C-PORT DISTAL ANASTOMOSIS SYSTEM

K053524 · Cardica, Inc. · FZP · Nov 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053524
• Device Name: C-PORT DISTAL ANASTOMOSIS SYSTEM
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 16, 2006
• Decision: SESE
• Submission Type: Traditional
• 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

The Cardica C-Port xA Anastomosis System is a sterile, single-use surgical instrument designed for creating patent 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 secure the anastomosis. Operated by a surgeon during cardiovascular procedures, the device is positioned against the target vessel; the user then presses an actuation button to complete the connection. This mechanical process replaces traditional manual suturing, aiming to provide a reliable, consistent anastomosis in coronary artery bypass grafting. The device is used in an operating room setting.

Clinical Evidence

Bench testing only. In vitro and in vivo testing performed to ensure substantial equivalence to the predicate device and to verify safety and effectiveness.

Technological Characteristics

Sterile, single-use mechanical surgical instrument. Components include conduit loading accessories and a clip-deployment mechanism. Materials include stainless steel clips. Operates via manual mechanical actuation. 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® Anastomosis System (K040832)

Submission Summary (Full Text)

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## Attachment 4

NOV 16 2006

## 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.

| 510(k) Number | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 15 December 2005 |
| Applicant Information | Cardica, Inc.<br>900 Saginaw<br>Redwood City, California 94063<br>Main: 650-364-9975<br>Fax: [phone] |
| Contact Person | David Casal, PhD<br>Office: 650-331-7145<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® Anastomosis System<br>Common Name: Cardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® Anastomosis System (K040832) |
| Device Description | The Cardica® C-Port® Anastomosis System is a sterile, single use device<br>for creation of a reliably patent end-to-side anastomosis between a<br>conduit and a small vessel. The product consists of accessories to assist<br>in the conduit loading and a device that completes the anastomosis with<br>stainless steel clips. Once the conduit has been loaded onto the device<br>and the device positioned against the target vessel, the anastomosis is<br>created by pushing the actuation button. |

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| 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. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device | The Cardica® C-Port® xA Anastomosis System is substantially equivalent to the Cardica® C-Port® Anastomosis System (K040832, 21 CFR §878.4300). The subject device is substantially equivalent to the predicate device with regard to indications, device characteristics, method of use, labeling and materials. |
| Device Testing Results and Conclusion | All necessary in vitro and in vivo testing has been performed on the C-Port® xA Anastomosis System and packaging to ensure substantial equivalence to the predicate device and to ensure the safety and effectiveness of the device. |
| Summary | Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the Cardica® C-Port® Anastomosis System has been shown to be substantially equivalent to the currently marketed predicate 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

NOV 16 2006

Tiffini Lalude Director of Regulatory Affairs Cardica, Inc. 900 Saginaw Drive Redwood City, CA 94063

Re: K053524

> C-Port™ xA Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulatory Class: Class II Product Code: FZP Dated: October 1, 2006 Received: October 4, 2006

Dear: Ms. Lalude:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note:

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Pagc 2 - Tiffini Lalude

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone].

Sincerely yours.

Duna R. Vahner

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Attachment 2

### Indications for Use Statement

| 510(k) Number:<br>(if known) | k053524 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cardica® C-Port® xA Anastomosis System |
| Indications for 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. |

#### PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-the Counter Use | <span style="text-decoration: overline;"></span> |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--------------------------|--------------------------------------------------|
| (per 21 CFR §801.109 | | | (Optional Format 1-2-96) | |
| | <div style="text-align:center;"> <span style="text-decoration: overline;">Donna R. Lehner</span> <p>(Division Sign-Off)</p> <p>Division of Cardiovascular Devices</p> </div> | | | |
| Cardica | | | | |
| 16 December 2005 | | | | |
| 510(k) Number | <span style="text-decoration: overline;">K²³053524</span> | | | |
| | Special 510(k) C-Port xA System | | | |