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

• K Number: K151287
• Device Name: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
• Manufacturer: GUANGDONG BIOLIGHT MEDITECH CO., LTD.
• Date Cleared: 2016-01-06 ( 237 days)
• Product Code: DQA
• Regulation Number: 870.2700

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 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.

Predicate Devices

K081712, K141128

Reference Devices

K081712

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies.

Therapeutic

No.
The device's intended use is to measure physiological parameters (functional arterial oxygen saturation and pulse rate), not to treat or prevent a medical condition.

Diagnostic

Yes

The device is intended to measure physiological parameters (functional arterial oxygen saturation and pulse rate), which are used to assess a patient's health status, thus serving a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are "fingertip devices" and mentions "the oximetry technology including the sensor was unchanged," indicating the presence of hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
• Device Function: The Fingertip Pulse Oximeter measures functional arterial oxygen saturation (SpO2) and pulse rate by placing the device on the fingertip. This is a non-invasive measurement taken on the living body.
• Intended Use: The intended use clearly states it measures SpO2 and pulse rate of patients, not that it performs tests on samples taken from patients.

Therefore, based on the provided information, the Fingertip Pulse Oximeter is a medical device, but it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

DQA

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.

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, child and adolescent patients

Intended User / Care Setting

hospital, hospital type facilities, as well as in the home care environment.

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• SpO2 Measuring Range: 0%-100%
• SpO2 Accuracy: 70~100%, ±2%
• PR Measuring Range: 25~250 bpm
• PR Accuracy: ±1% or ± 1 bpm, whichever is greater

Predicate Device(s)

K081712, K141128

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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
(K081712)	Predicate Device 2
(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
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	The M70 fingertip pulse
oximeter is intended to
measure functional
arterial oxygen saturation
(SpO2) and pulse rate of
adult 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	The Fingertip Pulse
Oximeter MD300CL37 is
a portable, non-invasive
device intended for spot
checking of oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate of adult,
adolescent, child and
infant patients in hospital,
hospital type facilities,
and home environment.
	continuously for long term.	term.
Configuration	Detector and emitter LED,
OLED display module,
CPU and power supply
module.	Detector and emitter
LED, OLED display
module, CPU and power
supply module.	Detector and emitter
LED, OLED display
module, CPU and power
supply module.
Working Mode	Spot Checking	Spot Checking	Spot Checking
Theory of Operation	Fingertip	Fingertip	Fingertip
Wavelengths	RED: 660 nm
Infrared: 905 nm	RED: 660 nm
Infrared: 905 nm	RED: 660 nm
Infrared: 940 nm
SpO2 Measuring
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
is greater	±1% or ± 1 bpm,
whichever is greater	30~99bpm, ±2bpm;
100~235bpm, ±2%
Single Use/Reuse	Reuse	Reuse	Reuse
Electrical Safety	Complied with IEC
60601-1	Complied with IEC
60601-1	Complied with IEC
60601-1
EMC	Complied with IEC
60601-1-2	Complied with IEC
60601-1-2	Complied with IEC
60601-1-2
Performance	Complied with
ISO80601-2-61	Complied with
ISO80601-2-61	Complied with
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.