ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

K964190 · Biotronik, Inc. · DTE · Jul 10, 1997 · Cardiovascular

Device Facts

• Record ID: K964190
• Device Name: ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
• Applicant: Biotronik, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Jul 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERA 300 is intended for use in the following conditions: - Temporary External Pacing Function. Provides temporary stimulation under DDD, DDI, VDD, DOO, VVI, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. - Lead Test Function. 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 Test Function. Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the parameters: modality, pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

Device Story

ERA 300 is a portable, non-implantable dual-chamber pacing system analyzer. Used by physicians during pacemaker implantation or invasive troubleshooting. Inputs include electrical signals from pacing leads and pulse generators. Device functions as an external programmable pulse generator and diagnostic tester. It measures lead impedance, capture threshold, P/R wave amplitude, slew rate, and retrograde conduction time. It also analyzes pulse generator parameters like modality, amplitude, width, sensitivity, refractory period, A/V delay, and rate/interval. Output is displayed for the clinician to evaluate pacing system performance and verify pulse generator function. Benefits include ensuring proper lead placement and verifying correct operation of implantable or external pulse generators during clinical procedures.

Clinical Evidence

No clinical data. Qualification testing performed, including system checks, electromagnetic compatibility, circuit design, firmware, battery, and test cable performance.

Technological Characteristics

Portable dual-chamber pacing system analyzer. Includes main unit, battery recharger (ACD 300), and pacemaker test cable (EK-4-E). Features firmware-based control for pacing stimulation and signal analysis. Operates as an external programmable pulse generator. Testing included electromagnetic compatibility and circuit design verification.

Indications for Use

Indicated for patients undergoing invasive pacing system procedures, including implantable pacemaker procedures or physician evaluations, requiring temporary external pacing, lead threshold determination, or pulse generator function testing.

Regulatory Classification

Identification

An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment. (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source ( *i.e.,* battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling; (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use; (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices ( *e.g.* data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use; (ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals; (iii) The labeling must list all pacing modes available in the device; (iv) Labeling must include a detailed description of any special capabilities ( *e.g.,* overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.

Predicate Devices

• SeaMED Model 3300 Dual-Chamber Pacing System Analyzer (K883930)
• Medtronic Model 5311B A-V Pacing System Analyzer (K884331)

Submission Summary (Full Text)

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October 18, 1996
510(k)
ERA 300
K964190
July 10, 1997

# A. 510(k) Summary of Safety and Effectiveness

## 1. General Information

| Device Name | |
| --- | --- |
| Proprietary Name | ERA 300 Dual Chamber Pacing System Analyzer |
| Classification Name | External Pacemaker Pulse Generator
Pacemaker Electrode Function Tester
Pacemaker Generator Function Analyzer |
| Manufacturer | BIOTRONIK GmbH & Co.
Woermannkehre 1
D-12359 Berlin
Germany |
| Manufacturer's Registration Number | 7010992 |
| Applicant's Name & Address | BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035 |
| Establishment Registration Number | 1028232 |
| Performance Standards | No applicable performance standards have been promulgated for these devices. |

## 2. Device Description

The ERA 300 is a portable, dual-chamber pacing system analyzer (non-implantable) 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 an external programmable pulse generator.

## 3. Substantial Equivalence

The ERA 300 is substantially equivalent to the FDA-cleared SeaMED Model 3300 Dual-Chamber Pacing System Analyzer, approved 8/19/86 (K883930), and the Medtronic Model 5311B A-V Pacing System Analyzer, approved (K884331). Data to support this statement are provided in the premarket notification.

## 4. Intended Use

The ERA 300 is intended for use in the following conditions:

- Temporary External Pacing Function. Provides temporary stimulation under DDD, DDI, VDD, DOO, VVI, VOO, AAI, or AOO

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October 18, 1996
510(k)
ERA 300

modalities during implantable pacemaker procedures or physician evaluations.

- Lead Test Function. 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 Test Function. Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the parameters: modality, pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

## 5. Qualification Testing

Qualification testing for the ERA 300 is provided in this submission for the tests described in Table III, pages 14–33. Table III is organized into six main categories: ERA 300 Main Unit (System Checks); ERA 300 Main Unit (Electromagnetic Compatibility and Circuit Design); ERA 300 Main Unit (Firmware); ERA 300 Battery; Battery Recharger (ACD 300); and Pacemaker Test Cable (EK-4-E). Internal standards and specifications were used when relevant international standards were not available.

## 6. Labeling

Proposed labeling for the ERA 300 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

JUL 10 1997

Mr. Taras Tatarko, M.S.
Biotronik, Inc.
6024 Jean Road
Lake Oswego, Oregon 97035-5369

Re: K964190
ERA 300 Dual Chamber Pacing System Analyzer
Regulatory Class: III (three)
Product Code: 74 DTE
Dated: May 20, 1997
Received: May 21, 1997

Dear Mr. Tatarko:

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

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Page 2 - Mr. Taras Tatarko, M.S.

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" (21 CFR 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/dsmamain.html".

Sincerely yours,


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 ERA 300 is indicated for use during invasive pacing system procedures in the following activities:

- **TEMPORARY EXTERNAL PACING**
To provide temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations.

- **LEAD THRESHOLD DETERMINATION**
To determine in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. To determine the in vivo retrograde conduction time.

- **PACEMAKER FUNCTION TEST**
To test and analyze the in vitro operation of external or implantable pulse generators. To determine the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.