The BSC Removable Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are recommended to be used by trained operators in a medical environment. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Device Description

The BSC ECG cable, model 6750 is an external device used to transmit ECG signals from electrodes which are affixed to the patient's body to an external BSC programming system that includes an ECG display monitor. Each leadwire clip is attached to ECG patient electrodes. The other end of the leadwire plugs into one end of the trunk cable. The trunk cable then plugs into the BSC programming system.

AI/ML Overview

Here's an analysis of the provided text regarding the Boston Scientific Removable Patient Leads ECG Cable:

This document is a 510(k) premarket notification for a medical device. For such devices, particularly those like an ECG cable, the acceptance criteria and supporting studies are primarily focused on bench testing and demonstrating substantial equivalence to a legally marketed predicate device, rather than clinical efficacy studies often seen with diagnostic AI algorithms.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity) are not applicable in this context as they pertain to performance claims that involve analysis of patient data, not the functional performance of a cable.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Indications for Use	Transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes.	The device's indications for use are substantially equivalent to the predicate device, fulfilling this function.
Patient Usage	Reusable	Reusable (substantially equivalent to predicate).
Sterility	Supplied non-sterile; cannot be sterilized	Supplied non-sterile; cannot be sterilized (substantially equivalent to predicate).
Anatomical Sites	Attached to electrodes placed at standard specified locations on chest wall and extremities	Attached to electrodes placed at standard specified locations on chest wall and extremities (substantially equivalent to predicate).
Functionality	Transmit signals from 5 patient-connected leadwires	Transmit signals from 5 patient-connected leadwires (substantially equivalent to predicate).
Design/Appearance	5 leadwires	5 leadwires (substantially equivalent to predicate).
	Trunk cable length: 120 ± 6 inches	120 ± 6 inches (substantially equivalent to predicate).
	Leadwire length (each): 40 ± 1.5 inches	40 ± 1.5 inches (substantially equivalent to predicate).
	Connector - Patient end: patient clip	Patient clip (substantially equivalent to predicate).
	Connector - Monitor end: 6 pin DIN AAMI	6 pin DIN AAMI (substantially equivalent to predicate).
	Packaging: outer labeled box inner labeled bubble pouch non-sterile	Outer labeled box inner labeled bubble pouch non-sterile (substantially equivalent to predicate).
	Leadwire colors (ANSI/AAMI/IEC 60601-2-27): white green brown red black	White green brown red black (substantially equivalent to predicate).
	Cable Coating Materials: Polyvinyl Chloride (PVC) Santoprene Elastollan	Polyvinyl Chloride (PVC), Santoprene, Elastollan (Predicate used PVC and Santoprene; the addition of Elastollan is noted but still considered substantially equivalent).
Regulatory & Safety	Electromagnetic compatibility compliant	Bench testing performed; results "provide reasonable assurance that the proposed device design meets the performance requirements."
	Electrical safety compliant	Bench testing performed; results "provide reasonable assurance that the proposed device design meets the performance requirements."
	Biocompatibility compliant	Bench testing performed; results "provide reasonable assurance that the proposed device design meets the performance requirements."
	No new safety or performance issues	"No new safety or performance issues were found during device testing."

Study Details (for predicate comparison and bench testing)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance data. The "test set" here refers to the specific units of the ECG cable that underwent bench testing. The document does not specify the number of individual cables tested.
- Data Provenance: The testing was conducted by Boston Scientific Corporation (or its manufacturing facility, TSE) as part of the 510(k) submission process. This implies testing was done in a controlled environment as an internal validation. No country of origin is specified for the data itself beyond the location of the manufacturing facility (Taiwan) and the applicant (USA). The testing is prospective for the purpose of the 510(k) submission.
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 diagnostic performance (e.g., presence/absence of disease) is not relevant for an ECG cable. The "ground truth" for this device's performance would be engineering specifications and international standards (e.g., for electromagnetic compatibility, electrical safety). Experts involved would be engineers and regulatory specialists, but their role is to ensure compliance with standards, not diagnose using the device.
Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert interpretations of patient data, which is not relevant here. The testing involves objective measurements against predefined engineering standards.
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:
- No. This is not applicable. MRMC studies are associated with evaluating diagnostic AI devices where human performance is part of the outcome. This document is for a medical cable, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- In a broad sense, yes, for bench tests. The "standalone" performance here refers to the physical and electrical characteristics of the cable itself, independent of human interpretation of ECG data. The document states "bench testing were performed to support a determination of substantial equivalence." This includes tests like electromagnetic compatibility, electrical safety, and biocompatibility, which are conducted on the device itself against established standards. The performance metrics are direct measurements of compliance with these standards (e.g., signal integrity, insulation resistance, etc.), rather than diagnostic metrics like AUC.
The type of ground truth used:
- Engineering Specifications and Regulatory Standards. The "ground truth" for this device is its adherence to established electrical, mechanical, and biocompatibility standards (e.g., ISO, ANSI, AAMI, IEC 60601-2-27 related to leadwire colors, etc.) and its functional equivalence to the predicate device. These standards define acceptable ranges for performance characteristics.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an ECG cable. This term is used for machine learning models.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary of the Study:

The "study" described in the 510(k) summary is not a clinical trial or an AI performance study, but rather a set of bench tests and a comparison to a predicate device to demonstrate "substantial equivalence."

The acceptance criteria are implicitly met through:

Demonstration of similar Indications for Use, Patient Usage, Sterility, Anatomical Sites, and Functionality as the predicate device (Tyco K771645).
Compliance with design specifications (e.g., number of leadwires, cable lengths, connector types, leadwire colors, materials) that are either identical or considered equivalent to the predicate.
Successful completion of Electromagnetic Compatibility, Electrical Safety, and Biocompatibility testing, ensuring the device performs as intended and introduces no new safety concerns.

The study proving the device meets the acceptance criteria consists of:

Bench Testing: Internal testing conducted by the manufacturer (Boston Scientific) on the device itself (the ECG cable model 6750). The results confirmed that the "device design meets the performance requirements and performs as intended" and that "no new safety or performance issues were found."
Predicate Device Comparison: A detailed characteristic-by-characteristic comparison (Table 2-1) between the Boston Scientific ECG cable and the Tyco predicate device (K771645) to demonstrate substantial equivalence in design, technology, and intended use.

This approach is standard for 510(k) submissions of Class II devices like ECG cables, where the primary regulatory hurdle is to show that the new device is as safe and effective as a legally marketed one, without necessarily requiring new, extensive clinical studies.

Summary

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·DEC 16 2013

K132253

BOSTON SCIENTIFIC REMOVABLE PATIENT LEADS ECG CABLE

2. 510(K) SUMMARY

2.1. GENERAL INFORMATION

Device Common/UsualGeneric Name:	ECG Cable
Device Trade Name:	Removable Patient Leads ECG Cable
Applicant's Name andAddress:	Boston Scientific Corporation4100 Hamline Avenue NorthSt. Paul, Minnesota 55112-5798ERN: 2124215
Product Code/Regulation Citation:	DSA, Cardiovascular21 CFR 870.2900
Contact Name andInformation:	Melissa KlamerusRegulatory SpecialistPhone: 651.582.6771Fax: 651.582.5134E-mail: melissa.klamerus@bsci.com
Owner /Operator:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760ERN: 9912058
ManufacturingFacility:	Technical Services for Electronics Inc. (TSE)2f No. 21 Jian Kang RoadChung Ho City TaiwanERN: 3008483389

2.2. DEVICE

Removable Patient Leads ECG Cable.

2.3. PREDICATE DEVICE

ECG Patient Cables & Lead Wire System, K771645 (Oct 13, 1977).

Property of Boston Scientific Corporation Confidential. Do not Copy July 2013

2-1

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2.4. DEVICE DESCRIPTION

2.5. INDICATIONS FOR USE

The Removable Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes.

ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are recommended to be used by trained operators in a medical environment. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

2.6. DEVICE COMPARISON TO PREDICATE

The BSC ECG cable incorporates substantially equivalent design, packaging, fundamental technology, and indications for use as the predicate, ECG Patient Cables & Lead Wire System (K771645). See Table 2-1 for a comparison between the BSC ECG cable and the predicate device.

Characteristic	BSC ECG Cable	Tyco predicate device
Indications for use	ECG cable is used to transmitsignals from patient-connectedelectrodes or transducers toelectrocardiographrecorders/monitors for bothdiagnostic and monitoringpurposes.	ECG leadwire is used to transmitsignals from patient-connectedelectrodes or transducers toelectrocardiographrecorders/monitors for bothdiagnostic and monitoringpurposes.
Patient usage	Reusable	Reusable
Sterility	Supplied non-sterile; cannot besterilized	Supplied non-sterile; cannot besterilized
Anatomical sites	Attached to electrodes placed atstandard specified locations onchest wall and extremities	Attached to electrodes placed atstandard specified locations onchest wall and extremities
Functionality	transmit signals from 5 patient-connected leadwires	transmit signals from 5 patient-connected leadwires

		Table 2-1: Comparison between BSC ECG cable and predicate device

Property of Boston Scientific Corporation Confidential. Do not Copy July 2013

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K132253 BOSTON SCIENTIFIC REMOVABLE PATIENT LEADS ECG CARLE

TRADITIONAL 510(K)

Number of leadwires(patient wire)	5	5
Trunk cable length	$120 \pm 6$ inches	$120 \pm 6$ inches
Leadwire length(each)	$40 \pm 1.5$ inches	$40 \pm 1.5$ inches
Connector - Patientend	patient clip	patient clip
Connector - Monitorend	6 pin DIN AAMI	6 pin DIN AAMI
Packaging	outer labeled box inner labeled bubble pouch non-sterile	outer labeled box inner labeled bubble pouch non-sterile
Leadwire colors(ANSI/AAMI/IEC 60601-2-27)	white green brown red black	white green brown red black
Cable CoatingMaterials	Polyvinyl Chloride (PVC) Santoprene Elastollan	Polyvinyl Chloride (PVC) Santoprene

2.7. PERFORMANCE DATA

Electromagnetic compatibility, electrical safety, biocompatibility and bench testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device design meets the performance requirements and performs as intended. No new safety or performance issues were found during device testing,

2.8. CONCLUSION .

Based on the indications for use, technological characteristics, and safety and performance testing, the Removable Patient Leads ECG Cable has been shown to be appropriate for its indications for use and is considered to be substantially equivalent to the predicate ECG cable, K771645.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the graphic. The text is in a circular format, with the graphic positioned in the center.

Public Health Service

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

December 16, 2013

Boston Scientific Cardiac Rhythm Management Ms. Melissa Klamerus 4100 Hamline Avenue North St. Paul, MN 55112

Re: K132253

Trade/Device Name: Boston Scientific Removable Patient Leads ECG Cable, Model 6750 Regulatory Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (including Connector) Regulatory Class: Class II (Two) Product Code: DSA Dated: November 14, 2013 Received: November 15, 2013

Dear Ms. Klamerus:

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.

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Page 2 - Ms. Melissa Klamerus

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 yours.

Owen-P. Faris -S

for

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

Enclosure

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K132253

Boston Scientific Removable Patient Leads ECG Cable Traditional 510(k)

APPENDIX 1

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Indications for Use Statement

510(k) Number(if known)
Device Name	Removable Patient Leads ECG Cable
Indications forUse	The BSC Removable Patient Leads ECG Cable is used to transmitsignals from patient-connected electrodes or transducers toelectrocardiograph recorders/monitors for both diagnostic andmonitoring purposes. ECG cables are supplied non-sterile and arenot sterilizable; they are reusable devices and are recommended tobe used by trained operators in a medical environment. Use islimited by the indications for use of the connected monitoring ordiagnostic equipment.

510(k) Number(if known)

Device Name

Removable Patient Leads ECG Cable

Indications forUse

The BSC Removable Patient Leads ECG Cable is used to transmitsignals from patient-connected electrodes or transducers toelectrocardiograph recorders/monitors for both diagnostic andmonitoring purposes. ECG cables are supplied non-sterile and arenot sterilizable; they are reusable devices and are recommended tobe used by trained operators in a medical environment. Use islimited by the indications for use of the connected monitoring ordiagnostic equipment.

Prescription Use _ × (Per 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clive Z.

Digitally signed by Owen P. Faris -5 Date: 2013. 12.16 16:21:28 -05'00'

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).