(211 days)
Biosense Webster Lasso Deflectable Circular Mapping Catheter, Cardima, Inc Pathfinder Catheter
Not Found
No
The summary describes a passive mapping catheter for recording electrograms and does not mention any AI/ML components or functions.
No.
The device is used for recording cardiac electrograms to evaluate arrhythmias, not for treating them.
Yes
The device is designed to record cardiac electrograms for the evaluation of cardiac arrhythmias, which is a diagnostic purpose.
No
The device description clearly details a physical catheter with electrodes, a handle, and a connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
- Device Function: The ProRhythm ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. It is designed to be inserted into the body (intracardiac, endocardial, intravascular) to record electrical signals directly from the heart.
- Intended Use: The intended use is to "record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures." This is a procedure performed within the body.
The device is used in vivo (within a living organism) to gather electrical data directly from the heart, not to analyze samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ProRhythm™, Inc. ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. The ProMap is designed to be used to record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures. The ProRhythm ProMap is to be used with the ProMap Connection Cable.
The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.
Product codes
DRF
Device Description
ProRhythm's ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment. The device has 6 electrodes mounted at the distal end. A passive mechanism at the distal end conforms into the shape of a ring ranging from 15 to 25 mm in diameter. The electrodes are spaced either evenly. The handle at the proximal end of the device allows the device to be manipulated into position within the left atrium. A connector at the proximal end of the device enables connection to the ProMap Connection Cable.
The ProMap Coaxial Mapping Catheter is designed to be inserted through a delivery sheath catheter and into the left atrium to record electro grams. The distal end extends past the delivery sheath catheter and forms into a circular ring that is optimized for use in the pulmonary veins. Electrodes mounted at the distal end and spaced uniformly along the circular ring allow recording of pulmonary vein potentials in the left atrium.
The ProMap Coaxial Mapping Catheter can be withdrawn and reinserted (without excessive friction) while the delivery sheath catheter can be deflected. This enables the electro physiologist to perform other functions through the sheaths lumen, such as contrast injections to obtain venograms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac, endocardial, intravascular, left atrium, pulmonary veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiology clinical procedures
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
The ProMap Coaxial Mapping Catheter is tested according to the specifications documented in Design Verification Testing Reports. Pre-clinical in-vivo testing further provided validation that the device performed as intended. In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected.
Key Metrics
Not Found
Predicate Device(s)
Biosense Webster Lasso Deflectable Circular Mapping Catheter, Cardima, Inc Pathfinder Catheter
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).
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JAN 12
10(k) SUMMARY ProRhythm, Inc's ProMap Coaxial Mapping Catheter
This 510(k) summary is provided as part of the Premarket Notification for ProRhythm, Inc's ProMap Coaxial Mapping Catheter
- Submitter: ProRhythm, Inc 105 Comac St. Ronkonkoma, New York 11779 Phone: +1-631-981-3907 ext. 127 Facsimile: +1-631-981-4068
Contact Person: John J. Talarico
June 12, 2005 Date Prepared:
Name of Device: ProMap Coaxial Mapping Catheter
Common or Usual Name: Mapping Catheter
Classification Name: Electrode Recording Catheter 21 CFR 870.1220
Predicate Devices:
Biosense Webster Lasso Deflectable Circular Mapping Catheter Cardima, Inc Pathfinder Catheter
Intended Use / Indications for Use
Intended Use
The ProRhythm™, Inc. ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. The ProMap is designed to be used to record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures. The ProRhythm ProMap is to be used with the ProMap Connection Cable.
THE Florythim ProMap is to be used with the ProMap Connect.
Indications for Use
The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.
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Contraindications
- This device is contraindicated for use as an ablation catheter.
- This device is contraindicated for use in the ventricles. The retrograde approach is contraindicated because of the risk of entrapping the catheter in the left or valvular apparatus.
- This device is contraindicated for use in patients with:
- This device is contraindicated for use in the ventricles. The retrograde approach is contraindicated because of the risk of entrapping the catheter in the left or valvular apparatus.
- left atrial thrombus .
- prosthetic heart valves .
Electrophysiology studies are contraindicated when the patient's underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death as in the following examples.
- . trial thrombus
- . Recent history of stroke or transient ischemic attack
- Unstable angina .
- Myocardial Infarctions within the last two weeks. ●
- Patients who do not tolerate anticoagulation . therapy.
- Previous systemic embolization from the left . side of the heart
- Technological Characteristics
ProRhythm's ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment. The device has 6 electrodes mounted at the distal end. A passive mechanism at the distal end conforms into the shape of a ring ranging from 15 to 25 mm in diameter. The electrodes are spaced either evenly. The handle at the proximal end of the device allows the device to be manipulated into position within the left atrium. A connector at the proximal end of the device enables connection to the ProMap Connection Cable.
The ProMap Coaxial Mapping Catheter is designed to be inserted through a delivery sheath catheter and into the left atrium to record electro grams. The distal end extends past the delivery sheath catheter and forms into a circular ring that is optimized for use in the pulmonary veins. Electrodes mounted at the distal end and spaced uniformly along the circular ring allow recording of pulmonary vein potentials in the left atrium.
The ProMap Coaxial Mapping Catheter can be withdrawn and reinserted (without excessive friction) while the delivery sheath catheter can be deflected. This enables the electro physiologist to perform other functions through the sheaths lumen, such as contrast injections to obtain venograms.
Performance Data
The ProMap Coaxial Mapping Catheter is tested according to the specifications documented in Design Verification Testing Reports. Pre-clinical in-vivo testing further
- Current systemic infection .
- Recent pulmonary emboli .
- Known or suspected left atrial myxoma
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provided validation that the device performed as intended. In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected.
Substantial Equivalence
The ProMap Coaxial Mapping Catheter is as safe and effective as the Biosense Webster circular Lasso™ and the Cardima Pathfinder™ catheter. The ProMap Coaxial Mapping Catheter has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ProMap Coaxial Mapping Catheter and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ProMap Coaxial Mapping Catheter is as safe and effective as the Biosense Webster circular Lasso™ and the Cardima Pathfinder™ catheter. Thus, the ProMap Coaxial Mapping Catheter is substantially equivalent to the predicate devices in construction, materials, and intended use
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ProRhythm, Inc. c/o Mr. John J. Talarico VP QA, Regulatory and Clinical Affairs 105 Comac Street Ronkonkoma, NY 11779
JAN 1 2 2007
Re: K061678
Trade Name: ProMap Coaxial Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: DRF Dated: January 8, 2007 Received: January 9, 2007
Dear Mr. Talarico:
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. Mr. Talarico
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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely vours.
стандарт
Bram D/Zuckerman. 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): K061678
Device Name: ProMap Coaxial Mapping Catheter
The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from Indications For Use: endocardial and intravascular sites.
The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.
Contraindications
- This device is contraindicated for use as an ablation catheter.
- This device is contraindicated for use in the ventricles. The retrograde approach is contraindicated because of the risk of entrapping the catheter in the left or valvular apparatus.
.
- This device is contraindicated for use in patients with:
- . left atrial thrombus
- . prosthetic heart valves
Electrophysiology studies are contraindicated when the patient's underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death as in the following examples:
. trial thrombus
- Unstable angina
- Myocardial Infarctions within the last two weeks. .
- . Patients who do not tolerate anticoagulation therapy,
- Previous systemic embolization from the left side of the . heart
Prescription Use X (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)
C.A.M.P.
510(k) Number K061678
Page 1 of 1
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attack . Current systemic infection
Recent history of stroke or transient ischemic -
. Recent pulmonary emboli
-
Known or suspected left atrial myxoma