CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150

K073123 · Cardica, Inc. · FZP · Dec 6, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073123
• Device Name: CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 6, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients requiring creation of anastomoses in blood vessels and grafts, including coronary artery bypass grafting procedures.

Regulatory Classification

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)

Submission Summary (Full Text)

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## 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<br>Information | Cardica, Inc.<br>900 Saginaw<br>Redwood City, California 94063<br>Main: 650-364-9975<br>Fax: [phone] | |
| Contact Person | Iskra Mrakovic<br>Office: 650-331-7153<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Establishment<br>Registration Number | 3004114958 | |
| Device Information | Classification Name:<br>Regulation Number:<br>Trade Name:<br>Common Name: | Clip, Implantable<br>21 CFR §878.4300<br>Cardica® C-Port® Flex-ATM Distal<br>Anastomosis System<br>Cardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® Flex-ATM Distal Anastomosis System<br>(#K070548) | |
| Device Description | The Cardica® C-Port® Flex-ATM Distal Anastomosis System is a<br>sterile, single use device for creation of a reliably patent end-<br>to-side anastomosis between a conduit and a small vessel.<br>The product consists of accessories to assist in the conduit<br>loading and a device that completes the anastomosis with<br>stainless steel clips. Once the conduit has been loaded onto<br>the device and the device positioned against the target vessel,<br>the anastomosis is created by pushing the actuation button. | |
| Intended Use | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System is<br>intended for the creation of anastomoses in blood vessels and<br>grafts, including use in coronary artery bypass grafting<br>procedures. | |
| Comparison to<br>Predicate Device | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System is<br>substantially equivalent to the Cardica® C-Port® Flex-AT™ Distal<br>Anastomosis System (#K070548, 21 CFR §878.4300). The<br>subject device is substantially equivalent to the predicate<br>device with regard to the intended use, device characteristics,<br>method of use, materials, labeling, sterilization method and<br>biocompatibility. | |
| Device Testing<br>Results and<br>Conclusion | All necessary <i>in vitro</i> and <i>in vivo</i> testing has been performed<br>on the C-Port® Flex-AT™ Distal Anastomosis System and its<br>packaging to ensure substantial equivalence to the predicate<br>device, and to ensure the safety and effectiveness of the<br>device. | |
| Substantial<br>Equivalence<br>Summary | Cardica® C-Port® Flex-AT™ Distal Anastomosis System has the<br>same indications for use and the same technological<br>characteristics as the predicate device (#K070548). This<br>premarket notification has described the characteristics of the<br>modified device in sufficient detail to assure substantial<br>equivalence. For the few characteristics that may not be<br>precise enough to ensure equivalence, performance data was<br>collected, and this data demonstrates substantial equivalence.<br>In keeping with the format of a Special 510(k) for Device<br>Modification, performance data were not included in the<br>submission, but the declarations provide certification that the<br>data demonstrate equivalence. | |
| Conclusions | This Special 510(k) for Device Modification submission has<br>demonstrated Substantial Equivalence as defined and<br>understood in the Federal Food Drug and Cosmetic Act and<br>various guidance documents issued by the Center for Devices<br>and Radiological Health. | |

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Cardica® and C-Port® are registered trademarks of Cardica, Inc.

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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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

una R. V. Auner

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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:<br>(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<br>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