(35 days)
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.
The Cardica C-Port xA 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.
The provided text is a 510(k) summary for the Cardica® C-Port® xA Anastomosis System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study with an AI component. Therefore, much of the requested information about AI model performance and study details is not present.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria or provide detailed performance metrics like sensitivity, specificity, accuracy, or F1-score for the device itself. Instead, the submission states that "All necessary verification testing has been performed on the C-Port xA Anastomosis System with the modified clip to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device."
The focus is on demonstrating that the modified device is as safe and effective as the predicate device (Cardica® C-Port® xA Anastomosis System, K053524). This is a common approach for 510(k) submissions where a modification to an already cleared device is being presented.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K053524) in terms of: | The Cardica C-Port xA Anastomosis System with the modified clip has been |
| - Indications for Use | shown to be substantially equivalent to the currently marketed predicate |
| - Scientific technology | device. |
| - Operation principles | |
| - Basic device design and size | |
| - Materials | |
| - Shelf life | |
| - Packaging and sterilization materials and processes | |
| Safety and effectiveness | Verification testing performed to assure safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The testing mentioned is "verification testing" to assure substantial equivalence, rather than a clinical trial with a defined test set for performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not present. The device is a surgical instrument (anastomosis system) and not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for a device like this would relate to its mechanical performance, biocompatibility, and ability to create a functional anastomosis, which would be assessed through engineering tests, animal studies, or potentially human clinical data (though not detailed here).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not present, as there is no diagnostic output that requires adjudication.
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
There is no mention of an MRMC study, AI, or human readers. The device is a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to an AI or diagnostic device (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" would be related to its engineering specifications, successful creation of an anastomosis, and patient outcomes related to the surgical procedure, as determined through various verification and potentially pre-clinical/clinical tests. The document broadly states "All necessary verification testing has been performed," without detailing the specific "ground truth" for each test.
8. The Sample Size for the Training Set
This is not applicable since the device is not an AI system that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above.
In summary, this 510(k) submission is for a modification to a mechanical surgical device and primarily focuses on demonstrating substantial equivalence to a predicate device through verification testing. It does not involve AI, image analysis, or diagnostic capabilities, and therefore, most of the requested information regarding AI model performance, expert ground truth, and study designs for such applications is absent.
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Attachment 3
510(k) Summary
JAN 1 1 2007
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states
| 510(k) Number | |
|---|---|
| Date Prepared | December 5, 2006 |
| Applicant Information | Cardica, Inc.900 Saginaw DriveRedwood 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® xA Anastomosis SystemCommon Name: Cardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® xA Anastomosis System (K053524)Cardica® C-Port® Anastomosis System (K040832) |
| Device Description | The Cardica C-Port xA Anastomosis System is a sterile, single usedevice for creation of a reliably patent end-to-side anastomosis betweena conduit and a small vessel. The product consists of accessories toassist in the conduit loading and a device that completes the anastomosiswith stainless steel clips. Once the conduit has been loaded onto thedevice and the device positioned against the target vessel, theanastomosis is created by pushing the actuation button. |
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| Intended Use | The Cardica® C-Port® xA Anastomosis System is intended for thecreation of anastomoses in blood vessels and grafts, including use incoronary artery bypass grafting procedures. |
|---|---|
| Comparison toPredicate Device | The Cardica C-Port xA Anastomosis System with the modified clip issubstantially equivalent to the original Cardica C-Port xA AnastomosisSystem (K053524, 21 CFR §878.4300). The clip design has beenmodified to improve manufacturability of the clip (i.e., eliminates the needto do the secondary operation of bending the tines and the loss of clipsdue to this secondary operation). The subject device is substantiallyequivalent to the predicate device with regard to indications, scientifictechnology, operation principles, basic device design and size, materials,shelf life, and packaging and sterilization materials and processes. |
| Device TestingResults andConclusion | All necessary verification testing has been performed on the C-Port xAAnastomosis System with the modified clip to assure substantialequivalence to the predicate device and to assure the safety andeffectiveness of the device. |
| Summary | Based upon the product technical information provided, intended use,and performance information provided in this pre-market notification, theCardica C-Port Anastomosis System with the modified clip has beenshown to be substantially equivalent to the currently marketed predicatedevice. |
| Cardica® and C-Port® are registered trademarks of Cardica, Inc. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2007
Cardica, Inc. c/o Ms. Tiffini Lalude Director Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K063644 Cardica® C-Port® xA Distal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: II Product Code: FZP Dated: December 6, 2006 Received: December 7, 2006
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. Tiffini 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 (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html . 300,00000
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Indications for Use
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ K063644
Device Name:__C-Port® xA Anastomosis System
The Cardica C-Port® xA Anastomosis System Indications For Use: indreacions for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Counter Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
lar Device
Page 1 of 1
510(k) Number K063644
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Page 4 – Ms. Tiffani Lalude
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-450 DCD D.O.
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
§ 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.