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CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES

Q: Who is the manufacturer of CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES?

Cardica, Inc. filed the 510(k) submission for CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES (K073304).

Q: What is the FDA product code for CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES?

FZP. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES?

Cardica® C-Port® xA™ Anastomosis System (K063644).

K073304 · Cardica, Inc. · FZP · Dec 20, 2007 · General, Plastic Surgery

Device Facts

Record ID	K073304
Device Name	CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
Applicant	Cardica, Inc.
Product Code	FZP · General, Plastic Surgery
Decision Date	Dec 20, 2007
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Cardica® C-PORT® X-CHANGE™ 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-use surgical instrument for creating patent end-to-side anastomoses between conduits and small vessels (e.g., coronary artery and saphenous vein graft). System comprises C-PORT® HANDLE X-CHANGE™, up to three C-PORT® xA™ X-CHANGE™ subassemblies, and a retractor mount. Device delivers stainless steel clips to form anastomosis, functioning as an alternative to hand-sutured, interrupted stitch techniques. Used by surgeons in clinical settings during cardiovascular procedures to facilitate vessel connection.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro and in vivo bench testing of the device and its packaging.

Technological Characteristics

Sterile, single-use cardiovascular surgical instrument. Materials include stainless steel clips. System consists of a handle, subassemblies, and retractor mount. Mechanical actuation principle for clip delivery. No software or electronic components.

Indications for Use

Indicated for 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™ Anastomosis System (K063644)

Related Devices

K063644 — CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM · Cardica, Inc. · Jan 11, 2007
K053524 — C-PORT DISTAL ANASTOMOSIS SYSTEM · Cardica, Inc. · Nov 16, 2006
K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM · Cardica, Inc. · Apr 21, 2009
K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 · Cardica, Inc. · Jun 25, 2010
K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 · Cardica, Inc. · Dec 6, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K073304 Cardica, Inc. ## 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 | 21 November 2007 | | Applicant Information | Cardica, Inc. 900 Saginaw Redwood City, California 94063 Main: 650-364-9975 Fax: 650-364-3134 | | Contact Person | Iskra Mrakovic Office: 650-331-7153 Fax: 650-364-3134 e-mail: mrakovic@cardica.com | | Establishment Registration Number | 3004114958 | | Device Information | Classification Name: Clip, Implantable Regulation Number: 21 CFR §878.4300 Trade Name: Cardica® C-PORT® X-CHANGE™ Anastomosis System Common Name: Cardiovascular Surgical Instruments | | Predicate Device(s) | Cardica® C-Port® xA™ Anastomosis System (#K063644) | | Device Description | The Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and a conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis which is functionally equivalent to a hand-sutured, interrupted stitch anastomosis. The system consists of one (1) C-PORT® HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X- CHANGE™ subassemblies and one (1) Retractor Mount. | {1}------------------------------------------------ F Cardica, Inc. 7 | Intended Use | The Cardica® C-PORT® X-CHANGE™ 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® X-CHANGE™ ANASTOMOSIS SYSTEM is substantially equivalent to the Cardica® C-Port® xA™Anastomosis System (#K063644, 21 CFR §878.4300). The subject device is substantially equivalent to the predicate device with regard to intended use, device characteristics. method of use, materials, labeling, sterilization method and biocompatibility. | | Device Testing Results and Conclusion | All necessary in vitro and in vivo testing has been performed on the C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device. | | Substantial Equivalence Summary | Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM has the same indications for use and the same technological characteristics as the predicate device (#K063644). This Premarket Notification has described the characteristics of the modified device in sufficient detail to assure substantial equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data was collected, and this data demonstrates substantial equivalence. In keeping with the format of a Special 510(k) for Device Modification, performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence. | | Conclusions | This Special 510(k) for Device Modification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. | Cardica® and C-Port® are registered trademarks of Cardica, Inc. . - - {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them. DEC 2 0 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Cardica, Inc. c/o Ms. Iskra Mrakovic Manager, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063 Re: K073304 Cardica® C-Port® X-Change™ Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: November 21, 2007 Received: November 23, 2007 Dear Ms. Mrakovic: 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. {3}------------------------------------------------ ## Page 2 - Ms. Iskra Mrakovic 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 (240) 276-0120. 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 Biometric's (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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, \$ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Cardica, Inc. ## Indications for Use Statement | 510(k) Number: (if known) | K073304 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM | | Indications for Use: | The Cardica® Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prescription Use × (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) | |--------------------------------------------------------| | (Division Sign-Off) | | Division of Cardiovascular | | 510(k) Number K073304 | Indications for Use Statement Pg. 1 of 1