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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a medical device: "Patient Monitoring Cable (SpO2 Extension Cable)" (K192404).

Based on the content, this document does not describe a study involving an AI/ML algorithm or human readers for diagnostic purposes. Instead, it details the substantial equivalence review for a physical medical cable. Therefore, many of the requested points regarding AI/ML device acceptance criteria and study designs are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (referring to the testing performed for this physical device) that proves it meets those criteria:

Device: Patient Monitoring Cable (SpO2 Extension Cable)
Purpose: Connects SpO2 sensors to a monitoring device to transmit signals.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable for a physical cable):

Acceptance Criteria (Standards/Tests)	Reported Device Performance (Compliance Statement)
Safety and Essential Performance (Electrical)
IEC 60601-1: 2005+A1:2012 (Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance)	"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." (Section 8)
ANSI AAMI EC53: 2013 (ECG Trunk Cables And Patient Leadwires)	Evaluated by lab bench testing according to this standard. (Section 8, Section 10 - Electrical safety and Performance row)
ISO 80601-2-61: 2017-12 (Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment)	Evaluated by lab bench testing according to this standard. (Section 8, Section 10 - Electrical safety and Performance row)
Performance Accuracy (Data Integrity)
Integrity testing (to prevent measured data corruption)	"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." (Section 8)
Biocompatibility (Patient Contact)
ISO 10993-1 (General principles governing biological evaluation of medical devices) for: Cytotoxicity, Sensitization, Irritation	"Meets ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation" (Section 10 - Biocompatibility row). Specifically, "conduct biocompatibility test on the SpO2 extension cable CR002-5301 including the following: Cytotoxicity, Sensitization, Irritation" (Section 9). The cable jacket (TPU) is categorized as "Surface-contacting device: Patient Skin" with a contact duration of "< 24 hours".

2. Sample Size Used for the Test Set and Data Provenance:
This information is not explicitly stated in the document. The testing performed would involve internal lab bench testing on manufactured samples of the cable, not a "test set" in the context of clinical data or AI validation. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's a physical device and not based on clinical data collection for performance evaluation.

3. Number of Experts Used to Establish Ground Truth for Test Set and Their Qualifications:
Not applicable. Ground truth for a physical cable's performance (e.g., electrical safety, material biocompatibility) is established by adhering to recognized international and national standards and performing lab tests. It does not involve expert consensus in the way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set:
Not applicable. There is no "adjudication method" in the context of a physical cable's testing for electrical and material performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:
For this device, "ground truth" refers to compliance with recognized engineering and medical device standards (e.g., IEC 60601-1, AAMI EC53, ISO 80601-2-61 for electrical performance and signal integrity; ISO 10993 for biocompatibility) and physical testing results demonstrating adherence to these standards.

8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning algorithms, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.

In summary, the provided document details the regulatory clearance process for a physical medical cable, demonstrating its substantial equivalence to predicate devices through adherence to established safety, performance, and biocompatibility standards via lab bench testing. It does not involve any AI/ML components or associated study methodologies like MRMC studies or ground truth establishment by clinical experts for diagnostic tasks.

Summary

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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

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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

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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)

Residential (Part of CER 901 Category)
Commercial/Industrial (Part of CER 901 Category)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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)

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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

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.

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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 RecognitionNo.	Date ofRecognition
ANSI AAMIES 60601-1	Medical Electrical Equipment -Part 1: General Requirementsfor Safety	2005/(R)2012And A1:2012,	19-4	07/09/2014
ISO 80601-2-61	Medical electrical equipment -Part 2-61: Particularrequirements for basic safetyand essential performance ofpulse oximeter equipment	2017-12	1-139	09/17/2018
ANSI AAMIEC53	ECG trunk cables and patientleadwires	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

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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 DeviceRequiring Biocompatibility	Material ofComponent	Body Contact Category(ISO 10993-1)	Contact Duration(ISO 10993-1)
Cable Jacket	TPU	Surface-contacting device: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 ofcomparison	Subject Device	Predicate Device	Reference device	Verdict
Manufacturer	Shenzhen CorerayTechnology Co., Ltd.	Shenzhen Med-link Electronics TechCo., Ltd.	Curbell Medical Products, Inc.	--
510K number	K192404	K120010	K182220	--
Elements ofcomparison	Subject Device	Predicate Device	Reference device	Verdict
Product Name	Patient Monitoring CablesSpO2 Extension CableCR002-5301	Cable/lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure)	Curbell Patient MonitoringCables	--
ClassificationName	Patient transducer andelectrode cable (includingconnector)	Patient transducer and electrodecable (including connector)	Patient transducer andelectrode cable (includingconnector)	SE
Regulation Class	2	2	2	SE
RegulationNumber	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 Cablesare intended to be used toconnect sensors, placed atappropriate sites on thepatient to a monitoringdevice for generalmonitoring by health careprofessional.	Shenzhen Med-link Cable / lead-wireare intended to be used with ECG,EKG, SpO2 and Invasive BloodPressure monitoring devices. TheCable / lead-wire are used to connectelectrodes, catheters, and/or sensorsplaced at appropriate sites on thepatient to a monitoring device forgeneral monitoring and/or diagnosticevaluation by heath careprofessional.	Curbell patient cables are usedto connect electrodes and/orsensors placed at theappropriate sites on thepatient to a monitoring devicefor general monitoring and/ordiagnostic evaluation by ahealthcare professional.	SENote 1
Design	Plug, Cable/Leadwires andconnectors	Connectors on each cable end and ashielded bulk cable	Patient trunk cable, Patientleadwire and Electrode/sensorconnectors	SENote 1
Usage	Reusable	Reusable	Reusable	SE
Cable lengths	8ft	Various specified standard lengths	Patient trunk cable: 7-20ftPatient leadwire: 18"-120"	SENote 2
Wire material	Shielded & UnshieldedCopper with TPU jacket	Shielded & Unshielded Copper withPVC or TPU jacket	Shielded & Unshielded Copperwith PVC or TPU jacket	SENote 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 ofcomparison	Subject Device	Predicate Device	Reference device	Verdict
	Cytotoxicity, ISO 10993-10Sensitization and Irritation	10993-10 Sensitization and Irritation	Cytotoxicity, ISO 10993-10Sensitization and Irritation
Electrical safetyand Performance	IEC 60601-1AAMI/ANSI EC53ISO 80601-2-61	IEC 60601-1AAMI/ANSI EC53	IEC 60601-1AAMI/ANSI EC53	SE

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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.

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).