Unimed Disposable and Reusable SPO2 Sensors

K142832 · Unimed Medical Supplies, Inc. · DQA · Feb 6, 2015 · Cardiovascular

Device Facts

• Record ID: K142832
• Device Name: Unimed Disposable and Reusable SPO2 Sensors
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.

Device Story

Sensors consist of two-wavelength LEDs (red, infrared) and a photodetector; designed for compatibility with specific OEM pulse oximeter monitors (Nellcor, Nonin, BCI, Ohmeda). Device functions by illuminating arterial tissue and measuring light transmission, which varies with arterial blood saturation and pulse rate. Output is processed by the host monitor to provide SpO2 and pulse rate readings. Used in clinical settings for continuous monitoring; operated by healthcare professionals. Benefits include non-invasive, real-time assessment of patient oxygenation status, aiding clinical decision-making regarding respiratory support or intervention.

Clinical Evidence

Clinical hypoxia testing performed on human adult volunteers. Accuracy validated by comparing SpO2 readings against arterial oxygen saturation (SaO2) measured via co-oximetry. Results support accuracy claims across the specified saturation range.

Technological Characteristics

Materials include silicone rubber, sponge, velcro, and medical tape laminate. Sensing principle: dual-wavelength (red/IR) LED transmission and photodiode detection. Connectivity: wired, OEM-compatible connector. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (pulse oximeter performance), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/hypersensitivity).

Indications for Use

Indicated for continuous non-invasive monitoring of SpO2 and pulse rate in adult patients (>40kg), pediatric patients (10-50kg), and neonatal patients (≥3kg).

Regulatory Classification

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.

Predicate Devices

• Solaris Medical Technology, Inc. Reusable & Disposable SPO2 Sensors (K100077)
• Masimo LNOP/M-LNCS/LNCS (K111888)
• Unimed compatible oximeter sensors (K082546)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 | [phone] |
| Fax | [phone] |
| Establishment<br>Registration No. | 3007307487 |

#### 3. Contact Person

| Contact person | Tan xinmei |
|----------------|------------------------------------------------------|
| Title | QA&RA manager |
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |

## 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.<br>Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. |
| K111888 | Masimo LNOP/M-LNCS/LNCS | Masimo Corporation |

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#### Unimed Medical Supplies Inc

No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

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<br>monitor model | SPO2 sensor model | Compatible<br>monitor model | SPO2 sensor<br>model |
|-----------------------------|--------------------------------------------------------------------------|-----------------------------|----------------------|
| Nellcor<br>NBP-40 | U403S-01, U403-01 ,<br>U103-01, U103S-01,<br>U543-01, U503-01<br>N543-01 | Masimo Radical<br>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.