ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

K022360 · Biotronik, Inc. · DTA · Jan 27, 2003 · Cardiovascular

Device Facts

• Record ID: K022360
• Device Name: ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
• Applicant: Biotronik, Inc.
• Product Code: DTA · Cardiovascular
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities: Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, AOO, or ODO modalities during implantable pacemaker procedures or physician evaluations. Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.

Device Story

Portable dual-chamber pacing system analyzer (PSA) used during invasive pacemaker implantation or troubleshooting. Device functions as temporary external pulse generator and diagnostic tool. Inputs: electrical signals from pacing leads and pulse generators. Operation: measures lead impedance, capture threshold, P/R wave amplitude, slew rate, and retrograde conduction time; analyzes pulse generator parameters (amplitude, width, A/V delay, rate/interval). Used in clinical/surgical settings by physicians. Output: real-time electrical measurements displayed for clinician review. Benefits: enables intraoperative verification of lead performance and pulse generator function, ensuring proper pacing therapy delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Portable dual-chamber pacing system analyzer. Features touch-proof configuration for patient safety. Performs electrical signal sensing and pulse generation. Connectivity: standalone. Sterilization: not applicable (external use).

Indications for Use

Indicated for patients undergoing invasive pacemaker procedures or physician evaluations requiring temporary external pacing or lead/generator function testing.

Regulatory Classification

Identification

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

Predicate Devices

• BIOTRONIK ERA 300 Pacing System Analyzer (K964190)

Submission Summary (Full Text)

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# ERA 3000 Dual Chamber Pacing System Analyzer (PSA)

#### 1. 510(K) SUMMARY

| Name and Address of Sponsor: | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 | | | | | | | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Establishment Registration Number: | 1028232 | | | | | | | | |
| Device Name: | ERA 3000 Dual Chamber Pacing System Analyzer | | | | | | | | |
| | Proprietary Names: Classification: Class II/III Classification Name: External Pacemaker Pulse Generator (21 CFR 870.3600)<br>Pacemaker Electrode Function Tester (21 CFR 870.3630)<br>Pacemaker Generator Function Analyzer (21 CFR 870.3720) Product Code: DTA | | | | | | | | |
| Date Prepared: | July 12, 2002 | | | | | | | | |

### General Description and Predicate Devices:

The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof confiquration to help prevent hazardous connection between patients and electrical power sources.

BIOTRONIK proposes the following Pacing System Analyzer cleared through 510(k) notification as a predicate device for the ERA 3000 Pacing System Analyzer:

- . BIOTRONIK's ERA 300 Pacing System Analyzer (#K964190, cleared 07-10-97)
## Indications for Use:

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:

- . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, A00, or ODO modalities during implantable pacemaker procedures or physician evaluations. Lead Threshold Determination ● Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. . Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval. Name and Address of Manufacturing Site: BIOTRONIK GmbH & Co. {reg. no. 9610139} Woermannkehre 1, 12359 Berlin, Germany Phone: [phone] Name and Address of Contract Manufacturing Site: BIOTRONIK AG {req. no. 8043892} Ackerstrasse 6, 8180 Bülach, Switzerland
Contact Person and Phone Number:

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

Phone: [phone]

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#### INDICATIONS FOR USE 2.

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:

- . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, A00, or OD0 modalities during implantable pacemaker procedures or physician evaluations.
- Lead Threshold Determination ● Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
- Pacemaker Function Test ●

Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.

See Appendix 1 for FDA's 510(k) Indications for Use Form.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol that appears to be three stylized birds in flight. The symbol is black and the background is white.

JAN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035

Re: K022360

Trade Name: Pacing System Analyzer Regulation Number: 21 CFR 870.3720 Regulation Name: Tester, Pacemaker Electrode Function Regulatory Class: Class III (three) Product Code: DTA Dated: October 31, 2002 Received: November 4, 2002

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 docs 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]. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

L. Dale Tull

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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Page 1 of 1

KO22360 510(k) Number (if known):_

Device Name: ERA 3000 Pacing System Analyzer

Indications For Use:

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:

· Temporary External Pacing

Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, AOO, or ODO modalities during implantable pacemaker procedures or physician evaluations.

· Lead Threshold Determination

Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.

• Pacemaker Function Test

Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

(Optional Format 3-10-98)