(589 days)
The Cardica® C-Port™ Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
The Cardica C-Port™ Anastomosis System is a sterile, single-patient use device. The Cardica® C-Port™ Anastomosis System is designed to create a reliable and consistent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device, and the device positioned against the target vessel, the anastomosis is created by pushing an actuation button.
The provided text states that "All necessary bench, animal, and clinical testing has been performed on the C-Port™ Anastomosis System and packaging to ensure substantial equivalence to the predicate devices and to ensure the safety and effectiveness of the device." However, no specific details about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, or different types of studies (MRMC, standalone) are provided.
Therefore, I cannot extract the requested information. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a study proving the device meets specific acceptance criteria.
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NOV 1 0 2005
C-Port Anastomosis System Premarket Notification
APPENDIX A 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
Name, Address, Phone and Fax number of the Applicant A. Cardica, Inc.
900 Saginaw Drive Redwood City, CA 94063 Telephone: (650)-364-9975 Fax: (650)-364-3134
B. Contact Persons
Sevrina Ciucci Senior Regulatory Affairs Associate Telephone: (650)-331-7147 Fax: (650)-331-3134
். Date Prepared
March 29, 2004
D. Device Name
.
Trade Name: Cardica® C-Port™ Anastomosis System Classification Name: Cardiovascular Surgical Instruments
E. Device Description
The Cardica C-Port™ Anastomosis System is a sterile, single-patient use device. The Cardica® C-Port™ Anastomosis System is designed to create a reliable and consistent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device, and the device positioned against the target vessel, the anastomosis is created by pushing an actuation button.
F. Intended Use
The C-Port™ Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
G. Substantial Equivalence
The C-Port™ Anastomosis System is substantially equivalent to US Surgical Corporation's Auto Suture™ Modified VCS™ Clip™ Applier (K962043, 21 CFR 878.4800 and the Ethicon ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers (K020779, 21 CFR 878.4750), and the Coalescent Surgical U-Clip™ (K031623, K994160, 21 CFR 870.4300). The subject device is substantially equivalent to the predicate devices with regard to indications, device characteristics, method of use, labeling, and materials.
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H. Device Testing Results and Conclusion
All necessary bench, animal, and clinical testing has been performed on the C-Port™ Anastomosis System and packaging to ensure substantial equivalence to the predicate devices and to ensure the safety and effectiveness of the device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 0 2005
Cardica. Inc. c/o Ms. Laurie Hook Clinical Affairs Manager 900 Saginaw Drive Redwood City, CA 94063
Re: K040832
Trade Name: Cardica® C-Port™ Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II (Two) Product Code: FZP Dated: August 09, 2005 Received: August 10, 2005
Dear Ms. Hook:
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 - Ms. Laurie Hook
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Diving R. Vichner
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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APPENDIX F INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 04 0832
Cardica® C-Port™ Anastomosis System Device Name:
Indications For Use:
The Cardica® C-Port™ Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. La chner
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_KO 40 8 3 2
Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-9 OR
Over-The-Counter Use
§ 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.