(129 days)
Not Found
No
The device description and performance studies focus on the optical sensing technology and clinical validation against co-oximetry, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is indicated for monitoring physiological parameters (SpO2 and pulse rate), not for treating or preventing a disease or condition.
Yes
The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)". Monitoring various bodily functions, especially to assess physiological states or detect abnormalities, is a key characteristic of diagnostic devices. While it doesn't diagnose a specific disease, it provides critical physiological parameters that aid in clinical diagnosis and patient management.
No
The device description explicitly details hardware components (LEDs, photo detector, sensor housing, cable, connector) and their function in measuring SpO2. It is a physical sensor, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Unimed Disposable and Reusable SpO2 Sensors are used for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate) directly on the patient's body. They use optical means to measure light absorption through tissue.
- No Specimen Examination: The device does not involve the examination of specimens (like blood or tissue samples) in vitro (outside the body).
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
Product codes
DQA
Device Description
The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor.
The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. 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.
Four types of sensor housings are described in this submission:
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda),please refer to the following table:
| Compatible monitor model | SPO2 sensor model | Compatible monitor model | SPO2 sensor model |
|---|---|---|---|
| Nellcor NBP-40 | U403S-01, U403-01 , U103-01, U103S-01, U543-01, U503-01 N543-01 | Masimo Radical RDS-1 | U403-125 |
| Ohmeda 3800 | U410-03 | BCI 3301 | U403-06 |
| Nonin 8500 | U403-08 | Ohmeda 3800 | U403-07 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients weighing greater than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Unimed Disposable and Reusable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
Unimed Medical Supplies, Inc. Xinmei Tan QA and RA Manager No. 37, Yanshan Road, Shekou Shenzhen, 518067 CHINA
Re: K142832
Trade/Device Name: Unimed Disposable and Reusable SpO2 Sensors Models: U103-01, U103S-01, U403-01, U403-06, U403-07, U403-08, U403-125, U403S-01, U410-03, U503-01, U543-01, N543-01 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 29, 2014 Received: January 6, 2015
Dear Ms. Tan,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Ms. Xinmei Tan
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142832
Device Name
Unimed Disposable And Reusable Spo2 Sensors
Indications for Use (Describe)
Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Unimed Medical Supplies. The word "unimed" is written in gray, sans-serif font, with the words "medical supplies" written in a smaller font below. To the right of the word "unimed" is a red oval with a white design inside.
Section 5 510(K) Summary
1. Prepared Date: 2014-12-25
2. Submitter Information
| Name | Unimed Medical Supplies Inc |
|---|---|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | +86-755 26695165 |
| Fax | +86-755 26697984 |
| Establishment | |
| Registration No. | 3007307487 |
3. Contact Person
| Contact person | Tan xinmei |
|---|---|
| Title | QA&RA manager |
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | +86-755 26695165 |
| Fax | +86-755 26697984 |
| tanxinmei@unimed.cn |
4. Manufacturer Information
| Name | Unimed Medical Supplies Inc |
|---|---|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Establishment | 3007307487 |
| Registration No. | 3007307487 |
5. Proposed Device Information
| Trade Name | Unimed Disposable and Reusable SPO2 Sensors |
|---|---|
| Common name | Oximeter |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |
6. Predicate Device Information
| 510(K)No. | Trade Name/model | Submitter |
|---|---|---|
| K100077 | Solaris Medical Technology, Inc. | |
| Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. | |
| K111888 | Masimo LNOP/M-LNCS/LNCS | Masimo Corporation |
4
Unimed Medical Supplies Inc
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/4/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The word "unimed" is written in gray, with the words "medical supplies" written in a smaller font below it. To the right of the word "unimed" is a red circle with a white design inside.
| Multisite-L Oximetry Sensors | ||
|---|---|---|
| K082546 | Unimed compatible oximeter sensors | Unimed Medical supplies Inc |
7. Device description
The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor.
The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. 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.
Four types of sensor housings are described in this submission:
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda),please refer to the following table:
| Compatible
monitor model | SPO2 sensor model | Compatible
monitor model | SPO2 sensor
model |
|-----------------------------|--------------------------------------------------------------------------|-----------------------------|----------------------|
| Nellcor
NBP-40 | U403S-01, U403-01 ,
U103-01, U103S-01,
U543-01, U503-01
N543-01 | Masimo Radical
RDS-1 | U403-125 |
| Ohmeda 3800 | U410-03 | BCI 3301 | U403-06 |
| Nonin 8500 | U403-08 | Ohmeda 3800 | U403-07 |
8. Intended use
Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
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Image /page/5/Picture/1 description: The image shows the logo for Unimed Medical Supplies. The word "Unimed" is written in gray, block letters. Below it, the words "medical supplies" are written in a smaller font. To the right of the words is a red oval with a white, stylized "UM" inside.
9. Comparison to predicate device
The Unimed Disposable and Reusable SpO2 Sensors utilize the same measurement principles as the listed predicate devices: two wavelengths of light (red, infrared) from light emitting diodes (LED's) illuminate the patients arterial tissue; and the light transmission through the tissue is measured using a photodiode light detector. The transmission properties vary with the patient's arterial blood saturation and pulse rate.
This method is fundamental to all pulse oximeter sensors and monitors for the non-invasive measurement of functional oxygen saturation (SpO2).
10. Non-clinical test data
The subject device meets the following the recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for ● Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro ● cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
11. Clinical test data
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Unimed Disposable and Reusable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
12. Substantial Equivalence Statement
Based on the comparison ,analysis, and the submitted performance data, Unimed believes that the Unimed Disposable and Reusable SPO2 Sensors are as safe and effective and are substantially equivalent to the predicate devices.