(21 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, ML, or related concepts in the intended use, device description, or other sections. The predicate device is also a pacing system analyzer, suggesting a similar, non-AI/ML technology.
Yes
The device provides temporary external pacing, which is a therapeutic intervention to treat cardiac rhythm disorders. It also tests pacemaker function, which supports the proper functioning of a therapeutic device.
Yes
The device is used to "Determine in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate" and "Determines the in vivo retrograde conduction time," which are diagnostic functions.
No
The device description explicitly states it is a "portable, dual chamber pacing system analyzer" and mentions a "touch-proof configuration," indicating it is a physical hardware device, not software only.
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 pacemaker procedures and for in situ (in the body) lead characteristic determination and in vivo (in the body) retrograde conduction time. It also tests the in vitro operation of pulse generators, but this is testing the device itself, not a biological sample.
- Device Description: The description reinforces its use during invasive procedures and for testing the electrical performance of the pacing system (pulse generator and leads).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device interacts directly with the patient's electrical system and implanted/external devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ERA 300's function is related to the performance and interaction of medical devices within the body, not the analysis of biological samples.
N/A
Intended Use / 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, 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. Deternines the following parameters: pulse and width, sensitivity, refractory period, AV delay, and rate/interval.
Product codes
DTA, DTC, DTE
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.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC - 8 2003
BIOTRONIK, Inc., ERA 300 Pacing System Analyzer, Special 510(k)
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K033613". The characters are written in a dark ink on a white background. The handwriting is somewhat rough, but the characters are still legible.
November 14, 2003
ERA 300 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 300 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: | November 14, 2003 |
General 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.
Device Modification:
A plastic foil was applied to four sides of the battery in order to reduce movement of the battery within the compartment, thereby reducing the number of sudden power-offs of the ERA 300.
Predicate Devices:
BIOTRONIK proposes the following Pacing System Analyzer cleared through 510(k) notification as a predicate device for the ERA 300 Pacing System Analyzer:
- � BIOTRONIK's ERA 300 Pacing System Analyzer (#K964190, cleared 07-10-97)
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, 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. Deternines the following parameters: pulse and width, sensitivity, refractory period, AV delay, and rate/interval.
| Name and Address of Manufacturing Site: | BIOTRONIK GmbH & Co. (reg. no. 9610139)
Woermannkehre 1, 12359 Berlin, Germany
Phone: 011-49-30-689-05-304 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2003
BIOTRONIK, Inc. c/o Mr. Jon Brumbaugh Director of Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035
Re: K033613
Trade Name: ERA 300 Dual Chamber Pacing System Analyzer Regulation Number: 21 CFR 870.3600, 870.3630 and 870.3720 Regulation Name: External Pacemaker Pulse Generator Pacemaker Electrode Function Analyzer Pacemaker Generator Function Analyzer Regulatory Class: Class III (three) Product Code: DTA, DTC and DTE Dated: November 14, 2003 Received: November 17, 2003
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
O. Malla
Image /page/2/Picture/5 description: The image shows a handwritten letter 'f' in cursive. The letter has a loop at the top and a curved line extending downwards. The stroke width varies slightly, giving it a natural, handwritten appearance.
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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2. 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, 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.
See Appendix 1 for FDA's 510(k) Indications for Use Form.
El. Mallis
of Cardiovascular Devices
510(k) Number K033613