Patient Monitoring Cable (SpO2 Extension Cable)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Shenzhen Coreray Technology., Ltd Simon Fan Manager 305, 307 Liangji Building, 1st Donghuan Road Longhua New District Shenzhen, 518109 Cn Re: K192404 Trade/Device Name: Patient Monitoring Cable (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: May 15, 2020 Received: May 22, 2020 Dear Simon Fan: 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. 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 {1}------------------------------------------------ 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 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-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, Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K192404 Device Name Patient Monitoring Cables (SpO2 Extension Cable) Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> <span>Residential (Part of CER 901 Category)</span> </div> | |----------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> <span>Commercial/Industrial (Part of CER 901 Category)</span> </div> | X 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." {3}------------------------------------------------ # Section 5 510(k) Summary # K192404 This is a traditional 510k submission, and there were no prior submissions for the subject device. #### 1. Submitter Information Sponsor: Shenzhen Coreray Technology Co., Ltd. Address: 305, 307 Liangji Building, 1st Donghuan Road Longhua New District, Shenzhen, Guangdong, China Contact Person: Simon Fan Title: General Manager Phone: +86-755-28239229 E-mail: manager@core-ray.com Summary prepared on 29 May, 2020 #### 2. Subject Device Information Type of 510(k) submission: Traditional Trade/Device Name: Patient Monitoring Cables Model: SpO2 Extension Cable CR002-5301 Classification Name: Cable, Transducer And Electrode, Patient, (Including Connector) Review Panel: Cardiovascular Classification Product Code: DSA, 21 CFR 870.2900 Regulation Class: 2 #### 3. Predicate Device Information Sponsor: Shenzhen Med-link Electronics Tech Co., Ltd. Device Name: Cable/lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) {4}------------------------------------------------ Classification Name: Patient transducer and electrode cable (including connector) 510(k) number: K120010 Review Panel: Cardiovascular Product Code: DSA Regulation Number: 21 CFR 870.2900 #### 4. Reference Device information Sponsor: Curbell Medical Products, Inc. Device Name: Curbell Patient Monitoring Cables Classification Name: Patient transducer and electrode cable (including connector) 510(k) number: K182220 Review Panel: Cardiovascular Product Code: DSA Regulation Number: 21 CFR 870.2900 #### 5. Device Description Patient Monitoring Cables (SpO2 Extension Cable, CR002-5301) 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, Patient Monitoring Cables (SpO2 Extension Cable, CR002-5301) can avoid measured date corrupted. The compatible patient monitor is Nellcor N-595 Pulse Oximeter and compatible SpO2 sensor is Nellcor OxiMax Durasensor adult oxygen sensor DS-100A, which both are cleared under K012891. {5}------------------------------------------------ #### 6. Intended Use 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. #### 7. Standard Utilization | Standards No. | Title of Standard | Edition | FDA Recognition<br>No. | Date of<br>Recognition | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------|------------------------| | ANSI AAMI<br>ES 60601-1 | Medical Electrical Equipment -<br>Part 1: General Requirements<br>for Safety | 2005/(R)2012<br>And A1:2012, | 19-4 | 07/09/2014 | | ISO 80601-2-<br>61 | Medical electrical equipment -<br>Part 2-61: Particular<br>requirements for basic safety<br>and essential performance of<br>pulse oximeter equipment | 2017-12 | 1-139 | 09/17/2018 | | ANSI AAMI<br>EC53 | ECG trunk cables and patient<br>leadwires | 2013 | 3-129 | 07/09/2014 | #### 8. Test Summary Patient Monitoring Cables has been evaluated the safety and performance by lab bench testing according to the following standards: - 风 IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance, 2005+A1:2012 - Note: Although IEC 60601-1 2005+A1: 2012 is no longer a FDA-recognized standard, the subject device has assessed the differences to US national standard (ANSI AAMI 60601-1: 2005/(R)2012 And A1:2012), and the test report attaches the compliance. - 风 ANSI AAMI EC53: 2013 ECG Trunk Cables And Patient Leadwires - 风 ISO 80601-2-61 Medical electrical equipment - Part 2-61: Requirements for basic {6}------------------------------------------------ safety and essential performance of pulse oximeter equipment Patient Monitoring Cables has also been evaluated the performance accuracy through integrity testing, which proves that no measured data corrupt during communication between SpO2 sensors and host monitors. #### 9. Biocompatibility There is one kind of patient-directly contacting component in the subject device as the following list. | Component of Device<br>Requiring Biocompatibility | Material of<br>Component | Body Contact Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) | |---------------------------------------------------|--------------------------|--------------------------------------------|-----------------------------------| | Cable Jacket | TPU | Surface-contacting device:<br>Patient Skin | < 24 hours | We conduct biocompatibility test on the SpO2 extension cable CR002-5301 including the following: - Cytotoxicity - Sensitization - Irritation #### 10. Comparison to Predicate/Reference Device Compare with predicate/reference devices, the subject device is very similar in design principle, intended use, material and the applicable standards. The differences between subject device and predicate/reference devices do not raise any new questions of safety or effectiveness. | Elements of<br>comparison | Subject Device | Predicate Device | Reference device | Verdict | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Manufacturer | Shenzhen Coreray<br>Technology Co., Ltd. | Shenzhen Med-link Electronics Tech<br>Co., Ltd. | Curbell Medical Products, Inc. | -- | | 510K number | K192404 | K120010 | K182220 | -- | | Elements of<br>comparison | Subject Device | Predicate Device | Reference device | Verdict | | Product Name | Patient Monitoring Cables<br>SpO2 Extension Cable<br>CR002-5301 | Cable/lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) | Curbell Patient Monitoring<br>Cables | -- | | Classification<br>Name | Patient transducer and<br>electrode cable (including<br>connector) | Patient transducer and electrode<br>cable (including connector) | Patient transducer and<br>electrode cable (including<br>connector) | SE | | Regulation Class | 2 | 2 | 2 | SE | | Regulation<br>Number | 21 CFR 870.2900 | 21 CFR 870.2900 | 21 CFR 870.2900 | SE | | Product Code | DSA | DSA | DSA | SE | | OTC & Rx | Rx | Rx | Rx | SE | | Indications for Use | Patient Monitoring Cables<br>are intended to be used to<br>connect sensors, placed at<br>appropriate sites on the<br>patient to a monitoring<br>device for general<br>monitoring by health care<br>professional. | Shenzhen Med-link Cable / lead-wire<br>are intended to be used with ECG,<br>EKG, SpO2 and Invasive Blood<br>Pressure monitoring devices. The<br>Cable / lead-wire are used to connect<br>electrodes, catheters, and/or sensors<br>placed at appropriate sites on the<br>patient to a monitoring device for<br>general monitoring and/or diagnostic<br>evaluation by heath care<br>professional. | Curbell patient cables are used<br>to connect electrodes and/or<br>sensors placed at the<br>appropriate sites on the<br>patient to a monitoring device<br>for general monitoring and/or<br>diagnostic evaluation by a<br>healthcare professional. | SE<br>Note 1 | | Design | Plug, Cable/Leadwires and<br>connectors | Connectors on each cable end and a<br>shielded bulk cable | Patient trunk cable, Patient<br>leadwire and Electrode/sensor<br>connectors | SE<br>Note 1 | | Usage | Reusable | Reusable | Reusable | SE | | Cable lengths | 8ft | Various specified standard lengths | Patient trunk cable: 7-20ft<br>Patient leadwire: 18"-120" | SE<br>Note 2 | | Wire material | Shielded & Unshielded<br>Copper with TPU jacket | Shielded & Unshielded Copper with<br>PVC or TPU jacket | Shielded & Unshielded Copper<br>with PVC or TPU jacket | SE<br>Note 2 | | Sterility | Non-sterile | Non-sterile | Non-sterile | SE | | Biocompatibility | Meets ISO 10993-5 | Meets ISO 10993-5 Cytotoxicity, ISO | Meets ISO 10993-5 | SE | | Elements of<br>comparison | Subject Device | Predicate Device | Reference device | Verdict | | | Cytotoxicity, ISO 10993-10<br>Sensitization and Irritation | 10993-10 Sensitization and Irritation | Cytotoxicity, ISO 10993-10<br>Sensitization and Irritation | | | Electrical safety<br>and Performance | IEC 60601-1<br>AAMI/ANSI EC53<br>ISO 80601-2-61 | IEC 60601-1<br>AAMI/ANSI EC53 | IEC 60601-1<br>AAMI/ANSI EC53 | SE | {7}------------------------------------------------ {8}------------------------------------------------ ## Note 1 The subject device is only intended to connect the SpO2 sensor to a monitoring device, while the predicate device could be applied to ECG, EKG, SpO2, IBP monitoring. So, the difference does not affect the safety and effectiveness. ## Note 2 Although the design and description between the predicate device and subject device have few differences, there is only one model of subject device complied with IEC 60601-1 and AAMI/ANSI EC53, and the cable length and material of subject device also applied to the predicate device, so the differences do not affect the safety and effectiveness. ## 11. Summary for clinical test Clinical performance is not deemed necessary. #### 12. Conclusion The subject device Patient Monitoring Cables has all features of the predicate/reference devices and has the same intended use as the predicate. The difference in technological features does not raise different questions of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.