PSA Cable

K170815 · Boston Scientific Corporation · DTC · Jul 6, 2017 · Cardiovascular

Device Facts

• Record ID: K170815
• Device Name: PSA Cable
• Applicant: Boston Scientific Corporation
• Product Code: DTC · Cardiovascular
• Decision Date: Jul 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3630
• Device Class: Class 2

Intended Use

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 Story

PSA Cable (Model 6763) is an external accessory cable; transmits sensing signals and pacing pulses between implanted leads and external Pacing System Analyzer (PSA) equipment. Used during pacemaker/defibrillator implantation; operated by clinicians to evaluate lead placement/integrity and determine pacing parameters. Leadwires attach to implanted leads; trunk cable connects to PSA device. Facilitates clinical decision-making regarding lead positioning and device settings; benefits patient by ensuring proper lead function and optimal pacing therapy. Non-patient contacting trunk cable; patient-contacting leadwires categorized as limited contact (<24 hours).

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing included sterilization, biocompatibility, electromagnetic compatibility, electrical safety, and performance testing to demonstrate substantial equivalence.

Technological Characteristics

Reusable cable; 4 patient-connected leadwires with alligator clips; 6-pin push/pull instrument connector. Trunk cable includes yoke and ferrite cylinder. Biocompatibility per ISO 10993-1 (limited contact <24 hours). Supplied non-sterile/resterilizable. No active electronic components or software.

Indications for Use

Indicated for use with Boston Scientific external Pacing System Analyzer (PSA) equipment during pacemaker and defibrillator implantation to evaluate lead placement and integrity and determine pacing parameters.

Regulatory Classification

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.

Predicate Devices

• PK-141 Patient Cable (K083674)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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

Type of Use (Select one or both, as applicable)

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> 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 [phone] Fax

www.bostonscientific.com

510(k) Summary for PSA Cable, Model 6763

Email: [e-mail]

## 1. Submitter

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

Contact: Melissa Klamerus Regulatory Affairs Phone: [phone]

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

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.

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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

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 for the support of other pacemaker functionality.

# 6. Substantial Equivalence

| Characteristic | BSC Model 6763 PSA Cable | Biotronik Model PK-141 PSA Cable |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The PSA cable is an accessory indicated<br>for use with external PSA equipment<br>distributed by Boston Scientific and is used<br>for the transmission of sensing signals and<br>pacing pulses for evaluation of lead<br>placement characteristics during implant of<br>pacemakers and defibrillators and for the<br>support of other pacemaker functionality. | The PK-141 cable is an accessory indicated<br>for use with external equipment from<br>Biotronik and is used for the transmission of<br>sensing signals and pacing pulses for<br>diagnosis and therapy in the context of<br>intracardiac examinations including the<br>following activities: temporary external<br>pacing, lead threshold determination, and<br>pacemaker function test. |
| Usage | Reusable | Reusable |
| Sterility | Supplied non-sterile/resterilizable | Supplied sterile/resterilizable |
| Functionality | transmit signals from 4 patient-connected<br>leadwires | transmit signals from 4 patient-connected<br>leadwires |
| Cable length | Overall length: ~ 112 inches<br>Trunk cable length: 100 ± 6 inches<br>Leadwire length (each)<br>2-9" ± 1 inch<br>2-12" ± 1 inch | Overall length: 2.8m (~110.2 inches)<br>Trunk cable length: 2.5m (~ 98.4 in)<br>Leadwire length (each)<br>2-0.23 m (~ 9 inches)<br>2-0.30 m (~11.8 inches) |
| Connectors | Alligator clip<br>6 pin push/pull | Alligator clip<br>6 pin push/pull |
| Packaging | ● outer labeled box<br>● inner bubble pouch/bag<br>● non-sterile | ● outer labeled box<br>● inner sterile box<br>● 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.