(115 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device is described as a deflectable catheter for electrophysiology studies, which is a standard medical device type.
No
The device is used for temporary use in electrophysiology studies, which are diagnostic in nature, not therapeutic.
No
No
The device description explicitly states "EP Deflectable Catheters," which are physical hardware devices used in electrophysiology studies. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary use in electrophysiology studies." Electrophysiology studies involve measuring electrical activity within the body, which is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) test.
- Device Description: The device is described as "EP Deflectable Catheters." Catheters are typically used to access internal body structures, again indicating an in vivo application.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the EP Deflectable Catheters are designed for a procedure performed within the patient's body, making them an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.
Product codes
DRF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that resemble a stylized human figure, and a circle around the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
APR 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EPMedSystems c/o Mr. James E. Kuhn Jr. Director of Regulatory Affairs Cooper Run Executive Park 575 Rt73 North Building D West Berlin, NJ 08091
Re: K033963
Trade Name: Ep Deflectable Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: March 31, 2004 Reccived: April 01, 2004
Dear Mr. Kuhn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered phor to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, de vices that have nech recuire approval of a premarket approval application (PMA). and Cosmeter receive, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelove, mainer are as Act include requirements for annual registration, listing of general controls province, 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 If your device is elassinod (ise as controls. Existing major regulations affecting your device can he 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 or any I 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 Cl K Fat 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quarty byevelm (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxiation only 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 premaince holicate 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) 594-4648. 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 from the Division of Small other golders, 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,
Diana R. Kirchner
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, abstract symbol to the left of the text "EPMedSystems". The symbol appears to be a series of curved lines or strokes, possibly representing a stylized brain or neural network. The text "EPMedSystems" is in a bold, sans-serif font.
:
Cooper Run Executive Park 575 Rt73 North Building D West Berlin, New Jersey 08091 Tel: (856)753-8533 Fax: (856)753-8544 E-Mail:Jkuhn@JEP MedSystems.com
April 14th , 2004
Indication for Use Statement
510(k) Number 033963
Device Name:EP Deflectable Catheters
ت ت ت (الا) الاق
Indication for Use
The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.
Prescription Use (Per 21 CFR 801 Subpart D)
or
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
High-Oil
of Cardiovascular Devices
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