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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the ERA 300 Dual Chamber Pacing System Analyzer. However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment methods, or information about expert involvement (like adjudication or MRMC studies).

The document primarily focuses on:

Device Description: What the ERA 300 is and its functions.
Substantial Equivalence: Comparing it to already cleared devices (SeaMED Model 3300 and Medtronic Model 5311B).
Intended Use/Indications for Use: The clinical scenarios for which the device is designed.
Qualification Testing: A general statement that testing was performed and provided in the submission (referencing "Table III, pages 14-33" which are not included in the provided text). This section mentions "Internal standards and specifications were used when relevant international standards were not available."
Regulatory Clearance: The FDA letter confirming 510(k) clearance based on substantial equivalence.

Without access to "Table III, pages 14-33" or other detailed performance study documentation, it's impossible to completely fill out the requested table and provide specific answers to many of the questions.

Based on the available information, here's what can be inferred or stated as unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Aspect Tested	Acceptance Criteria	Reported Device Performance
System Checks	Not specified in provided text.	Not specified in provided text.
EMC & Circuit Design	Not specified in provided text.	Not specified in provided text.
Firmware	Not specified in provided text.	Not specified in provided text.
Battery Performance	Not specified in provided text.	Not specified in provided text.
Battery Recharger	Not specified in provided text.	Not specified in provided text.
Pacemaker Test Cable	Not specified in provided text.	Not specified in provided text.
Specific Functions (e.g., Impedance, Capture Threshold, P/R wave amplitude accuracy)	Not specified in provided text.Likely based on comparison to predicate devices' performance or internal engineering specifications.	Not specified in provided text.
Overall Performance	Substantially equivalent to SeaMED Model 3300 and Medtronic Model 5311B.	Determined to be substantially equivalent by FDA (K964190).

Note: The document states "Qualification testing for the ERA 300 is provided in this submission for the tests described in Table III, pages 14-33." This Table III would contain the specific acceptance criteria and reported performance data. Without it, these fields cannot be filled.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text. The device tests various electrical parameters. The "test set" would likely refer to the number of individual tests performed on each parameter, or the number of simulated/actual pacemakers/leads used for testing.
Data Provenance: Not specified. Given it's a 510(k) submission, the testing would have been conducted by the manufacturer (BIOTRONIK GmbH & Co. / BIOTRONIK, Inc.) or its designated testing facilities. "Country of origin" for data collection is not mentioned. "Retrospective or prospective" is not applicable as this is a device performance test, not a clinical study on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. For a device like a pacing system analyzer, "ground truth" is typically established against calibrated reference equipment, known electrical signals, or by comparison to predicate device measurements, not by human expert consensus or clinical evaluation.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Device performance for electrical parameters is measured objectively, not adjudicated by human experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a pacing system analyzer for objective electrical measurements, not an AI diagnostic tool that assists human readers/interpreters.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Yes, in essence. The "qualification testing" described in the document (referencing Table III) would have assessed the device's ability to accurately measure electrical parameters independently. The device's primary function is to perform these measurements standalone.

7. The type of ground truth used

Type of Ground Truth: Most likely calibrated measurements (e.g., from oscilloscopes, multimeters, signal generators, or other reference testing equipment) and comparison to the established performance of legally marketed predicate devices (SeaMED Model 3300 and Medtronic Model 5311B). For lead characteristics like impedance and capture threshold, known values in test circuits or in animal/human models (under controlled, ethical conditions if applicable) would serve as ground truth, or comparisons to predicate devices in the same setting.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is an analyzer for electrical signals, not a machine learning/AI algorithm that requires a "training set" in the conventional sense. Its "training" is in its engineering design and calibration.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary

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A.	510(k) Summary of Safety and Effectiveness
	1. General Information
	Device Name
	Proprietary Name	ERA 300 Dual Chamber Pacing SystemAnalyzer
	Classification Name	External Pacemaker Pulse GeneratorPacemaker Electrode Function TesterPacemaker Generator Function Analyzer
	Manufacturer	BIOTRONIK GmbH & Co.Woermannkehre 1D-12359 BerlinGermany
	Manufacturer's Registration Number	7010992
	Applicant's Name & Address	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
	Establishment Registration Number	1028232
	Performance Standards	No applicable performance standards havebeen promulgated for these devices.

2. Device Description

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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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.

Qualification Testing 5.

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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 1997

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

K964190 Re: ERA 300 Dual Chamber Pacing System Analyzer Requlatory 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, Druq, 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 requlations 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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.

Donald Tilling

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices Va64190 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.3600 External pacemaker pulse generator.

(a)
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.(b)
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.