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 Description

The Cardica® C-Port® 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 consists of accessories to assist in the 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 the actuation button.

AI/ML Overview

This submission concerns a medical device, the Cardica® C-Port® xA Anastomosis System, and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

The submission is a 510(k) Pre-market Notification for a device intended for surgical anastomosis. The primary method of demonstrating acceptance criteria is by claiming substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary from 510(k))
Indications for Use: Must be substantially equivalent to the predicate device.	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. This is stated to be substantially equivalent to the predicate device (K040832).
Device Characteristics: Must be substantially equivalent in design, materials, and function to the predicate device.	The device is described as a sterile, single-use device for end-to-side anastomosis between a conduit and a small vessel using stainless steel clips. It consists of accessories for conduit loading and a device to complete anastomosis. Claimed substantially equivalent in device characteristics, method of use, and materials to K040832.
Method of Use: Must be substantially equivalent to the predicate device.	The operation involves loading the conduit, positioning the device against the target vessel, and pushing an actuation button to create the anastomosis. Claimed substantially equivalent in method of use to K040832.
Labeling: Must be substantially equivalent to the predicate device.	Claimed substantially equivalent in labeling to K040832.
Safety and Effectiveness: Demonstrated through non-clinical testing to ensure equivalence.	"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." Further details of specific test results are not provided in this summary.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a substantial equivalence determination based on a comparison to the predicate device (Cardica® C-Port® Anastomosis System, K040832). This is a non-clinical study typically involving engineering analysis, bench testing (in vitro), and potentially animal studies (in vivo) to demonstrate that the new device performs as intended and is as safe and effective as the predicate device.

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated in this summary. For a non-clinical 510(k) submission based on substantial equivalence, the "test set" would refer to the samples and conditions used in the in vitro and in vivo studies. The summary only broadly states "All necessary in vitro and in vivo testing has been performed."
Data provenance: Not explicitly stated. Such testing is typically conducted internally by the manufacturer or by contract research organizations (CROs) in a controlled environment. It is not patient or country-specific data as would be the case for clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This relates to clinical data evaluation, which is not the primary basis of this 510(k) submission. The "ground truth" here is the performance and safety established for the predicate device, against which the new device is compared through non-clinical testing.

4. Adjudication method for the test set:

Not applicable. This applies to clinical study endpoints and data interpretation by multiple readers/experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this substantial equivalence submission is the established safety and effectiveness profile of the predicate device (Cardica® C-Port® Anastomosis System, K040832). The new device's performance, as measured through in vitro and in vivo testing, is then compared to this established profile to demonstrate equivalent safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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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.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-364-3134
Contact Person	David Casal, PhDOffice: 650-331-7145Fax: 650-364-3134e-mail: casal@cardica.com
EstablishmentRegistration Number	3004114958
Device Information	Classification Name: Clip, ImplantableRegulation Number: 21 CFR §878.4300Trade Name: Cardica® C-Port® Anastomosis SystemCommon 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 devicefor creation of a reliably patent end-to-side anastomosis between aconduit and a small vessel. The product consists of accessories to assistin the conduit loading and a device that completes the anastomosis withstainless steel clips. Once the conduit has been loaded onto the deviceand the device positioned against the target vessel, the anastomosis iscreated 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 (240) 276-0120. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (240) 276-3150.

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:(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	✓	Over-the Counter Use
(per 21 CFR §801.109		(Optional Format 1-2-96)
	Donna R. Lehner (Division Sign-Off) Division of Cardiovascular Devices
Cardica
16 December 2005
510(k) Number	K23053524
	Special 510(k) C-Port xA System

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.