(30 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as being used for "diagnostic electrical stimulation of the heart," which focuses on identifying and assessing heart conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used for diagnostic electrical stimulation of the heart."
No
The intended use describes diagnostic electrical stimulation of the heart, which inherently requires hardware components to deliver the stimulation and acquire data. The summary does not mention the device being software-only.
Based on the provided information, the EP-WorkMate® with RPM™ System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "diagnostic electrical stimulation of the heart". This involves interacting directly with the patient's heart to gather electrical information.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They do not involve direct interaction with the patient's internal organs for diagnostic purposes.
The EP-WorkMate® with RPM™ System is a device used for in vivo (within the living body) diagnostic procedures related to the heart's electrical activity.
N/A
Intended Use / Indications 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.
Product codes
DQK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be a stylized depiction of an eagle or bird with three wing-like shapes.
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.
1
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
2
Image /page/2/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the company name. The graphic is a series of curved lines that form a spiral shape. The text "EPMedSystems" is written in a serif font.
Image /page/2/Picture/1 description: The image shows a logo with the text "ISO9001 / EN46001 CERTIFIED COMPANY". To the left of the text is a square logo with a crown on top. The text is in bold and is black. The logo is also black and white.
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: