(58 days)
Not Found
No
The description focuses on the physical design and function of the catheter for electrophysiological mapping and pacing, with no mention of data analysis or interpretation using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a diagnostic mapping catheter intended for recording and pacing electrograms, not for treating conditions.
Yes
The device description explicitly states, "The Flower High-Density Mapping Catheter is a 7 Fr diagnostic, multi-electrode electrophysiological mapping catheter..." and further indicates its purpose is for "diagnostic electrogram recording."
No
The device description clearly details a physical catheter with electrodes, spines, a handle, and a lumen, indicating it is a hardware device, not software-only.
Based on the provided information, the Biosense Webster Flower High-Density Mapping Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of cardiac structures in the heart, i.e., recording or pacing only." This involves directly interacting with the patient's heart to record electrical signals.
- Device Description: The description details a catheter designed to be inserted into the heart to obtain electrograms. This is an invasive procedure performed in vivo (within the living organism).
- 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 performed in vitro (outside the living organism).
The Flower High-Density Mapping Catheter is a medical device used for diagnosis and potentially treatment (pacing) within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or electrogram only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
MTD
Device Description
The Flower High-Density Mapping Catheter is a 7 Fr diagnostic, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram recording and pacing in the heart. It has a unique distal multi-spine array of five 3 Fr 1.5 cm long spines. Model D-1245-02has the electrodes evenly spaced 4 mm apart on all spines, whereas Model D-1245-02 has the electrodes spaced 2, 0, and then 2 min a star-like pattern that presents the 20 multiple heart electrodes in a two-dimensional arraythmias. A tube with a Luer connector on the neatle endocardian to detect various along the entire length of the catheter for continuous proximal end provides an open ranten along and encommend by a handle at the proximal end delivery of anticoagulation fram. "The catheter, and/or deflects the catheter to that activalies of Tetracts the sations of the catheter is connected to appropriate recording equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures in the heart, atrial and ventricular regions of the 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)
The Flower High-Density Mapping Catheter underwent bench testing and was tested under simulated use conditions in animals and it passed all intended criteria in accordance with appropriate test criteria and standards. In addition, this catheter has been successfully appropriate test r. 80 clinical cases in humans to date with no reports of patient injury or death.
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.
K002333, K021232, K011361, K982740
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
§ 870.1220 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
K050217
1/2
MAR 3 0 2005
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Road
Diamond Bar, CA 91765 USA
Tel.: 800-729-9010
Fax: 909-839-8804 | | Date: |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------|
| Contact: | Wayne R. Hohman | | |
| Trade (Propreitary)Name: | Flower High-Density Mapping Catheter | | |
| Common Name: | Electrophysiological mapping catheter | | |
| Classification Name: | Electrode recording catheter or electrode recording probe | | |
| Device Classification: | Class II, 21 CFR 870.1220 | | |
| Product Code: | D-1245-01, D-1245-02 | | |
| Equivalent Devices: | K002333 | Lasso™ Deflectable Circular Mapping Catheter,
Biosense Webster, Inc. | |
| | K021232 | Constellation® Multiple Electrode Recording
and Pacing Catheters System, Boston Scientific
Corp. (EPT) | |
| | K011361 | Desai VectoCath™ Mapping Catheter,
CathEffects, LLC | |
| | K982740 | Preface Guiding Sheath (Braided), Biosense | |
Substantially Equivalent To:
The Flower High-Density Mapping Catheter is substantially equivalent to the Lasso™ Deflectable Circular Mapping Catheter (Biosense Webster, Inc., K002333), Constellation® Multiple Electrode Recording and Pacing Catheters System (Boston Scientific Corp. (EPT), K021232), Desai VectoCath™ Mapping Catheter (Catheffects, LLC, K982740), and Preface Guiding Sheath (due to possessing a central lumen for heparinized saljne).
Description of the Device Subject to Premarket Notification:
The Flower High-Density Mapping Catheter is a 7 Fr diagnostic, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram recording and
1
KD50217
2/2
pacing in the heart. It has a unique distal multi-spine array of five 3 Fr 1.5 cm long spines. pacing in the heart. Ti has a unque unstal mans of 20 electrodes. Model D-1245-02has the electrodes evenly spaced 4 mm apart on all spines, whereas Model D-1245-02 has the has the electrodes eventy spaced 4 inn apart on each spines. The spines are pressed against the electrodes spaced 2, 0, and then 2 min a star-like pattern that presents the 20 nultiple heart endocardium where they open into a star mice patient of electrodes maps areas of the electrodes in a two-unnensional arraythmias. A tube with a Luer connector on the neatle endocardian to detect various along the entire length of the catheter for continuous proximal end provides an open ranten along and encommend by a handle at the proximal end delivery of anticoagulation fram. "The catheter, and/or deflects the catheter to that activalies of Tetracts the sations of the catheter is connected to appropriate recording equipment.
Indications for Use:
The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple The Dioschse website Website Ingir De of cardiac structures in the heart, i.e., recording or ciccuropity. This catherer is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Technical Characteristics:
The Flower High-Density Mapping Catheter is a typical electrophysiological catheter that is The I rower ingil Delimity of 20 ring electrodes on five individual spines at its distal tip. Otherwise, there are no special technical aspects of the ability of this catheter to detect electrical signals from heart endocardium and transmit this information to recording equipment for display, analysis, and interpretation in detection of various heart arrhythmias.
Performance Data:
The Flower High-Density Mapping Catheter underwent bench testing and was tested under simulated use conditions in animals and it passed all intended criteria in accordance with appropriate test criteria and standards. In addition, this catheter has been successfully appropriate test r. 80 clinical cases in humans to date with no reports of patient injury or death.
Basis for Determination of Substantial Equivalence:
The Flower High-Density Mapping Catheter is substantially equivalent to other diagnostic mapping catheters such as the Biosense Webster Lasso Catheter (K002333), Boston Scientific's Constellation Multiple Electrode Recording Catheters (K021232), and CathEffects Desai VectoCath™ Mapping Catheter (K982740). The Preface Sheath was included as an example of an existing device that has a central lumen for irrigation of antithrombotic fluids.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAR 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosense Webster, Inc. c/o Mr. Wayne R. Hohman Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar CA 91765
Re: K050217
K050217
Trade Name: Flower high-density mapping catheter, models D-1245-01 and D-1245-02 Regulation Number: 21 CFR 870.1220 Regulation Name: 21 CFR 876.1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: MTD Dated: January 27, 2005 Received: January 31, 2005
Dear Mr. Hohman:
We have reviewed your Section 510(k) premarket notification of intent to market the device the madication we have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced andve and nave decembled the acres to received ate devices marketed in interstate for use stated in the encrosule for legally mances of the Medical Device Amendments, or to commerce prof to May 28, 1776, the enacement with the provisions of the Federal Food. Drug, devices that have been reclassified in acceraanse while tapproval application (PMA)).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act, The and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merelore, market the devree, bacycer to weeks for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Secure) into existing major regulations affecting your device can may be subject to such additional controller Lines of Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Wayne R. Hohman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device adders and must that FDA has made a determination inal your drives by other Federal agencies. You must
or any Federal statutes and regulations administered to: registration and listing or any Federal statutes and regulations administered or registration and listing (21)
comply with all the Act's requirements, including, but not be registration asset comply with all the Act S requirements, monama, variasturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if annlicable, the electronic CFR Part 807); labeling (21 CFK Patl on ); good manthstaning (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if a forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the sour Section S product radiation control provisions (Scetions 95 device as described in your Section 510(k)
This letter will allow you to temp a lientes as described in your device to a leg This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial end this permits vo premarket notification. The PDA Imalig of substantal equivations or your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the reading the may of 1648 - All on alsos note the requiries note the r If you desire specific advice for your de necess. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 594-4648. Also, please note the regula contact the Office of Compliance at (301) 571 16. 1726, FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by relerence to premarks. notification (1) on the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at in the largements attral Manufacturers, International and Consultive Picessor Prisesson of Carb/dsmardsmamain.html
Sincerely yours,
Blummer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
KOSO217 510(k) Number (if known): __
Device Name: Flower High-Density Mapping Catheter
Indication for Use:
The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple The Blosense website Trower Tigh Delexty Trappens
electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or election only. This cather is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Contraindications:
- The Biosense Webster Flower High-Density Mapping Catheter has not been shown to . be safe and effective for radiofrequency (RF) ablation.
- Use of this catheter may not be appropriate for use in patients with prosthetic valves. . Ose of this catheter may not appear atheter procedures is active systemic infection.
- A relative contraindicated in contraindicated in patients with left atrial thrombus or 4 myxoma, or interatrial baffle or patch.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
s 0217 Bflummerson
.vision Sign-Off) Msion of Cardlovascular Devices 510(K) Number