We have submitted a 510(k) file for one of our ECG devices. The indication
for use is "to be used by a physician to analyze cardiac performance" and
in the description we say: "can be equipped with a resting interpretation
program offered to the physician on advisory basis only". We classified it
as a 74DPS Class II device. The reviewer has told us that "in view of the
interpretative ECG capabilities of your device, it will be placed into
regulatory class III, with product code of 74DSI"
My questions are:
1. Why FDA considers of higher concern a device equipped with an
interpretation program whose analysis the physician is asked to over-read
and validate or change?
2. Where can you find detailed classification rules?
3. Why such a device has to be classified as a DSI (Arrhythmia Detector and
Alarm) as it could "produce a audible or visible signal or alarm when an
arrhythmia exists" while the physician is not on the bed side?
Thanks for any answer.
Massimo
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ESAOTE S.p.A. Massimo Polignano
Research & Product Development Regulatory Affairs
Via di Caciolle,15 tel:+39.55.4229402
I- 50127 Florence fax:+39.55.4223305
e-mail: [email protected]
