C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050

K040832 · Cardica, Inc. · FZP · Nov 10, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K040832
• Device Name: C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C-Port™ 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-patient use device for creating end-to-side anastomoses between conduits and small vessels; used in coronary artery bypass grafting. System includes conduit loading accessories and an anastomosis device utilizing stainless steel clips. Operation: conduit loaded onto device; device positioned against target vessel; anastomosis created via manual actuation button. Used in clinical settings by surgeons. Device provides consistent, reliable vascular connections; benefits include standardized anastomosis creation.

Clinical Evidence

Bench, animal, and clinical testing performed to ensure safety and effectiveness. No specific performance metrics or study results provided in the summary document.

Technological Characteristics

Sterile, single-patient use device. Materials include stainless steel clips. Mechanical actuation principle. Manual operation via button. No software or electronic components.

Indications for Use

Indicated for 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

• Auto Suture™ Modified VCS™ Clip™ Applier (K962043)
• Ethicon ENDOPATH™ Linear Cutters and Staplers (K020779)
• Ethicon PROXIMATE™ Linear Cutters and Staplers (K020779)
• Coalescent Surgical U-Clip™ (K031623)
• Coalescent Surgical U-Clip™ (K994160)

Submission Summary (Full Text)

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### NOV 1 0 2005

K040832

C-Port Anastomosis System Premarket Notification

# APPENDIX A 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.

#### Name, Address, Phone and Fax number of the Applicant A. Cardica, Inc.

900 Saginaw Drive Redwood City, CA 94063 Telephone: [phone] Fax: [phone]

#### B. Contact Persons

Sevrina Ciucci Senior Regulatory Affairs Associate Telephone: [phone] Fax: [phone]

#### ். Date Prepared

March 29, 2004

#### D. Device Name

.

Trade Name: Cardica® C-Port™ Anastomosis System Classification Name: Cardiovascular Surgical Instruments

#### E. Device Description

The Cardica C-Port™ Anastomosis System is a sterile, single-patient use device. The Cardica® C-Port™ Anastomosis System is designed to create a reliable and consistent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in 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 an actuation button.

#### F. Intended Use

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

#### G. Substantial Equivalence

The C-Port™ Anastomosis System is substantially equivalent to US Surgical Corporation's Auto Suture™ Modified VCS™ Clip™ Applier (K962043, 21 CFR 878.4800 and the Ethicon ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers (K020779, 21 CFR 878.4750), and the Coalescent Surgical U-Clip™ (K031623, K994160, 21 CFR 870.4300). The subject device is substantially equivalent to the predicate devices with regard to indications, device characteristics, method of use, labeling, and materials.

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#### H. Device Testing Results and Conclusion

All necessary bench, animal, and clinical testing has been performed on the C-Port™ Anastomosis System and packaging to ensure substantial equivalence to the predicate devices and to ensure the safety and effectiveness of the device.

·

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 0 2005

Cardica. Inc. c/o Ms. Laurie Hook Clinical Affairs Manager 900 Saginaw Drive Redwood City, CA 94063

Re: K040832

Trade Name: Cardica® C-Port™ Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II (Two) Product Code: FZP Dated: August 09, 2005 Received: August 10, 2005

### Dear Ms. Hook:

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. Laurie Hook

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,

Diving R. Vichner

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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# APPENDIX F INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 04 0832

Cardica® C-Port™ Anastomosis System Device Name:

Indications For Use:

The Cardica® C-Port™ 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)

Duma R. La chner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_KO 40 8 3 2

Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-9 OR

Over-The-Counter Use