SpO2 Extension Cable

K222370 · Beijing Rongrui-Century Science & Technology Co., Ltd. · DSA · Apr 2, 2023 · Cardiovascular

Device Facts

• Record ID: K222370
• Device Name: SpO2 Extension Cable
• Applicant: Beijing Rongrui-Century Science & Technology Co., Ltd.
• Product Code: DSA · Cardiovascular
• Decision Date: Apr 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended 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.

Device Story

SpO2 Extension Cable acts as passive interface between SpO2 sensors and patient monitors; transmits physiological signals generated by sensor to host monitor. Comprised of plug, cable/leadwires, and connector. Used in clinical settings by healthcare professionals. Device ensures signal integrity between sensor and monitor; prevents data corruption. Benefits patient by enabling continuous SpO2 monitoring via compatible host devices.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance/compatibility testing (ISO 80601-2-61, ANSI AAMI EC53).

Technological Characteristics

Passive cable assembly; shielded/unshielded copper wires with PVC or TPE jacket. Length 2m ± 10%. Non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, and ANSI AAMI EC53:2013/(R)2020.

Indications for Use

Indicated for use by healthcare professionals to connect SpO2 sensors to monitoring devices for patient SpO2 monitoring. No specific age or disease state contraindications provided.

Regulatory Classification

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.

Predicate Devices

• Patient Monitoring Cables (SpO2 Extension Cable) (K192404)

Submission Summary (Full Text)

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April 2, 2023

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

Re: K222370

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 Dated: March 3, 2023 Received: March 3, 2023

Dear Ray Wang:

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 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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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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-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,

# James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of 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) K222370

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number:

# Tab #3 510(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:2023/03/29
- 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: Calen Chen Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 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: [phone] Fax: [phone] Email: information(@believe-med.com

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#### 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 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:

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.

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

The SpO2 Extension Cable is comprised of Plug, Cable/Leadwires and Connector. It's intended to plug into monitoring device and connect with SpO2 sensor, for transmitting signals which generated by SpO2 sensor to monitoring device.

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 compatible sensors and monitors are shown in the following table:

| NO. | Model | Compatible Rongrui Sensor | Compatible Monitors<br>& Nellcor OEM Boards | | |
|-----|--------|------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------|
| 1 | RCT006 | RSJ002A, RSA002DN<br>RSJ002I, RSA002DI<br>RST002A, RSA002DP<br>RST002I, RSA002DA<br>RSW002N, RSY002N | NELLCOR: N-600X、N-595 | | |
| | | 2 | RCT018 | RSJ001A,RSJ001I,<br>RST001A,RST001I,<br>RSW001N,RSY001N,<br>RSA001DN,RSA001DI,<br>RSA001DP,RSA001DA | Philips: CM100、MP2、X2、MP5 |

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- 5. Identification of Predicate Device(s)
Predicate Device K192404 Patient Monitoring Cables (SpO2 Extension Cable) Shenzhen Coreray Technology Co., Ltd.

- Non-Clinical Test Conclusion 6.
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 A And Skin Sensitization.
- > IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-2:2014, 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 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.

- Clinical Test Conclusion 7.
No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.
#### Table 1 General Comparison

| Item | Proposed Device | Predicate Device | Remark |
|----------------|----------------------|----------------------------------------------------------------|--------|
| Product name | SpO2 Extension Cable | Patient Monitoring Cables (SpO2<br>Extension Cable)<br>K192404 | / |
| Classification | 21 CFR 870.2900 | 21 CFR 870.2900 | SAME |

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| Regulation | | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Classification | II | II | SAME |
| Product Code | DSA | DSA | SAME |
| Common Name | Cable, Transducer And Electrode,<br>Patient, (Including Connector) | Cable, Transducer And Electrode,<br>Patient, (Including Connector) | SAME |
| Indications<br>for use | SpO2 Extension Cables are intended<br>to be used to connect SpO2 sensors,<br>placed at appropriate sites on the<br>patient to a monitoring device for<br>SpO2 monitoring by health care<br>professional. | Patient Monitoring Cables are intended<br>to be used to connect sensors, placed at<br>appropriate sites on the patient to a<br>monitoring device for general<br>monitoring by health care professional. | SAME |
| Design | Plug, Cable/Leadwires and connectors | Plug, Cable/Leadwires and connectors | SAME |
| Usage | Reusable | Reusable | SAME |
| Cable lengths | $2m \pm 10%$ | 8ft | Difference1 |
| Wire material | Shielded & Unshielded Copper with<br>PVC or TPE jacket | Shielded & Unshielded Copper with<br>TPU jacket | Difference2 |
| Sterility | Non-sterile | Non-sterile | SAME |
| Biocompatibility | Meets ISO 10993-5 Cytotoxicity, ISO<br>10993-10 Sensitization and Irritation | Meets ISO 10993-5 Cytotoxicity, ISO<br>10993-10 Sensitization and Irritation | SAME |
| Electrical safety<br>and Performance | IEC 60601-1<br>ISO 80601-2-61<br>ANSI AAMI EC53 | IEC 60601-1<br>ISO 80601-2-61<br>ANSI AAMI EC53 | SAME |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | SAME |

## Analysis:

Difference 1 :

There is difference on the cable length, the cable length of the proposed device is 2m ± 10% (Approximately 6.6 ft), the cable length of the predicate device is 8ft, but these cables are same function , the cable length difference would not affect its safety and effectiveness.

#### Difference 2:

Although the wire material between the proposed device and predicate device have few differences, the proposed device comply with electrical safety standard IEC 60601-1 and the performance standard ISO 80601-2-61 and ANSI AAMI EC53, so the differences would not affect its safety and effectiveness.

#### 9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.