(35 days)
Not Found
No
The summary describes a pacing system analyzer with standard electrical testing and temporary pacing functions. There is no mention of AI, ML, or related concepts in the intended use, device description, or the specific sections for AI/ML information.
Yes
The device explicitly states its intention to provide "temporary stimulation" during pacemaker procedures and "operate as a temporary external pulse generator," which are therapeutic functions.
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 to "Test and analyze the in vitro operation of external or implantable pulse generators." These activities involve assessing the condition and function of medical devices and patient physiological parameters, which are characteristic of 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 in vitro operation of pulse generators, but this is testing the device itself, not a biological sample.
- Device Description: The description reinforces its use as a pacing system analyzer and temporary external pulse generator used at the time of pacemaker implantation and during invasive procedures.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to provide information about a person's health. The ERA 300 does not analyze biological samples. It interacts with the electrical system of the heart and implanted devices.
Therefore, the ERA 300 falls under the category of a medical device used for diagnosis and treatment in vivo, not an IVD device used for testing in vitro 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 870.3720 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
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 Road
Lake Oswego, OR 97035 | DEC 2 0 2007 |
|--------------------------------------|-------------------------------------------------------------|--------------|
| Establishment Registration Number: | 1028232 | |
| Device Name: | | |
| Proprietary Name:
Classification: | ERA 300 Dual Chamber Pacing System Analyzer
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
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 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)
1
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. KG
Woermannkehre 1,
12359 Berlin, Germany
011-49-30-689-05-1210 |
|-------------------------------------|-----------------------------------------------------------------------------------------------|
| 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.
3
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
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