← Product Code [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP) · K073123 # CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 (K073123) _Cardica, Inc. · FZP · Dec 6, 2007 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K073123 ## Device Facts - **Applicant:** Cardica, Inc. - **Product Code:** [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP.md) - **Decision Date:** Dec 6, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Cardica® C-Port® Flex-A™ Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. ## Device Story Sterile, single-use surgical instrument; creates end-to-side anastomosis between conduit and small vessel. System includes conduit loading accessories and anastomosis device. Surgeon loads conduit onto device; positions device against target vessel; pushes actuation button to deploy stainless steel clips. Used in clinical settings (e.g., OR) by surgeons. Facilitates reliable patent anastomosis; benefits patient by enabling precise vessel connection during bypass procedures. ## Clinical Evidence Bench testing only; no clinical data presented. In vitro and in vivo testing performed to ensure safety and effectiveness. ## Technological Characteristics Sterile, single-use mechanical device. Materials include stainless steel clips. Manual actuation mechanism. No software or electronic components. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - Cardica® C-Port® Flex-ATM Distal Anastomosis System ([K070548](/device/K070548.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) Summary ## DEC 0 6 2007 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | 510(k) Number | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | November 2, 2007 | | | Applicant
Information | Cardica, Inc.
900 Saginaw
Redwood City, California 94063
Main: 650-364-9975
Fax: 650-364-3134 | | | Contact Person | Iskra Mrakovic
Office: 650-331-7153
Fax: 650-364-3134
e-mail: mrakovic@cardica.com | | | Establishment
Registration Number | 3004114958 | | | Device Information | Classification Name:
Regulation Number:
Trade Name:
Common Name: | Clip, Implantable
21 CFR §878.4300
Cardica® C-Port® Flex-ATM Distal
Anastomosis System
Cardiovascular Surgical Instruments | | Predicate Device(s) | Cardica® C-Port® Flex-ATM Distal Anastomosis System
(#K070548) | | | Device Description | The Cardica® C-Port® Flex-ATM Distal Anastomosis System is a
sterile, single use device for creation of a reliably patent end-
to-side anastomosis between a conduit and a small vessel.
The product consists of accessories to assist in the 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 the actuation button. | | | Intended Use | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System is
intended for the creation of anastomoses in blood vessels and
grafts, including use in coronary artery bypass grafting
procedures. | | | Comparison to
Predicate Device | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System is
substantially equivalent to the Cardica® C-Port® Flex-AT™ Distal
Anastomosis System (#K070548, 21 CFR §878.4300). The
subject device is substantially equivalent to the predicate
device with regard to the intended use, device characteristics,
method of use, materials, labeling, sterilization method and
biocompatibility. | | | Device Testing
Results and
Conclusion | All necessary in vitro and in vivo testing has been performed
on the C-Port® Flex-AT™ Distal Anastomosis System and its
packaging to ensure substantial equivalence to the predicate
device, and to ensure the safety and effectiveness of the
device. | | | Substantial
Equivalence
Summary | Cardica® C-Port® Flex-AT™ Distal Anastomosis System has the
same indications for use and the same technological
characteristics as the predicate device (#K070548). This
premarket notification has described the characteristics of the
modified device in sufficient detail to assure substantial
equivalence. For the few characteristics that may not be
precise enough to ensure equivalence, performance data was
collected, and this data demonstrates substantial equivalence.
In keeping with the format of a Special 510(k) for Device
Modification, performance data were not included in the
submission, but the declarations provide certification that the
data demonstrate equivalence. | | | Conclusions | This Special 510(k) for Device Modification submission has
demonstrated Substantial Equivalence as defined and
understood in the Federal Food Drug and Cosmetic Act and
various guidance documents issued by the Center for Devices
and Radiological Health. | | {1}------------------------------------------------ : Cardica® and C-Port® are registered trademarks of Cardica, Inc. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, symbolizing health and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo. DEC 0 6 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Cardica, Inc. c/o Ms. Iskra Mrakovic Manager, Regulatory Affairs 900 Saginaw Dr. Redwood City, CA 94063 Re: K073123 Cardica® C-Port® Flex-A™ Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable Regulatory Class: Class II (two) Product Code: FZP Dated: November 02, 2007 Received: November 06, 2007 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. {3}------------------------------------------------ Page 2 - Ms. Iskra Mrakovic 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. una R. V. Auner Image /page/3/Picture/5 description: The image contains a handwritten symbol or character on the left side, which appears to be a combination of curved and looped lines. To the right of this symbol are the capital letters 'B' and 'D', stacked vertically. The letters are in a simple, sans-serif font and are positioned closely together. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement | 510(k) Number:
(if known) | K073123 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Cardica® C-Port® Flex-A™ Distal Anastomosis System | | Indications for Use: | The Cardica® C-Port® Flex-A™ Distal Anastomosis System is intended for
the creation of anastomoses in blood vessels and grafts, including use in | coronary artery bypass grafting procedures. Prescription Use × (Part 21 CFR§801.109) > : and the comments of the country 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) Suane R. V. Aunes (Division Sign-Off) Division of Caralovascular Devices Indications for Use Statement 510(k) Number_k0 7317 3 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K073123](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K073123) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com