (i.e. heart) response to
a stimulus is associated with increased morbidity and mortality in the diabetic patient.
A decrease in cardiac heart rate variability activity (and especially in vagal activity) occurs usually
after acute myocardial infarction. Patients at risk of sudden cardiac death display persistent
reduction of heart rate variability. Studies have shown diminished HRV to be a powerful predictor
of long-term mortality in survivors of myocardial infarction. This predictor has been shown to be
independent of other indices (such as frequency and complexity of ventricular ectopic beats or
left ventricular ejection fraction). Autonomic neuropathy is also a recognized complication of HIV
infection.
I have included the above with this response.
6.
Please include in your 510(k) summary a brief discussion of the nonclinical tests submitted,
referenced, or relied on in the 510(k) for a determination of substantial equivalence (see
“510(k) summary requirements,” attached).
There has been no testing done to compare the results of the QMED Ndx Heart Rate Variability
test to the Caird HRV test, the accuracy of the Caird HRV test lies in the QRS detection algorithm.
These results have been submitted previously to the FDA and are again supplied with this
submission. The basis of the substantial equivalence determination was done by comparison of
the QMED Ndx Heart Rate Variability operators manual and the QMED Ndx Heart Rate Variability
FDA submission which is available to the public.
7.
Please use the updated “Indications for Use” form (attached) which requires the sponsor to
check the prescription or OTC use boxes.
The indications for use document has been modified to include the 510(K) Number and the
Prescription Use has been checked.
I have included the above with this response.