CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM

K063644 · Cardica, Inc. · FZP · Jan 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063644
• Device Name: CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Jan 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cardica® C-Port® xA Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.

Device Story

Cardica C-Port xA Anastomosis System is a sterile, single-use surgical instrument for creating end-to-side anastomoses between a conduit and a small vessel. The system includes accessories for conduit loading and a mechanical device that deploys stainless steel clips to complete the anastomosis. Used by surgeons in cardiovascular procedures, including coronary artery bypass grafting. Operation involves loading the conduit onto the device, positioning the device against the target vessel, and pressing an actuation button to deploy the clips. The device facilitates reliable vessel connection, potentially improving surgical efficiency and outcomes in bypass procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Sterile, single-use mechanical surgical instrument. Components include conduit loading accessories and a clip-based anastomosis deployment mechanism. Materials include stainless steel clips. Operation is manual via actuation button. No software, electronics, or energy sources involved.

Indications for Use

Indicated for the creation of anastomoses in blood vessels and grafts, including coronary artery bypass grafting procedures. No specific patient population age or gender restrictions provided.

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® xA Anastomosis System (K053524)
• Cardica® C-Port® Anastomosis System (K040832)

Submission Summary (Full Text)

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## Attachment 3

## 510(k) Summary

JAN 1 1 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.

and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states

| 510(k) Number | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | December 5, 2006 |
| Applicant Information | Cardica, Inc.<br>900 Saginaw Drive<br>Redwood City, California 94063<br>Main: 650-364-9975<br>Fax: [phone] |
| Contact Person | Tiffini Lalude<br>Office: 650-331-7153<br>Fax: [phone]<br>e-mail: [e-mail] |
| Establishment<br>Registration Number | 3004114958 |
| Device Information | Classification Name: Clip, Implantable<br>Regulation Number: 21 CFR §878.4300<br>Trade Name: Cardica® C-Port® xA Anastomosis System<br>Common Name: Cardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® xA Anastomosis System (K053524)<br>Cardica® C-Port® Anastomosis System (K040832) |
| Device Description | The Cardica C-Port xA Anastomosis System is a sterile, single use<br>device for creation of a reliably patent end-to-side anastomosis between<br>a conduit and a small vessel. The product consists of accessories to<br>assist in the conduit loading and a device that completes the anastomosis<br>with stainless steel clips. Once the conduit has been loaded onto the<br>device and the device positioned against the target vessel, the<br>anastomosis is created by pushing the actuation button. |

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______________________________________________________________________________________________________________________________________________________________________________

| Intended Use | The Cardica® C-Port® xA Anastomosis System is intended for the<br>creation of anastomoses in blood vessels and grafts, including use in<br>coronary artery bypass grafting procedures. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device | The Cardica C-Port xA Anastomosis System with the modified clip is<br>substantially equivalent to the original Cardica C-Port xA Anastomosis<br>System (K053524, 21 CFR §878.4300). The clip design has been<br>modified to improve manufacturability of the clip (i.e., eliminates the need<br>to do the secondary operation of bending the tines and the loss of clips<br>due to this secondary operation). The subject device is substantially<br>equivalent to the predicate device with regard to indications, scientific<br>technology, operation principles, basic device design and size, materials,<br>shelf life, and packaging and sterilization materials and processes. |
| Device Testing<br>Results and<br>Conclusion | All necessary verification testing has been performed on the C-Port xA<br>Anastomosis System with the modified clip to assure substantial<br>equivalence to the predicate device and to assure the safety and<br>effectiveness of the device. |
| Summary | Based upon the product technical information provided, intended use,<br>and performance information provided in this pre-market notification, the<br>Cardica C-Port Anastomosis System with the modified clip has been<br>shown to be substantially equivalent to the currently marketed predicate<br>device. |
| | Cardica® and C-Port® are registered trademarks of Cardica, Inc. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2007

Cardica, Inc. c/o Ms. Tiffini Lalude Director Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063

Re: K063644 Cardica® C-Port® xA Distal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: II Product Code: FZP Dated: December 6, 2006 Received: December 7, 2006

Dear Ms. Lalude:

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. Tiffini Lalude

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 [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/dsma/dsmamain.html . 300,00000

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## Indications for Use

510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ K063644

Device Name:__C-Port® xA Anastomosis System

The Cardica C-Port® xA Anastomosis System Indications For Use: indreacions for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Counter Use (Part 21 CFR 801 Subpart D) AND / OR

Over-The-

(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)

(Division

lar Device

Page 1 of 1

**510(k) Number** *K063644*

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Page 4 – Ms. Tiffani Lalude

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-450 DCD D.O.

OC Numbers:

| Division of Enforcement A | 240-276-0115 |
|-----------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |