OXIMETER PRE-AMP CABLE

• K Number: K965172
• Device Name: OXIMETER PRE-AMP CABLE
• Manufacturer: EPIC MEDICAL EQUIPMENT SERVICES, INC.
• Date Cleared: 1997-07-16 ( 204 days)
• Product Code: DQA
• Regulation Number: 870.2700
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for an "Oximeter Pre-AMP Cable." This document primarily grants marketing clearance for the device based on its substantial equivalence to a predicate device.

It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined. The FDA letter is a regulatory approval, not a performance study report.

Therefore, I cannot populate the requested table and information based on the provided text. The document doesn't include:

1. Acceptance criteria or reported device performance metrics.
2. Sample sizes used for test sets.
3. Details about experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for training set.
9. How ground truth for the training set was established.

The document states that the device is a "Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only." This indicates its intended use, but not specific performance criteria or test results.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey Secunda VP Product Development & Regulatory Affairs Epic Medical Equipment Services, Inc. 4643 Westgrove Drive Dallas, Texas 75248

JUL 16 1997

Re: K965172 Oximeter Pre-AMP Cable Requlatory Class: II (Two) Product Code: 74 DQA Dated: April 16, 1997 Received: April 17, 1997

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 Existing major regulations affecting your device additional controls. 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 requirement, 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 begin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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Page 1 of 1

K965172 510(k)

DEVICE NAME: OXIMETER PRE-AMP CABLE

INDICATIONS FOR USE:

Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

eplacement point

Over-the-Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Lank madon 7-14-97

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K965172

Regulation Number and Section

§ 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).