Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description of the device components and the signal processing module (MCU) does not mention any AI or ML capabilities. The performance studies focus on standard pulse oximetry accuracy metrics (ARMS) and do not describe any AI/ML-specific validation.

Therapeutic

No.
The device is described as a non-invasive device for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate". This indicates it is a diagnostic tool for monitoring and measuring, not for actively treating or curing a medical condition.

Diagnostic

Yes

Explanation: The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate," and the device description states it is used "for diagnosis." Measuring and displaying these physiological parameters to provide information about a patient's condition falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, and user interface and button control circuit. This indicates it is a physical device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The Pulse Oximeter FS20P, FS20C, and FS10C measure oxygen saturation and pulse rate non-invasively by shining light through the fingertip. They do not analyze samples taken from the body.
Intended Use: The intended use clearly states "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate". This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.

Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

Product codes

DOA

Device Description

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertips (while using)

Indicated Patient Age Range

FS20P: adolescent, child and infant patients
FS20C and FS10C: adult patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:

ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff

Study 1 (FS20P):

Study Type: Clinical study to evaluate SpO2 accuracy performance
Sample Size: 10 healthy female adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6)
Data Source: N/A (clinical study)
Key Results: The SpO2 accuracy performance results showed FS20P Pulse Oximeter to have an ARMS of 1.70% during steady state conditions over the range of 70-100%.

Study 2 (FS20C):

Study Type: Clinical study to evaluate SpO2 accuracy performance
Sample Size: 13 healthy adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6)
Data Source: N/A (clinical study)
Key Results: The SpO2 accuracy performance results showed FS20C Pulse Oximeter to have an ARMS of 1.71% during steady state conditions over the range of 70-100%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

ARMS:

FS20P: 1.70% (over the SpO2 range of 70-100%)
FS20C: 1.71% (over the SpO2 range of 70-100%)

SpO2 Accuracy:

FS20C, FS20P: 70%~~100%: ±2%; 0~~69% no definition
FS10C: 70%~~99%: ±2%; 0~~69% no definition

PR Accuracy: ±3bpm

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K230172

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 2, 2025

Hunan Accurate Bio-Medical Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K243049

Trade/Device Name: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: September 27, 2024 Received: December 6, 2024

Dear Jie Yang:

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

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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 (OS) 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-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 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-regulatory

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assistance/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)

K243049

Device Name

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Indications for Use (Describe)

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

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

Prepared Date: 2024/09/27

1. Submission sponsor

Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, 410208 Changsha, Hunan Province, PEOPLE'S REPUBLIC OF China Contact person: Zhang Li Title: General Manager E-mail: regulation@accbiomed.com Tel: +86 731-8559853

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China

Contact person: Yang Jie

E-mail: yangjie(@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Pulse Oximeter
Model	FS20P, FS20C,FS10C
Common Name	Fingertip Pulse Oximeter
Regulatory Class	Class II
Classification	21CFR 870.2700 / Oximeter / DQA
Submission type	Traditional 510(K)

Subiect Device Information 3.

4. Predicate Device

Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Device name: Pulse Oximeter, Model: MD300C19 510(K) Number: K230172

5. Device Description

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The

5

device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.

6. Intended use & Indication for use

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

| ITEM | Proposed Device
Pulse Oximeter
Model: FS20P,
FS20C,FS10C | Predicate Device
Pulse Oximeter
Model: MD300C19
K230172 | Comparison Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacture | Hunan Accurate Bio-Medical
Technology Co., Ltd. | Beijing Choice Electronic
Technology Co., Ltd. | Same |
| Indications for Use | The Pulse Oximeter FS20P is
a handheld non-invasive
device intended for spot-
checking of oxygen saturation
of arterial hemoglobin
(SpO2) and Pulse Rate of
adolescent, child and infant
patients in hospitals, hospital-
type facilities and
homecare. The device is not
intended for continuous
monitoring, use during
motion or use with low
perfusion. The device is | The Pulse Oximeter is a
handheld non-invasive device
intended for spot-checking of
oxygen saturation of arterial
hemoglobin (SpO2) and Pulse
Rate of adult, adolescent child
and infant patients in hospitals,
hospital-type facilities and
homecare. The device is not
intended for continuous
monitoring, use during motion
or use with low perfusion. The
device is intended for reuse. | Same |
| | | | |
| | intended for reuse. The
device is wearing on
fingertips while using.

The Pulse Oximeter FS20C
and FS10C is a handheld non-
invasive device intended for
spot-checking of oxygen
saturation of arterial
hemoglobin (SpO2) and Pulse
Rate of adult patients in
hospitals, hospital-type
facilities and homecare. The
device is not intended for
continuous monitoring, use
during motion or use with
low perfusion. The device is
intended for reuse. The
device is wearing on
fingertips while using. | The device is wearing on
fingertips while using. | |
| Population | FS20C and FS10C: adult
FS20P: adolescent, child and
infant patients. | adult, adolescent, child and
infant patients | Similar |
| Components | Power supply module,
detector and emitter LED,
signal collection and
processor module, display
module, user interface and
button control. | Power supply module, detector
and emitter LED, signal
collection and processor
module, display module, user
interface and button control. | Same |
| Type of SpO2
Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | Same |
| Application
Site | Finger | Finger | Same |
| Measurement | Red (660 nm)
Infrared (905 nm) | Red (660 nm)
Infrared (905 nm) | Same |
| Display Type | OLED or LED | LED | Similar |
| Power
Supply | 2AAA alkaline batteries | 2AAA alkaline batteries | Same |
| Display Data | SPO2 , PR | SPO2 , PR | Same |
| SPO2 | FS20C,FS20P:
SpO2 Display Range:
0%100%
Measurement range:
70100%
Accuracy: 70%100%: ±2%;
069% no definition
FS10C:
SpO2 Display Range:
0%99%
Measurement range:
7099%
Accuracy: 70%99%: ±2%;
069% no definition | SpO2 Display Range:
0%100%
Measurement range:
70%100%
Accuracy: 70%100%: ±2%;
069% no definition | Similar |
| PR | PR Display Range
25250bpm
Measurement range:
25250bpm
Resolution: 1bpm
Accuracy:±3bpm; | PR Display Range
0255bpm
Measurement range:
30250bpm
Resolution: 1bpm
Accuracy: 3099bpm, ±2bpm;
100250bpm, ±2% | Similar |
| Environment
Requirements | Operating Temperature:
5~40°C
Ambient Humidity:
10%95%, no condensation
Storage/Transportation: -
20°C60°C Ambient
Humidity: 10%95% no
condensation | Operating Temperature:
040°C
Ambient Humidity: 15%93%,
no condensation
Storage/Transportation: -
25°C70°C Ambient Humidity: