PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A

K093858 · St. Jude Medical, Cardiac Rhythm Management Divisi · DSA · Apr 2, 2010 · Cardiovascular

Device Facts

• Record ID: K093858
• Device Name: PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
• Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
• Product Code: DSA · Cardiovascular
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field. The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field. The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

Device Story

PSA cables and adapters facilitate electrical connection between implanted cardiac pacing leads and external Pacing System Analyzers (PSA). Cables (Models 4160, 4161) are disposable; adapters (Model 4053A) are non-disposable. Devices operate by transmitting electrical signals from leads within the sterile field to PSAs located outside the sterile field. Used by clinicians during cardiac procedures to enable lead testing and pacing system analysis. Output allows healthcare providers to assess lead performance and pacing parameters, supporting clinical decision-making regarding lead placement and system integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive electrical connection cables and adapters. Materials and design are consistent with previously cleared predicate devices for cardiac pacing lead connectivity. No active electronic components, software, or energy sources.

Indications for Use

Indicated for connecting cardiac pacing leads (IS-1 or SJ4) to Pacing System Analyzers (PSA) for patients undergoing cardiac pacing procedures. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• St. Jude Medical PSA cables (P910023/S154, P030054/S67, P950022/S42)
• Remington Medical cable adapter Model 4053 (K971968)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION [510(K)] SUMMARY

Date Prepared:

March 30, 2010

Sylmar, CA 91342

St. Jude Medical, CRMD 15900 Valley View Court APR - 2 2010

Submitter: Address:

Phone: Fax:

Contact Person:

Beena Flynn

818-493-3592

818 493-3615

Trade Name/Proprietary Name:

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

Disposable Surgical PSA cables Non-Disposable PSA adapters

Class II, 21 CFR 870.3720

Class II, 21 CFR 870.2900

Classification:

Common Name:

Legally marketed device to which your firm is claiming equivalence:

St. Jude Medical PSA cables and adapters under review are all currently commercially available.

| Model<br>Number<br>(Cables) | Equivalent<br>Device | PMA Number | Approval Date |
|-----------------------------|----------------------|----------------------------------------------------|------------------|
| 4160 | 4160 | P910023 / S154,<br>P030054 / S67,<br>P950022 / S42 | January 13, 2009 |
| 4161 | 4161 | P910023 / S154,<br>P030054 / S67,<br>P950022 / S42 | January 13, 2009 |

| Model Number<br>(Adaptor) | Equivalent Device | 510(k) Number | Approval Date |
|---------------------------|--------------------------------------------------------|---------------|---------------|
| 4053A | Remington<br>Medical<br>cable<br>adapter<br>Model 4053 | K971968 | July 23, 1997 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services-GSA. The logo consists of a circular arrangement of text surrounding a stylized image of a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-GSA" in a circular pattern. The bird is depicted with flowing lines, suggesting movement and freedom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

St. Jude Medical CRMD c/o Ms. Beena Flynn Regulatory Affairs 15900 Valley View Court Sylmar, CA 91342

## APR - 2 2010

Re: K093858

> Trade/Device Name: PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II (two) Product Code: DSA and DTA Dated: December 15, 2009 Received: December 16, 2009

Dear: Ms. Flynn

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.

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. Beena Flynn

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/ucm115800.html from 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director

> Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Radiological Health

Enclosure

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### STATEMENT OF INDICATIONS FOR USE

Device Name: PSA Cable Model Numbers 4160 and 4161

Indications for Use: The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

> The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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

(Division Sign-Off)
Division of Cardiovascular Devi

| 510(k) Number | K693858 |
|---------------|---------|
|---------------|---------|

Page 2

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### STATEMENT OF INDICATIONS FOR USE

Device Name: PSA Cable Adapter Model Number 4053A

Indications for Use: The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

. .

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

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