(354 days)
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Not Found
No
The summary describes a standard SpO2 finger probe and does not mention any AI or ML components or capabilities.
No
The device is described as a SpO2 finger probe for monitoring SpO2 saturation and pulse rate, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device is used for "noninvasive SpO2 saturation and pulse rate monitoring," which are measurements taken to assess a patient's physiological state and can indicate a medical condition, thus serving a diagnostic purpose.
No
The device description explicitly states "SpO2 Finger Probe Models...", indicating a physical hardware component (a finger probe) is the device being described, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short term continuous noninvasive SpO2 saturation and pulse rate monitoring". This involves measuring physiological parameters directly from a living patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device is a probe that attaches to the finger to measure oxygen saturation and pulse rate directly.
Therefore, this device falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The compatible Medical Cables, Inc. SpO2 Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO2 saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO2 Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.
Product codes
74 DQA
Device Description
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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
patients weighing greater than 40kg
Intended User / Care Setting
in a medical or clinical environment under the direction of a physician.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OGT g 10008
Mr. Christopher J. Fontana Medical Cables, Inc. 1340 Logan Avenue Costa Mesa, CA 92626
Re: K973970 SpO2 Finger Probe Models P856RA, P861RA, P862RA, P867RA, and P876RA Regulatory Class: II (two) Product Code: 74 DQA Dated: June 28, 1998 Received: July 16, 1998
Dear Mr. Fontana:
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, Druq, 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 requlation may result in requlatory 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 requlations.
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Page 2 - Mr. Christopher J. Fontana
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
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 of
510(k) Number (if known): K973970
Medical Cables SpO2 Finger Probe Device Name:
Indications For Use:
The compatible Medical Cables, Inc. SpO2 Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO2 saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO2 Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Klan (Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)