(35 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 any data-driven decision-making components.
No.
The device is used for creating anastomoses (surgical connections) in blood vessels and grafts, which is a surgical tool rather than a device intended to treat or ameliorate a disease or condition. While used in a therapeutic procedure (coronary artery bypass grafting), the device itself is a surgical instrument for creating connections, not directly providing therapy.
No
The device is used for creating anastomoses in blood vessels and grafts (e.g., for coronary artery bypass grafting procedures), which is a surgical procedure, not a diagnostic one. It mechanically connects vessels using clips.
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," which are physical hardware components.
Based on the provided information, this device 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 mentioning coronary artery bypass grafting. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a system for mechanically creating a connection between vessels using clips. This is a surgical tool, not a device used to examine specimens from the human body in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical instrument used for a therapeutic procedure.
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
FZP
Device Description
The Cardica C-Port xA 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 verification testing has been performed on the C-Port xA Anastomosis System with the modified clip to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
JAN 1 1 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.
and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states
| 510(k) Number | |
|---|---|
| Date Prepared | December 5, 2006 |
| Applicant Information | Cardica, Inc. |
| 900 Saginaw Drive | |
| 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® xA Anastomosis System | |
| Common Name: Cardiovascular Surgical Instruments | |
| Predicate Device(s) | Cardica® C-Port® xA Anastomosis System (K053524) |
| Cardica® C-Port® Anastomosis System (K040832) | |
| Device Description | The Cardica C-Port xA 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 with the modified clip is
substantially equivalent to the original Cardica C-Port xA Anastomosis
System (K053524, 21 CFR §878.4300). The clip design has been
modified to improve manufacturability of the clip (i.e., eliminates the need
to do the secondary operation of bending the tines and the loss of clips
due to this secondary operation). The subject device is substantially
equivalent to the predicate device with regard to indications, scientific
technology, operation principles, basic device design and size, materials,
shelf life, and packaging and sterilization materials and processes. |
| Device Testing
Results and
Conclusion | All necessary verification testing has been performed on the C-Port xA
Anastomosis System with the modified clip to assure substantial
equivalence to the predicate device and to assure 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 with the modified clip has been
shown to be substantially equivalent to the currently marketed predicate
device. |
| | Cardica® and C-Port® are registered trademarks of Cardica, Inc. |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2007
Cardica, Inc. c/o Ms. Tiffini Lalude Director Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K063644 Cardica® C-Port® xA Distal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: II Product Code: FZP Dated: December 6, 2006 Received: December 7, 2006
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. Tiffini 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 (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html . 300,00000
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4
Indications for Use
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ K063644
Device Name:__C-Port® xA Anastomosis System
The Cardica C-Port® xA Anastomosis System Indications For Use: indreacions for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Counter Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
lar Device
Page 1 of 1
510(k) Number K063644
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Page 4 – Ms. Tiffani Lalude
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-450 DCD D.O.
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |