(118 days)
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures reguiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.
The Estech Aortic Easy Flow Cannula is a medical device intended for use in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours. The documentation provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device based on clinical outcomes.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or a table of performance metrics for the ESTECH Aortic Easy Flow Cannula. Instead, the core of the submission relies on demonstrating substantial equivalence to predicate devices.
The acceptance criteria implied are:
- Biocompatibility: The device must meet the criteria for biocompatibility consistent with ISO 11193.
- Labeled Performance Claims: The device must be able to meet its labeled performance claims.
- Substantial Equivalence: The device must be demonstrated to be substantially equivalent to the predicate devices in terms of intended use, technology, design, materials, manufacture, and packaging.
The reported device performance is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "The ESTECH Aortic Easy Flow Cannula met the criteria for biocompatibility." |
| Labeled Performance Claims | "Preclinical performance data was supplied to demonstrate that the ESTECH Aortic Easy Flow Cannula can meet its labeled performance claims." |
| Substantial Equivalence | "Estech concludes that the ESTECH Aortic Easy Flow Cannula is substantially equivalent to the predicate devices." |
Study Information
Based on the provided text, the "study" conducted is a preclinical performance data assessment and biocompatibility testing to support the claim of substantial equivalence. This is typical for a 510(k) submission where a new device is compared to existing legally marketed devices. There is no mention of a human clinical trial or a study designed to quantify device performance in terms of clinical outcomes, sensitivity, specificity, accuracy, or similar metrics typically associated with AI/diagnostic device evaluations.
Given this context, most of the requested information regarding sample size, expert involvement, and ground truth establishment (which are common for AI/diagnostic device studies) is not directly applicable or explicitly detailed in this 510(k) summary.
- Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of a clinical trial. The "preclinical performance data" would involve bench testing or possibly animal studies, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) are detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is typically based on established engineering principles, regulatory standards (like ISO 11193 for biocompatibility), and comparison to the known performance characteristics of the predicate devices. Expert consensus in the context of human data interpretation (e.g., radiology reads) is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in human subject studies, which are not detailed here.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a cardiopulmonary bypass vascular cannula, not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the preclinical performance data would be derived from:
- Regulatory Standards: ISO 11193 for biocompatibility.
- Engineering Specifications: Performance characteristics (e.g., flow rates, pressure drops, durability) measured against design specifications and predicate device performance.
- Predicate Device Data: Performance characteristics of the legally marketed predicate devices serving as benchmarks.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a "training set."
- How the ground truth for the training set was established: Not applicable.
Conclusion
The provided document details a 510(k) summary for a cardiopulmonary bypass vascular cannula, focusing on demonstrating substantial equivalence to predicate devices through biocompatibility testing and preclinical performance data. It does not contain the kind of detailed information about acceptance criteria, test sets, expert involvement, or ground truth establishment that would be relevant for an AI/diagnostic device performance study.
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| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Estech |
| 2603 Camino Ramon | |
| Suite 100 | |
| San Ramon, CA 94583 | |
| Tel: 925-866-7111 | |
| Correspondent ContactInformation: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Device Classification & Code: | Class II, DWF (21 CFR 870.4210) |
| Device Classification Name: | Cardiopulmonary bypass vascular catheter, cannulaor tubing |
| Device Proprietary Name: | ESTECH Aortic Easy Flow Cannula |
Section 5: 510(k) Summary
Predicate Device Information:
| Predicate Devices: | Low Jetting Aortic Arch Cannula (K934127)ESTECH Remote Access Perfusion FVCannula (K052081) |
|---|---|
| Predicate Device Manufacturers: | Sarns a division of TerumoESTECH, Inc. |
| Predicate Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |
b. Date Summary Prepared
6 January 2006
c. Description of Device
The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.
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d. Intended Use
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures reguiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
e. Comparison to Predicate Device
The ESTECH Aortic Easy Flow Cannula is identical in intended use, technology, design, to that of the Low Jetting Aortic Arch Cannula (K934127). The ESTECH Aortic Easy Flow Cannula is identical in materials, manufacture, and packaging to the ESTECH Remote Access Perfusion FV Cannula (K052081).
Estech concludes that the ESTECH Aortic Easy Flow Cannula is substantially equivalent to the predicate devices.
f. Summary of Supporting Data
Biocompatibility testing consistent with ISO 11193 is presented in Section 15. The ESTECH Aortic Easy Flow Cannula met the criteria for biocompatibility.
Preclinical performance data was supplied to demonstrate that the ESTECH Aortic Easy Flow Cannula can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 10 2005
Endoscopit Technologies, Incorporated c/o Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501
Re: K060101
Trade/Device Name: ESTECH Arotic Easy Flow Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: April 17, 2006 Received: April 28, 2006
Dear Mr. Coombs:
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.
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Page 2 - Mr. Craig Coombs
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 (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. 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 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,
Signature
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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ESTECH Aortic Easy Flow Cannula Premarket Notification
Section 4: Indications for Use Statement
510(k) Number (if known):
ESTECH Aortic Easy Flow Cannula Device Name:
Indications For Use:
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
(Division/Sign-Off:
Division of Cardiovascular Devices
510(k) Number
CONFIDENTIAL
Section 4
§ 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).