The Fixed 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-sterilizable; they are reusable devices and are intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or dagnostic equipment.

Device Description

The BSC Model 3153 ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body to an external BSC programming system display monitor. One end of each leadwire clip is attached to an ECG patient electrode; the other end is affixed / molded into one end of the trunk cable. The trunk cable then plugs into the BSC programming system.

AI/ML Overview

The provided text describes the regulatory clearance for the Fixed Patient Leads ECG Cable (Model 3153) and its comparison to a predicate device, rather than a clinical study evaluating its diagnostic or AI-assisted performance. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted from the provided text, with "N/A" for sections not covered:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (What was measured/tested?)	Reported Device Performance (Did it meet the criteria?)
Component Qualification	Ability for Affinity to provide ECG Cables that meet BSC mechanical and electrical specifications, as well as functionality/performance requirements.	Verified the ability to meet BSC mechanical and electrical specifications, and functionality/performance requirements.
Electrical Device Verification Testing (DVT)	- Electromagnetic Immunity / Electromagnetic Compatibility (EMI/EMC) standards: IEC 60601-1-2:2014 - Electrical Safety standards: IEC 60601-1:2005 - General functional testing - System electrical design specifications (for Model 3300 Programmer and associated cables).	All requirements were met (including EMI/EMC, Electrical Safety, and general functional testing). Verified that the Model 3300 Programmer and associated cables meet system electrical design specifications.
Design Validation Testing	User needs and intended use of the ECG Cable.	Demonstrated that the cable meets user needs and its intended use.
Biocompatibility Assessment	Standards: EN ISO 10993-5:2009 (in vitro cytotoxicity), EN ISO 10993-10:2013 (irritation and skin sensitization).	Demonstrated that the ECG Cable is biocompatible for its intended use, based on the specified standards.
Design Analysis and Evaluation Testing	Device robustness and correct implementation of the design intent.	Evaluated device robustness and correct implementation of the design intent. Results provided here are a general statement of positive outcome.
Packaging Assessment	Adhesion, legibility, and indelibility requirements for Affinity-manufactured ECG Cable box labels.	Demonstrated that Affinity-manufactured ECG Cable box labels meet adhesion, legibility, and indelibility requirements.
General Performance (Overall Conclusion)	- Meets performance requirements - Performs as intended - Appropriate for its Indications for Use - Substantially equivalent to predicate device.	- Provides reasonable assurance that the proposed device design meets performance requirements and performs as intended. - Considered substantially equivalent to the predicate BSC Removable Patient Leads ECG Cable (K132253) based on Indications for Use, technological characteristics, and safety and performance testing.
Physical/Structural Characteristics (Comparison)	- Trunk Cable Length: Proposed: $80\pm2"$ vs. Predicate: $120\pm6"$ - Leadwire Length: Proposed: $30\pm2"$ vs. Predicate: $40\pm1.5"$ - Leadwire/Trunk Cable Joint: Proposed: Fixed vs. Predicate: Removable	The table explicitly states these differences but implies they are acceptable variations for substantial equivalence, as the overall conclusion states substantial equivalence. The document does not describe a performance impact due to these differences.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes engineering and bench testing, not a clinical study with a "test set" of patient data. Therefore, this information is N/A.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is N/A as the testing was not clinical or involving expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is N/A.

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

This is N/A. The device is an ECG cable, not an AI-powered diagnostic tool.

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

This is N/A. The device is a physical cable, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by adherence to engineering specifications, electrical safety standards, biocompatibility standards, and functional requirements for a medical device rather than medical "ground truth" like pathology or expert consensus. For example, "ground truth" for electrical safety would be defined by the limits set in IEC 60601-1.

8. The sample size for the training set

This is N/A as there is no "training set" for an ECG cable.

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

This is N/A.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

November 3, 2017

Boston Scientific Corporation Elizabeth Lisowski Principal Regulatory Affairs Specialist 4100 Hamline Avenue North St. Paul, Minnesota 55112

Re: K172591

Trade/Device Name: Fixed Patient Leads ECG Cable (Model 3153) Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: October 4, 2017 Received: October 5, 2017

Dear Elizabeth Lisowski:

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 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);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Willemen

for 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) K172591

Device Name Fixed Patient Leads ECG Cable (Model 3153)

Indications for Use (Describe)

The Fixed 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.

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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510(k) Summary

1. GENERAL INFORMATION

Device Common / UsualGeneric Name:	ECG Cable
Device Trade Name:	Fixed Patient Leads ECG Cable (Model 3153)
Applicant's Name andAddress:	Boston Scientific Corporation4100 Hamline Avenue NorthSt. Paul, Minnesota 55112-5798FDA Registration Establishment No. 2124215
Product Code /Regulation Citation:	DSA, Cardiovascular / 21 CFR Part §870.2900The ECG Cable is a Class II device as defined in 21 CFR Part§870.2900 and has a product code of DSAPanel: 74 Cardiovascular
Contact Name andInformation:	Elizabeth A. LisowskiPrincipal Regulatory SpecialistPhone: 651-532-5131Fax: 651-582-5134E-mail: beth.lisowski@bsci.com
Owner / Operator:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, Massachusetts 01760FDA Registration Establishment No: 9912058
Manufacturing Facility:	Affinity Medical Technologies3545 Harbor BoulevardCosta Mesa, California 92626FDA Registration Establishment No: 2031044

2. DEVICE

Fixed Patient Leads ECG Cable (Model 3153)

3. PREDICATE DEVICE

Removable Patient Leads ECG Cable (K132253; cleared December 16, 2013)

DEVICE DESCRIPTION 4.

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5. INDICATIONS FOR USE

The Fixed 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 intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or diagnostic equipment.

DEVICE COMPARISON TO PREDICATE 6.

The BSC ECG cable incorporates substantially equivalent design, packaging, fundamental technology, and Indications for Use as the predicate ECG Cable (Removable Patient Leads ECG Cable; K132253). Refer to Table 1 for a comparison between the BSC Fixed Patient Leads ECG Cable and the BSC Predicate Removable Patient Leads ECG Cable.

Characteristic	Proposed BSC Fixed Patient LeadsECG Cable	Predicate BSC Removable PatientLeads ECG Cable
Indications for Use	ECG Cable is used to transmit signalsfrom patient-connected electrodes ortransducers to electrocardiographrecorders / monitors for bothdiagnostic and monitoring purposes.	ECG Cable is used to transmit signalsfrom patient-connected electrodes ortransducers to electrocardiographrecorders / monitors for both diagnosticand monitoring purposes.
Patient Usage	Reusable	Reusable
Sterility	Supplied non-sterile; cannot besterilized	Supplied non-sterile; cannot besterilized
Anatomical Sites	Attached to electrodes placed atstandard specified locations on chestwall and extremities	Attached to electrodes placed atstandard specified locations on chestwall and extremities
Design / Appearance / Functionality
Functionality	Transmits signals from 5 patient-connected leadwires	Transmits signals from 5 patient-connected leadwires
No. of Leadwires(Patient Wire)	5	5
Leadwire / TrunkCable Joint	Fixed	Removable
Trunk Cable Length(from edge of yoke toedge of patient clip)	$80\pm2"$	$120\pm6"$
Leadwire Length(each)	$30\pm2"$	$40\pm1.5"$
Connector - PatientEnd	Patient Clip	Patient Clip
Connector - MonitorEnd	6 pin DIN AAMI	6 pin DIN AAMI

Table 1: Comparison between BSC Fixed Patient Leads ECG Cable and BSC Predicate
Removable Patient Leads ECG Cable.

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Characteristic	Proposed BSC Fixed Patient LeadsECG Cable	Predicate BSC Removable PatientLeads ECG Cable
Materials	Biocompatible per 10993-1	Biocompatible per 10993-1
Leadwire Colors(IEC 60601-2-27)	White RedGreen BlackBrown	White RedGreen BlackBrown
Packaging	Outer labeled boxInner labeled bubble pouchNon-sterile	Outer labeled boxInner labeled bubble pouchNon-sterile

7. PERFORMANCE DATA

Component Qualification, Electrical Device Verification Testing (DVT) (including Electromagnetic Immunity / Electromagnetic Compatibility (EMI / EMC), Electrical Safety, and general functional testing), Biocompatibility Assessment, and a Packaging Assessment were performed to support a determination of substantial equivalence.

Design Verification Testing conducted to support this submission demonstrated that all requirements were met. Component Qualification verified the ability for Affinity to provide ECG Cables that meet BSC mechanical and electrical specifications, as well as functionality / performance requirements. Electrical DVT verified that the Model 3300 Programmer and associated cables, including the proposed ECG Cable, meet system electrical design specifications.

Design Validation Testing conducted on the proposed ECG Cable demonstrated that the cable meets user needs and its intended use. Results of Biocompatibility Testing demonstrated that the ECG Cable is biocompatible for its intended use.

Design Analysis and Evaluation Testing evaluated device robustness and correct implementation of the design intent. Results of the Packaging Assessment demonstrated that Affinity-manufactured ECG Cable box labels meet adhesion, legibility, and indelibility requirements.

Standards applicable to the proposed ECG Cable:

ANSI/AAMI EC53:2013: ECG trunk cables and patient leadwires ●
IEC 60601-1:2005: 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 safety - Collateral standard: Electromagnetic compatibility - requirements and tests

Standards used to perform Biocompatibility Testing:

. EN ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

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EN ISO 10993-10:2013: Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
Results of this testing provide reasonable assurance that the proposed device design meets the performance requirements and performs as intended.

CONCLUSION 8.

Based on the Indications for Use, technological characteristics, and safety and performance testing, the BSC Fixed 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 BSC Removable Patient Leads ECG Cable cleared by FDA on December 16, 2013 (K132253).

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).