(57 days)
The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired.
The Cobra Catheter is an externally communicating device in limited contact with circulating blood.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cobra™ Catheter, structured according to your request:
Acceptance Criteria and Device Performance
The provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices rather than clearly defined numerical acceptance criteria for the Cobra™ Catheter itself. The text implies that the acceptance criteria are met if the device demonstrates:
- Biological compatibility, non-toxicity, and safety for limited contact (up to 6 hours) with circulating blood.
- Structural integrity.
- Key device functionality.
- Ease of use.
- Adequate venous oxygen saturation delivery.
- Preservation of cerebral autoregulation (implied by differential temperatures).
However, no specific quantitative thresholds or numerical targets are provided for these criteria. The "reported device performance" is descriptive and comparative.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility, non-toxicity, safety for blood contact (up to 6 hours) | "Based on the test results, the Cobra Catheter is biologically compatible, non-toxic and safe for use in limited contact (up to 6 hours) with circulating blood." (Results from "standardized in vitro and in vivo tests" and "Good Laboratory Practice Regulation, 21 CFR Part 58" compliance). |
| Structural integrity | "In vitro and in vivo testing was designed to ensure device structural integrity..." (Implied positive outcome, no specific performance metric given). |
| Key device functionality | "In vitro and in vivo testing... [designed to ensure] key device functionality..." "Test results provided a high degree of confidence that the Cobra Catheter function as intended." (Implied positive outcome, no specific performance metric given). Compared directly to currently marketed devices for these aspects. |
| Ease of use | "In vitro and in vivo testing... [designed to ensure]... ease of use." (Implied positive outcome, no specific performance metric given). |
| Adequate venous oxygen saturation delivery | "Feasibility and randomized clinical studies demonstrated that adequate venous oxygen saturation was delivered..." (No specific saturation percentage or range provided, but reported as "adequate"). |
| Preservation of cerebral autoregulation | "... with differential temperatures indicating the preservation of cerebral autoregulation." (Implied through the presence and effectiveness of differential temperatures, but no specific physiological parameter or threshold for autoregulation is provided. This is a functional claim tied to the device's ability to provide differential perfusion for hypothermic arch perfusate). |
| Substantial Equivalence to Predicate Devices | "The Cobra Catheter is substantially equivalent to currently marketed devices... Substantial equivalence is also supported through comparison with several marketed devices with the same indications for use... Technological characteristics (design and materials) of the Cobra Catheter are substantially equivalent to arterial return devices currently marketed for CPB." "Thus, the Cobra Catheter is substantially equivalent to predicate arterial return devices with regard to intended use, technological characteristics and device performance." |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "clinical studies" including "Feasibility and randomized clinical studies" and "und case" (likely a typo for "one case" or "study case"). However, no specific numerical sample sizes are provided for these clinical studies.
- Data Provenance: The document does not explicitly state the country of origin. Given the applicant is Cardeon Corporation in Cupertino, CA, and the FDA is the reviewer, it's highly probable the studies were conducted in the United States. The studies were prospective as they were conducted to demonstrate the safety and effectiveness of a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The studies are described in terms of "clinical studies" and "standard surgical techniques," implying a clinical setting, but details on expert involvement for ground truth establishment are absent.
4. Adjudication Method:
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as described. This device is a medical catheter, not an imaging or diagnostic AI device that typically involves human readers interpreting data. The comparison is between the new device's performance and predicate devices, or between the device and standard clinical practices/outcomes, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone AI algorithm performance study was not done. The Cobra™ Catheter is a physical medical device, not an AI algorithm. Its performance is evaluated through in vitro, in vivo, and clinical studies of its physical function and clinical impact, not through an algorithm's output.
7. Type of Ground Truth Used:
- For the in vitro and in vivo tests, the ground truth was likely established through direct measurement against engineering specifications and biological response assessments (e.g., cell viability, clotting, inflammation).
- For the clinical studies, the ground truth was based on clinical outcomes and physiological measurements such as "adequate venous oxygen saturation" and "differential temperatures indicating the preservation of cerebral autoregulation." This constitutes outcomes data and physiological markers monitored during surgical procedures.
8. Sample Size for the Training Set:
- This information is not applicable/not provided because the Cobra™ Catheter is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable/not provided as there is no AI training set involved for this physical device.
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510(k) SUMMARY
510(k) number:
This summary of information is being provided in accordance with 21 CFR 807.92(a).
| Applicant Information: | Cardeon Corporation10600 N. Tantau AvenueCupertino, CA 95014 |
|---|---|
| Contact Person: | Jane BeggsRegulatory AffairsCardeon Corporation |
| Date: | 9 August 2004 |
| Device Trade Name: | Cobra™ Catheter |
| Device Common Name | Catheter, cannula and tubing, vascular, cardiopulmonary |
| Regulation No.: | bypass 870.4210 |
| Classification / Code: | Class II / DWF |
Indications for Use: The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to cannulate the aorta and provide hypothermic arch perfusate and normothermic corporeal perfusate.
Summary of Substantial Equivalence: The Cobra Catheter is substantially equivalent to currently marketed devices used to directly cannulate the aorta and return perfusion to patients undergoing general cardiac surgery. Perfusion is achieved through standard connections to the extracorporeal circuit. ). Intended use and indications for the subject and predicate devices are substantially equivalent for arterial return during CPB. Substantial equivalence is also supported through comparison with several marketed devices with the same indications for use, including arterial return cannulae with directed flow (i.e., specified flow patterns). Directed flow is a feature offered by devices cleared through premarket notification and currently marketed for CPB and peripheral vascular thrombectomy. Selective perfusion systems have been reported on extensively and safely used for over two decades. These selective perfusion systems utilize predicate cannulae and standard perfusion circuitry for cooling the brain independently from the rest of the body. Arterial line pressures, nasopharyngeal and rectal temperatures, radial arterial pressures, oxygen saturation, etc. are standard clinical practices for monitoring the patient used in predicate selective perfusion systems. Technological characteristics (design and materials) of the Cobra Catheter are substantially equivalent to arterial return devices currently marketed for CPB. Differences between the Cobra Catheter and currently marketed devices do not substantially alter arterial return during cardiopulmonary bypass.
Substantial equivalence with regard to safety and effectiveness has also been Product Testing: demonstrated through standardized in vitro and in vivo tests as well clinical study.
The Cobra Catheter is an externally communicating device in limited contact with circulating blood. Tests were conducted and inspected in accordance with Good Laboratory Practice Regulation, 21 CFR Part 58. Based on the test results, the Cobra Catheter is biologically compatible, non-toxic and safe for use in limited contact (up to 6 hours) with circulating blood.
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In vitro and in vivo testing was designed to ensure device structural integrity, key device functionality and ease of use. Device in vivo performance was evaluated using standard surgical techniques and und case. Dor cardiopulmonary bypass and patient monitoring. Test results provided a high degree of confidence that the Cobra Catheter function as intended. Many of the tests allowed direct comparison to currently marketed devices.
Clinical studies were conducted to demonstrate the safety and effectiveness of the Cobra Catheter. Feasibility and randomized clinical studies demonstrated that adequate venous oxygen saturation was delivered with differential temperatures indicating the preservation of cerebral autoregulation. Thus, the Cobra Catheter is substantially equivalent to predicate arterial return devices with regard to intended use, technological characteristics and device performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract human figure with three flowing lines representing the human form.
OCT 6 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardeon Corp. c/o Ms. Jane Beggs Regulatory Affairs 10600 N. Tantau Avenue Cupertino, CA 95014
Re: K042156
Cardeon® Cobra™ Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: August 9, 2004 Received: August 10, 2004
Dear Ms. Beggs;
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 for ass based or 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 - Ms. Jane Beggs
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that I broundevice complies with other requirements of the Act that I Drinas Intact a and regulations administered by other Federal agencies. You must or any I eath 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 CI It Fart 6077; accems (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. product in the 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 premaired predicated 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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510(k) Number (if known): _________
Page 1 of 1
Device Name: Cardeon® Cobra™ Catheter
Indications for Use:
The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the Counter Use __________
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K042156
OR
§ 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).