CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001

K091017 · Cardica, Inc. · FZP · Apr 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091017
• Device Name: CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
• Applicant: Cardica, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Apr 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PAS-Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Device Story

Mechanical device for creating aortic anastomosis of autologous vein grafts; replaces traditional sutures. System comprises a connector and delivery system. Used by surgeons in clinical settings to facilitate secure, patent, and reproducible anastomoses during cardiovascular procedures. Benefits include improved procedural efficiency and graft patency compared to manual suturing.

Clinical Evidence

Bench testing and in vivo testing performed to ensure safety and effectiveness; no specific clinical trial data provided in the summary.

Technological Characteristics

Mechanical implantable clip/connector system. Includes a delivery system. Class II device (21 CFR 878.4300).

Indications for Use

Indicated for creating aortic anastomosis of aortic autologous vein grafts in patients undergoing bypass surgery.

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

• PAS-Port® Proximal Anastomosis System (K081225)

Submission Summary (Full Text)

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#### K091017 Pg 10f 2 PAS-Port® Proximal Anastomosis System

#### 510(k) Summary

# APR 2 9 2009

### PAS-Port™ Proximal Anastomosis System

| 510(k) Number | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 7, 2009 |
| Applicant Information | 900 Saginaw<br>Redwood City, California 94063<br>Main: 650-364-9975<br>Fax: [phone] |
| Contact Person | Kimberlee Leon<br>Office: 650-331-7119<br>Fax: [phone]<br>e-mail: [e-mail] |
| Establishment Registration Number | 3004114958 |
| Device Information | Classification Name: Clip, Implantable<br>Regulation Number: 21 CFR §878.4300<br>Trade Name: Cardica® PAS-Port® Proximal Anastomosis System<br>Common Name: Cardiovascular Surgical Instruments |
| Legally Marketed Predicate Device(s) | PAS-Port® Proximal Anastomosis System (K081225) |
| Device Description | The Cardica® PAS-Port® Proximal Anastomosis System is a<br>mechanical device used to facilitate an aortic vein graft<br>anastomosis. The connector replaces sutures to create a<br>secure, patent and reproducible anastomosis. The PAS-Port®<br>Proximal Anastomosis System consists of a connector and a<br>delivery system. |

·

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| Indications for Use | The PAS-Port® System is intended to create the aortic<br>anastomosis of aortic autologous vein grafts. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device | The PAS-Port® Proximal Anastomosis System is substantially<br>equivalent to the PAS-Port® Proximal Anastomosis System<br>(K081225, 21 CFR §878.4300). |
| 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 PAS-Port® Proximal 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. |
| Technological<br>Characteristics | See Device Description above. |
| Substantial<br>Equivalence<br>Summary | Both, the Cardica® PAS-Port® Proximal Anastomosis System<br>have the same indications for use and the same technological<br>characteristics as the predicate device (K081225). This<br>premarket notification has described the characteristics of the<br>modified device in sufficient detail to assure substantial<br>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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2009

Cardica, Inc. c/o Ms. Kimberlee Leon Manager, Quality Systems 900 Saginaw Drive Redwood City, CA 94063

Re: K091017

Cardica® PAS-Port® Proximal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class II Product Code: FZP Dated: April 7, 2009 Received: April 9, 2009

Dear Ms. Leon:

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. Kimberlee Leon

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

R. becher

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

Enclosure

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## K091017 PAS-Port® Proximal Anastomosis System

## . Indications for Use Statement 510(k) Number: K091017 (if known) Cardica® PAS-Port® Proximal Anastomosis System Device Name: The Cardica® PAS-Port® Proximal Anastomosis System is intended to Indications for Use: create the aortic anastomosis of aortic autologous vein grafts.

Prescription Use X (Part 21 CFR§801.109)

.

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)

Dname R. Liciason
(Division Sign-Off)

Division of Cardiovascular Devices

H. Indications for Use Statement

510(k) Number Korano(7

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