The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.

Device Description

The HS10A is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and functional arterial oxygen saturation in arterial blood. The HS10A include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings. The device also has menu features to allow the user to set the time, date and measurement alarm limits.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from ISO 80601-2-61, implied)	Reported Device Performance (HS10A)
SpO2 Accuracy (no motion, 70-100%)	≤ 2% Arms	1.391% Arms
Pulse Rate Accuracy (no motion)	± 3 bpm (implied from predicate)	Not explicitly stated for HS10A but similar to predicate
General Safety	Conformance to IEC60601-1	Conformed
EMC	Conformance to IEC60601-1-2	Conformed
Biocompatibility	Conformance to ISO 10993-1, -5, -10	Conformed

Note: The document directly states the SpO2 accuracy criterion and result. For other specifications like pulse rate, the acceptance criteria are not explicitly detailed for the subject device but are implicitly met through overall equivalence claims and conformance to standards. The predicate also has a SpO2 accuracy of "$70-100% no less than ±2%(No motion)$," which serves as the basis for the acceptance criteria for the new device.

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

Sample Size for Test Set: 12 healthy adult male and female volunteers.
Number of Blood Samples: 300 blood samples.
Data Provenance: The study was conducted on "healthy adult male and female volunteers with light to dark skin pigmentations." The country of origin is not explicitly stated, but the company is based in China. The study appears to be prospective as it's described as "clinical testing" specifically for this device.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for SpO2 was established using a laboratory CO-Oximeter.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by instrumental measurement (CO-Oximeter), not human adjudication.

5. 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 laboratory reference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The "clinical testing" described measures the intrinsic accuracy of the pulse oximeter (HS10A) itself against a reference standard.

7. The Type of Ground Truth Used

The ground truth used for the SpO2 accuracy evaluation was an instrumental reference standard, specifically a laboratory CO-Oximeter. This is compared to "outcomes data" in the sense that the CO-Oximeter provides definitive physiological measurements.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This suggests that the device's underlying algorithms or calibration were developed prior to this validation study, and details about their training are not part of this 510(k) summary. Pulse oximeters typically rely on established physiological models and calibration rather than machine learning training sets in the way AI algorithms do.

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

Not applicable, as no training set information is provided.

Summary

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March 27, 2018

Image /page/0/Picture/1 description: The image shows the contact information for Hunan Accurate Bio-Medical Technology Co., Ltd. The contact person is Zhou Le, who is the RA Manager. The address is M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development, Changsha, 410208 CN.

Re: K171241

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 2, 2018 Received: February 23, 2018

Dear Zhou Le:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171241

Device Name

Pulse Oximeter

Indications for Use (Describe)

The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.

Type of Use (Select one or both, as applicable)

X 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.

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"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."

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Image /page/3/Picture/1 description: The image shows the logo for Accurate. The logo consists of an orange symbol on the left and the word "accurate" in orange on the right. The symbol on the left is made up of three overlapping triangles, with each triangle having a slightly different shade of orange. The word "accurate" is written in a sans-serif font.

Section 5 510(K) Summary

Prepared Date: 2018/1/31

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

There is no prior submission for the device.

Submitter Information

Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China, Phone number: +86- 731-89745029 Fax number: +86- 731-89745029 Contact person: Zhou Le E-mail: regulation@accbiomed.com

Name of device

Trade name: Pulse Oximeter Models: HS10A Classification name: Oximeter Production requlation: 21CFR 870.2700 Product code: DQA Classification Panel: Cardiovascular Device Classification: Class2

Predicate Device

OxiMaX™ NPB-40 Pulse Oxirneter (K051352, Nelicor Pui-itan Bennett)

Description

l ntended use

The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.

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Image /page/4/Picture/1 description: The image features the word "accurate" in a bold, sans-serif font, rendered in a vibrant orange color. To the left of the word, there is a stylized logo consisting of three overlapping triangles, also in varying shades of orange, creating a sense of depth and dimension. The logo and the word "accurate" are positioned horizontally, forming a cohesive brand representation.

Substantially Equivalent

A comparison of key similarities and differences between the subject device (Model HS10A) and the predicate devices (K051352) is provided below.

Item	HS10ASubject device	OxiMaXTM NPB-40Predicate device	Comment
Intended use&indications foruse	The handheld pulse oximeter isindicated for continuous or spotcheck monitoring of functionalarterial oxygensaturation(SpO2) and pulse rate of adultpatients in hospitals and clinics.	The OxiMaxTM NPB-40 handheldpulse oximeter is indicated forcontinuous or spotcheck monitoring of functionalarterial oxygensaturation(SpO2) and pulse rate of adult,pediatric and neonatal patients inhospital, hospital type facilities,transport and mobileenvironments as well as in thehome care environment.	Similar
Prescriptive	Prescription Use	Prescription Use	Same
Measurementplace	Finger	Finger or toes	Similar
OperationPrinciple	The Pulse Oximeter works byapplying a sensor to a pulsatingarteriolar vascular bed. Thesensor contains a dual lightsource and photo detector.Skin,bone, tissue, and venousnormally absorb a constantamount of light during systoleand diastole, as blood volumeincreases and decreases. Theratio of light absorbed at systoleand diastole is translated into anoxygen saturation measurement.This measurement is referred toas SpO2.	The NPB-40 uses pulse oximetryto measure functional oxygensaturation in the blood. Pulseoximetry works by applying anOXIMAX sensor to a pulsatingarteriolar vascular bed, such as afinger or toe. The OXIMAX sensorcontains a dual light source and aphoto detector. Bone, tissue,pigmentation, and venousvessels normally absorb aconstant amount of light overtime. The arteriolar bed normallypulsates and absorbs variablemounts of light during thepulsations. The ratio of lightabsorbed is translated into ameasurement of functionaloxygen saturation (SpO2).	Same
Display	LCD	LCD	Same
Power supply	3*1.5 V, AA	4*1.5 V, AA	-----
Display range	SPO2:1-100% PR:25-300bpm	SPO2: 1-100%PR: 20-300bpm	Similar
Sp02measurementrange&accuracy	70-100% no less than ±2%(Nomotion)	70-100% no less than ±2%(Nomotion)70-100% no less than±3%(motion)70-100% no less than ±2%( LowPerfusion)	Similar
PRmeasurementrange&accuracy	25-250 bpm no less than ±3bpm (No motion)	20-250bpm no less than+3bpm(No motion)on55-125bpmlessthan±5bpm(motion)20-250bpm no less than ±3bpm(Low perfusion)	Similar
Perfusion range	No	0.03%-20%	Similar
DisplayResolution	SP02:1%,PR:1bpm	SP02:1%,PR:1bpm	Same
Alarm type	visual alarm and information	visual alarm and information	Same
Alarmlimitrange	SPO2 high limit:low limit +1 to100%SpO2 low limit:20% to (highlimit-1)PR high limit: (low limit + 1) to 250PR low limit: 30 to (high limit-1)	SPO2 high limit:low limit +1 to100%SpO2 low limit:20% to (highlimit-1)PR high limit: (low limit + 1) to 170PR low limit: 30 to (high limit-1)	Similar
Default limit	SPO2: High 100%,Low90%PR: High 90 bpm,Low 40bpm	SPO2: High 100%,Low85%PR: High 170bpm, Low 40bpm	Similar
Memory	No	Yes	Similar
Buzzer	Yes	Yes	Same
Auto power-off	Yes	Yes	Same
OperatingEnvironment	Temperature: 5℃~+40℃Humidity : 15% ~ 95% non-condensing	Temperature: 5℃~+40℃15% ~Humidity :95% non-condensing	Same
StorageEnvironment	Temperature: -20℃~+60℃;Humidity :15% ~ 95%non-condensing	Temperature: -20℃~+60℃;15% ~ 95%Humidity :non-condensing	Same
Weight	300g	280g	---
Size	56×124×30 mm	73X159X35mm	---
Conformancestandard	IEC60601-1IEC60601-1-2	IEC60601-1IEC60601-1-2	Same
ISO10993-5/-10	ISO10993-5/-10
ISO80601-2-61	ISO80601-2-61

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Image /page/5/Picture/1 description: The image shows the logo for Accurate. The logo consists of a stylized letter "A" made up of three overlapping triangles in shades of orange, followed by the word "accurate" in orange lowercase letters. The logo is simple and modern, with a focus on the company name.

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Image /page/6/Picture/1 description: The image shows the word "accurate" in orange font. To the left of the word is an orange logo that consists of three overlapping triangles. The triangles are arranged in a way that they appear to be stacked on top of each other. The logo and the word "accurate" are the only elements in the image.

From the comparison form above, the subject device and predicate device have similar intended use, are both prescription use, and have the same Operation Principle, Display screen, Conformance to standard. The subject device claims slightly different patient population & use environment, measurement site and technology parameter. But the subject device met the requirements of IEC60601-1, IEC60601-1-2, ISO80601-2-61and IFU, so these differences between subject device and predicate device do not raise different questions of safety or effectiveness issues since the intended use is a subset of the predicate's intended use.

Non-clinical Performance Data

The following practices were followed and monitored for development of the Digital blood pressure monitor:

. IEC 60601-1 Electrical Equipment-Part 1: General Requirements for Safety, 2005
IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General . Requirements for for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: . Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 10993-1, Biological evaluation of medical devices-Part 1: . Evaluation and testing, 2009
. 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

Clinical Performance Data

The pulse oximeter was subjected to clinical testing. The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult male and female volunteers (with a total of 300 blood samples) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The SpO2 accuracy results include:

. 1.391% which meets the accuracy requirement of less than or equal to 2% under no motion condition.
The accuracy specification is reported as accuracy root mean square (Arms).

Conclusion

The non-clinical and clinical testing provided in this 510(k) submission demonstrates that the subject device, the Pulse Oximeter, is as safe and as effective, and substantially equivalent to the predicate device.

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).