(20 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the CardioVations Steerable Coronary Sinus Catheter. However, it does not contain detailed information about specific acceptance criteria or the results of a formal study proving the device meets those criteria, as one would typically expect for an AI/ML device or a device requiring extensive performance testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Results of verification testing indicates that the product meets the established performance requirements."
This is a very general statement and does not provide specific acceptance criteria or quantitative performance measures. Therefore, a table cannot be constructed with detailed information.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Meets established performance requirements | Product meets the established performance requirements. |
| Functions as intended | The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar. |
| Safety and Effectiveness | Device is substantially equivalent to legally marketed predicate devices, implying similar safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The text only mentions "verification testing" without specifying the sample size, type of data (e.g., in vitro, animal, human), or provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. Given the nature of the device (a catheter), the "ground truth" would likely relate to its physical performance, material properties, and ergonomic aspects, rather than expert interpretation of medical images or data. No mention of expert consensus for performance evaluation is made.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. An MRMC study is typically relevant for diagnostic devices where human readers interpret output, often with AI assistance. This device is a catheter for surgical procedures, so an MRMC study is highly unlikely for this type of product.
6. Standalone (Algorithm Only) Performance Study:
This information is not provided. This device is a physical medical instrument, not an AI algorithm, so a "standalone algorithm only" performance study is not applicable.
7. Type of Ground Truth Used:
The document implies that the ground truth for evaluating the device would be based on its physical and functional performance against established engineering specifications and its comparison to a predicate device. It's not explicitly stated, but for a catheter, this would typically involve:
- Physical measurements (e.g., diameter, length, lumen size).
- Material testing (e.g., biocompatibility, tensile strength, kink resistance).
- Functional testing (e.g., balloon inflation, fluid delivery rates, steerability).
- Performance in simulated environments or animal models to assess occlusion, cardioplegia delivery, and pressure monitoring.
The concept of "expert consensus," "pathology," or "outcomes data" as ground truth is not directly applicable in the typical sense for this device.
8. Sample Size for the Training Set:
This information is not provided. The device is a physical product, not an AI/ML model, so the concept of a "training set" in the context of machine learning is not applicable here.
9. How the Ground Truth for the Training Set was Established:
This information is not provided, as the concept of a training set is not applicable to this type of device.
In summary: The provided document is a 510(k) summary for a medical device that predates the modern era of AI/ML devices. Therefore, it focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and unspecified "verification testing" results, rather than detailed performance studies against specific acceptance criteria using AI-centric methodologies. The information requested regarding sample sizes, ground truth establishment for training/test sets, expert involvement, and MRMC studies is not present because these concepts are generally not relevant to the evaluation of a physical, non-AI medical instrument described in this submission.
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DEC 1 1 2002
ATTACHMENT V
510(k) SUMMARY
| Statement | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ".... 510(k) Summariesand 510(k) Statements ...." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency. | |
|---|---|---|
| MODIFIED DEVICE NAME: | CardioVations SteerableCoronary Sinus Catheter | |
| PREDICATE DEVICE NAME: | Endocoronary Sinus Catheter | |
| Device Description | The Steerable Coronary sinus Catheter is a 9 Fr., three-lumencatheter in the distal balloon. The three lumen are used to inflatethe balloon (to occlude the coronary sinus), monitor coronary sinuspressure and for delivery of cardioplegia solution. | |
| Intended Use | The catheter is designed to occlude the coronary sinus, delivercardioplegic solution to the coronary sinus and monitor thecoronary sinus pressure during cardiopulmonary bypass. | |
| Indications Statement | The Steerable Coronary Sinus Catheter is indicated for occlusionof the coronary sinus, delivery of cardioplegic solution, andmonitoring of coronary sinus pressure during cardiopulmonarybypass. | |
| TechnologicalCharacteristics | The modified device has the same technological characteristics asthe predicate device. The form, fit, function and method ofoperation are similar. | |
| Continued on next page | ||
| Performance Data | Results of verification testing indicates that the product meets theestablished performance requirements. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act. | |
| Contact | Peter CecchiniManagerRegulatory AffairsETHICON, Inc.Rt. 22 WestSomerville, NJ 08876-0151 | |
| Date | November 20, 2002 |
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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
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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
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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.
§ 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).