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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D by Guangdong Biolight Meditech Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

While the document outlines performance specifications and compliance with standards, it does not contain a detailed study report that proves the device meets specific acceptance criteria in the format typically required for an AI/ML medical device submission. This document focuses on the substantial equivalence argument based on performance specifications and compliance with general medical device standards, rather than a dedicated clinical study with a defined test set, ground truth experts, or MRMC analysis often seen for novel AI/ML device evaluations.

However, I can extract the relevant information from the document to construct an answer based on the provided text, interpreting "acceptance criteria" as the claimed performance specifications and "study" as the non-clinical tests and substantial equivalence comparison.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

The device, Fingertip Pulse Oximeter, is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate. The "acceptance criteria" can be inferred from the device's claimed performance specifications that are stated to be compliant with ISO 80601-2-61.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from Proposed Device Specifications)	Reported Device Performance (from Proposed Device Specifications)
SpO2 Measuring Range	0%-100%	0%-100%
SpO2 Accuracy	70~100%, ±2%	70~100%, ±2%
PR Measuring Range	25~250 bpm	25~250 bpm
PR Accuracy	±1% or ± 1 bpm, whichever is greater	±1% or ± 1 bpm, whichever is greater

Note: The document states that the subject device models have more accurate pulse rate and SpO2 specifications than the predicate device K141128. This implies the listed specifications are the target "acceptance criteria" for the new devices.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "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: ... ISO 80601-2-6: 2011, Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment."

Sample Size for Test Set: The exact sample size for the non-clinical tests is not specified in the provided text. The document refers to compliance with ISO 80601-2-61, which would dictate the methodology and sample sizes for testing SpO2 accuracy (e.g., typically requires human subject studies with induced hypoxia). However, the specific study details are not presented.
Data Provenance: The document does not specify the country of origin of data or whether the tests were retrospective or prospective. It only mentions "Non clinical tests were conducted." Given the nature of a 510(k) for a pulse oximeter, human subject testing would typically be prospective to determine SaO2 accuracy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For pulse oximeters, the 'ground truth' for oxygen saturation (SaO2) is typically established by co-oximetry of arterial blood samples, performed by trained medical personnel. It is not typically established by 'experts' in the sense of radiologists or other clinicians interpreting outputs for AI/ML devices.

4. Adjudication Method for the Test Set

This information is not provided in the document. It's not applicable in the context of typical pulse oximetry accuracy testing, where the reference method itself (co-oximetry) serves as the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study performed or reported. This type of study is typically relevant for AI/ML devices that aim to assist human readers in diagnostic tasks, demonstrating how AI impacts human performance. A pulse oximeter is a standalone measurement device.

6. Standalone (Algorithm Only) Performance

The document describes the performance of the device itself (algorithm + hardware), which is inherently "standalone" in mechanical terms, as it provides direct SpO2 and pulse rate readings. However, it's not an "algorithm-only" performance as typically evaluated for AI/ML, but rather the performance of the integrated medical device. The "non-clinical tests" and compliance with ISO 80601-2-61 essentially represent the standalone performance evaluation.

7. Type of Ground Truth Used

For pulse oximeter accuracy, the ground truth for arterial oxygen saturation (SaO2) is typically established by co-oximetry of arterial blood samples. This is implied by compliance with ISO 80601-2-61, which sets out requirements for determining SpO2 accuracy through human subject testing with induced hypoxia and comparison against arterial blood gas analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for oximeters.

8. Sample Size for the Training Set

The document is for a traditional pulse oximeter and does not describe an AI/ML algorithm or a "training set." Therefore, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI/ML algorithm or a "training set," this information is not applicable and not provided.

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 (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 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)

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
1. 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: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn

1. 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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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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

1. 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 PulseOximeter is intended tomeasure functional arterialoxygen saturation (SpO2)and pulse rate of adult, childand adolescent patients inhospital, hospital typefacilities, as well as in thehome care environment.The oximeter is not suitableto monitor patient	The M70 fingertip pulseoximeter is intended tomeasure functionalarterial oxygen saturation(SpO2) and pulse rate ofadult patients in hospital,hospital type facilities, aswell as in the home careenvironment.The oximeter is notsuitable to monitor patientcontinuously for long	The Fingertip PulseOximeter MD300CL37 isa portable, non-invasivedevice intended for spotchecking of oxygensaturation of arterialhemoglobin (SpO2) andpulse rate of adult,adolescent, child andinfant 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 supplymodule.	Detector and emitterLED, OLED displaymodule, CPU and powersupply module.	Detector and emitterLED, OLED displaymodule, CPU and powersupply module.
Working Mode	Spot Checking	Spot Checking	Spot Checking
Theory of Operation	Fingertip	Fingertip	Fingertip
Wavelengths	RED: 660 nmInfrared: 905 nm	RED: 660 nmInfrared: 905 nm	RED: 660 nmInfrared: 940 nm
SpO2 MeasuringRange	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, whicheveris greater	±1% or ± 1 bpm,whichever is greater	30~~99bpm, ±2bpm;100~~235bpm, ±2%
Single Use/Reuse	Reuse	Reuse	Reuse
Electrical Safety	Complied with IEC60601-1	Complied with IEC60601-1	Complied with IEC60601-1
EMC	Complied with IEC60601-1-2	Complied with IEC60601-1-2	Complied with IEC60601-1-2
Performance	Complied withISO80601-2-61	Complied withISO80601-2-61	Complied withISO80601-2-61
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.

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).