CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

K041574 · Guidant Corporation · DTD · Jul 12, 2004 · Cardiovascular

Device Facts

• Record ID: K041574
• Device Name: CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
• Applicant: Guidant Corporation
• Product Code: DTD · Cardiovascular
• Decision Date: Jul 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals. Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal. Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

Device Story

Pacemaker lead adapters (Models 6017, 6018, 6020) serve as mechanical interfaces between cardiac pacing leads and pulse generators. Device facilitates electrical continuity when lead connector dimensions differ from pulse generator terminal dimensions. Used in clinical settings by physicians during pacemaker implantation or lead revision procedures. Adapters allow continued use of existing leads when upgrading or replacing pulse generators, avoiding unnecessary lead extraction. Output is a secure physical and electrical connection between lead and generator.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive mechanical adapters. Models 6017, 6018, 6020. Designed for specific connector sizes: 3.2mm, 5mm (4.75), and 6mm (5.38). Function as physical bridges for electrical signals between leads and pulse generators. No energy source, software, or active components.

Indications for Use

Indicated for patients requiring connection of specific CPI bipolar or unipolar pacemaker leads to incompatible pacemaker terminals. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2004

Guidant Corporation c/o Ms. Amita Shenai Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul. MN 55112

Re: K041574

Trade Name: Pacemaker Lead Adapter Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker Lead Adaptor Regulatory Class: II (two) Product Code: DTD Dated: June 11, 2004 Received: June 14, 2004

Dear Ms. Shenai:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered proct of they 20, 1978, is accordance with the provisions of the Federal Food, DNI, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (710) that the novice, subject to the general controls provisions of the Act. The r ou may, merelore, mans. of the Act include requirements for annual registration, listing of general connois profilesing 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Couvecements concerning your device in the Federal Register.

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Page 2 - Ms. Amita Shenai

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden

Bram D. Zuckerman, M.I 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): K041574

Device Name: Models 6017, 6018, and 6020

Indications For Use:

1) Model 6017:

It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.

2) Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.

3) Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

Michard Ogden for 602

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Nu

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

AND/OR
Over-The-
(21 CFR 807(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)