(20 days)
Not Found
No
The document describes a device for testing and temporary pacing during pacemaker procedures, focusing on electrical performance analysis and standard pacing modalities. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device provides temporary external pacing and acts as a temporary external pulse generator, which directly treats a physiological condition (cardiac rhythm).
Yes
The device "Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate" and "Tests and analyzes the in vitro operation of external or implantable pulse generators." This indicates it gathers information about the state of the leads and the function of pulse generators, which are diagnostic activities.
No
The device description explicitly states it is a "portable, dual chamber pacing system analyzer" and mentions "touch-proof configuration," indicating it is a physical hardware device, not software only.
Based on the provided information, the ERA 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use during invasive pacemaker procedures and involves temporary external pacing, lead threshold determination, and pacemaker function testing. These activities are performed in vivo (within a living organism) or on the device itself, not on biological samples in vitro (outside of a living organism).
- Device Description: The description reinforces its use in testing the electrical performance of the pulse generator and pacing lead system at the time of pacemaker implantation and during invasive procedures. It also functions as a temporary external pulse generator.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on biological markers, or any other typical IVD functions.
Therefore, the ERA 3000 is a medical device used for the assessment and management of cardiac pacing systems, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DTA, DTC, DTE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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 Road
Lake 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:
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.
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
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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
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