(128 days)
The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.
The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.
The provided text is a 510(k) Premarket Notification for the Cardica® PAS•Port® Proximal Anastomosis System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets such criteria.
The document states:
"All necessary in vitro and in vivo testing has been performed on the PAS-Port™ Proximal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."
This statement confirms that testing was done, but it does not provide details about:
- A table of acceptance criteria and reported device performance: No such table is present.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable (not an AI/ML algorithm).
- How ground truth for the training set was established: Not applicable.
The 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (St. Jude Medical Aortic Connector System). This process typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons of materials, design, and general in vitro/in vivo testing, but it doesn't usually present detailed acceptance criteria and performance data in the way requested for an AI/ML product.
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SEP - 5 2008 S•Port® Proximal Anastomosis System Cardica, Inc. Traditional 510(k) Premarket Notification
510(k) Summary
PAS•Port™ Proximal Anastomosis System
| 510(k) Number | |
|---|---|
| Date Prepared | 28 April, 2008 |
| ApplicantInformation | Cardica, Inc.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-364-3134 |
| Contact Person | Iskra MrakovicOffice: 650-331-7153Fax: 650-364-3134e-mail: mrakovic@cardica.com |
| EstablishmentRegistration Number | 3004114958 |
| Device Information | Classification Name: Clip, ImplantableRegulation Number: 21 CFR §878.4300Trade Name: Cardica® PAS•Port® ProximalAnastomosis SystemCommon Name: Cardiovascular Surgical Instruments |
| Legally MarketedPredicate Device(s) | St. Jude Medical Aortic Connector System (#K003446) |
| Device Description | The Cardica® PAS•Port® Proximal Anastomosis System is amechanical device used to facilitate an aortic vein graftanastomosis. The connector replaces sutures to create asecure, patent and reproducible anastomosis. The PAS•Port®Proximal Anastomosis System consists of a connector and adelivery system. |
| Indications for Use | The PAS-Port' System is intended to create the aorticanastomosis of aortic autologous vein grafts. |
| Comparison toPredicate Device | The PAS•Port® Proximal Anastomosis System is substantiallyequivalent to the St. Jude Medical Aortic Connector System(#K003446, 21 CFR $878.4300). |
| Device TestingResults andConclusion | All necessary in vitro and in vivo testing has been performedon the PAS-Port' Proximal Anastomosis System and itspackaging to ensure substantial equivalence to the predicatedevice, and to ensure the safety and effectiveness of thedevice. |
| TechnologicalCharacteristics | See Device Description above. |
| SubstantialEquivalenceSummary | Both, the Cardica® PAS-Port' Proximal Anastomosis Systemand the St. Jude Aortic Connector System are intended forcreation of the aortic anastomoses made of aortic autologousvein grafts. Both devices include a metal implant and adelivery system. With both devices, a graft vessel is loadedonto an implant and the delivery device is used to form theimplant into a circular grommet-like structure that seals the veingraft to the aorta.The primary difference between the two devices is the materialused for the implant. The PAS-Port' Proximal AnastomosisSystem implant is made of a medical grade 316L StainlessSteel whereas the St. Jude Symmetry device is made fromnitinol, i.e., a nickel-titanium alloy. |
| Conclusions | This Traditional 510(k) Premarket Notification submission hasdemonstrated Substantial Equivalence with the St. Jude AorticConnector System (#K003446) as defined and understood inthe Federal Food Drug and Cosmetic Act and various guidancedocuments issued by the Center for Devices and RadiologicalHealth. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Cardica. Inc. c/o Ms. Iskra Mrakovic VP, Clinical Affairs Manager, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K081225
PAS-Port Proximal Anastomosis System Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: II (two) Product Code: FZP Dated: August 15, 2008 Received: August 18, 2008
Dear Ms. Mrakovic:
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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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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Duna R. Vicher
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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 Statement
| 510(k) Number: (if known) | K081225 |
|---|---|
| Device Name: | Cardica® PAS•Port® Proximal Anastomosis System |
| Indications for Use: | The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts. |
Prescription Use X (Part 21 CFR§801.109)
Over-The-Counter Use OR (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumar D. V. V. Luis
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko81225
Indications for Use Statement
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§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.