(71 days)
The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit.
The provided text describes the Cardeon® Ascending Balloon Cannula (ABCTM) and its regulatory clearance (K022042). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or data provenance as requested.
The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study with quantitative acceptance criteria and detailed performance data.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific force limits, flow rates, failure rates thresholds). The general "acceptance criteria" are implied to be that the device functions "as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
- Reported Device Performance:
- "Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
- This is a qualitative statement of equivalence, not specific quantitative performance data against defined criteria (e.g., "burst pressure > X mmHg", "flow rate > Y L/min with < Z mmHg pressure drop").
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate devices | Functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons. |
| Biocompatibility | Satisfied (based on assessment). |
| In vitro performance consistent with predicate devices | Satisfied (based on assessment). |
| In vivo performance consistent with predicate devices | Satisfied (based on assessment). |
| Aortic occlusion when balloon inflated | Confirmed (implied by "occlusion balloon isolates the heart from the ascending aorta when inflated" as a functional description). |
| Ability to deliver antegrade cardioplegia and vent aortic root | Confirmed (implied by "ABC also allows delivery of antegrade cardioplegia and venting of the aortic root" as a functional description). |
| Perfusion of aorta during CPB up to 6 hours | Confirmed (implied by "intended to perfuse the aorta... up to 6 hours" and overall substantial equivalence to devices with this intended use duration). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for any specific in vitro or in vivo tests. The document only mentions "product testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable as this is not a study involving expert review for diagnostic accuracy. The "ground truth" for this device would be its functional performance and safety, assessed through engineering tests and potentially animal studies, not expert interpretation of image data.
4. Adjudication Method for the Test Set:
- Not applicable for the type of device testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images with and without AI assistance. The Cardeon Ascending Balloon Cannula is a therapeutic/surgical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Not applicable. This device is a physical medical device, not an algorithm, so "standalone algorithm performance" is not a relevant concept here. The "standalone" performance refers to the device's functional integrity as a physical product (e.g., material strength, flow characteristics), which was assessed via "product testing" (in vitro and in vivo).
7. The Type of Ground Truth Used:
- For a device like the Ascending Balloon Cannula, the "ground truth" for performance assessment is based on:
- Engineering specifications and standards: The device must meet predefined physical and functional parameters (e.g., material strength, burst pressure, flow rates, occlusion capability).
- Biocompatibility testing: Compliance with ISO 10993 standards or similar.
- In vivo functional assessment: Performance in animal models (if applicable) or benchtop models simulating physiological conditions.
- Clinical experience with predicate devices: The "ground truth" for safety and effectiveness is largely benchmarked against the established performance of existing, legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML device.
In summary:
The provided 510(k) summary for the Cardeon Ascending Balloon Cannula demonstrates substantial equivalence primarily through comparison to predicate devices and general "product testing" (biocompatibility, in vitro, and in vivo performance). It does not provide the detailed, quantitative study specifics often expected for AI/ML devices or studies focused on precise diagnostic accuracy metrics. The regulatory pathway for this device emphasizes demonstrating that it performs "as safely and effectively" as similar devices already on the market, rather than meeting specific novel performance benchmarks established through a detailed, publicly documented study with specified sample sizes and expert adjudication.
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510(k) SUMMARY
K022042 510(k) number:
This summary of information is being provided in accordance with 21 CFR 807.92(a).
| Applicant Information: | Cardeon Corporation10161 Bubb RoadCupertino, CA 95014 |
|---|---|
| Contact Person: | Jane BeggsRegulatory AffairsCardeon Corporation |
| Date Summary Prepared: | 23 August 2002 |
| Device Trade Name: | Cardeon® Ascending Balloon Cannula (ABCTM) |
| Device Common NameRegulation No.: | Catheter, cannula and tubing, vascular, cardiopulmonarybypass 870.4210 |
| Classification / Code: | Class II / DWF |
Indications for Use: The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
Summary of Substantial Equivalence: The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit. Substantial equivalence is supported through comparison with several marketed devices with the same indications for use, including arterial cannulae integral occlusive balloon and external cross clamps. Differences between the Ascending Balloon Cannula and other devices do not raise any new issues of safety and effectiveness.
Based on comparisons to currently marketed devices and performance testing of the subject device. the Cardeon Ascending Balloon Cannula is substantially equivalent to predicate devices with regard to intended use, indications for use, device performance and technological characteristics,
Product Testing: The determination of substantial equivalence was also based on an assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 SEP
Cardeon Corporation c/o Ms. Jane Beggs VP. Regulatory Affairs 10161 Bubb Road Cupertino, CA 95014
Re: K022042
Trade Name: Cardeon® Ascending Balloon Cannula (ABCTM) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: June 13, 2002 Received: June 14, 2002
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 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. Iisting 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Noa Bram D. Zuckerman, M.D.
ABram 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): ΚύλλΟΥ Σ
Page 1 of 1
Device Name: Cardeon Ascending Balloon Cannula (ABC™)
Indications for Use:
The Cardeon Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the Counter Use _
(Division Sign-Off)
Division of Cardiovascular and Respiratory Devices
510(k) Number K022042
§ 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).