(20 days)
Not Found
Not Found
No
The summary describes a mechanical catheter with lumens for inflation, pressure monitoring, and solution delivery. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used for occlusion of the coronary sinus and delivery of cardioplegic solution, which are therapeutic interventions.
No
The device is primarily used for therapeutic purposes (occlusion, delivery of solution) and monitoring, not for diagnosing a disease or condition. While it monitors coronary sinus pressure, this information is used during a procedure (cardiopulmonary bypass) rather than for initial diagnosis.
No
The device description clearly states it is a physical catheter with lumens and a balloon, 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:
- Intended Use: The intended use describes a device used in vivo (within the body) for procedures related to the coronary sinus. This includes occlusion, delivery of solution, and pressure monitoring.
- Device Description: The description details a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing samples outside the body. This device is clearly designed for direct interaction with the patient's anatomy.
N/A
Intended Use / Indications for Use
The Steerable Coronary Sinus Catheter is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Steerable Coronary sinus Catheter is a 9 Fr., three-lumen catheter in the distal balloon. The three lumen are used to inflate the balloon (to occlude the coronary sinus), monitor coronary sinus pressure and for delivery of cardioplegia solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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)
Results of verification testing indicates that the product meets the established performance requirements.
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.
Endocoronary Sinus Catheter
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
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
DEC 1 1 2002
ATTACHMENT V
510(k) SUMMARY
| Statement | Information supporting claims of substantial equivalence, as
defined under the Federal Food, Drug, and Cosmetic Act,
respecting safety and effectiveness is summarized below. For the
convenience of the Reviewer, this summary is formatted in
accordance with the Agency's final rule ".... 510(k) Summaries
and 510(k) Statements ...." (21 CFR 807) and can be used to
provide a substantial equivalence summary to anyone requesting it
from the Agency. | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | MODIFIED DEVICE NAME: | CardioVations Steerable
Coronary Sinus Catheter |
| | PREDICATE DEVICE NAME: | Endocoronary Sinus Catheter |
| Device Description | The Steerable Coronary sinus Catheter is a 9 Fr., three-lumen
catheter in the distal balloon. The three lumen are used to inflate
the balloon (to occlude the coronary sinus), monitor coronary sinus
pressure and for delivery of cardioplegia solution. | |
| Intended Use | The catheter is designed to occlude the coronary sinus, deliver
cardioplegic solution to the coronary sinus and monitor the
coronary sinus pressure during cardiopulmonary bypass. | |
| Indications Statement | The Steerable Coronary Sinus Catheter is indicated for occlusion
of the coronary sinus, delivery of cardioplegic solution, and
monitoring of coronary sinus pressure during cardiopulmonary
bypass. | |
| Technological
Characteristics | The modified device has the same technological characteristics as
the predicate device. The form, fit, function and method of
operation are similar. | |
| | Continued on next page | |
| Performance Data | Results of verification testing indicates that the product meets the
established performance requirements. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
subject device is substantially equivalent to the predicate devices
under the Federal Food, Drug and Cosmetic Act. | |
| Contact | Peter Cecchini
Manager
Regulatory Affairs
ETHICON, Inc.
Rt. 22 West
Somerville, NJ 08876-0151 | |
| Date | November 20, 2002 | |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DFC 11 2002
Ethicon, Inc. c/o Mr. Peter Cecchini Route 22 West Somerville, NJ 08876
Re: K023880
CardioVations Steerable Coronary Sinus Catheter Regulation Number: 870.4210 Regulation Name: CPB Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 20, 2002 Received: November 21, 2002
Dear Mr. Cecchini:
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.
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
3
Page 2 - Mr. Peter Cecchini
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
L
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
CardioVations Steerable Coronary Sinus Catheter
Indications for Use:
The Steerable Coronary Sinus Catheter is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Figure/8 description: The image shows a form with two options: "Prescription Use" and "Over-The Counter Use". The "Prescription Use" option has a checkmark next to it, indicating that it has been selected. Below the options, there is a signature and a number "K02 3880".
CardioVations Steerable Coronary Sinus Catheter ETHICON, Inc.