(472 days)
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda, Novametrix 500, Novametrix Superbright, Spacelabs oximeter module, Criticare, BCI, Datascope.
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring.
This document is a 510(k) clearance letter from the FDA for a medical device (Epic Series E100 SpO2 Finger Sensor). It does not contain the detailed acceptance criteria and study information typically found in a device's design validation report or clinical study summary.
Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not elaborate on the specific performance metrics or the studies conducted to demonstrate those metrics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Mr. Jeffrey Secunda Epic Medical Equipment Services, Inc. 4643 Westgrove Drive Dallas, TX 75248
Re: K970098 Epic Series E100 SpO2 Finger Sensor Regulatory Class: II (two) Product Code: 74 DQA Dated: February 1, 1998 February 3, 1998 Received:
Dear Mr. Secunda:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jeffrey Secunda
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K970098
DEVICE NAME: EPIC SERIES E100 SpO2 FINGER SENSOR
INDICATIONS FOR USE
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters:
| Oximeter | Epic M/N |
|---|---|
| Ohmeda | E112-02 |
| Novametrix 500 | E192-03 |
| Novametrix Superbright | E112-03 |
| Spacelabs oximeter module | E112-04 |
| Criticare | E112-05 |
| BCI | E103-06 |
| Datascope | E112-07 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
Or
Over-the-Counter Use
(per 21 CFR 801.109)
M.P.S
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory, Divisionrological Devices
510(k) Number
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).