PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A

K993434 · Biotronik, Inc. · DXY · Nov 10, 1999 · Cardiovascular

Device Facts

• Record ID: K993434
• Device Name: PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
• Applicant: Biotronik, Inc.
• Product Code: DXY · Cardiovascular
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3610
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following: - Symptomatic paroxysmal or permanent second or third-degree AV block . - Symptomatic bilateral bundle branch block . - Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders - . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias - Vasovagal syndromes or hypersensitive carotid sinus syndromes .

Device Story

Pikos pulse generators are single-chamber implantable pacemakers. The NIPS (Non-Invasive Programmed Stimulation) feature, previously locked via software, is enabled via a release code to the B-H02.0.U programmer software. NIPS allows clinicians to perform cardiac electrophysiological (EP) studies and invoke high-rate pacing using the existing implanted pulse generator and lead system. The feature is activated by a programmer wand placed over the device; no additional hardware is required. The system assists clinicians in diagnosing and managing cardiac rhythm disorders by enabling controlled stimulation protocols. Benefits include non-invasive access to advanced diagnostic pacing features without surgical intervention or hardware modification.

Clinical Evidence

No clinical data provided. The submission relies on the fact that the NIPS feature was already present in the cleared hardware and is simply being unlocked via software update.

Technological Characteristics

Implantable single-chamber pulse generator. Connectivity via programmer wand (inductive coupling). Software-based feature activation (NIPS) via B-H02.0.U programmer software. No hardware modifications. Lead ports include IS-1, 5-mm, and 6-mm configurations.

Indications for Use

Indicated for patients with symptomatic AV block (2nd/3rd degree), bilateral bundle branch block, sinus node dysfunction, bradycardia-tachycardia syndrome, or vasovagal/hypersensitive carotid sinus syndromes. Contraindicated for atrial use in patients with AV conduction disorders, atrial fibrillation, or atrial flutter. Ventricular pacing not indicated if pacemaker syndrome is present and dual-chamber pacing is viable.

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.

Submission Summary (Full Text)

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NOV 1 0 1999

BIOTRONIK, Inc., Pikos Family of Pulse Generators, NIPS Feature

# Pikos Family of Pulse Generators Release of the NIPS Feature

#### SPECIAL 510(K) SUMMARY 1.

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

Establishment Registration Number: 1028232

| Device Name:<br>Device Class: | Proprietary Names:<br>Classification:<br>Classification Name:<br>Product Code:<br> |
|-------------------------------|------------------------------------------------------------------------------------|
| Date Prepared: | October 7, 1999 |
| | Pikos<br>Class III<br>Implantable Pacemaker Pulse Generator<br>74 WST; KRG |

### General Description

BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these
pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators.

| Pulse Generator Name | Cleared | Feature Set | Lead Port |
|----------------------|----------|-------------|-----------|
| Pikos 01 | K914109A | Full | IS-1 |
| Pikos E01 | K914109A | Full | IS-1 |
| Pikos 01-A | K923026C | Full | 5-mm |
| Pikos E01-A | K923026C | Full | 5-mm |
| Pikos 01-B | K9141937 | Full | 6-mm |
| Pikos E01-B | K9141937 | Full | 6-mm |

### Table 1

Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies.

The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U.

There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system
to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.

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### Indications for Use:

The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators.

The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used.

Name and Address of Manufacturing Site: BIOTRONIK GmbH & Co. (rea. no. 7010992) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304

## Contact Person(s) and Phone Number:

Jon Brumbaugh Director, Requlatory Affairs Phone [phone] Fax [phone]

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 0 1999

Mr. Jon Brumbaugh Director, Requlatory Affairs Biotronik, Inc. 6024 Jean Road 97035 Lake Oswego, OR

K993434 Re: Implantable Pacemaker Pulse Generator Regulatory Class: III (three) Product Codes: DXY October 7, 1999 Dated: Received: October 12, 1999

Dear Mr. Brumbaugh:

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 Regulations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Jon Brumbaugh

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note 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,

Kla V. Tille

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number: K993434

Device Name: BIOTRONIK, Inc. Pikos single chamber pacemakers Models 01/01-A/E01/LP 01/LP E01/E01-B

Indications For Use:

Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:

- Symptomatic paroxysmal or permanent second or third-degree AV block .
- Symptomatic bilateral bundle branch block .
- Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders
- . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
- Vasovagal syndromes or hypersensitive carotid sinus syndromes .

(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 | K993434 | |

Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1.2.96)

(Optional Format 1-2-96)