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, 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, A/V delay, and rate/interval.

Device Description

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 configuration to help prevent hazardous connection between patients and electrical power sources.

AI/ML Overview

The ERA 3000 Pacing System Analyzer (Model: ERA 301.4) underwent a Special 510(k) notification (K042708) to update its software to correct several anomalies. The original predicate device was BIOTRONIK's ERA 3000 Pacing System Analyzer (#K022360, cleared 01-27-03).

The provided text does not contain details of specific acceptance criteria or an explicit study proving the device meets these criteria. The document primarily focuses on the device modification (software update), its general description, indications for use, and regulatory classification.

Therefore, many of the requested details cannot be extracted from the provided text.

However, based on the information provided, here's what can be inferred or stated as not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(Specific performance metrics and thresholds for the software update are not described in the provided text.)	(Specific reported performance data for the software update is not described in the provided text.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not available.
Data Provenance: Not available. The document mentions the manufacturing sites (Germany and Switzerland) but provides no information about where any testing or data collection took place.
Retrospective or Prospective: Not available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not available.
Qualifications of Experts: Not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not available.

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, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and not mentioned.

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

Standalone Performance: The document describes a software update for a "Pacing System Analyzer designed to test the electrical performance of the pulse generator and the pacing lead system." While the device operates automatically, the text does not explicitly detail a "standalone performance" study in the context of a new algorithm's evaluation, but rather refers to corrections of "anomalies" in existing software. The update is for an existing device's functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not available. The "anomalies" corrected by the software update would imply that the "ground truth" for the original software's performance (and the corrected version) would relate to the accurate measurement and analysis of pacing parameters (e.g., impedance, capture threshold, pulse amplitude, width, A/V delay, rate/interval). However, the method for verifying these corrections is not described.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a software update to correct anomalies, not a machine learning algorithm requiring a separate training set.

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

Ground Truth for Training Set: Not applicable. As it's not a machine learning algorithm, there is no training set in the typical sense.

Summary

{0}------------------------------------------------

OCT 2 0 2004

BIOTRONIK, Inc., ERA 3000 Pacing System Analyzer, Special 510(k)

K04d708

September 29, 2004

ERA 3000 Pacing System Analyzer Special 510(k) Notification

1. 510(K) SUMMARY

Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Establishment Registration Number:	1028232
Device Name:
Proprietary Name:	ERA 3000 Dual Chamber Pacing System Analyzer
Classification:	Class 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
Date Prepared:	September 29, 2004

General Description:

Device Modification:

The ERA 3000 PSA software was updated to correct several anomalies. The modified software is designated as ERA 301.4.

Predicate Devices:

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 3000 Pacing System Analyzer (#K022360, cleared 01-27-03) ●

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, or AOO modalities during implantable pacemaker procedures or physician evaluations.
t 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. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany Phone: 011-49-30-689-05-1210

Name and Address of Contract Manufacturing Site: BIOTRONIK AG (reg. no. 8043892)

Ackerstrasse 6, 8180 Bülach, Switzerland Phone: 011-41-1-864-5169

Contact Person and Phone Number:

Jon Brumbaugh Director, Regulatory Affairs Phone: (888) 345-0374 Fax: (503) 635-9936

Page 4 of 26
page 1 of 1

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

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

K042708 Re:

Era 3000 Pacing System Analyzer Regulation Number: 21 CFR 870.3600 Regulation Name: Pulse Generator, Pacemaker, External Regulatory Class: III Product Code: DTE Dated: September 29, 2004 Received: September 30, 2004

Dear Mr. Brumbaugh:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) promation is substantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Amendments for use stated in the enclosure) to regally manced produced as a caracters, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the enaculiers with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approval ons of the A and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the geniret for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the recements of them.
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 If your device is classified (see above) mito exist on the percentations affecting your device can
may be subject to such additional controls. Tim may be subject to such additional controlist Extrong might of 0998 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies or a subscription with other requirements of the Act
that FDA has made a determination that your device of a concies . You must that FDA has made a determination that Jointer Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with all the Act s requirements, mortaing, carefally, careforments as set

{2}------------------------------------------------

Page 2 – Mr. Jon Brumbaugh

forth in the quality systems (QS) regulation (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors over device as described in your Section 510(k) This letter will anow you to ocgin manieting of substantial equivalence of your device to a legally premarket notheadon: "The PDF mining of cation 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 If you desire specific at not 10. Jour 2011) 276-0120. Also, please note the regulation entitled, Coliable of Compullier of Compullies in (21CFR Part 807.97). You may obtain Misoraliums by releveloc to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 101) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B Zimmerman for
R. D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): < >4 2708

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, 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, A/V delay, and rate/interval.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Simmons

Division Sian-Off Division of Cardiovascular Devices 510(k) Number

Page 1 of

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.