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 Description

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.

AI/ML Overview

The Shenzhen Creative Industry Co., Ltd. Pulse Oximeter, AP-10, underwent a clinical study to establish its accuracy for measuring oxygen saturation (SpO2). The study was conducted in accordance with Annex EE of ISO 80601-2-61:2018 (or 2011, as listed in the provided text).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (ISO 80601-2-61)	Reported Device Performance (AP-10)
SpO2 Accuracy	±3% (during 70%-100% SpO2)	±3% (during 70%-100% SpO2)
Pulse Rate Accuracy	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)

Note: The document explicitly states that the AP-10's reported performance for SpO2 and Pulse Rate accuracy meets the ISO 80601-2-61 standard's requirements, which are the acceptance criteria.

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

The document states that clinical testing was conducted. However, it does not explicitly mention the sample size for the test set or the country of origin. It refers to the "Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011." This guideline typically involves healthy volunteers studied under controlled hypoxia conditions. Therefore, the data would be prospective.

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

The provided text does not contain information regarding the number of experts or their qualifications used to establish ground truth for the test set. For pulse oximetry, the "ground truth" for SpO2 is usually established via a co-oximeter measuring arterial blood gas (PaO2), overseen by medical professionals, but this detail is not present in the document.

4. Adjudication Method

The document does not specify an adjudication method. For pulse oximetry studies, adjudication typically refers to how reference SpO2 values are determined from blood samples, which doesn't usually involve multiple human readers in the same way imaging studies might.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The AP-10 is a direct measurement device (pulse oximeter), so this type of study is not applicable.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was conducted. The "Reported Device Performance" in the table above reflects the algorithm's accuracy in measuring SpO2 and pulse rate as a standalone device. The clinical study mentioned in "Clinical: Clinical testing was conducted per Annex EE Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011" specifically evaluates the device's intrinsic accuracy.

7. Type of Ground Truth Used

The type of ground truth used, though not explicitly stated as "co-oximetry," is implied by the reference to Annex EE of ISO 80601-2-61. This standard's Annex EE describes a method where arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples is considered the ground truth against which the pulse oximeter's SpO2 readings are compared.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. It refers to non-clinical and clinical testing for the current device's performance validation, but not to machine learning model training data. Given that pulse oximeters primarily rely on established biophysical principles (light absorption at different wavelengths by oxygenated and deoxygenated hemoglobin) rather than complex machine learning models directly trained on vast datasets in the same way an AI diagnostic tool might, the concept of a "training set" for the core physiological measurement might not be directly applicable or detailed in this type of submission.

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

As with the previous point, the document does not provide information on how ground truth for a training set (if one was used for specific algorithm development within the device) was established. The focus of the submission is on the device's adherence to established performance standards for pulse oximetry.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: +86-755-26433325 Fax: +86-755-26435433 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: 931-6254938 Email: charliemack@irc-us.com
1. 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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1. Predicate Devices:

Manufacturer	Device	510(k)Number
Shenzhen CreativeIndustry Co., Ltd	Handheld Pulse Oximeter, SP-20	K172792

Reason for submission: New device 4.

Device Description: 5.

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 andrecording the functional oxygen saturation (SpO2)and pulse rate (PR). It is intended for spot check andcontinuous recording of SpO2, PR of adult orpediatric patients in hospitals, clinics, or home. Thisdevice is not intended for continuous monitoring.	This Handheld Pulse Oximeter is intended formeasuring and recording the pulse rate,functional oxygen saturation (SpO2), andtemperature (optional). It is intended for spotcheck and recording of SpO2, pulse rate, andtemperature of adult and pediatric patients inclinical institutions and homes. The HandheldPulse Oximeter is not intended for activecontinuous monitoring.	Similar.
Type of SpO2Sensor	Transmittance Optical Sensor	Transmittance Optical Sensor	The difference of SpO2 Sensordoes 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-YW02 probe	of safety and effectiveness andstill complies with the ISO80601-2-61
Application Site	Finger	Finger
Output	Red (660 nm) @ 2 mW maximum	Red (660 nm) @ 2 mW maximum
Wavelength andRadiant Power ofSpO2 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 doesnot raise any new questions ofsafety and effectiveness.
Measuring Mode	Spot-check and Continuous recording	Spot-check and Continuous recording	Spot-check and Continuousrecording
Display Range	SpO2: 0-100 %Pulse Rate: 30-250 bpm	SpO2: 0-100 %Pulse Rate: 30-240 bpm	The Pulse Rate display range ofAP-10 is wider than SP-20, butstill 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(LxWxH)	Watch Case: D 56mmx W 44mmxH 16mm	158 mm (L) x 73 mm (W) x 25 mm (H)	The physical dimension differencedoes not raise any new questionsof safety and effectiveness.
Weight	Net Weight: about 45g	230g (including battery)	The weight difference does notraise any new questions of safetyand effectiveness.
Patient ContactMaterials	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 thePC through USB or to asmartphone through Bluetooth. Itcomplies with the applicablestandard FCC part 15B.
Operating	Operating temperature: 5~40°COperating humidity: 15%~~93% (non-condensing)Atmospheric pressure: 70kPa~~106kPa	Operating Temperature: 5°C ~40°COperating Humidity: 15%~~93%, non-condensingAtmospheric pressure: 70kPa~~106kPa	Operating Temperature: 5°C~40°COperating Humidity: 15%~~93%,non-condensingAtmospheric pressure:70kPa~~106kPa
Storage	Ambient temperature: -20°C ~60°C,Relative humidity 10%~~95%,Atmospheric pressure: 50kPa~~107.4kPa.	Ambient temperature: -20°C~60°CRelative humidity: 10%~~95%Atmospheric pressure: 50kPa~~107.4kPa	Ambient temperature: -20°C~60°CRelative humidity: 10%~~95%Atmospheric pressure: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

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).