The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality.

Device Description

The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.

AI/ML Overview

This document is a 510(k) summary for the Boston Scientific PSA Cable, Model 6763. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria with numerical performance targets for an AI device.

Therefore, many of the requested sections about acceptance criteria, performance metrics, sample sizes, and expert adjudication are not applicable or cannot be extracted from this document, as it pertains to a physical cable intended for signal transmission, not an AI-powered diagnostic device.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI device's performance metrics (e.g., sensitivity, specificity). The "Performance Data" section describes categories of testing for a physical cable.

Acceptance Criteria Category	Reported Device Performance (as far as applicable for a cable)
Sterilization	Verification and Validation (V&V) testing performed. Implied successful.
Biocompatibility	V&V testing performed. Implied successful.
Electromagnetic Compatibility	V&V testing performed. Implied successful.
Electrical Safety	V&V testing performed. Implied successful.
Performance/Bench testing	V&V testing performed. Implied successful.

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

Not applicable. This document describes testing for a physical cable, not a software device that uses a test set of data. The performance section mentions "Design verification and validation (V&V) testing" which refers to laboratory and bench tests for electrical, mechanical, and safety aspects, not a dataset from patients.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic AI.

4. Adjudication method for the test set

Not applicable.

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 device for diagnostic assistance.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" for a cable's performance would be engineering specifications and standards, verified through bench testing, not clinical outcomes or expert consensus on medical images/data.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.

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

July 6, 2017

Boston Scientific Corporation Melissa Klamerus Regulatory Specialist 4100 Hamline Ave North St. Paul. Minnesota 55112

Re: K170815

Trade/Device Name: PSA Cable Regulation Number: 21 CFR 870.3630 Regulation Name: Pacemaker Generator Function Analyzer Regulatory Class: Class II Product Code: DTC Dated: March 16, 2017 Received: March 17, 2017

Dear Melissa 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.

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,

M.A. Hilleman

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) K170815

Device Name PSA Cable

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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K170815 Page 1 of 3

4100 Hamline Avenue North St. Paul, MN 55112-5798

651.582.4000 Tel 651.582.5134 Fax

www.bostonscientific.com

510(k) Summary for PSA Cable, Model 6763

Email: Melissa.klamerus@bsci.com

1. Submitter

Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798

Contact: Melissa Klamerus Regulatory Affairs Phone: (651) 582-6771

Date Prepared: February 25, 2017

2. Device

Trade Name: PSA Cable Common Name: PSA Cable Product Code and Panel: DTC, Cardiovascular Classification Regulation: 21 CFR 870.3630

3. Predicate Device

Trade Name: PK-141 Patient Cable (PSA Cable) Manufacturer: Biotronik Clearance Number: K083674, April 1 2009 Common Name: PSA Cable Product Code: DTC Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR 870.3630

4. Device Description

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K170815 Page 2 of 3

The PSA cable leadwires may incidentally contact the patient's skin as they lay across the body while attached to the leads. Per ISO 10993-1, skin/body contact for this device is categorized as Limited (<24 hours). The trunk cable (including yoke, ferrite cylinder and instrument connector) is non-patient contacting.

5. Indication for Use

6. Substantial Equivalence

Characteristic	BSC Model 6763 PSA Cable	Biotronik Model PK-141 PSA Cable
Indications foruse	The PSA cable is an accessory indicatedfor use with external PSA equipmentdistributed by Boston Scientific and is usedfor the transmission of sensing signals andpacing pulses for evaluation of leadplacement characteristics during implant ofpacemakers and defibrillators and for thesupport of other pacemaker functionality.	The PK-141 cable is an accessory indicatedfor use with external equipment fromBiotronik and is used for the transmission ofsensing signals and pacing pulses fordiagnosis and therapy in the context ofintracardiac examinations including thefollowing activities: temporary externalpacing, lead threshold determination, andpacemaker function test.
Usage	Reusable	Reusable
Sterility	Supplied non-sterile/resterilizable	Supplied sterile/resterilizable
Functionality	transmit signals from 4 patient-connectedleadwires	transmit signals from 4 patient-connectedleadwires
Cable length	Overall length: ~ 112 inchesTrunk cable length: 100 ± 6 inchesLeadwire length (each)2-9" ± 1 inch2-12" ± 1 inch	Overall length: 2.8m (~~110.2 inches)Trunk cable length: 2.5m (~~ 98.4 in)Leadwire length (each)2-0.23 m (~ 9 inches)2-0.30 m (~11.8 inches)
Connectors	Alligator clip6 pin push/pull	Alligator clip6 pin push/pull
Packaging	● outer labeled box● inner bubble pouch/bag● non-sterile	● outer labeled box● inner sterile box● sterile

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7. Performance Data

Design verification and validation (V&V) testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device design meets performance requirements and performs as intended.

Design verification and validation testing included:

. Sterilization
. Biocompatibility
. Electromagnetic compatibility
. Electrical safety
Performance/Bench testing ●

8. Conclusion

Based on the indications for use, technological characteristics, and performance testing, the BSC PSA cable has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate cable.

Regulation Number and Section

§ 870.3630 Pacemaker generator function analyzer.

(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).