(27 days)
The Cardica® Cardica® C-PORT® X-CHANGE™ 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® X-CHANGE™ 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 delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and a conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis which is functionally equivalent to a hand-sutured, interrupted stitch anastomosis. The system consists of one (1) C-PORT® HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X-CHANGE™ subassemblies and one (1) Retractor Mount.
The provided text is a 510(k) summary for the Cardica® C-PORT® X-CHANGE™ Anastomosis System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance data for a new device.
Therefore, the information requested regarding acceptance criteria and a study proving a device meets them is largely not applicable in the context of this 510(k) summary. The submission's core argument is that the new device is "substantially equivalent" to an already cleared device, not that it independently meets pre-defined performance thresholds through a separate study.
However, I can extract the information that is present and explain why certain sections cannot be fully addressed based on the provided document.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit. The submission relies on establishing substantial equivalence to a predicate device (Cardica® C-Port® xA™ Anastomosis System, #K063644). Explicit, quantitative acceptance criteria for this specific modified device are not stated in the summary. | The submission states that "All necessary in vitro and in vivo testing has been performed on the C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device." It also notes that "performance data was collected, and this data demonstrates substantial equivalence." However, the specific results of this performance data against quantitative criteria are not included in this summary, as per the typical structure of a Special 510(k) for Device Modification. |
Study Details (as far as can be inferred from a 510(k) summary)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the summary.
- Data Provenance: Not specified in the summary. The testing performed includes "in vitro and in vivo testing," which suggests a mix of laboratory and potentially animal or pre-clinical human studies, but details are not provided.
- Retrospective or Prospective: Not specified.
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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. This information is typically relevant for studies involving human interpretation (e.g., imaging devices) where "ground truth" is established by expert consensus. For a mechanical medical device, ground truth is typically established through direct physical measurements, functional tests, or histological analysis, not expert interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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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 device is a surgical instrument, not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a surgical instrument, not an algorithm. Performance would be assessed through its mechanical and functional characteristics, not algorithm-only evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device (anastomosis system), "ground truth" would likely be established through:
- Physical measurements: verifying dimensions, clip deployment accuracy.
- Mechanical testing: burst pressure, tensile strength of anastomoses.
- Histological analysis: confirming vessel wall apposition and patency in animal models.
- In vivo patency and healing studies: assessing long-term success of anastomoses in animal models.
- The summary generically mentions "in vitro and in vivo testing," implying these types of methods were used to ensure safety, effectiveness, and substantial equivalence to the predicate.
- For this type of device (anastomosis system), "ground truth" would likely be established through:
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The sample size for the training set:
- Not Applicable. This information is typically relevant for machine learning or AI-based devices. For a mechanical device, there isn't a "training set" in the same sense. Design iterations and verification/validation testing are performed, but not referred to as a "training set."
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
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Cardica, Inc.
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 | 21 November 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: Clip, ImplantableRegulation Number: 21 CFR §878.4300Trade Name: Cardica® C-PORT® X-CHANGE™ Anastomosis SystemCommon Name: Cardiovascular Surgical Instruments |
| Predicate Device(s) | Cardica® C-Port® xA™ Anastomosis System (#K063644) |
| Device Description | The Cardica® C-PORT® X-CHANGE™ ANASTOMOSISSYSTEM is a sterile, single use device for creation of a reliablypatent end-to-side anastomosis between a conduit and a smallvessel. The product delivers a series of clips that create ananastomosis between a small target vessel (e.g. coronaryartery) and a conduit (e.g. saphenous vein graft). Thestainless steel clips create a complete end-to-side anastomosiswhich is functionally equivalent to a hand-sutured, interruptedstitch anastomosis. The system consists of one (1) C-PORT®HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X-CHANGE™ subassemblies and one (1) Retractor Mount. |
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Cardica, Inc.
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| Intended Use | The Cardica® C-PORT® X-CHANGE™ 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® X-CHANGE™ ANASTOMOSISSYSTEM is substantially equivalent to the Cardica® C-Port®xA™Anastomosis System (#K063644, 21 CFR §878.4300).The subject device is substantially equivalent to the predicatedevice with regard to 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® X-CHANGE™ ANASTOMOSIS SYSTEM andits packaging to ensure substantial equivalence to thepredicate device, and to ensure the safety and effectiveness ofthe device. |
| SubstantialEquivalenceSummary | Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEMhas the 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. 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. |
Cardica® and C-Port® are registered trademarks of Cardica, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardica, Inc. c/o Ms. Iskra Mrakovic Manager, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K073304
Cardica® C-Port® X-Change™ Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: November 21, 2007 Received: November 23, 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
$
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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Cardica, Inc.
Indications for Use Statement
| 510(k) Number:(if known) | K073304 |
|---|---|
| Device Name: | Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM |
| Indications for Use: | The Cardica® Cardica® C-PORT® X-CHANGE™ ANASTOMOSISSYSTEM is intended for the creation of anastomoses in blood vessels andgrafts, including use in coronary artery bypass grafting procedures. |
Prescription Use × (Part 21 CFR§801.109)
Over-The-Counter Use ___ OR (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Cardiovascular |
| 510(k) Number K073304 |
Indications for Use Statement
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.