SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

Device Description

SpO2 Extension Cable consists of two parts: the SpO2 patient cable and the adapter. The SpO2 patient cable is used for connecting the monitors, and the adapter is used for connecting the SpO2 patient cable and the SpO2 sensor.

The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.

The proposed device was modification from the legally marketed (existing) device "SpO2 Extension Cable"/K222370, manufactured by "Beijing Rongrui-Century Science & Technology Co., Ltd.", same as the sponsor of this submission.

Compared to the initial product (K222370), only the structure of the SpO2 Extension Cable has changed. Originally a non-separable complete extension cable, now an extension cable can be separated into two parts, called the SpO2 patient cable and the adapter.

The type of instrument connector (which connects one end of the monitoring device) for the SpO2 patient cable is 20pin, there are four types pairing interfaces between SpO2 patient cable and adapter, the pairing interfaces name for the SpO2 patient cable and adapter connection is DB9F-LNCS, MLNCS-MLNCS, LNOP-LNOP, RD-RD and the other end of the adapter connecting to SpO2 sensor is DB9F. Adapters are divided into two categories: with cable and without cable. Adapters for each type of interface are available with and without cables.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the "SpO2 Extension Cable" is for a Class II medical device, specifically an extension cable used to connect SpO2 sensors to monitoring devices. Based on the content of the letter, the submission is about demonstrating substantial equivalence to a predicate device, not necessarily proving that an AI/ML algorithm meets specific performance criteria.

Therefore, many of the requested points, such as AI/ML specific acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML, are not applicable to this type of device clearance. This clearance focuses on electrical safety, EMC, biocompatibility, and functional compatibility of a hardware component.

Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:

Analysis of Acceptance Criteria and Study for SpO2 Extension Cable (K242986)

This submission (K242986) pertains to an SpO2 Extension Cable, which is a hardware component. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (K222370), rather than establishing performance of an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML devices are not relevant here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of hardware device are primarily based on compliance with recognized consensus standards and functional compatibility. The "performance" here refers to meeting these engineering and safety specifications, rather than clinical accuracy metrics typically seen for diagnostic algorithms.

Acceptance Criterion (Standard Compliance / Test)	Reported Device Performance (Compliance)
Biocompatibility:
ISO 10993-5: In Vitro Cytotoxicity	Meets standard
ISO 10993-10: Irritation and Skin Sensitization	Meets standard
Electrical Safety & Performance:
IEC 60601-1 (Edition 3.2): General requirements	Complies
ISO 80601-2-61: Pulse Oximeter Equipment specifics	Complies
ANSI AAMI EC53: ECG trunk cables/leadwires (likely for general cable integrity/materials, given context)	Complies
Electromagnetic Compatibility (EMC):
IEC 60601-1-2 (Edition 4.1): EMC requirements	Complies
Functional Performance:
Compatibility testing (no measured data corrupt during communication between SpO2 sensors and host monitors)	Performance accuracy evaluated and proven

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

Sample Size: Not explicitly stated in terms of a "test set" like in AI/ML validation. Compliance is shown through testing of engineering samples of the device itself and its components against the specified standards.
Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The "data" here comes from laboratory testing of the physical cable. The device manufacturer is Beijing Rongrui-Century Science & Technology Co., Ltd. in China. The testing would have been conducted in a controlled lab environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. Ground truth, in the sense of expert annotation for clinical data, is not established for this type of hardware device. The device's performance is verified against engineering standards and functional specifications.

4. Adjudication Method for the Test Set

Not Applicable. As there's no "ground truth" derived from expert consensus on clinical cases, no adjudication method is relevant.

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

Not Applicable. An MRMC study is designed to assess the impact of an AI algorithm on human reader performance. This device is an extension cable, not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not Applicable. This is a physical cable, not a software algorithm.

7. Type of Ground Truth Used

Not Applicable. The "ground truth" for this device's acceptance is its adherence to recognized engineering, electrical, biocompatibility, and functional performance standards. This is established through non-clinical testing results, not clinical outcomes data or expert consensus on patient cases.

8. Sample Size for the Training Set

Not Applicable. No training set exists as this is a hardware product, not a machine learning model.

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

Not Applicable. No training set or associated ground truth for training.

Summary of the K242986 Submission's Core Argument:

The core of the K242986 submission is to demonstrate that the modified structure of the SpO2 Extension Cable (now separable into two parts) does not negatively impact its safety and effectiveness when compared to the predicate device (K222370), which was a non-separable cable. This is achieved by showing continued compliance with relevant performance, safety, and compatibility standards. The primary difference noted is a structural change, and the manufacturer successfully demonstrated that this change "will not affect the safety and effectiveness of the proposed device" through non-clinical testing.

Summary

FDA 510(k) Clearance Letter - SpO2 Extension Cable

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 2, 2025

Beijing Rongrui-Century Science & Technology Co., Ltd.
℅ Wang Ray
General Manager
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing, 102401
China

Re: K242986
Trade/Device Name: SpO2 Extension Cable
Regulation Number: 21 CFR 870.2900
Regulation Name: Patient Transducer And Electrode Cable (Including Connector)
Regulatory Class: Class II
Product Code: DSA, DQA
Dated: September 25, 2024
Received: September 26, 2024

Dear Wang Ray:

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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K242986 - Wang Ray
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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 (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 (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-reporting-combination-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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K242986 - Wang Ray
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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,

JAMES J. LEE -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K242986

Device Name
SpO2 Extension Cable

Indications for Use (Describe)
SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

The assigned 510(k) Number: K242986

510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 2025/03/31

2. Sponsor Identification

Beijing Rongrui-Century Science & Technology Co., Ltd.
3rd Floor, West zone, No.1 Building, No.7 Yard, Fengxian middle Road, HaiDian District, Beijing, 100094, P.R.China.

Contact Person: Zhenghua Zhang
Position: Quality Manager
Tel: +86-13371720965
Fax: +86-10-58711218
Email: zl05@r-rui.onaliyun.com

3. Designated Submission Correspondent

Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@believe-med.com

Page 6

4. Identification of Proposed Device

Trade Name: SpO2 Extension Cable
Common Name: Cable, Transducer And Electrode, Patient, (Including Connector)

Regulatory Information

Classification Name: Cable, Transducer And Electrode, Patient, (Including Connector)
Classification: II
Product Code: DSA, DQA
Regulation Number: 21 CFR 870.2900
Review Panel: Cardiovascular

Indication for use Statement:

SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

Device Description:

The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.

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The materials and the manufacturing process technology are the same. We selected K222370 as our reference device. Detailed comparison information can be found in the 510k Summary.

The compatible sensors and monitors are shown in the following table:

SpO2 patient cable Model	Adapter Model	Compatible Rongrui Sensor	Compatible Monitors Manufacture
RCT032	RCT083-AL	RSJ002A, RSA002DN, RSJ002I, RSA002DI, RST002A,RSA002DP, RST002I, RSA002DA, RSW002N, RSY002N	Masimo Corporation
	RCT083-CL
RCT032-M	RCT083-AM		Masimo Radical-7 (K212161)
	RCT083-CM
RCT032-P	RCT083-AP
	RCT083-CP
RCT032-R	RCT083-AR
	RCT083-CR

5. Identification of Predicate Device(s)

Predicate Device
K222370
SpO2 Extension Cable
Beijing Rongrui-Century Science & Technology Co., Ltd.

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical Electrical Equipment–Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility- Requirements And Tests
ISO 80601-2-61:2017 Medical electrical equipment-Part 2-61: Particular requirements for

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basic safety and essential performance of pulse oximeter equipment

ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires

SpO2 Extension Cable has also been evaluated the performance accuracy through Compatibility testing, which proves that no measured data corrupt during communication between SpO2 sensors and host monitors.

7. Clinical Test Conclusion

No clinical study is included in this submission.

8. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

Different--Structure:

Item	Proposed Device	Predicate Device	Remark
Product name	SpO2 Extension Cable	SpO2 Extension Cable K222370	/
Classification Regulation	21 CFR 870.2900	21 CFR 870.2900	SAME
Classification	II	II	SAME
Product Code	DSA, DQA	DSA	SAME
Common Name	Cable, Transducer And Electrode, Patient, (Including Connector)	Cable, Transducer And Electrode, Patient, (Including Connector)	SAME
Indications for use	SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.	SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.	SAME
Structure	Separate extension cable	Non-separable extension cable	Different
Usage	Reusable	Reusable	SAME
Cable lengths	2m±10%	2m±10%	SAME
Wire material	Shielded & Unshielded Copper with PVC or TPE jacket	Shielded & Unshielded Copper with PVC or TPE jacket	SAME
Sterility	Non-sterile	Non-sterile	SAME
Biocompatibility	Meets ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation	Meets ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation	SAME
Electrical safety and Performance	IEC 60601-1 ISO 80601-2-61 ANSI AAMI EC53	IEC 60601-1 ISO 80601-2-61 ANSI AAMI EC53	SAME
EMC	IEC 60601-1-2	IEC 60601-1-2	SAME

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The structure of the proposed device and predicate device is minor different. The predicate device is a non-separable complete extension cable, the proposed device can be separated into two parts:SpO2 patient cable and the adapter. Though their structure is different, they all contain Plug, Cable/Leadwires and connectors. And the proposed device comply with electrical safety standard IEC 60601-1,IEC6061-1-2, the performance standard ISO 80601-2-61 and ANSI AAMI EC53. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

9. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, SpO2 Extension Cable, cleared under K222370.

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).