(30 days)
The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.
Not Found
The provided document is a 510(k) premarket notification clearance letter for the EP-WorkMate® with RPM™ Mapping System, dated August 2, 2003. This type of document indicates substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or extensive study results in the format requested. The letter focuses on regulatory clearance, not detailed performance metrics.
However, based only on the information provided in this document, here's what can be extracted, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the clearance letter. Regulatory clearance letters confirm substantial equivalence to a predicate device, but they do not typically detail the specific acceptance criteria or the specific device performance values as determined by studies submitted to the FDA.
2. Sample size used for the test set and the data provenance:
This information is not provided in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the clearance letter.
4. Adjudication method for the test set:
This information is not provided in the clearance letter.
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:
This information is not provided in the clearance letter. The device is described as an "EP-WorkMate® with RPM™ Mapping System," which is a "Programmable diagnostic computer" for "diagnostic electrical stimulation of the heart." This suggests the device is used for electrophysiology (EP) studies and mapping, not necessarily an AI-powered image analysis tool that would typically involve a multi-reader study of human interpretation improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not provided in the clearance letter. Given the nature of a "diagnostic computer" for EP procedures, it's highly likely that it's intended to be used with human operators (electrophysiologists).
7. The type of ground truth used:
This information is not provided in the clearance letter.
8. The sample size for the training set:
This information is not provided in the clearance letter.
9. How the ground truth for the training set was established:
This information is not provided in the clearance letter.
Summary based on the provided document:
The document is an FDA 510(k) clearance letter confirming that the EP-WorkMate® with RPM™ Mapping System is "substantially equivalent" to legally marketed predicate devices. It states the "Indication for Use" is "for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping."
The letter does not include details about specific performance metrics, acceptance criteria, study designs (like sample sizes, expert qualifications, adjudication methods), or ground truth establishment for either training or test sets. Such granular information is typically found in the 510(k) submission itself or related study publications, not in the clearance letter.
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Public Health Service
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AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James E. Kuhn, Jr. Director of Regulatory Affairs EP MedSystems Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293
Re: K032225
Trade Name: EP-WorkMate® with RPM™ Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: July 18, 2003 Received: July 21, 2003
Dear Mr. Kuhn:
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. James E. Kuhn, Jr.
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 (OS) 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 yours,
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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Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 Tel: (856) 753-8533 Fax: (856) 753-8544
July 18th , 2003
Indication for Use Statement
510(K) Number:
EP-WorkMate with ®RPM™ System Device Name:
Indication for Use
The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) the markdown representation of the image is:
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).