The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

Device Description

The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.

The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.

Principle of the fingertip pulse oximeter as follows:

A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones.

Operation principle of the instrument:

Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Fingertip Pulse Oximeter relate to its accuracy in measuring SpO2 and Pulse Rate.

Acceptance Criterion	Reported Device Performance
SpO2 Accuracy	±2%: (70%~100%)
Pulse Rate	±2 bpm

Note: For SpO2, no definition is provided for the 0%~69% range, implying the device is not specified to be accurate in this range.

The device's performance is stated to meet the criteria specified in ISO 80601-2-61.

Study Details

The assessment of the device's accuracy was conducted through a clinical study described as a "Clinical hypoxia accuracy testing (controlled desaturation study)."

Sample Size used for the test set and Data Provenance:
- Sample Size: 12 subjects were enrolled.
- Total Data Sets Collected: 294
- Valid Data Sets: 288 (6 data sets less than 70% SpO2 were excluded).
- Data Provenance: The study was conducted during "induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory." This indicates a prospective study design. The country of origin is not explicitly stated, but the manufacturer and consultant are based in China.
Number of experts used to establish the ground truth for the test set and their qualifications:
The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by a "CO-oximeter (control device)" from arterial blood samples. This implies that medical professionals (e.g., lab technicians, clinicians) would have been involved in collecting and analyzing these samples, but their specific roles or qualifications are not detailed.
Adjudication method for the test set:
The text does not mention an adjudication method (like 2+1, 3+1). The "ground truth" was directly compared from the CO-oximeter.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a ground truth, not on how human readers' performance improved with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The "measured arterial hemoglobin saturation value (SpO2) of the subject device" was directly compared to the arterial blood samples, indicating an assessment of the device's accuracy on its own.
The type of ground truth used:
The ground truth was established using arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). This is considered a highly accurate and direct measurement suitable for establishing ground truth for oxygen saturation.
The sample size for the training set:
The document does not provide information about a specific training set or its size. This submission is for the device's performance evaluation, implying the device (or its underlying algorithms) would have been developed and "trained" prior to this evaluation.
How the ground truth for the training set was established:
As no information about a training set is provided, how its ground truth was established is also not available in this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 19, 2017

Shenzhen Fitfaith Technology Co.,ltd % Migo. Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1122#, Internation Mayor Communication Center, Baishizhong Rd 55#, Nanshan District, Shenzhen, 518000 CN

Re: K163135

Trade/Device Name: Fingertip Pulse Oximeter (Model: A300, A310, M110, M120, M130, M150, M160, M170, M230) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 15, 2017 Received: August 7, 2017

Dear Migo. Yang:

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

{1}------------------------------------------------

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.

Tara A. Ryan -S

for Tina Kiang, Ph.D. Acting 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) K163135

Device Name

Fingertip Pulse Oximeter (Model: A300, A310, M100, M110,M120,M130,M150,M170,M230)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.

1 Administrative Information

Submission Date	Aug 18,2016
Manufacturerinformation	Submitter's Name: Shenzhen Fitfaith Technology Co.,Ltd.Address: Area B, Floor 9, Building D1, Tangwei Industrial ParkDonglong Road, Guangming New District, ShenZhen,Guangdong, China.Contact person: Yuan.JunfengTEL: +86-0755-29544253-803FAX: +86-0755-29544253-801E-Mail: 160666@qq.com
SubmissionCorrespondent	Contact person: Miss Migo. YangE-Mail: migo@cefda.comShenzhen Joyantech Consulting Co., Ltd.1122#, International Mayor Communication Center,Baishizhong Road 55#, Nanshan District, Shenzhen,Guangdong, China.
Image: Logo	Contact person: Mr. Field.FuE-Mail: cefda13485@163.comShenzhen Joyantech Consulting Co., Ltd.1122#, International Mayor Communication Center,Baishizhong Road 55#, Nanshan District, Shenzhen,Guangdong, China
Establishmentregistration number	NA

2 Device Information

Type of 510(k)submission:	Traditional
Trade Name:	Fingertip Pulse Oximeter (Model: A300, A310, M100,M110,M120,M130,M150,M160,M170,M230)
Classificationname:	Oximeter
Review Panel:	Anesthesiology
Product Code:	DQA
Device Class:	II
Regulation	870.2700
Number:	K163135

{4}------------------------------------------------

3 Predicate Device Information

Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: JPD-500A Fingertip Pulse Oximeter Device: K140582 510(K) Number:

4 Device Description

The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.

Principle of the fingertip pulse oximeter as follows:

A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones.

Operation principle of the instrument:

5 Intended Use

The subject device is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.

6 Indications for Use

{5}------------------------------------------------

7 Contraindications

High-frequency electrosurgical
Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line
The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
The patient is in cardiac arrest or is in shock.
Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

{6}------------------------------------------------

8 SE Comparison

Characteristics	Subject device	Predicate device(K140582)	Remark
Device name	Fingertip Pulse OximeterA300,A310,M100,M110,M120,M130,M150,M160,M170,M230	Fingertip Pulse Oximeter	/
Model	Note:A300 and M110 are totallyidentical model except formodel name based oncustomer's requirement;A310 and M100 are totallyidentical model except formodel name based oncustomer's requirement;	JPD-500A	/
Manufacturer	Shenzhen FitfaithTechnology Co.,Ltd.	Shenzhen JumperMedical EquipmentCo.,Ltd	/
Intended patientpopulation	Adult & Pediatric	Adult & Pediatric	same
Intended applicationsite	Fingertip		same
IntendedEnvironments	home & hospital		same
Prescription & OTC	Prescription		same
Intended use	The subject device is intended for measuring thefunctional oxygen saturation and pulse rate throughpatient's finger. It is applicable for spot-checking SpO2and pulse rate of adult and pediatric patients in homesand clinics.		same
Indications for Use	The Fingertip PulseOximeter is non-invasivedevice intended for spot-checking of functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate(PR). The portablefingertip device isindicated for adult andpediatric patients in homeand hospital environments(including clinical use ininternist/ surgery,anesthesia, intensivecare, etc).	The JPD-500A FingertipPulse Oximeter is non-invasive device intendedfor spot-checking offunctional oxygensaturation of arterialhemoglobin (Spo2) andpulse rate. The portablefingertip device isindicated for adult andpediatric patients in homeand hospitalenvironments (includingclinical use in internist/surgery, anesthesia,intensive care, etc).	Similar(Note01)
Characteristics		Subject device	Predicate device(K140582)	Remark
Working Principle		A mathematical formula is established making use ofLambert Beer Law according to Spectrum AbsorptionCharacteristics of Reductive hemoglobin (RHb) andOxyhemoglobin (HbO2) in red and near-infraredzones. Operation principle of the instrument:Photoelectric Oxyhemoglobin Inspection Technology isadopted in accordance with Capacity PulseScanning and Recording Technology, so that twobeams of different wavelength of lights can be focusedonto a human nail tip through a clamping finger-typesensor. A measured signal obtained by aphotosensitive element, will be shown on theOximeter's display through process in electroniccircuits and microprocessor.		same
LightSpecificationon	wavelength	660nm±3nm for red light,905nm±5nm for infrared light (IR)		same
	maximumopticalpower	1.5 mW for red light (660nm)1.2 mW for IR (905nm)		same
Contact Material		ABS for enclosure, silica gel for clip		same
Internal Power supply		2*AAA 1.5v alkaline battery		same
Working Current		Less than 40mA(Normal)	35mA	Similar(Note02)
Resolution	SpO2	1%		same
	Pulserate	1 bpm		same
MeasurementRange	SpO2	0%~100%		same
	Pulserate	25~250 bpm		same
MeasurementAccuracy	SpO2	±2%: (70%~100%)Unspecified : (0%~69%)	±2%: (70%~100%)no definition(0%~69%)	same
	Pulserate	±2 bpm	±2 bpm	same

OperatingEnvironment	Temperature	5°C~40°C		Similar (Note03)
	Humidity	15%~85% non-condensing	15%~80% non-condensing
Storage &TransportEnvironment	Temperature	-20°C~+55°C	-10°C~+50°C	Similar(Note04)
	Humidity	10%~95%	10%~93%

Table 1. Substantial Equivalence Comparison

{7}------------------------------------------------

Note01:

The trade name is different, but SE determination does not depend on trade name.

Note02:

The working currents of subject device and predicate device are similar. The subject device met the requirements of IEC 60601-1.

{8}------------------------------------------------

Note03:

The humidity under operating environment of subject device and predicate device are similar. The subject device met the requirements of ISO 80601-2-61. Note04:

The Storage & Transport environment of subject device and predicate device are similar. The subject device met the requirements of ISO 80601-2-61.

The subject device is the same as the predicate device in intended use, intended patient population, intended application site, working principle, contact material, internal power supply, display range, resolution. Only their appearance, indication for use (Note01), working current (Note02), operation environment (Note03), storage transport environment (Note04), are a little bit different. However, the minor differences do not raise different questions of safety and effectiveness.

9 Brief discussions of tests

9.1 Brief discussions of the nonclinical tests

The subject device conforms to the following standards:

ゃ IEC 60601-1:2005+A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ゃ Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests;
や IEC 60601-1-11: Requirements for Medical Electrical (ME) Equipment and ME Systems used in the Home Healthcare Environment;
ゃ ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for In Vitro cytotoxicity;
� ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
ゃ ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment;
ゃ Cleaning and low level disinfection validation.

9.2 Brief discussions of clinical tests

Clinical testing according to ISO 14155:2011 and ISO 80601-2-61: 2011 has also been performed on the device.

Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial

{9}------------------------------------------------

hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%. Data was calculated and analyzed using the mean bias (B), root-mean-square (Ams), PRECISION (standard deviation of the residuals (Sres) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the ISO 80601-2-61;

Besides, the Agreement between methods of measurement with multiple observations for both all subjects pooled and individual test subjects were analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. The outliers only occurred occasionally and after being analyzed, it was determined that the outliers do not raise performance concerns regarding the accuracy and precision of the device.

During the clinical study, 12 subjects were enrolled, who are healthy, nonsmoking, competent adults, between twenty-one and thirty-two (21-32) years of age, and they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. No case was lost in this trial. The trial completed 12 cases, on which 294 data sets were collected, of which 288 were valid. 6 data sets which less than 70% were excluded. The result met the criteria specified in the ISO 80601-2-61; In addition, there were no reported adverse effects during these investigations.

10 Other information (such as required by FDA guidance)

No other information.

11 Conclusions

Based on the clinical and non-clinical testing performed, the results demonstrate that the subject device fingertip pulse oximeter is substantially equivalent to the predicate device JPD-500A Fingertip Pulse Oximeter manufactured by Shenzhen Jumper Medical Equipment Co., Ltd.

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).