The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.

Device Description

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Fingertip Pulse Oximeter, based on the provided document:

This document describes a 510(k) premarket notification for a medical device, which means the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy from scratch. Therefore, the "acceptance criteria" discussed here are primarily focused on meeting regulatory standards and demonstrating comparable performance to the predicate device, rather than establishing de novo clinical effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance claims for this pulse oximeter relate to SpO2 accuracy and Pulse Rate accuracy. The acceptance criteria are implicitly defined by the standard ISO 80601-2-61 and the device's stated accuracy, which is compared directly to the predicate device.

Performance Parameter	Acceptance Criteria (from predicate/standard)	Reported Device Performance
SpO2 Range	0% to 100% (Predicate)	35% to 100%
SpO2 Accuracy	70% to 100%: ±2%	70% to 100%: ±2%
Pulse Rate Range	25 bpm ~ 250 bpm	25 bpm ~ 250 bpm
Pulse Rate Accuracy	±2 bpm	±2 bpm

Note on SpO2 Range Difference: The document explicitly states and justifies the difference in SpO2 range. While the predicate measures 0-100%, the subject device measures 35-100%. The justification is that this difference is acceptable as it aligns with the verification per ISO 80601-2-61.

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

Sample Size (Clinical Test Set): 12 adult healthy volunteers.
Data Provenance: The document does not explicitly state the country of origin for the clinical study. It describes the study as "Clinical testing conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2017... and the FDA Guidance Document for Pulse Oximeters." This suggests it was a prospective study designed to meet these specific guidelines. The volunteers had varying skin tones (Fitzpatrick I-VI), indicating an effort for demographic representation.

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

This type of device (pulse oximeter) does not typically involve expert readers for ground truth establishment. The ground truth for SpO2 accuracy is based on arterial blood CO-Oximetry, which is considered the gold standard for measuring blood oxygen saturation. This is a direct physiological measurement and does not require subjective expert interpretation in the same way imaging studies might.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by direct physiological measurement (CO-Oximetry), which does not involve subjective interpretation or a need for adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI algorithms where human readers interpret medical images, and the AI is used to assist or replace human interpretation. A pulse oximeter directly measures physiological parameters and does not involve human interpretation of complex medical cases.

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

Yes, the core performance testing of the device for SpO2 and Pulse Rate accuracy is a standalone assessment of the algorithm's ability to measure these parameters against the gold standard (CO-Oximetry). The device operates independently to provide these measurements.

7. The Type of Ground Truth Used

The type of ground truth used was outcomes data / physiological measurement, specifically: arterial blood CO-Oximetry. This is the standard reference method for determining actual arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not provide information on the training set size. For a medical device like a pulse oximeter, "training" might refer to the development and calibration of the internal algorithms and hardware during the design phase, rather than a distinct "training set" of data in the common machine learning sense used for AI algorithms. The clinical study described served as the validation test set.

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

The document does not describe how a "training set" ground truth was established. The focus of this 510(k) submission is on validating the final device's performance against established standards (ISO 80601-2-61) and comparing it to a predicate device, using clinical data collection and CO-Oximetry as ground truth for that validation. If there were internal iterative development and calibration, the specifics of those processes are not detailed in this public regulatory summary.

Summary

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November 21, 2024

Shenzhen Smallsignal Technology Co., Ltd. Qingliang Liu General Manager Room 901-7,Building 1, No.9, Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan Shenzhen, Guangdong 518122 China

Re: K232520

Trade/Device Name: Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: March 2, 2024 Received: October 22, 2024

Dear Qingliang Liu:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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 Advice (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

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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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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

Submission Number (if known)

K232520

Device Name

Fingertip Pulse Oximeter (Models Alpine20, Alpine20H, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine30, Alpine30, Alpine30H, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20L, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH)

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) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter: Shenzhen Smallsignal Technology Co., Ltd. Address: Room 40205, Building 1, Huahan Science and Technology Industrial Park, No. 19, Qiyun West Road, Heping Community, Pingshan Street, Pingshan District, Shenzhen, Guangdong Province, China, 518083 TEL: 86 755 23010489
Contact Person: Qingliang Liu
Prepare date: October 22, 2024

Device name Device Name: Fingertip Pulse Oximeter

and classification Models: Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20BA, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH Classification Name: 21 CFR 870.2700 Oximeter

Product code: DQA

Regulatory Class: Class II

New submission. No prior submission associated with the current submission. 3. Reason for
Submission

Shenzhen AOJ Medical Technology Co.,Ltd., AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D and 4. Predicate Device(s) AOJ-70E Pulse Oximeter / K202173

1. Device The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one Description side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.

6. Indications for The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is Use not intended to be used under motion or low perfusion scenarios.

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7. Predicate Device Comparison

Please refer to following table to find differences between the subject device and predicate device.

ITEM	Proposed DeviceAlpine20 series PulseOximeter	Predicate DeviceAOJ-70A, AOJ-70B, AOJ-70C,AOJ-70D and AOJ-70E	ComparisonResult
Manufacture	Shenzhen SmallsignalTechnology Co., Ltd.	Shenzhen AOJ MedicalTechnology Co., Ltd.	---
Indications forUse	The pulse oximeter is areusable device and intendedfor spot-checking of oxygensaturation and pulse rate foruse with the finger of adultpatients in healthcareenvironments. And it is notintended to be used undermotion or low perfusionscenarios.	The pulse oximeter is a reusabledevice and intended forspot-checking of oxygensaturation and pulse rate for usewith the finger of adult patientsin healthcare environments. Andit is not intended to be usedunder motion or low perfusionscenarios.	Same
Operational Specifications
Intended patientpopulation	Adult	Adult	Same
Intendedapplication site	Finger	Finger	Same
use undermotion and lowperfusionconditions	No	No	Same
MeasurementPrinciples	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption	Same
Signal DetectionMethod	Photodetector	Photodetector	Same
SpO2 Range	35~100%	0~100%	Different¹
SpO₂ Resolution	1%	1%	Same
SpO2 Accuracy	70~100%: ±2%0% to 69%: unspecified	70~100%: ±2%0% to 69%: unspecified	Same
Pulse Rate Range	25 bpm ~ 250 bpm	25 bpm ~ 250 bpm	Same
Pulse RateAccuracy	±2 bpm	±2 bpm	Same
PulseRate Resolution	1 bpm	1 bpm	Same
Shipped Sterile	No	No	Same
Storage andTransportEnvironment	Temperature: -10 °C - 40 °CHumidity: 15%-93%Atmospheric pressure:50 kPa-106 kPa	Temperature: -20 °C - 50 °CHumidity (non-condensing):10%-95%Atmospheric pressure: 70kPa-106 kPa	Different 2
OperatingEnvironment	Temperature: 5 °C - 40 °CHumidity: 15%-80%Atmospheric pressure: 86kPa-106 kPa	Temperature: 10 °C - 40 °CHumidity (non-condensing):15%-95%Atmospheric pressure: 70kPa-106 kPa
Compliance Standards
Bio-compatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23	ISO 10993-1ISO 10993-5ISO 10993-10	Different 3
Electrical Safety	IEC 60601-1IEC 60601-1-11	IEC 60601-1IEC 60601-1-11	Same
EMC	IEC 60601-1-2	IEC 60601-1-2
Performance	ISO 80601-2-61	ISO 80601-2-61
Physical Specifications
Dimension(WidthHeightDepth)	Alpine20/ 20L series:61mm×37mm×33mmAlpine30/ 30L series:61mm×34mm×32mm	57mm×30mm×30 mm	Different 4
Data Transmission
Datatransmission	Bluetooth is available forAlpine20B, Alpine20BA,Alpine20BH, Alpine20BHA,Alpine30B, Alpine30BA,Alpine30BH, Alpine30BHA,Alpine20LB, Alpine20LBH,Alpine30LB and Alpine30LBH	No available	Different 5

Table 1 Comparison between the predicate and the subject device

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Justification for the differences:

1. Different SpO2 Range
  The measuring range of the predicate is 0~~100% , while that of the subject is 35~~100%, and such specification is verified per the international standard ISO 80601-2-61, same as the standard complied with of the predicate, so the different range will be acceptable for the subject device.
1. Different operating, storage and transport environment
  Minor difference to operation, storage/transport environment for the subject device, but the system has been proved to be safe and effective since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes will not cause any safety and effectiveness problem.
1. Different Biocompatibility test standard

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The endpoints for the biocompatibility are the same, which include cytoxicity, skin irritation and sensitization, the difference happened due to the irritation was taken from ISO 10993-10 to ISO 10993-23 without no change for the parts applied in the subject device, both of which are used for evaluation for test of irritation. This difference will not raise any safety and effectiveness questions.

1. Different Physical Specifications
  The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different will not raise any safety and effectiveness questions.
1. Different data transmission function
  Some models of the subject devices have Bluetooth data transmission function, and the wireless function has been verified to assure its data transmission and cybersecurity. No new safety and effectiveness questions raised.

As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness as demonstrated in the non-clinical and clinical evidence.

8. Performance Testing

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

Non-Clinical Testing:

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

Biocompatibility testing

The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+A1: 2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2015+A1:2020 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and

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essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104.

Software Verification and Validation Testing

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

Clinical data

Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2ACCURACY in human subjects of ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to evaluate the Sp02 accuracy performance of the subject device during stationary (non motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. There were 12 adult healthy volunteers to validated the SpO2 accuracy of the pulse oximeter, aged 22-37 years old, with skin tones varying from Fitzpatrick I-VI,including five females and seven males. The measure results showed that the subject device perform as claimed during the measurement range of 70-100% with 2% accuracy.

9. Conclusion

Verification and validation testing was conducted on the subject device Fingertip Pulse Oximeter and all testing passed pre-specified criteria. The subject device and the predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the subject device is 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).