C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM

K070548 · Cardica, Inc. · FZP · Mar 29, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070548
• Device Name: C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cardica® C-Port® FlexA™ 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

The Cardica C-Port FlexA Distal Anastomosis System is a sterile, single-use surgical instrument designed for creating compliant end-to-side anastomoses between a graft vessel and a target vessel. The system comprises a delivery device and pre-loaded implantable stainless steel clips. During a coronary artery bypass grafting procedure, the surgeon loads the graft onto the delivery device and positions it against the target vessel. Upon activation of the actuation button, the device simultaneously creates the arteriotomy and the anastomosis. The FlexA model introduces a flexible shaft and remote graft clamp actuators compared to previous iterations. The device is intended for use by surgeons in a clinical or operating room setting to facilitate vascular connection, potentially improving procedural efficiency and consistency in bypass surgeries.

Clinical Evidence

Bench testing only. Verification and validation testing were performed to confirm substantial equivalence and ensure safety and effectiveness.

Technological Characteristics

System consists of a delivery device and implantable stainless steel clips. Features a flexible shaft and remote graft clamp actuators. Sterile, single-use. Operates via manual mechanical actuation to create arteriotomy and anastomosis simultaneously.

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® xA™ Distal Anastomosis System (K053524 and K063644)

Submission Summary (Full Text)

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K070548

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Attachment 3

MAR 2 9 2007

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## 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.

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| 510(k) Number | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared | February 21, 2007 | |
| Applicant Information | Cardica, Inc.<br>900 Saginaw<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: <a href="mailto:[e-mail]">[e-mail]</a> | |
| Establishment<br>Registration Number | 3004114958 | |
| Device Information | Classification Name: Clip, Implantable<br>Regulation Number: 21 CFR §878.4300<br>Trade Name: Cardica ^® C-Port ^® FlexA™ Distal Anastomosis System<br>Common Name: Cardiovascular Surgical Instruments | |
| Predicate Device(s) | Cardica ^® C-Port ^® xA™ Distal Anastomosis System (K053524 and K063644) | |
| Device Description | The Cardica ^® C-Port ^® FlexA™ Distal Anastomosis System is a sterile, single use device for creation of a compliant end-to-side anastomosis between a graft vessel and target vessel. The product consists of a delivery device that holds the graft and deploys the pre-loaded clips, and the implantable stainless steel clips. Once the graft has been loaded onto the device and the device positioned against the target vessel, the arteriotomy and anastomosis are simultaneously created by pushing the | |

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| | actuation button. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cardica ^® C-Port ^® FlexA™ 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 FlexA™ Distal Anastomosis System is substantially equivalent to the Cardica C-Port xA™ Distal Anastomosis System; (K053524 and K063644, 21 CFR §878.4300). The deployment device design has been modified to allow the user the option of an anastomosis device with a flexible shaft and remote graft clamp actuators. The subject device is substantially equivalent to the predicate device with regard to indications, scientific technology, operation principles, basic device design and size, shelf life, packaging and sterilization materials and processes. |
| Device Testing Results and Conclusion | All necessary verification testing has been performed on the C-Port ^® FlexA™ Distal Anastomosis System to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device. Based on the results of risk assessment and verification/validation testing the modifications to the FlexA System raise no new safety or efficacy issues. |
| Summary | Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the C-Port ^® FlexA™ Distal 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.Cardica and C-Port are registered trademarks of Cardica, Inc.

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Cardica C-Port FlexA System Special 510(k)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2007

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

Re: K070548

Trade/Device Name: Cardica C-Port FlexA Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable Regulatory Class: Class II Product Code: FZP Dated: February 21, 2007 Received: February 26, 2007

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. 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 (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.

Blymmmon for

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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# Attachment 1

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### Indications for Use Statement and the comments of the comments of the comments of the Children of the Children and Children and Children

| 510(k) Number:<br>(if known) | K070548 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cardica® C-Port® FlexA™ Distal Anastomosis System |
| Indications for Use: | The Cardica® C-Port® FlexA™ Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|------------------|---------------------------------------------------|
|------------------|---------------------------------------------------|

(per 21 CFR §801.109
OR

| Over-the Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|

Blamminado(Optional Format 1-2-96)
(Division Sign-Off)

Cardica C-Port FlexA System
Special 510(k)
Division of Cardiovascular Devices

| 510(k) Number | <span style="text-decoration: overline;">K070548</span> |
|---------------|---------------------------------------------------------|
|---------------|---------------------------------------------------------|

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