(262 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No
The device is a pacing system analyzer that tests the electrical performance of pulse generators and lead systems, and can operate as an external programmable pulse generator for temporary external pacing. While temporary pacing can be a therapeutic intervention, the primary function described is analysis and testing, not long-term therapeutic treatment.
Yes
The device is described as a "pacing system analyzer" used for "lead threshold determination" and "pacemaker function test" to "determine in situ lead characteristics" and "test and analyze the in vitro operation of external or implantable pulse generators." These activities involve assessing the condition and function of medical components, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "portable, dual-chamber pacing system analyzer (non-implantable)" and mentions testing of a "Main Unit," "Battery," "Battery Recharger," and "Pacemaker Test Cable." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the ERA 300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the ERA 300 is used during invasive pacing system procedures to interact with the patient's pacing system (leads and pulse generator) and the patient's body (for temporary pacing and lead threshold determination). This involves direct interaction with the patient's physiological system.
- Device Description: The description reinforces its use in testing the electrical performance of the pacing system at the time of implantation and during invasive procedures. It also functions as an external programmable pulse generator, which directly interacts with the patient's heart.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, disease, or congenital abnormality. The ERA 300 does not analyze specimens outside the body.
The ERA 300 is a medical device used in vivo (within the living body) or in direct connection with a medical device implanted in vivo. It's a tool used during surgical procedures and patient evaluations related to cardiac pacing.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DTE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Invasive pacing system procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Not Found
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).
Not Found
§ 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
,
| 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
1
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
4
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)