(90 days)
Not Found
No
The document describes a standard pulse oximeter sensor that uses optical means to measure oxygen saturation and pulse rate. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on light absorption, which is a traditional method for pulse oximetry.
No
The device is indicated for measurement and monitoring of physiological parameters (oxygen saturation and pulse rate), not for treatment or therapy.
No
The device measures physiological parameters (oxygen saturation and pulse rate) but does not provide a diagnosis itself. It is a sensor that gathers data to be used by an oximeter, which may contribute to a diagnosis but is not a diagnostic device on its own.
No
The device description explicitly details hardware components (LEDs, photo detector, cable, connector) and mentions physical testing (biocompatibility, electrical safety, electromagnetic testing), indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device measures arterial oxygen saturation and pulse rate non-invasively by being connected between the patient and the oximeter. It uses optical means to analyze light absorption through the finger.
- No Sample Analysis: There is no mention of analyzing any biological samples taken from the patient.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Unimed's Spo2 reusable sensors are designed to function the same as the compatible Original Equipment Manufacturer (OEM) Puise Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the silicon pads. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
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
finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was conducted during clinical hypoxia studies conducted in an independent lab and was shown to validate performance claims and accuracy. Bench testing was performed to verify pulse rate accuracy. Biocompatibility was confirmed for all patient contact materials per ISO 10993. Electrical safety and electromagnetic testing was also performed per IEC 60601-1. All testing was performed in accordance with ISO 9919 and supported the conclusion that the devices were safe and effective for their intended use.
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.
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).
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).
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K0802546
p. 1 of 2
Unmedical Medical Supplies Inc
Med
Uni
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067
Tel: 86 755 26828795 Fax: 86 755 26697984 Email: info@unimed.cn www. Unimed.cn
510(k) Section 5
510(K) Summary
Submitter Information:
Unimed Medical supplies Inc No.37, yanshan Road, Shekou, Shenzhen, China 518067
Contact:
Mr. Don Melnikoff W322S8863 McCarthy Drive, Mukwonago Wi 53149, USA Tel: (262) 565-6797 - Office Tel: (262) 312-8342 - Mobile Email: dmelnikoff@wi.rr.com
Date Prepared: 8/20/08
Trade Name: Unimed compatible oximeter sensors Common Name: SPO2 Sensor (accessories to pulse Oximeter) Product Classification: Oximeter (DQA), per 21 CFR 870.2700
Applicable Part Numbers:
| U410-09 | Datex Compatible Adult Finger Clip Reusable Sensor |
|---|---|
| U410-02 | Ohmeda Compatible Adult Finger Clip Reusable Sensor |
| U403S-91 | Phillips Compatible Adult Soft Tip Reusable Sensor |
Predicate Information:
| Unimed Sensors | Predicate 510(K) | Predicate
Manufacturer/Models |
|----------------|------------------|----------------------------------------------------|
| U4XX Series | K053420 | Tenacore Holdings, Inc.
Adult Finger Clip Probe |
| U4XXS Series | K053420 | Tenacore Holdings, Inc.
Adult Soft Cuff Probe |
Tip
510(K) submission
DEC 0 2 2008
1
Description:
Unimed's Spo2 reusable sensors are designed to function the same as the compatible Original Equipment Manufacturer (OEM) Puise Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the silicon pads. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
Intended Use:
The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.
Manufacturing Facility:
Unimed Medical Supplies inc is the China based manufacturer and distributor of medical cables and accessories. 2500 square meters facility is equipped with all tools and equipments required to produce high quality cables and lead wires.
Unimed is a CE certificated of Class II products and ISO13485-2003 full quality management registered company.
Technology Comparison:
The Unimed sensors employ the same technological characteristics as the predicate devices to determine arterial oxygen saturation: Arterially perfused tissue is illuminated sequentially by two different wavelengths of LEDs, and the time varying absorbance of tissue is measured by a photo detector.
The method is characteristic of all sensors that are subject of this submission as well as the predicate devices.
Performance date & Conclusions:
Performance testing was conducted during clinical hypoxia studies conducted in an independent lab and was shown to validate performance claims and accuracy. Bench testing was performed to verify pulse rate accuracy. Biocompatibility was confirmed for all patient contact materials per ISO 10993.
Electrical safety and electromagnetic testing was also performed per IEC 60601-1
All testing was performed in accordance with ISO 9919 and supported the conclusion that the devices were safe and effective for their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Unimed Medical Supplies Incorporated C/O Mr. Don Melnikoff Biomedical Engineering Consultant Don Melnikoff W322S8863 McCarthy Drive Mukwonago, Wisconsin 53149
DEC 0 2 2008
Re: K082546
Trade/Device Name: Unimed Oximetry Finger Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 25, 2008 Received: September 3, 2008
Dear Mr. Melnikoff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Melnikoff
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Ches
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): N/A
Unimed oximetry finger sensors Device Name:
Indications For Use:
The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of OSTR/A
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082566 510(k) Page 12 of 276
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