(31 days)
No
The device description focuses on mechanical components and actions (delivery device, clips, actuation button) and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to create anastomoses in blood vessels, including in coronary artery bypass grafting procedures, which is a therapeutic intervention.
No
Explanation: The device is intended for creating anastomoses (surgical connections) in blood vessels and grafts, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a sterile, single-use device consisting of a delivery device and implantable stainless steel clips, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Cardica® C-Port® FlexA™ Distal Anastomosis System is a surgical device used during a procedure (coronary artery bypass grafting) to physically connect blood vessels. It does not analyze any bodily fluids or tissues to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "creation of anastomoses in blood vessels and grafts," which is a surgical function, not a diagnostic one.
The device is a surgical tool used for a therapeutic purpose, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
FZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels and grafts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cardica ® C-Port ® xA™ Distal Anastomosis System (K053524 and K063644)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
.
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 Saginaw | ||
| Redwood City, California 94063 | ||
| Main: 650-364-9975 | ||
| Fax: 650-331-7193 | ||
| Contact Person | Tiffini Lalude | |
| Office: 650-331-7153 | ||
| Fax: 650-331-7193 | ||
| e-mail: lalude@cardica.com | ||
| Establishment | ||
| Registration Number | 3004114958 | |
| Device Information | Classification Name: Clip, Implantable | |
| Regulation Number: 21 CFR §878.4300 | ||
| Trade Name: Cardica ® C-Port ® FlexA™ Distal Anastomosis System | ||
| Common 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 |
1
| 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.
11
Cardica C-Port FlexA System Special 510(k)
11.00
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:
2
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.
3
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
4
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 |
|---|---|
| ------------------ | --------------------------------------------------- |
(per 21 CFR §801.109
OR
| Over-the Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
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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February 21, 2006.