PIKOS LP 01, PIKOS LP E01

K945627 · Biotronik, Inc. · DXY · Mar 4, 1996 · Cardiovascular

Device Facts

• Record ID: K945627
• Device Name: PIKOS LP 01, PIKOS LP E01
• Applicant: Biotronik, Inc.
• Product Code: DXY · Cardiovascular
• Decision Date: Mar 4, 1996
• Decision: SESP
• Submission Type: Traditional
• Regulation: 21 CFR 870.3610
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Pikos LP 01/LP E01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions: - Sinus node arrest or bradycardia with or without AV conduction disorder. - Intermittent or complete AV conduction block. - Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia. - Atrial fibrillation and ventricular bradyarrhythmia.

Device Story

Pikos LP 01/LP E01 are multi-programmable single-chamber implantable pacemaker pulse generators; designed for use with atrial or ventricular leads. Device monitors cardiac electrical activity; provides electrical stimulation to heart to treat bradyarrhythmias. Used by physicians in clinical settings to manage patients with conduction disorders. Provides therapy via programmable pacing parameters; output affects clinical decision-making by maintaining adequate heart rate. Benefits patient by preventing symptomatic bradycardia and associated complications.

Clinical Evidence

Bench testing only. Qualification testing included electrical and mechanical testing of hybrid circuit modifications, and validation of the self-sealing header (vibration, shock, temperature, transport, and leakage resistance). Battery qualification data was leveraged from the predicate device (K914109/A).

Technological Characteristics

Implantable single-chamber pulse generator; multi-programmable. Features self-sealing header; hybrid circuit architecture. Connectivity via external programmer. Sterilization validated. No applicable performance standards promulgated.

Indications for Use

Indicated for patients with sinus node arrest, bradycardia (with/without AV conduction disorder), intermittent or complete AV conduction block, brady/tachy syndrome, sick sinus syndrome with symptomatic bradycardia, or atrial fibrillation with ventricular bradyarrhythmia.

Regulatory Classification

Identification

An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.

Predicate Devices

• Pikos 01 (K914109/A)
• Pikos E01 (K914109/A)

Submission Summary (Full Text)

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November 14, 1994
510(k)
Pikos LP 01/LP E01

# V. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K945627

## GENERAL INFORMATION

| Device Name: | Proprietary Name
Classification Name |
| --- | --- |
| Pikos LP 01, Pikos LP E01 | Implantable Pacemaker Pulse Generators |
| Device Classification: | Class III (21 CFR 870.3610) |
| Manufacturer: | BIOTRONIK GmbH & Co.
Woermannkehre 1
D-12359 Berlin
Germany |
| Registration No.: | 7010992 |
| Applicant's Name & Address: | BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035 |
| Establishment Registration No.: | 1028232 |
| Performance Standards: | No applicable performance standards have been promulgated for these devices. |

## DESCRIPTION OF DEVICE

The Pikos LP 01/LP E01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.

## SUBSTANTIAL EQUIVALENCE

The Pikos LP 01/LP E01 pulse generators are substantially equivalent to the currently marketed Pikos 01 and Pikos E01 respectively (K914109/A, approved February 26, 1992). Data to support this statement is provided in the premarket notification.

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November 14, 1994
510(k)
Pikos LP 01/LP E01

# INTENDED USE

The Pikos LP 01/LP E01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:

- Sinus node arrest or bradycardia with or without AV conduction disorder.
- Intermittent or complete AV conduction block.
- Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
- Atrial fibrillation and ventricular bradyarrhythmia.

# QUALIFICATION TESTING

Qualification testing for the Pikos LP 01/LP E01 models is provided in this submission with the exception of battery qualification data which is identical to that submitted in the Pikos 01/E01 premarket notification (K914109/A). Qualification reports describing the testing conducted for validation of the self-sealing header are included in this submission. The qualification of the self-sealing header included vibration, shock, temperature and transport tests; tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization of the self-sealing header was validated. Hybrid circuit modifications were qualified with complete electrical and mechanical testing.

# LABELING

Proposed labeling for the Pikos LP 01/LP E01 models is included in the premarket notification. The product labeling includes instructions for use adequate to assure safe and effective operation of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 21 2009

Mr. Jon Brumbaugh
Vice President, Regulatory Affairs and Compliance
BIOTRONIK, Inc
6024 Jean Road
Lake Oswego, OR 97035

Re: K945627
Trade/Device Name: Pikos LP 01 and Pikos LP E 01 Pacemakers
Regulation Number: 21 CRF 870.3610
Regulation Name: Implantable pacemaker pulse generator
Regulatory Class: III (three)
Product Code: 74 DXY
Dated: November 22, 1995
Received: November 24, 1995

Dear Mr. Brumbaugh:

This letter corrects our substantially equivalent letter of March 5, 1995.

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 (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 - 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); 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 contact the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,


Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

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