The ERA 300 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, or AOO 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, sensitivity, refractory period, A/V delay, and rate/interval.

Device Description

The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a modification to the BIOTRONIK ERA 300 Pacing System Analyzer (PSA). The modification concerns the additional battery supplier for the device, not the device's main functionalities or its performance in diagnostic tasks. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance evaluation, sample sizes, ground truth establishment, expert roles, and comparative effectiveness studies is not directly applicable to this specific 510(k) submission.

The 510(k) essentially states that a new battery supplier (pbq) has been identified because the previous supplier (Panasonic) will no longer manufacture the existing 8 Volt battery. The key point for this regulatory submission is that the newly sourced battery meets the same internal specifications as the original one, thus ensuring that the core device's performance remains unchanged.

However, I can extract information related to the device's general description, intended use, and the regulatory aspect of the modification.

Here's an interpretation based on the provided document, addressing your points where possible, and explicitly stating when the information is not present or relevant to this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) about a battery supplier change, the acceptance criteria are that the new battery meets the existing internal specifications for the ERA 300 PSA. The "device performance" refers to the new battery performing indistinguishably from the old one, thereby maintaining the ERA 300's established performance.

Acceptance Criteria (for the new battery)	Reported Device Performance (with the new battery)
Meets the same internal BIOTRONIK specifications	"manufactured battery meets the same internal BIOTRONIK specifications"
Including purchasing specifications	(Inferred as met by "same internal BIOTRONIK specifications")
Including incoming inspection specifications	(Inferred as met by "same internal BIOTRONIK specifications")
Including performance specifications	(Inferred as met by "same internal BIOTRONIK specifications")

Note: The document does not detail the specific performance specifications (e.g., battery life, voltage output range, charge time) as these are presumed to be the same as established for the original battery and are internal BIOTRONIK specifications. The crucial aspect is equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This submission is for a battery supplier change, not a performance study comparing the ERA 300's diagnostic capabilities. The "test set" here would refer to the new battery being tested against specifications, not a clinical data set. The document does not specify the number of batteries tested.
Data Provenance: Not applicable. No clinical or observational data are described. The testing described relates to internal product specifications for the battery.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. There is no "ground truth" in the diagnostic sense for this battery modification. The "truth" is whether the new battery meets the specifications. Biotronik's internal engineers and quality control personnel would be responsible for verifying this, but their number and specific qualifications (beyond being competent in product testing) are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" (e.g., 2+1, 3+1 consensus) in the medical imaging or diagnostic sense for this type of component change. The assessment is against pre-defined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is completely irrelevant to a 510(k) for an additional battery supplier. An MRMC study would be used to evaluate the diagnostic accuracy of a system, potentially comparing human readers' performance with and without AI assistance on a given task (e.g., interpreting medical images). This document is not about such a system or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This submission is for a medical device (Pacing System Analyzer), not an algorithm or AI. Standalone performance studies are typically for AI/CAD systems.

7. The Type of Ground Truth Used

The "ground truth" in this context is the pre-established internal BIOTRONIK specifications for the 8 Volt battery used in the ERA 300 PSA. The new battery needed to demonstrate that it met these specifications. This is a technical specification truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no AI/algorithm being trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI/algorithm being trained.

Summary regarding the device's overall performance (as described in the document, but not the focus of this specific 510(k)):

The ERA 300 Pacing System Analyzer is broadly characterized by its functionalities, which include:

Temporary External Pacing: Provides temporary stimulation under various modalities (DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO).
Lead Threshold Determination: Determines in situ lead characteristics (impedance, capture threshold, P/R wave amplitude, P/R wave slew rate) and in vivo retrograde conduction time.
Pacemaker Function Test: Tests and analyzes in vitro operation of pulse generators to determine parameters such as pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

The original ERA 300 Pacing System Analyzer (K964190, cleared 07-10-97 and K033613, cleared on 12-08-03) would have had performance studies and acceptance criteria related to these functionalities. This 510(k) for the battery change relies on the substantial equivalence principle, meaning the change (new battery) does not alter the fundamental safety or effectiveness parameters that were established for the predicate device.

Summary

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November 14, 2007

ERA 300 Pacing System Analyzer Additional Battery Supplier

Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035	DEC 2 0 2007
Establishment Registration Number:	1028232
Device Name:
Proprietary Name:Classification:	ERA 300 Dual Chamber Pacing System AnalyzerClass II/III

Classification Name: External Pacemaker Pulse Generator (21 CFR 870.3600) Pacemaker Electrode Function Tester (21 CFR 870.3630) Pacemaker Generator Function Analyzer (21 CFR 870.3720) Product Code: DTA, DTC, DTE

General Description:

Device Modifications:

The 8 Volt battery currently supplied with the ERA 300 Pacing System Analyzer (PSA) is manufactured by Panasonic. However, in the future this supplier will no longer manufacture this battery model. Therefore, an additional supplier for the 8 Volt battery supplied with the ERA 300 PSA was identified, pbq. The pbq manufactured battery meets the same internal BIOTRONIK specifications including purchasing specifications, incoming inspection, and performance specifications.

Predicate Devices:

BIOTRONIK proposes the following predicate device for the battery modification to the ERA 300 Pacing System Analyzer:

. BIOTRONIK's ERA 300 Pacing System Analyzer (#K964190, cleared 07-10-97 and #K033613, cleared on 12-08-03)

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Indications for Use:

The ERA 300 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, or AOO 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 and width, sensitivity, refractory period, AV delay, and rate/interval.

Name and Address of Manufacturer:	BIOTRONIK GmbH & Co. KGWoermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210
Manufacturer's Registration Number:	9610139

Contact Person(s) and Phone Number:

Jon Brumbaugh Vice President, Regulatory Affairs and Compliance Phone (888) 345-0374 Fax (503) 635-9936 jon.brumbaugh@biotronik.com

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Public Health Service

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035

Re: K073230

Trade/Device Name: ERA 300 Pacing System Analyzer Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III (three) Product Code: DTA, DTC, DTE Dated: November 14, 2007 Received: November 15, 2007

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 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfsimmmon for

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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Indications for Use

510(k) Number (if known): K073230

Device Name: ERA 300 Pacing System Analyzer

Indications for Use:

The ERA 300 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, or AOO 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, sensitivity, refractory period, A/V delay, and rate/interval.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummer

øn Sign-Off Division of Cardiovascular Devices 510/k) Number

Page 1 of 1

Regulation Number and Section

§ 870.3720 Pacemaker electrode function tester.

(a)
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.(b)
Classification. Class II (performance standards).