Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

K151287 · Guangdong Biolight Meditech Co., Ltd. · DQA · Jan 6, 2016 · Cardiovascular

Device Facts

• Record ID: K151287
• Device Name: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

Device Story

Fingertip pulse oximeter (models M70, M70A, M70B, M70C, M70D) measures functional arterial oxygen saturation (SpO2) and pulse rate. Device uses red (660 nm) and infrared (905 nm) LED emitters and a detector to perform non-invasive optical sensing at the fingertip. Operates via spot-checking; displays SpO2, pulse rate, and pulse amplitude waveform on an OLED screen. Used in hospitals, clinical facilities, and home environments by patients or healthcare providers. Provides immediate physiological data to assist in clinical assessment of oxygenation status. Benefits include portable, non-invasive, and rapid assessment of patient oxygen levels.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-61 verified through non-clinical testing.

Technological Characteristics

Fingertip form factor; optical sensing via red (660 nm) and infrared (905 nm) LEDs. Materials include medical-grade silica gel patch. Components: detector, emitter LED, OLED display, CPU, power supply. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (pulse oximeter performance).

Indications for Use

Indicated for adult, child, and adolescent patients requiring spot-check measurement of functional arterial oxygen saturation (SpO2) and pulse rate in hospital, hospital-type facilities, or home care environments. Not for continuous long-term monitoring.

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

• Fingertip Pulse Oximeter M70 (K081712)
• Fingertip Pulse Oximeter MD300CL37 (K141128)

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

January 6, 2016

Guangdong Biolight Meditech Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, China 200120

Re: K151287

Trade/Device Name: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 2, 2015 Received: December 7, 2015

Dear Ms. Hong:

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.

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

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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 I. Keith, M.S. 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) K151287

Device Name

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

Indications for Use (Describe)

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

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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# Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K151287

- 1. Date of Preparation: 01/06/2016
- 2. Sponsor Identification

### Guangdong Biolight Meditech Co., Ltd

Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Jin Liang Position: R&D Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

## Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Fingertip Pulse Oximeters Common Name: Pulse Oximeter Models: M70, M70A, M70B, M70C, M70D

### Regulatory Information

Classification Name: Oximeter Classification: 2 Product Code: DQA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

### Intended Use Statement:

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital type facilities, as well as in the home care environment.

The oximeter is not suitable to monitor patient continuously for long term.

Device Description

The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are fingertip devices, which can display %SpO3, pulse rate value, waveform pulse amplitude bar indication.

The five models share the same configuration, intended use, safety and performance, the only difference is extrinsic feature.

The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are modified versions of the predicate device, M70, cleared under K081712. The oximetry technology including the sensor was unchanged.

Because the predicate device cleared under K081712 is only indicated for adult use and the subject device models are indicated for both adult and pediatric use, an additional predicate device was cited (cleared under K141128). Please refer to the substantial equivalence table below for a comparison between the technological characteristics of the subject device models and the device cleared under K141128.

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- న. Identification of Predicate Devices
Predicate Device 1

510(k) Number: K081712 Product Name: Fingertip Pulse Oximeter Model Name: M70

Predicate Device 2

510(k) Number: K141128 Product Name: Fingertip Pulse Oximeter Mode Name: MD300CL37

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- > IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
- > ISO 80601-2-6: 2011, Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment.
- Clinical Test Conclusion 7.

Because the differences between the subject device models and predicate device cleared under K081712, no additional clinical performance testing was needed.

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### Substantially Equivalent (SE) Comparison 8.

| | | Table 1 Comparison of Technology Characteristics | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Devices | Predicate Device 1<br>(K081712) | Predicate Device 2<br>(K141128) |
| Product Code | DQA | DQA | DQA |
| Regulation Number | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 |
| Class | Class II | Class II | Class II |
| Intended Use | The Fingertip Pulse<br>Oximeter is intended to<br>measure functional arterial<br>oxygen saturation (SpO2)<br>and pulse rate of adult, child<br>and adolescent patients in<br>hospital, hospital type<br>facilities, as well as in the<br>home care environment.<br>The oximeter is not suitable<br>to monitor patient | The M70 fingertip pulse<br>oximeter is intended to<br>measure functional<br>arterial oxygen saturation<br>(SpO2) and pulse rate of<br>adult patients in hospital,<br>hospital type facilities, as<br>well as in the home care<br>environment.<br>The oximeter is not<br>suitable to monitor patient<br>continuously for long | The Fingertip Pulse<br>Oximeter MD300CL37 is<br>a portable, non-invasive<br>device intended for spot<br>checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate of adult,<br>adolescent, child and<br>infant patients in hospital,<br>hospital type facilities,<br>and home environment. |
| | continuously for long term. | term. | |
| Configuration | Detector and emitter LED,<br>OLED display module,<br>CPU and power supply<br>module. | Detector and emitter<br>LED, OLED display<br>module, CPU and power<br>supply module. | Detector and emitter<br>LED, OLED display<br>module, CPU and power<br>supply module. |
| Working Mode | Spot Checking | Spot Checking | Spot Checking |
| Theory of Operation | Fingertip | Fingertip | Fingertip |
| Wavelengths | RED: 660 nm<br>Infrared: 905 nm | RED: 660 nm<br>Infrared: 905 nm | RED: 660 nm<br>Infrared: 940 nm |
| SpO2 Measuring<br>Range | 0%-100% | 0%-100% | 0~99% |
| SpO2 Accuracy | 70~100%, ±2% | 70~100%, ±2% | 70%~99%: ±3%; |
| PR Measuring Range | 25~250 bpm | 25~250 bpm | 30~235 bpm |
| PR Accuracy | ±1% or ± 1 bpm, whichever<br>is greater | ±1% or ± 1 bpm,<br>whichever is greater | 30~99bpm, ±2bpm;<br>100~235bpm, ±2% |
| Single Use/Reuse | Reuse | Reuse | Reuse |
| Electrical Safety | Complied with IEC<br>60601-1 | Complied with IEC<br>60601-1 | Complied with IEC<br>60601-1 |
| EMC | Complied with IEC<br>60601-1-2 | Complied with IEC<br>60601-1-2 | Complied with IEC<br>60601-1-2 |
| Performance | Complied with<br>ISO80601-2-61 | Complied with<br>ISO80601-2-61 | Complied with<br>ISO80601-2-61 |
| Patient Contact | Silica Gel Patch: Medical | Silica Gel Patch: Medical | Silica Gel Patch: Medical |

Table 1 Comparison of Technology Characteristics

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| Material | Silicon | Silicon | Silicon |
|----------|---------|---------|---------|
|----------|---------|---------|---------|

#### 9. Substantially Equivalent (SE) Conclusion

As per the technological characteristics of the subject device models are the same or similar to those of the predicate device cleared under K141128. Of note is that the pulse rate and SpO2 specifications are more accurate for the subject device models than those for the device cleared under K141128.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.