(87 days)
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No
The summary describes a precision instrument for testing pulse oximeters and measuring LED quality, with no mention of AI, ML, or related concepts.
No
The device is described as an analyzer designed to perform tests on Pulse Oximeters and measure LED quality, indicating it is a testing or calibration device, not one used for treatment.
No
Explanation: The device is described as a "precision instrument designed to perform tests on Pulse Oximeters," indicating it is a testing or calibration device for other medical equipment, not a device that diagnoses a patient's condition.
No
The description explicitly states the device is a "precision instrument" and performs measurements on LEDs, which strongly implies the presence of hardware components beyond just software.
Based on the provided information, the Metron U.S. QA-510 SpO2 Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform tests on Pulse Oximeters" and measure the quality of LEDs. This describes a device used for testing and calibrating other medical devices, not for analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a patient's health condition.
- Device Description: The description reinforces its function as a "precision instrument designed to perform tests on Pulse Oximeters."
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or patient-specific results derived from biological material.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Metron U.S. QA-510 SpO2 Analyzer's function falls outside this definition.
N/A
Intended Use / 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.
Product codes
74 DQA
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The QA-510 is designed to be used by trained service technicians.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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 |