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 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 actuation button.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study specifically proving the device meets those criteria with statistical measures. Instead, it describes a Special 510(k) submission where the device is compared to a previously cleared predicate device, asserting "substantial equivalence" rather than presenting a de novo study with explicit acceptance criteria.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific bond strengths, leak rates, or success percentages with defined thresholds).
Reported Device Performance: The document generally states: "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."

This implies that the implicit acceptance criteria are that the new device (Cardica C-Port FlexA™) performs functionally and safely at least as well as the predicate device (Cardica C-Port xA™), and its modifications introduce no new risks related to its intended use in creating anastomoses.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "All necessary verification testing has been performed" but does not give specific numbers of tests or samples.
Data Provenance: Not specified. It's likely internal testing by the manufacturer (Cardica, Inc.), but the location or whether it was retrospective/prospective is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not stated. This type of device (a surgical instrument) does not typically involve human expert interpretation of data to establish ground truth in the same way an AI diagnostic device would. Performance is assessed through engineering and functional tests.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not stated. As mentioned above, ground truth for this device's performance relies on objective physical and functional testing, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI algorithms where reader performance is a key outcome. The Cardica C-Port FlexA™ is a surgical instrument.

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

Standalone Performance: Not applicable. This is not an AI algorithm; it is a mechanical surgical device. Performance is inherent to the device's design and function, not an algorithm.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for this device would be established through objective engineering and functional testing. This would include tests for:
- Mechanical strength (e.g., clip integrity, holding power)
- Leak integrity of the anastomosis created
- Biocompatibility of implantable materials
- Sterility
- Functional operation of the delivery system (e.g., smooth deployment, proper clip formation).
  The document mentions "risk assessment and verification/validation testing," which implies these types of objective measures were used.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in that context.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable. As there's no machine learning, there's no training set or associated ground truth for it.

Summary of the Study (Based on the Provided Text):

The submission is a Special 510(k) for the Cardica® C-Port® FlexA™ Distal Anastomosis System. This means the device is being cleared as a modification to an already legally marketed device (the predicate: Cardica® C-Port® xA™ Distal Anastomosis System, K053524 and K063644).

The "study" involved verification testing to demonstrate that the modified device is substantially equivalent to the predicate device. The key changes were in the deployment device design to include a flexible shaft and remote graft clamp actuators. The manufacturer states that these modifications raise no new safety or efficacy issues when compared to the predicate device.

The study's conclusion is that, based on technical information, intended use, and performance information from the verification testing, the FlexA System is substantially equivalent to the predicate device for its intended use in creating anastomoses in blood vessels and grafts, including coronary artery bypass grafting procedures. No specific quantitative performance metrics from this testing are provided in the summary, relying instead on the established safety and effectiveness of the predicate device and the absence of new risks.

Summary

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K070548

Attachment 3

MAR 2 9 2007

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	February 21, 2007
Applicant Information	Cardica, Inc.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-331-7193
Contact Person	Tiffini LaludeOffice: 650-331-7153Fax: 650-331-7193e-mail: lalude@cardica.com
EstablishmentRegistration Number	3004114958
Device Information	Classification Name: Clip, ImplantableRegulation Number: 21 CFR §878.4300Trade Name: Cardica ® C-Port ® FlexA™ Distal Anastomosis SystemCommon 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.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

. ..

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:(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.

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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(per 21 CFR §801.109
OR

Over-the Counter Use	_________________
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Blamminado(Optional Format 1-2-96)
(Division Sign-Off)

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

510(k) Number	K070548
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Page 12
February 21, 2006.

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.