MODEL 2872 BIPOLAR LEAD ADAPTOR KIT

K982220 · Medtronic Vascular · DTD · Oct 15, 1998 · Cardiovascular

Device Facts

• Record ID: K982220
• Device Name: MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
• Applicant: Medtronic Vascular
• Product Code: DTD · Cardiovascular
• Decision Date: Oct 15, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 BI) to a pulse generator featuring a bipolar connector block which meets the IS-1 BI standard.

Device Story

Model 2872 is a permanent implantable bipolar lead adaptor kit; used to bridge pacing leads to pulse generators. Kit includes stainless steel connectors, MP35N conductor coils, silicone rubber insulation, wrench/setscrew assemblies, and medical grade adhesive. Device is implanted in pacemaker pocket by physician. Adaptor facilitates electrical connection between leads and generator; ensures mechanical fit per IS-1 BI standard. Benefits patient by allowing continued use of existing leads with new pulse generators. Device integrity verified via bench testing including visual, dimensional, electrical, pull strength, and flex life assessments.

Clinical Evidence

No clinical data. Bench testing only: visual, dimensional, electrical, pull strength, and flex life verification.

Technological Characteristics

Materials: Stainless steel connectors, MP35N conductor coils, silicone rubber insulation. Dimensions: 130 mm length, 2.31 mm body diameter. Connector type: IS-1 BI. Resistance: max 200Ω. Sterilization: 100% EtO. Packaging: Spunbonded olefin tray and pouch.

Indications for Use

Indicated for patients requiring connection of two pacing leads with bipolar connectors (IS-1 BI) to a pulse generator with a compatible IS-1 BI bipolar connector block. Implanted in a pacemaker pocket.

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.”

Predicate Devices

• Medtronic Model 5866-38M Lead Adaptor Kit (K911302)

Submission Summary (Full Text)

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K982220

## 510(k) Summary

| 1. SUBMITTER'S NAME<br>& ADDRESS | Brian Edwards, Product Regulation Manager<br>Medtronic, Inc.<br>7000 Central Avenue NE<br>Minneapolis, MN 55432<br>Phone: [phone]<br>Fax: [phone] | | |
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| 2. TRADE NAME: | Bipolar lead adaptor kit, Model 2872 | | |
| Common Name: | Pacemaker Lead Adaptor | | |
| Classification Name: | Adaptor, Lead, Pacemaker 74DTD | | |
| Classification | This device has been classified by the Circulatory Systems Device<br>Panel into Class III, (21 CFR 870.3680(a)). | | |
| 3. SUBSTANTIALLY<br>EQUIVALENT DEVICE(S) | Medtronic Model 5866-38M Lead Adaptor Kit, marketed via K911302 | | |
| 4. DEVICE DESCRIPTION | The Model 2872 lead adaptor consists of stainless steel connectors,<br>MP35N conductor coils, and silicone rubber insulation. Also packaged<br>in the kit are wrench / setscrew assemblies, and a tube of medical<br>grade adhesive. | | |
| 5. INDICATIONS FOR USE | The Model 2872 Lead Adaptor Kit is designed to connect two pacing<br>leads with bipolar connectors (IS-1 BI) to a pulse generator featuring a<br>bipolar connector block which meets the IS-1 BI standard. | | |
| 6. TECHNOLOGICAL<br>CHARACTERISTIC<br>COMPARISONS | The Model 2872 Bipolar Lead Adaptor Kit is substantially equivalent to<br>the following product:<br>Medtronic Model 5866-38M Lead Adaptor Kit (K911302)<br>The table that follows contains a comparison of the similarities and<br>differences of the Model 2872 to the predicate devices to which it is<br>substantially equivalent. Similarities between the Model 2872 and the<br>comparison device are noted. | | |
| Feature | Model 2872 Lead Adaptor | Model 5866-38M Lead<br>Adaptor (K911302) | |
| Lead Adaptor Type | Bipolar | | |
| Intended use (including<br>anatomical site) | Implanted in a pacemaker pocket;<br>intended to connect two pacing<br>leads with bipolar connectors (IS-1<br>BI)* to a pulse generator featuring<br>a bipolar connector block which<br>meets the IS-1 BI* standard | Implanted in a pacemaker<br>pocket; intended to connect two<br>pacing leads with unipolar<br>connectors (IS-1UNI)* to a pulse<br>generator featuring a bipolar<br>connector block which meets the<br>(IS-1 BI)* standard. | |
| Application | Permanent Implantable bipolar<br>lead adaptor kit | | |
| | | | |
| (Minimum) Device Compatability | Medtronic pulse generators<br>featuring a bipolar connector block<br>which meets the IS-1BI standard | | |
| Conductor Material | MP35N conductor coils | | |
| Outer Insulation material | Silicone rubber | | |
| Connector Material | Stainless Steel | | |
| Lead adaptor length | 130 mm | 139.7 mm | |
| Lead adaptor body diameter | 2.31mm | | |
| Resistance:<br>Tip / tip connector block<br>Ring / ring connector block | maximum 200Ω<br>maximum 200Ω | maximum 15Ω<br>maximum 15Ω | |
| Connector type | IS-1BI | | |
| Included accessories | Wrench and setscrew assemblies,<br>tube of medical adhesive | | |
| Sterilization Method | 100% EtO | | |
| Packaging materials | Spunbonded olefin tray and pouch | | |
| 7. SUMMARY OF STUDIES | Medtronic, Inc. performed device integrity testing to support the Model<br>2872 is substantially equivalent to the predicate device.<br>Device integrity testing included: | | |
| | Visual verification | Dimensional verification | |
| | Electrical verification | Pull strength verification | |
| | Flex life verification | | |
| | All test results for the device met specified requirements. | | |
| 8. CONCLUSION (STATEMENT<br>OF EQUIVALENCE) | Through the data and information provided in this submission,<br>numerous similarities support a substantial equivalence determination,<br>and, therefore, clearance of the 510(k) notification for the Model 2872 | | |


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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

OCT 1 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian J. Edwards, M.S. Product Regulation Manager Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 5543 2-3576

Re: K982220 Model 2872 Bipolar Lead Adaptor Kit Trade Name: Regulatory Class: III Product Code: DTD Dated: October 1, 1998 Received: October 2, 1998

Dear Mr. Edwards:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such accumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act

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Page 2 - Mr. Brian J. Edwards

for devices under the Electronic Product Radiation Control provisions,
or other Federal laws or requiations or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) promarket 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotions of Compliance advertising of your device, please contact the office of Compliance at [phone]. Also, please note the regulation entitle of Co.
"Misbranding by reference the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. CallaHan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard.

*IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K982220

Prescription Use
OR
Over-The-Counter
Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

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