(240 days)
Not Found
No
The device description and performance studies focus on the physical cable's function and compatibility, with no mention of AI/ML algorithms or data processing beyond signal transmission.
No
The device is described as an SpO2 Extension Cable that transmits signals from an SpO2 sensor to a monitoring device, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
No
The device, an SpO2 Extension Cable, is explicitly stated to transmit signals from an SpO2 sensor to a monitoring device. It does not perform the diagnostic function itself; it is an accessory for the monitoring device that performs the SpO2 monitoring.
No
The device description explicitly states it is comprised of "Plug, Cable/Leadwires and Connector," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpO2 Extension Cable is a physical cable used to connect a SpO2 sensor (which measures oxygen saturation in the blood in vivo, on the patient) to a monitoring device. It facilitates the transmission of signals from the sensor to the monitor.
- Lack of Sample Analysis: The device itself does not analyze any biological samples taken from the patient. It is a passive component in a system that measures a physiological parameter directly on the patient.
The description clearly states its purpose is to connect a sensor placed on the patient to a monitoring device for in vivo SpO2 monitoring. This aligns with the definition of a medical device used for physiological monitoring, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
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 & Nellcor OEM Boards |
|---|---|---|---|
| 1 | RCT006 | RSJ002A, RSA002DN RSJ002I, RSA002DI RST002A, RSA002DP RST002I, RSA002DA RSW002N, RSY002N | NELLCOR: N-600X、N-595 |
| 2 | RCT018 | RSJ001A,RSJ001I, RST001A,RST001I, RSW001N,RSY001N, RSA001DN,RSA001DI, RSA001DP,RSA001DA | Philips: CM100、MP2、X2、MP5 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional.
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)
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.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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).
0
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.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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.
-
- Date of Preparation:2023/03/29
-
- 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: +86-769-22243880 Fax: +86-769-22242882 Email: info@r-rui.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
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
4
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
& Nellcor OEM Boards | | |
|-----|--------|------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------|
| 1 | RCT006 | RSJ002A, RSA002DN
RSJ002I, RSA002DI
RST002A, RSA002DP
RST002I, RSA002DA
RSW002N, RSY002N | NELLCOR: N-600X、N-595 | | |
| | | 2 | RCT018 | RSJ001A,RSJ001I,
RST001A,RST001I,
RSW001N,RSY001N,
RSA001DN,RSA001DI,
RSA001DP,RSA001DA | Philips: CM100、MP2、X2、MP5 |
5
-
- Identification of Predicate Device(s)
Predicate Device K192404 Patient Monitoring Cables (SpO2 Extension Cable) Shenzhen Coreray Technology Co., Ltd.
- Identification of Predicate Device(s)
-
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 | |
| Extension Cable) | |||
| K192404 | / | ||
| Classification | 21 CFR 870.2900 | 21 CFR 870.2900 | SAME |
6
| Regulation | |||
|---|---|---|---|
| Classification | II | II | SAME |
| Product Code | DSA | 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. | Patient Monitoring Cables are intended | ||
| to be used to connect sensors, placed at | |||
| appropriate sites on the patient to a | |||
| monitoring device for general | |||
| 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 | ||
| PVC or TPE jacket | Shielded & Unshielded Copper with | ||
| TPU jacket | Difference2 | ||
| 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 |
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.