(22 days)
The Cardica® C-Port® XATM PLUS™ Distal 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® xATM PLUSTM Distal 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 describes a 510(k) submission for the C-Port® xA PLUS™ Distal Anastomosis System, which is a sterile, single-use device intended for creating end-to-side anastomoses between a conduit and a small vessel, specifically for coronary artery bypass grafting procedures.
It's important to note that this document is a 510(k) Summary for a Special 510(k) for Device Modification. This means the device is being compared to a previously cleared predicate device (Cardica® C-Port® xA™ Distal Anastomosis System, K063644). The clearance is based on demonstrating "substantial equivalence" rather than a full, de novo clinical trial proving effectiveness against specific acceptance criteria in the same way a PMA device might. Therefore, the information regarding specific acceptance criteria and detailed study outcomes will be limited compared to a novel device submission.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria (e.g., performance metrics with numerical thresholds) or reported device performance against those criteria for this specific modified device in a clinical setting.
Instead, the submission relies on the concept of substantial equivalence to a predicate device (K063644). The "acceptance criteria" are implied to be that the modified device's performance, as demonstrated through various testing, is not significantly different from, and is as safe and effective as, the legally marketed predicate device.
The study that proves the device meets the acceptance criteria (of substantial equivalence) is described as:
- Device Testing Results and Conclusion: "All necessary in vitro and in vivo testing has been performed on the C-Port® XATM PLUS™ Distal Anastomosis System to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."
Without access to the full 510(k) submission, the specifics of these in vitro and in vivo tests and their individual results against defined performance parameters are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The summary states "All necessary in vitro and in vivo testing has been performed." However, it does not provide details on the sample size for any test sets (neither for in vitro nor in vivo studies). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of any animal or human data if such was collected beyond basic engineering tests). Given it's a Special 510(k) for modification and not a de novo clearance, extensive human clinical data might not have been required or provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the summary. Since the submission relies on demonstrating substantial equivalence through in vitro and in vivo testing (likely mechanical, functional, and possibly animal studies), the concept of "experts establishing ground truth" in the context of clinical accuracy or diagnosis (e.g., for AI/imaging devices) does not directly apply here. The "ground truth" would be established by the performance metrics of the tests themselves (e.g., burst pressure, clip retention, patency in animal models).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus among experts is needed (e.g., radiologists reviewing images). This device is a surgical instrument, and its performance would be assessed through objective measurements from engineering tests or animal studies, not human adjudication of subjective data.
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
No MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for diagnostic devices, particularly AI-powered image analysis tools, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a surgical instrument, not a diagnostic or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not done. This device is a mechanical surgical instrument. The concept of "standalone algorithm performance" without human-in-the-loop is specific to AI/software devices and does not apply to the C-Port® xA PLUS™ Distal Anastomosis System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro and in vivo testing mentioned, the "ground truth" would likely be derived from:
- Physical and mechanical measurements: For in vitro tests (e.g., clip retention strength, burst pressure of an anastomosis, leakage rates).
- Physiological and anatomical observations: For in vivo animal studies (e.g., patency of anastomosis, histological assessment of tissue healing, absence of foreign body reaction, functional outcomes).
The summary does not specify the exact types of ground truth used for each test.
8. The sample size for the training set
Not Applicable/Not provided. This device is a mechanical surgical instrument and does not involve AI or machine learning, therefore, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable/Not provided. As there is no training set for an AI/ML model, this question does not apply.
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C-Port® xA Distal Anastomosis System
510(k) Summary
r
APR 2 1 2009
10F2
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 | March 26, 2009 | |
| ApplicantInformation | Cardica, Inc.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-331-7195 | |
| Contact Person | Kimberlee LeonOffice: 650-331-7119Fax: 650-331-7195e-mail: leon@cardica.com | |
| EstablishmentRegistration Number | 3004114958 | |
| Device Information | Classification Name:Regulation Number:Trade Name:Common Name: | Clip, Implantable21 CFR §878.4300Cardica® C-Port® xATM PLUSTM DistalAnastomosis SystemCardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® xATM Distal Anastomosis System (K063644) | |
| Device Description | The Cardica® C-Port® xATM PLUSTM Distal AnastomosisSystem is a sterile, single use device for creation of a reliablypatent end-to-side anastomosis between a conduit and a smallvessel. The product consists of accessories to assist in theconduit loading and a device that completes the anastomosiswith stainless steel clips. Once the conduit has been loadedonto the device and the device positioned against the targetvessel, the anastomosis is created by pushing the actuationbutton. | |
| Intended Use | The Cardica® C-Port® XATM PLUS™ Distal AnastomosisSystem is intended for the creation of anastomoses in bloodvessels and grafts, including use in coronary artery bypassgrafting procedures. | |
| Comparison toPredicate Device | The Cardica® C-Port® XATM PLUS™ Distal AnastomosisSystem is substantially equivalent to the Cardica® C-Port® XATMDistal Anastomosis System (K063644, 21 CFR §878.4300).The subject device is substantially equivalent to the predicatedevice with regard to the intended use, device characteristics,method of use, materials, labeling, sterilization method andbiocompatibility. | |
| Device TestingResults andConclusion | All necessary in vitro and in vivo testing has been performedon the C-Port® XATM PLUS™ Distal Anastomosis System toensure substantial equivalence to the predicate device, and toensure the safety and effectiveness of the device. | |
| SubstantialEquivalenceSummary | Cardica® C-Port® XATM PLUS™ Distal Anastomosis System hasthe same indications for use and the same technologicalcharacteristics as the predicate device (K063644). Thispremarket notification has described the characteristics of themodified device in sufficient detail to assure substantialequivalence. | |
| Conclusions | This Special 510(k) for Device Modification submission hasdemonstrated Substantial Equivalence as defined andunderstood in the Federal Food Drug and Cosmetic Act andvarious guidance documents issued by the Center for Devicesand Radiological Health. |
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K090872
C-Port® xA Distal Anastomosis System
20F2
Cardica and C-Port are registered trademarks of Cardica, Inc.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, a symbol of medicine and health.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 2009
Cardica®, Inc. c/o Ms. Kimberlee Leon Manager, Quality Systems 900 Saginaw Drive Redwood City, CA 94063
Re: K090872
C-Port® xATM PLUS Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable and Delivery System Regulatory Class: Class II Product Code: FZP Dated: March 26, 2009 Received: March 30, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
iana R. Vachner
Bram 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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| 510(k) Number: (if known) | K090872 |
|---|---|
| Device Name: | Cardica ® C-Port ® XA ™ PLUS ™ Distal Anastomosis System |
| Indications for Use: | The Cardica ® C-Port ® XA ™ PLUS ™ Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. |
Prescription Use
X
OR Over-The-Counter Use
(Part 21 CFR§801.109)
(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 Devices
| Indications for Use Statement | 510(k) Number K090872 Pg. 1 of 1 |
|---|---|
| ------------------------------- | ---------------------------------- |
§ 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.