(43 days)
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.
The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.
The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
The provided 510(k) summary for the Edwards Lifesciences Arterial Perfusion Cannula II does not contain the kind of detailed information about acceptance criteria, study design, expert ground truth, or statistical analyses that would typically be found in a submission for a device that uses AI or machine learning.
This submission is for a medical device that is a physical product (an arterial perfusion cannula), and its safety and efficacy are demonstrated through comparative analysis and functional/safety testing against a predicate device, not through studies involving AI or complex data analysis with expert consensus.
Therefore, I cannot extract the requested information as it is not present in the provided document.
Here's why and what kind of information is available instead:
- Acceptance Criteria & Device Performance: The document states that the "functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device." This implies the acceptance criteria were met if the new device's functional performance was deemed equivalent to the predicate. Specific numerical targets or performance metrics are not provided, as this is a traditional medical device submission focused on physical characteristics and performance.
- Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Functional/Safety Testing" and "Comparative Analysis." These studies demonstrate that the new APC II cannulae are "comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations."
- Points 2-9 (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set, etc.): These points are specific to studies involving algorithms, data analysis, and expert interpretation (common in AI/ML submissions). They are entirely absent because this submission is for a physical medical device. The "ground truth" for a physical device like a cannula would be its physical integrity, material properties, flow rates, pressure resistance, etc., which are assessed through engineering and bench testing, not expert consensus on interpretations of data.
In summary, the provided text describes a 510(k) submission for a physical medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML study design and ground truth are not applicable and cannot be answered from the given information.
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510(k) Summary
| Submitter: | Edwards Lifesciences Research Medical, Inc. |
|---|---|
| Contact Person: | John W. Nicholson, Senior Regulatory Affairs Associate6864 South 300 WestMidvale, UT 84047801-565-6282 |
| Date Prepared: | December 18, 2007 |
| Trade Name: | Edwards Lifesciences Arterial Perfusion Cannula II |
| Classification Name: | Cardiovascular Diagnostic Devices, CFR 870.1300, CatheterCannula, Product Code DQR, Class II |
| Predicate Device: | Edwards Lifesciences Arterial Perfusion Cannula |
Device Description: Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.
The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.
The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Intended Use: The Edwards Lifesciences Arterial Perfusion Cannula is indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
Comparative Analysis: It has been demonstrated that the APC II arterial perfusion cannulae are comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations.
Functional/Safety Testing: The functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device.
Conclusion: The APC II arterial cannulae are substantially equivalent to the cited predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
JAN 31 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences Research Medical, Inc. c/o Mr. John Nicholson Senior Regulatory Affairs Associate 6864 South 300 West Midvale, Utah 84047
Re: K073559
Arterial Perfusion Cannula II Regulation Number: 21 CFR 870.1300 Regulation Name: Catheter cannula Regulatory Class: Class II (two) Product Code: DOR Dated: January 24, 2008 Received: January 22, 2008
Dear Mr. Nicholson:
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. John Nicholson
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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dma R. Vachner
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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Section 5.
Indications for Use Statement
510(k) Number (if known):
Device Name: Edwards Lifesciences Arterial Perfusion Cannula II
Indications for Use:
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Dummer R. Vuhmes
Division Sign-Off)
sion of Cardiovascular Devices
。10(k) Number_K073559
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).