BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pasing of pasing therapy is medically indicated. This indication for them single of the Class I definition of the ACC/AHANASPE This Indication This Indication inal recommended in Title Class I demind of the of Cardiac Pacemakers Reports, Aladoa Aloon More 2 2002 Ghuelle Opdate of Inplantabon CordialemyAmadon Mond Anad Anada Arabarhythmia Devices: A Report of the American Colleg CardiologyAmerican Heart Association Task Force on Practice Guidelines (ACCAHANASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002).

The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed distal end to facilitate lead placement in the ight atrial appendage.

Device Description

AI/ML Overview

The provided document is a 510(k) premarket notification for "Packaging Changes for Endocardial Pacing Leads." This submission is about modifications to the packaging process and containers for existing, previously approved bradycardia pacing leads, not the leads themselves or any associated AI/software-based device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, as typically understood for AI/software devices (e.g., accuracy, sensitivity, specificity studies), is not applicable here.

This 510(k) is demonstrating substantial equivalence for a manufacturing/packaging change. The "proof" for this type of submission would typically involve:

Engineering studies and validation reports showing that the new packaging maintains the safety, sterility, and functional integrity of the leads as established for the predicate devices. This would include tests like:
- Sterilization validation (if the sterilization method or cycle is affected by packaging changes).
- Packaging integrity tests (e.g., seal strength, burst testing, dye penetration).
- Shelf-life studies to ensure sterility and material integrity are maintained over the claimed shelf-life.
- Biocompatibility assessments (if new packaging materials are introduced that could interact with the device).
- Transit testing to simulate shipping stresses.

Since the document provided is only the 510(k) summary and the FDA's clearance letter, it does not contain the detailed study reports or acceptance criteria for these packaging validation tests. The FDA's clearance indicates that they reviewed these underlying data and found them acceptable to demonstrate substantial equivalence.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance statistics because the nature of this 510(k) submission does not involve a "device performance study" in the context of typical AI/software or diagnostic devices.

Summary

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Ko61212

April 28, 2006

Packaging Changes for Endocardial Pacing Leads

Special 510(k) Premarket Notification

1. 510(k) SUMMARY

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 JUL 1 0 2000

Establishment Registration Number:

1028232

Device Name:

Product	Proprietary Name (Multiple)	FDA Product Code	Classification Name	Device Classification
Arox	Arox 53-BP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	Arox 60-BP
	Arox 45-JBP
	Arox 53-JBP
Synox	Synox-SX 45-JBP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	Synox-SX 53-JBP
	Synox SX 53-BP
	Synox SX 60-BP
Synox with 15 mm tipto ring spacing	Synox SX 53/15-BP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	Synox SX 60/15-BP
Polyrox w/ 15 mmSpacing	PX 53/15-BP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	PX 60/15-BP
Polyrox	PX 45-JBP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	PX 53-BP
	PX 53-JBP
	PX 60-BP
YP	YP 45/15-BP	DTB	Electrode,Pacemaker,Permanent	III (21 CFR870.3680)
	YP 53/15-BP
	YP 60/15-BP

General Description and Predicate Devices:

BIOTRONIK proposes modifications to the packaging process and containers for bradycardia pacing leads, at BIOTRONIK's manufacturing and sterilization facility (BIOTRONIK GmbH & Co. KG) in Pertin, Germany and contract manufacturing facility (BIOTRONIK AG) in Bülach Switzerland. BIOTRONIK believes that the previously approved products cleared through 510(k) notifications and manufactured and sterilized at BIOTRONIK GmbH & Co. KG in Berlin, Germany or BIOTRONIK AG in Bulach Switzerland are appropriate as predicate devices for the products affected by the aforementionaed packaging modifications. The above table provides a list of the products that are manufacturned nad/or sterlized at BIOTRONIK GmbH & Co. KG in Berlin, Germany or BIOTRONIK & G in Billadoh Switzrdand and the 510(k) notifications under which the products were cleared.

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Indication for Use:

BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class t definition of the ACC/AHA/NASPE Task Force Report, entitled "ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002).

The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage.

Name and Address of Manufacturer:	BIOTRONIK GmbH & Co. KG (reg. no. 9610139)Woermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210
Name and Address of Contract Manufacturer:	BIOTRONIK AG (reg. no. 8043892)Ackerstrasse 68180 Bülach,Switzerland 011-41-44-864-5169
Contact Person(s) and Phone Number:	Jon BrumbaughDirector, Regulatory Affairs and CompliancePhone (888) 345-0374Fax (503) 635-9936jon.brumbaugh@biotronik.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2006

Biotronik, Inc. C/O Jon Brumbaugh 6024 Jean Rd. Lake Oswego, OR 97035

Re: K061212

Trade/Device Name: Biotronik Endocardial Pacing Leads Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode. Regulatory Class: Class III Product Code: DTB Dated: June 21, 2006 Received: June 22, 2006

Dear Mr. Brumbaugh:

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 such 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 - Mr. Jon Brumbaugh

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Ashley B. Bvan

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):

Device Name: Bradycardia Pacing Leads, (see attached list)

Indications for Use:

Pacing Leads -

BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pasing of pasing therapy is medically indicated. This indication for them single of the Class I definition of the ACC/AHANASPE This Indication This Indication inal recommended in Title Class I demind of the of Cardiac Pacemakers Reports, Aladoa Aloon More 2 2002 Ghuelle Opdate of Inplantabon
CordialemyAmadon Mond Anad Anada Arabarhythmia Devices: A Report of the American Colleg CardiologyAmerican Heart Association Task Force on Practice Guidelines (ACCAHANASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arilla B. Beane

510(k) Number LC61212

Page 1 of 2

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.