The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Device Description

The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

AI/ML Overview

The provided text does not describe acceptance criteria for a medical device in the typical sense of performance metrics for an AI/ML model, nor does it detail a study proving such criteria are met. Instead, it is a 510(k) Premarket Notification summary for "Caremed Patient Cable and Leadwires."

This document focuses on establishing substantial equivalence to a previously cleared predicate device, rather than defining and proving performance against specific quantitative acceptance criteria of an AI/ML system.

However, I can extract the relevant information from the document that pertains to the device's characteristics and the standards it meets, which serve as its "acceptance criteria" in the context of a 510(k) submission for a non-AI medical device.

Here's an interpretation based on the provided text, recognizing it's not about AI performance metrics:

The "acceptance criteria" for this device are its compliance with recognized industry standards and its substantial equivalence to a predicate device. The "study" proving this involves a comparison to the predicate device and demonstration of compliance with relevant safety and performance standards through testing (though detailed test results are not provided in this summary).

Here's the information formatted as requested, with explanations where the categories don't directly apply to this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Compliance with Standards / Equivalence)	Reported Device Performance (Claimed Compliance / Comparison)
Intended Use & Indications for Use: Matches predicate device.	The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. (Matches predicate)
Anatomical Sites: Matches predicate device.	Attached to electrodes placed at standard specified locations on chest wall and extremities. (Matches predicate)
Design / Appearance: Similar to predicate (cables with grabber, snap & needle configuration of ECG electrode connector and common "header" connection).	Cables with "grabber,snap&needle" configuration of ECG electrode connector (distal connector) and common "header" connection (proximal connector). (Predicate had "grabber/snap" only, but difference is deemed not to bring safety/effectiveness problem).
Sterility: Supplied non-sterile.	Supplied non-sterile. (Matches predicate)
Usage: Reusable.	Reusable. (Predicate was single-patient use; difference deemed not to bring safety/effectiveness problem).
Material: PA66, PVC, ABS.	PA66, PVC, ABS. (Matches predicate)
Cable Length: Various lengths (0.9m, 3.4m, 2.5m, 2.4m).	0.9m/3.4m/2.5m/2.4m. (Predicate had 0.9m/3.4m; difference deemed not to bring safety/effectiveness problem).
Cable Construction: Flexible shielded multi conductor electrical cable.	Flexible shielded multi conductor electrical cable. (Matches predicate)
Wire Color: Grey.	Grey. (Predicate was White; difference not stated as problematic).
Leadwire Construction: Shielded copper leadwire with polymer jacket.	Shielded copper leadwire with polymer jacket. (Matches predicate)
Lead Number: 5 & 10.	5 & 10. (Predicate had 3, 5 & 6; difference deemed not to bring safety/effectiveness problem).
Proximal Connector Design: Compatible to MultiLink yoke design.	Compatible to MultiLink yoke design. (Matches predicate)
Distal Connector Design: "Grabber," "Snap," & "Needle" electrode connectors.	"Grabber","Snap"&"Needle"electrode connectors. (Predicate had "Grabber" or "Snap"; difference deemed not to bring safety/effectiveness problem).
Conformance Standards: ANSI/AAMI EC53-1995 (R)2001, R(2008), ANSI/AAMI EC13 (product markings only), 21 CFR Part 898, IEC 60601-1, ISO 10993-5, ISO 10993-10.	Device "meets the requirements of EC53 and IEC60601-1" for differences in usage, cable length, lead number, and distal connector design. The device "meets the following the recognized standards" as listed in the acceptance criteria.
Clinical Test Data: Not applied.	Not applied.
Substantial Equivalence: Equivalent to K142489.	Claimed Substantially Equivalent (SE) to predicate K142489.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. For this type of device (patient cables and leadwires), the "test set" for substantial equivalence is primarily a comparison against technical specifications and performance standards, not a clinical data set in the way an AI/ML model would be evaluated. The text indicates "Not applied" for clinical test data.
Data Provenance: Not applicable. The "data" are technical specifications, material properties, and compliance test results (which are not detailed in this summary).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of an AI/ML model evaluation does not apply to this device. The "ground truth" here is the established safety and performance requirements set by industry standards and regulatory bodies, along with the characteristics of the predicate device.

4. Adjudication method for the test set

Not applicable. There's no "adjudication method" described as would be used for expert consensus on AI outputs. The evaluation is based on technical specifications and compliance with standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device; therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Ground Truth: For this type of device, the "ground truth" is defined by:
- Regulatory Standards: Specifically, ANSI/AAMI EC53, ANSI/AAMI EC13, 21 CFR Part 898, IEC 60601-1, ISO 10993-5, and ISO 10993-10.
- Predicate Device Characteristics: The characteristics, indications for use, and performance of the Unimed Disposable ECG lead wires (K142489).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI/ML model; the "ground truth" for compliance testing is established by recognized standards and the clear specifications of the predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are depicted with simple, curved lines, creating a sense of unity and connection.

October 24, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Caremed Medical Technology Co., Ltd. Xinlin Xiao, QA Manager Zone B. 3/f. 11 Building, Hebei Industrial Area, Longhua Office, Longhua New D Shenzhen, 518021 CHINA

Re: K153188

Trade/Device Name: Caremed Patient Cable and Leadwires, Models: 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ and MQ10-LN Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 2, 2016 Received: September 16, 2016

Dear Xinlin Xiao:

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mada Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153188

Device Name

Caremed patient cable and leadwires, Models 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN

Indications for Use (Describe)

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)
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Image /page/3/Picture/1 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray. The logo is simple and modern, and the colors are eye-catching.

Section 5

510(K) Summary

1. Prepared Date: 2016/9/2

2. Submitter Information

Name	Shenzhen Caremed Medical Technology Co., Ltd.
Address	Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen,China
Tel	0086-755-27184369
Fax	0086-755-27186486

3. Contact Person

Contact person	Xinlin Xiao
Title	QA manager
Address	Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen, China
Tel	0086-755-27184369
Fax	0086-755-27186486
E-mail	cm001@szcaremed.com

4. Proposed Device Information

Trade Name	Caremed patient cable and leadwires
Model	2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN
Common name	Patient Transducer and electrode cable (including connector)
Regulatory class	II
Production regulation	21 CFR §870.2900
Product code	DSA
Panel	Cardiovascular

5. Predicate Device Information

510(K)No.	Trade Name/model	Submitter
K142489	Unimed Disposable ECG lead wires	Unimed MedicalSupplies,Inc.

6. Device description

The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various

Caremed patient cable and lead wires -510(k) Submission

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Image /page/4/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray.

electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

7. Intended use

Comparisonitem	Subject DeviceApplied present	Predicate DeviceK142489
Intended use&Indicationsfor Use	The subject device are intendedfor use only by trained healthcareprofessionals for measurement ofa patient's ECG for bothdiagnostic and monitoringpurposes. Use is limited by theindications for use of theconnected monitoring ordiagnostic equipment.	The unimed disposable ECG leadwires are intended for use only bytrained healthcare professionalsfor measurement of a patient'sECG for both diagnostic andmonitoring purposes. Use islimited by the indications for useof the connected monitoring ordiagnostic equipment. Theseleadwires are intended forshort-term use only (an averagepatient stay of 5 days).
AnatomicalSites	Attached to electrodes placed atstandard specified locations onchest wall andextremities	Attached to electrodes placed atstandard specified locations onchest wall andextremities
Design/Appearance	Cables with"grabber,snap&needle"configuration of ECG electrodeconnector (distal connector) andcommon "header" connection(proximal connector)	Cables with "grabber/snap"configuration of ECG electrodeconnector (distal connector) andcommon "header" connection(proximal connector)
Sterility	Supplied non-sterile	Supplied non-sterile
Usage	Reusable	Single patient use
Material	PA66,PVC,ABS	PA66,PVC,ABS
Cable Length	0.9m/3.4m/2.5m/2.4m	0.9m/3.4m
Caremed patient cable and lead wires -510(k) SubmissionPage 2 of 4

8. Comparison to predicate device

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Image /page/5/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters.

CableConstruction	Flexible shielded multi conductorelectrical cable	Flexible shielded multi conductorelectrical cable
Wire Color	Grey	White
LeadwireConstruction	Shielded copper leadwire withpolymer jacket	Shielded copper leadwire withpolymer jacket
Lead number	5&10	3,5&6
ProximalconnectorDesign	Compatible to MultiLinkyoke design	Compatible to MultiLinkyoke design
DistalconnectorDesign	"Grabber","Snap"&"Needle"electrodeconnectorslabeledLL(red),RA(white),RL(green),LA(black)&,V(brown) or socketconnecting with lead wires	"Grabber"or"Snap"electrodeconnectors are labeledLL(red),RA(white),RL(green),LA(black)&,V(brown)
Conformancestandard	IEC60601-1(Safety)EC53(Performance)ISO10993-5,-10(Biocompatibility)	IEC60601-1(Safety)EC53(Performance)ISO10993-5,-10(Biocompatibility)

From the comparison form above, both devices have the same Intended use &Indications for Use Anatomical Sites, Design /Appearance, Sterility, Material,Cable Construction,& Conformance standard.

But in Usage,cable length, Lead number& Distal connector Design item,both devices have some difference,But these units meet the requirements of EC53 and IEC60601-1, so these difference does not bring any safety and effectiveness problem.

9. Clinical test data

Not applied

10. Substantial Equivalence Statement

The subject device meets the following the recognized standards:

ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires ● (except4.3.1)
ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
Part 898: Performance Standard for Electrode Lead Wires and Patient Cables ●
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010

Caremed patient cable and lead wires -510(k) Submission

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Image /page/6/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red, and two Chinese characters in gray below. The logo is simple and modern, and the colors are eye-catching.

11. Discussion

Based on the comparison ,analysis, and the submitted performance data, the proposed device is claimed to be Substantially Equivalent (SE) to the predicate devices in K142489.

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).