Pulse Oximeter

K201468 · Shenzhen Creative Industry Co., Ltd. · DQA · Jan 25, 2021 · Cardiovascular

Device Facts

• Record ID: K201468
• Device Name: Pulse Oximeter
• Applicant: Shenzhen Creative Industry Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.

Device Story

Wrist-worn pulse oximeter; measures SpO2 and pulse rate via transmittance optical sensor (red 660nm, infrared 905nm) applied to finger. Device displays results on 1.44" color TFT LCD; stores up to 500 hours of data. Data transfer to PC/smartphone via USB or Bluetooth. Used in hospitals, clinics, or home by patients or clinicians. Provides spot-check and continuous recording; output used by healthcare providers for clinical assessment of oxygenation status. Benefits include portable, non-invasive monitoring of physiological parameters.

Clinical Evidence

Clinical testing conducted per Annex EE of ISO 80601-2-61:2011 to evaluate SpO2 accuracy in human subjects. Results demonstrate compliance with accuracy requirements (±3% for 70-100% SpO2 range).

Technological Characteristics

Wrist-worn device; transmittance optical sensor (660nm/905nm); 1.44" color TFT LCD; rechargeable 3.7V 500mAh Li-ion polymer battery. Connectivity: USB, Bluetooth. Biocompatibility per ISO 10993-1. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61.

Indications for Use

Indicated for adult and pediatric patients in hospitals, clinics, or home settings for spot check and continuous recording of functional oxygen saturation (SpO2) and pulse rate (PR). Not intended for continuous monitoring.

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

• Handheld Pulse Oximeter, SP-20 (K172792)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Shenzhen Creative Industry Co., Ltd. % Charles Mack Principal Engineer International Regulatory Consultants (IRC) 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K201468

Trade/Device Name: Pulse Oximeter, AP-10 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 11, 2020 Received: December 28, 2020

Dear Charles Mack:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name Pulse Oximeter, AP-10

Indications for Use (Describe)

This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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#### 510(k) Summarv

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

Date: December 11, 2020

- 1. Company and Correspondent submitting:
Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, P.R.China 518110 Tel: [phone] Fax: [phone] Contact - Mrs. Jia Wang General Manager US Agent and Correspondent Mr. Charles Mack Principal Engineer IRC USA 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: [phone] Email: [e-mail]

- 2. Device:
Trade/proprietary name: Pulse Oximeter, AP-10 Common Name : Pulse Oximeter Classification Name : Oximeter Product Code : DQA Regulation Number: 21CFR870.2700 Device Class : 2

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- 3. Predicate Devices:

| Manufacturer | Device | 510(k)<br>Number |
|----------------------------------------|--------------------------------|------------------|
| Shenzhen Creative<br>Industry Co., Ltd | Handheld Pulse Oximeter, SP-20 | K172792 |

#### Reason for submission: New device 4.

#### Device Description: 5.

This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.

The following page exhibits a brief tabular display of the device functions and operation as compared to the predicate device.

# Indication for use:

This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediatric patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.

# Comparison with the predicate device:

Shenzhen Creative Industry Co., Ltd. believes that the Pulse Oximeter, AP-10 is substantially equivalent to the Shenzhen Creative Industry Co., Ltd; Handheld Pulse Oximeter, Model SP-20 (K172972).

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#### Comparison to Predicate Devices

| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shenzhen Creative Industry Co., LTD. | Shenzhen Creative Industry Co., LTD. | N/A |
| Name and model | Pulse Oximeter, AP-10 | Handheld Pulse Oximeter, SP-20 | N/A |
| 510(K) Number | Pending | K172792 | N/A |
| Product Code | DQA | DQA | Same |
| Indication for Use | This Pulse Oximeter is intended for measuring and<br>recording the functional oxygen saturation (SpO2)<br>and pulse rate (PR). It is intended for spot check and<br>continuous recording of SpO2, PR of adult or<br>pediatric patients in hospitals, clinics, or home. This<br>device is not intended for continuous monitoring. | This Handheld Pulse Oximeter is intended for<br>measuring and recording the pulse rate,<br>functional oxygen saturation (SpO2), and<br>temperature (optional). It is intended for spot<br>check and recording of SpO2, pulse rate, and<br>temperature of adult and pediatric patients in<br>clinical institutions and homes. The Handheld<br>Pulse Oximeter is not intended for active<br>continuous monitoring. | Similar. |
| Type of SpO2<br>Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | The difference of SpO2 Sensor<br>does not raise any new questions |
| SpO2 Module | KM-SPO-04 SpO2 Module with KS-AR01 Probe | KM-SPO-01 SpO2 Module with KS-C01, KS-<br>YW02 probe | of safety and effectiveness and<br>still complies with the ISO80601-<br>2-61 |
| Application Site | Finger | Finger | |
| Output | Red (660 nm) @ 2 mW maximum | Red (660 nm) @ 2 mW maximum | |
| Wavelength and<br>Radiant Power of<br>SpO2 Sensor | Infrared (905 nm) @ 2 mW maximum | Infrared (905 nm) @ 2 mW maximum | |
| Display | 1.44" color TFT LCD | 3.5" color TFT LCD | The display size difference does<br>not raise any new questions of<br>safety and effectiveness. |
| Measuring Mode | Spot-check and Continuous recording | Spot-check and Continuous recording | Spot-check and Continuous<br>recording |
| Display Range | SpO2: 0-100 %<br>Pulse Rate: 30-250 bpm | SpO2: 0-100 %<br>Pulse Rate: 30-240 bpm | The Pulse Rate display range of<br>AP-10 is wider than SP-20, but<br>still complies with ISO80601-2-61 |
| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
| Display | SpO2: 1% | SpO2: 1% | SpO2: 1% |
| Resolution | Pulse Rate: 1 bpm | Pulse Rate: 1 bpm | Pulse Rate: 1 bpm |
| SpO2 | SpO2: | SpO2: | SpO2: |
| Measurement | Adult and Pediatric: | Adult and Pediatric: | Adult and Pediatric: |
| Accuracy | ±3% (during 70%-100%) | ±3% (during 70%-100%) | ±3% (during 70%-100%) |
| | Undefined (during 0-70%) | Undefined (during 0-70%) | Undefined (during 0-70%) |
| Pulse Rate | Pulse Rate: ±2bpm or ±2% (whichever is greater) | Pulse Rate: ±2bpm or ±2% (whichever is | Pulse Rate: ±2bpm or ±2% |
| Accuracy | | greater) | (whichever is greater) |
| Data Memory | Up to 24 hours data storage (500 pieces of record at | Up to 500 hours of data storage for SpO2 and | The little difference does not raise |
| | most) | PR and can be recalled | any new questions of safety and |
| | | | effectiveness. |
| Power Supply | Rechargeable Lithium-lon Polymer Battery | Rechargeable Lithium-Ion Polymer Battery | Both devices are powered by a |
| | (3.7V,500mAh) | (3.7V d.c.,1000mAh) | lithium battery, which matches the |
| | | | design requirement and complies |
| | | | with the applicable standards, |
| | | | including IEC60601-1, IEC60601- |
| | | | 1-2, and IEC62133, etc. |
| AC Power for | 100-240VAC, 50-60Hz,15VA max | 100-240VAC, 50-60Hz,0.5A | Both devices are powered by a |
| Battery Charger | | | lithium battery that full match the |
| | | | design requirement and comply |
| | | | with the applicable standards, |
| | | | including IEC60601-1 and |
| | | | IEC60601-1-2. |
| Type of | Internal Powered | Internal Powered | Internal Powered |
| Protection | | | |
| Degree of | Type BF - applied part | Type BF - applied part | Type BF - applied part |
| Protection - | | | |
| sensor | | | |
| Enclosure | IP22 | IP22 | The enclosure Degree of Ingress |
| Degree of | | | Protection complies with the |
| Ingress | | | applicable standards, including |
| Protection | | | IEC60601-1 and ISO80601-2-61. |
| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
| Dimension<br>(LxWxH) | Watch Case: D 56mmx W 44mmxH 16mm | 158 mm (L) x 73 mm (W) x 25 mm (H) | The physical dimension difference<br>does not raise any new questions<br>of safety and effectiveness. |
| Weight | Net Weight: about 45g | 230g (including battery) | The weight difference does not<br>raise any new questions of safety<br>and effectiveness. |
| Patient Contact<br>Materials | Complies with ISO10993-1 | Complies with ISO10993-1 | Complies with ISO10993-1 |
| Data update | USB, Bluetooth | N/A | The AP-10 can upload data to the<br>PC through USB or to a<br>smartphone through Bluetooth. It<br>complies with the applicable<br>standard FCC part 15B. |
| Operating | Operating temperature: 5~40°C<br>Operating humidity: 15%~93% (non-condensing)<br>Atmospheric pressure: 70kPa~106kPa | Operating Temperature: 5°C ~40°C<br>Operating Humidity: 15%~93%, non-<br>condensing<br>Atmospheric pressure: 70kPa~106kPa | Operating Temperature: 5°C<br>~40°C<br>Operating Humidity: 15%~93%,<br>non-condensing<br>Atmospheric pressure:<br>70kPa~106kPa |
| Storage | Ambient temperature: -20°C ~60°C,<br>Relative humidity 10%~95%,<br>Atmospheric pressure: 50kPa~107.4kPa. | Ambient temperature: -20°C~60°C<br>Relative humidity: 10%~95%<br>Atmospheric pressure: 50kPa~107.4kPa | Ambient temperature: -20°C<br>~60°C<br>Relative humidity: 10%~95%<br>Atmospheric pressure:<br>50kPa~107.4kPa |

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### Testing Summary:

The following performance data were provided in support of the substantial equivalence determination.

## Non-Clinical:

## Safety and EMC

To verify the basic safety and essential performance of the AP-10, we performed the tests as noted below:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012

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

IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

The test results demonstrate the subject device complies with the standard's requirements.

### Biocompatibility

Patient contact classification is surface contact <24 hours. The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1. and the testing included the following test results of which demonstrate the biocompatibility of the subject device:

- Cytotoxicity
- Skin Sensitization
- Skin Irritation

### Performance

For the subject device, AP-10, it meets the performance standards: ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

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## Software Verification and Validation

Software documentation, including verification & validation, was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.

# Cleaning Validation

The AP-10 was cleaned following the procedure defined in the User's Manual. The device was checked for performance following the cleaning and met all performance requirements following the cleaning.

# Shelf Life:

The Pulse Oximeter, AP-10, is not subject to the shelf life, as the device doesn't contain any sterile or degradable components.

# Clinical:

Clinical testing was conducted per Annex EE Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

# Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Shenzhen Creative Industry Co., Ltd. concludes that the Pulse Oximeter, AP-10 is substantially equivalent to predicate device as described herein. The subject device has the same intended use as the predicate device and the technological differences do not raise different questions of safety and effectiveness

END