(30 days)
The Cardica® C-Port® Flex-A™ 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® Flex-ATM 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 document is a 510(k) summary for the Cardica® C-Port® Flex-AT™ Distal Anastomosis System. This type of submission is for device modification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria as requested. Instead, it relies on the declaration that performance data was collected and demonstrates substantial equivalence to the predicate device.
Here's a breakdown of why the requested information is absent or cannot be fully provided based solely on the given text:
1. A table of acceptance criteria and the reported device performance:
- Not present in the document. The 510(k) summary states, "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This implies that specific acceptance criteria and detailed performance results are not publicly available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present in the document. The document mentions "All necessary in vitro and in vivo testing has been performed," but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not present. Since this is a device for creating anastomoses and not an imaging or diagnostic device requiring expert interpretation for ground truth, this information is not relevant to the type of testing described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. As mentioned above, this type of adjudication is typically for diagnostic interpretation, which is not the primary evaluation method for this device.
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/Not present. This device is an anastomosis system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not present. This device is a surgical instrument. "Standalone" performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for specific tests. For a device like this, ground truth would likely involve direct measurement of anastomotic integrity, flow, burst pressure, and histological evaluation of healing in in vivo models. However, the document only broadly states "necessary in vitro and in vivo testing."
8. The sample size for the training set:
- Not applicable/Not present. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not present. This is not an AI/machine learning device that requires a training set.
Summary of available information regarding compliance:
The 510(k) summary states that the device is substantially equivalent to the predicate device Cardica® C-Port® Flex-AT™ Distal Anastomosis System (#K070548). The basis for this equivalence is:
- Same indications for use.
- Same technological characteristics.
- Same device characteristics, method of use, materials, labeling, sterilization method, and biocompatibility.
The document explicitly states that "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This means that while internal testing was conducted to prove equivalency, the specifics of these tests, including acceptance criteria and detailed results, are not part of this public summary.
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510(k) Summary
DEC 0 6 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.
| 510(k) Number | ||
|---|---|---|
| Date Prepared | November 2, 2007 | |
| ApplicantInformation | Cardica, Inc.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-364-3134 | |
| Contact Person | Iskra MrakovicOffice: 650-331-7153Fax: 650-364-3134e-mail: mrakovic@cardica.com | |
| EstablishmentRegistration Number | 3004114958 | |
| Device Information | Classification Name:Regulation Number:Trade Name:Common Name: | Clip, Implantable21 CFR §878.4300Cardica® C-Port® Flex-ATM DistalAnastomosis SystemCardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® Flex-ATM Distal Anastomosis System(#K070548) | |
| Device Description | The Cardica® C-Port® Flex-ATM Distal Anastomosis System is asterile, 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 conduitloading and a device that completes the anastomosis withstainless steel clips. Once the conduit has been loaded ontothe device and the device positioned against the target vessel,the anastomosis is created by pushing the actuation button. | |
| Intended Use | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System isintended for the creation of anastomoses in blood vessels andgrafts, including use in coronary artery bypass graftingprocedures. | |
| Comparison toPredicate Device | The Cardica® C-Port® Flex-AT™ Distal Anastomosis System issubstantially equivalent to the Cardica® C-Port® Flex-AT™ DistalAnastomosis System (#K070548, 21 CFR §878.4300). Thesubject 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® Flex-AT™ Distal Anastomosis System and itspackaging to ensure substantial equivalence to the predicatedevice, and to ensure the safety and effectiveness of thedevice. | |
| SubstantialEquivalenceSummary | Cardica® C-Port® Flex-AT™ Distal Anastomosis System has thesame indications for use and the same technologicalcharacteristics as the predicate device (#K070548). Thispremarket notification has described the characteristics of themodified device in sufficient detail to assure substantialequivalence. For the few characteristics that may not beprecise enough to ensure equivalence, performance data wascollected, and this data demonstrates substantial equivalence.In keeping with the format of a Special 510(k) for DeviceModification, performance data were not included in thesubmission, but the declarations provide certification that thedata demonstrate equivalence. | |
| 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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Cardica® and C-Port® are registered trademarks of Cardica, Inc.
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DEC 0 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardica, Inc. c/o Ms. Iskra Mrakovic Manager, Regulatory Affairs 900 Saginaw Dr. Redwood City, CA 94063
Re: K073123
Cardica® C-Port® Flex-A™ Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable Regulatory Class: Class II (two) Product Code: FZP Dated: November 02, 2007 Received: November 06, 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.
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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 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.
una R. V. Auner
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character on the left side, which appears to be a combination of curved and looped lines. To the right of this symbol are the capital letters 'B' and 'D', stacked vertically. The letters are in a simple, sans-serif font and are positioned closely together.
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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Indications for Use Statement
| 510(k) Number:(if known) | K073123 |
|---|---|
| Device Name: | Cardica® C-Port® Flex-A™ Distal Anastomosis System |
| Indications for Use: | The Cardica® C-Port® Flex-A™ Distal Anastomosis System is intended forthe creation of anastomoses in blood vessels and grafts, including use in |
coronary artery bypass grafting procedures.
Prescription Use × (Part 21 CFR§801.109)
: and the comments of the country
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)
Suane R. V. Aunes
(Division Sign-Off) Division of Caralovascular Devices
Indications for Use Statement
510(k) Number_k0 7317 3
§ 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.