(332 days)
Not Found
No
The summary describes a mechanical device for creating anastomoses and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for creating anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures, which are therapeutic medical interventions.
No
The device is described as an "Anastomosis System" intended for the "creation of anastomoses in blood vessels and grafts." This describes a surgical tool used to join physiological lumens, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use device consisting of accessories and a device that completes the anastomosis with stainless steel clips, indicating it is a physical medical device, not software only.
Based on the provided information, the Cardica® C-Port® xA Anastomosis System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the creation of anastomoses (surgical connections) in blood vessels and grafts, specifically mentioning coronary artery bypass grafting procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a sterile, single-use device that creates an anastomosis using stainless steel clips. This is a surgical tool used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The description of the C-Port® xA Anastomosis System does not involve the analysis of any biological specimens.
Therefore, the Cardica® C-Port® xA Anastomosis System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Cardica® C-Port® 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels and grafts, including in coronary artery bypass grafting procedures.
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 in vitro and in vivo testing has been performed on the C-Port® xA Anastomosis System and packaging to ensure substantial equivalence to the predicate device and to ensure the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cardica® C-Port® Anastomosis System (K040832)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 4
NOV 16 2006
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 | 15 December 2005 |
| Applicant Information | Cardica, Inc. |
| 900 Saginaw | |
| Redwood City, California 94063 | |
| Main: 650-364-9975 | |
| Fax: 650-364-3134 | |
| Contact Person | David Casal, PhD |
| Office: 650-331-7145 | |
| Fax: 650-364-3134 | |
| e-mail: casal@cardica.com | |
| Establishment | |
| Registration Number | 3004114958 |
| Device Information | Classification Name: Clip, Implantable |
| Regulation Number: 21 CFR §878.4300 | |
| Trade Name: Cardica® C-Port® Anastomosis System | |
| Common Name: Cardiovascular Surgical Instruments | |
| Predicate Device(s) | Cardica® C-Port® Anastomosis System (K040832) |
| Device Description | The Cardica® C-Port® 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. |
1
| Intended Use | 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. |
|---|---|
| Comparison to Predicate Device | The Cardica® C-Port® xA Anastomosis System is substantially equivalent to the Cardica® C-Port® Anastomosis System (K040832, 21 CFR §878.4300). The subject device is substantially equivalent to the predicate device with regard to indications, device characteristics, method of use, labeling and materials. |
| Device Testing Results and Conclusion | All necessary in vitro and in vivo testing has been performed on the C-Port® xA Anastomosis System and packaging to ensure substantial equivalence to the predicate device and to ensure the safety and effectiveness of the device. |
| Summary | Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the Cardica® C-Port® 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.
:
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2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 16 2006
Tiffini Lalude Director of Regulatory Affairs Cardica, Inc. 900 Saginaw Drive Redwood City, CA 94063
Re: K053524
C-Port™ xA Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulatory Class: Class II Product Code: FZP Dated: October 1, 2006 Received: October 4, 2006
Dear: Ms. Lalude:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note:
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus.
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Pagc 2 - Tiffini Lalude
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-0120. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (240) 276-3150.
Sincerely yours.
Duna R. Vahner
Image /page/3/Picture/6 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly an 'S' or a stylized initial. The character is drawn with a single, continuous stroke, featuring a loop at the top and a curved line extending downwards.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Attachment 2
Indications for Use Statement
| 510(k) Number:
| (if known) | K053524 |
|---|---|
| Device Name: | Cardica® C-Port® xA Anastomosis System |
| Indications for Use: | 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. |
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the Counter Use | |
|---|---|---|---|---|
| (per 21 CFR §801.109 | (Optional Format 1-2-96) | |||
| Donna R. Lehner (Division Sign-Off) Division of Cardiovascular Devices | ||||
| Cardica | ||||
| 16 December 2005 | ||||
| 510(k) Number | K23053524 | |||
| Special 510(k) C-Port xA System |