(30 days)
Not Found
No
The description focuses on a mechanical device for creating anastomoses using stainless steel clips and an actuation button. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No.
The device is used for creating anastomoses (surgical connections) in blood vessels and grafts, which is a surgical procedure, not a therapeutic treatment itself.
No
The device is described as a system for creating anastomoses in blood vessels and grafts, which is a surgical procedure, not a diagnostic one. It is used to join vessels, not to identify or monitor medical conditions.
No
The device description explicitly 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® Flex-A™ Distal Anastomosis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the creation of anastomoses (surgical connections) in blood vessels and grafts, specifically for 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 system for creating an anastomosis using stainless steel clips. This is a mechanical device used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the C-Port® Flex-A™ does not involve any testing of samples.
Therefore, the device is a surgical instrument used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardica® C-Port® Flex-AT™ 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 (comma separated list FDA assigned to the subject device)
FZP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels and grafts, including use 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® Flex-AT™ Distal Anastomosis System and its 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.
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
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 | |
| Applicant | ||
| Information | Cardica, Inc. | |
| 900 Saginaw | ||
| Redwood City, California 94063 | ||
| Main: 650-364-9975 | ||
| Fax: 650-364-3134 | ||
| Contact Person | Iskra Mrakovic | |
| Office: 650-331-7153 | ||
| Fax: 650-364-3134 | ||
| e-mail: mrakovic@cardica.com | ||
| Establishment | ||
| Registration Number | 3004114958 | |
| Device Information | Classification Name: | |
| Regulation Number: | ||
| Trade Name: | ||
| Common Name: | Clip, Implantable | |
| 21 CFR §878.4300 | ||
| Cardica® C-Port® Flex-ATM Distal | ||
| Anastomosis System | ||
| Cardiovascular 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 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. | ||
| Intended Use | The Cardica® C-Port® Flex-AT™ 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® Flex-AT™ Distal Anastomosis System is | |
| substantially equivalent to the Cardica® C-Port® Flex-AT™ Distal | ||
| Anastomosis System (#K070548, 21 CFR §878.4300). The | ||
| subject device is substantially equivalent to the predicate | ||
| device with regard to the intended use, device characteristics, | ||
| method of use, materials, labeling, sterilization method and | ||
| biocompatibility. | ||
| Device Testing | ||
| Results and | ||
| Conclusion | All necessary in vitro and in vivo testing has been performed | |
| on the C-Port® Flex-AT™ Distal Anastomosis System and its | ||
| packaging to ensure substantial equivalence to the predicate | ||
| device, and to ensure the safety and effectiveness of the | ||
| device. | ||
| Substantial | ||
| Equivalence | ||
| Summary | Cardica® C-Port® Flex-AT™ Distal Anastomosis System has the | |
| same indications for use and the same technological | ||
| characteristics as the predicate device (#K070548). This | ||
| premarket notification has described the characteristics of the | ||
| modified device in sufficient detail to assure substantial | ||
| equivalence. For the few characteristics that may not be | ||
| precise enough to ensure equivalence, performance data was | ||
| collected, and this data demonstrates substantial equivalence. | ||
| In keeping with the format of a Special 510(k) for Device | ||
| Modification, performance data were not included in the | ||
| submission, but the declarations provide certification that the | ||
| data demonstrate equivalence. | ||
| Conclusions | This Special 510(k) for Device Modification submission has | |
| demonstrated Substantial Equivalence as defined and | ||
| understood in the Federal Food Drug and Cosmetic Act and | ||
| various guidance documents issued by the Center for Devices | ||
| and Radiological Health. |
1
:
Cardica® and C-Port® are registered trademarks of Cardica, Inc.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, symbolizing health and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo.
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.
3
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
4
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 for |
| the 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