(87 days)
The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
This document is a 510(k) Pre-market Notification from the FDA regarding the Metron U.S. QA-510 SpO2 Analyzer. It is a regulatory approval letter and an indications for use statement. Therefore, it does not contain the detailed technical study information requested about acceptance criteria and device performance.
The document discusses:
- Device Name: Metron U.S. QA-510 SpO2 Analyzer
- Regulatory Class: II (two)
- Product Code: 74 DQA
- Indications for Use: "The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED. The QA-510 is designed to be used by trained service technicians."
- Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot provide the requested information about acceptance criteria and study details because this type of information is typically found in the 510(k) submission itself (which includes engineering reports, test data, and performance specifications), not in the FDA's clearance letter.
The letter confirms the device's clearance for marketing, but it does not disclose the specific performance metrics, study designs, sample sizes, or ground truth methodologies that were part of the underlying submission that led to this clearance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 1998
Mr. E.J. Smith Metron U.S., Inc. c/o Smith Associates P.O. Box 4343 Crofton, MD 21114-4341
Re: K973991 Metron QA-510 SpO2 Analyzer Regulatory Class: II (two) Product Code: 74 DQA Dated: October 8, 1997 October 21, 1997 Received:
Dear Mr. Smith:
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. E.J. Smith
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 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 general 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, 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
510(k) Number (if known):
Device Name: QA-510
Indications for Use:
. .
The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
The QA-510 is designed to be used by trained service technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, | ||
| and Neurological Devices | ||
| 510(k) Number | K973991 | |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
§ 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).