Pulse Oximeter

K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · DQA · Mar 27, 2018 · Cardiovascular

Device Facts

• Record ID: K171241
• Device Name: Pulse Oximeter
• Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for 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.

Device Story

The HS10A is a handheld, battery-powered pulse oximeter for monitoring SpO2 and pulse rate in adult patients. It utilizes a finger-applied sensor containing a dual light source and photo detector; the device measures light absorption ratios across the pulsating arteriolar vascular bed to calculate oxygen saturation. It features an LCD display, audible alarms, and user-adjustable settings for measurement limits, time, and date. Operated by clinicians in hospitals and clinics, the device provides real-time monitoring to assist in patient assessment. It includes an auto-power-off function and is designed for non-invasive monitoring.

Clinical Evidence

Clinical validation performed on 12 healthy adult volunteers (male and female) with varying skin pigmentations. A total of 300 blood samples were compared against a laboratory CO-Oximeter across the 70% to 100% SpO2 range. The device achieved an accuracy (Arms) of 1.391%, meeting the requirement of ≤2% under no-motion conditions, in accordance with ISO 80601-2-61.

Technological Characteristics

Handheld pulse oximeter; battery-powered (3x 1.5V AA); LCD display. Sensing principle: dual light source and photo detector for photoplethysmography. Conformance: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61. Biocompatibility: ISO 10993-1, -5, -10. Dimensions: 56x124x30 mm; Weight: 300g.

Indications for Use

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

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

• OxiMaX™ NPB-40 Pulse Oximeter (K051352)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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: [phone] Fax number: [phone] Contact person: Zhou Le E-mail: [e-mail]

#### 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

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.

## 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 | HS10A<br>Subject device | OxiMaXTM NPB-40<br>Predicate device | Comment |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended use<br>&indications for<br>use | The handheld pulse oximeter is<br>indicated for continuous or spot<br>check monitoring of functional<br>arterial oxygen<br>saturation<br>(SpO2) and pulse rate of adult<br>patients in hospitals and clinics. | The OxiMaxTM NPB-40 handheld<br>pulse oximeter is indicated for<br>continuous or spot<br>check monitoring of functional<br>arterial oxygen<br>saturation<br>(SpO2) and pulse rate of adult,<br>pediatric and neonatal patients in<br>hospital, hospital type facilities,<br>transport and mobile<br>environments as well as in the<br>home care environment. | Similar |
| Prescriptive | Prescription Use | Prescription Use | Same |
| Measurement<br>place | Finger | Finger or toes | Similar |
| Operation<br>Principle | The Pulse Oximeter works by<br>applying a sensor to a pulsating<br>arteriolar vascular bed. The<br>sensor contains a dual light<br>source and photo detector.<br>Skin,bone, tissue, and venous<br>normally absorb a constant<br>amount of light during systole<br>and diastole, as blood volume<br>increases and decreases. The<br>ratio of light absorbed at systole<br>and diastole is translated into an<br>oxygen saturation measurement.<br>This measurement is referred to<br>as SpO2. | The NPB-40 uses pulse oximetry<br>to measure functional oxygen<br>saturation in the blood. Pulse<br>oximetry works by applying an<br>OXIMAX sensor to a pulsating<br>arteriolar vascular bed, such as a<br>finger or toe. The OXIMAX sensor<br>contains a dual light source and a<br>photo detector. Bone, tissue,<br>pigmentation, and venous<br>vessels normally absorb a<br>constant amount of light over<br>time. The arteriolar bed normally<br>pulsates and absorbs variable<br>mounts of light during the<br>pulsations. The ratio of light<br>absorbed is translated into a<br>measurement of functional<br>oxygen 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%<br>PR: 20-300bpm | Similar |
| Sp02<br>measurement<br>range&<br>accuracy | 70-100% no less than ±2%(No<br>motion) | 70-100% no less than ±2%(No<br>motion)<br>70-100% no less than<br>±3%(motion)<br>70-100% no less than ±2%( Low<br>Perfusion) | Similar |
| PR<br>measurement<br>range&<br>accuracy | 25-250 bpm no less than ±3<br>bpm (No motion) | 20-250bpm no less than<br>+3<br>bpm(No motion)<br>on<br>55-125<br>bpm<br>less<br>than±5bpm(motion)<br>20-250bpm no less than ±3<br>bpm(Low perfusion) | Similar |
| Perfusion range | No | 0.03%-20% | Similar |
| Display<br>Resolution | SP02:1%,PR:1bpm | SP02:1%,PR:1bpm | Same |
| Alarm type | visual alarm and information | visual alarm and information | Same |
| Alarm<br>limit<br>range | SPO2 high limit:low limit +1 to<br>100%<br>SpO2 low limit:20% to (high<br>limit-1)<br>PR high limit: (low limit + 1) to 250<br>PR low limit: 30 to (high limit-1) | SPO2 high limit:low limit +1 to<br>100%<br>SpO2 low limit:20% to (high<br>limit-1)<br>PR high limit: (low limit + 1) to 170<br>PR low limit: 30 to (high limit-1) | Similar |
| Default limit | SPO2: High 100%,Low<br>90%<br>PR: High 90 bpm,Low 40bpm | SPO2: High 100%,Low<br>85%<br>PR: High 170bpm, Low 40bpm | Similar |
| Memory | No | Yes | Similar |
| Buzzer | Yes | Yes | Same |
| Auto power-off | Yes | Yes | Same |
| Operating<br>Environment | Temperature: 5℃~+40℃<br>Humidity : 15% ~ 95% non-<br>condensing | Temperature: 5℃~+40℃<br>15% ~<br>Humidity :<br>95% non-<br>condensing | Same |
| Storage<br>Environment | Temperature: -20℃~+60℃;<br>Humidity :<br>15% ~ 95%<br>non-<br>condensing | Temperature: -20℃~+60℃;<br>15% ~ 95%<br>Humidity :<br>non-<br>condensing | Same |
| Weight | 300g | 280g | --- |
| Size | 56×124×30 mm | 73X159X35mm | --- |
| Conformance<br>standard | IEC60601-1<br>IEC60601-1-2 | IEC60601-1<br>IEC60601-1-2 | 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.