(27 days)
Not Found
No
The description focuses on a mechanical device for creating surgical anastomoses using clips, with no mention of AI/ML terms or functionalities.
Yes
The device is described as forming anastomoses in blood vessels and grafts for procedures like coronary artery bypass grafting, which directly addresses a medical condition or performs a therapeutic function.
No
The device is described as an anastomosis system used for creating connections in blood vessels and grafts, particularly in coronary artery bypass grafting, which is a surgical procedure for treatment, not diagnosis. Its function involves delivering clips to create an anastomosis, not to detect or identify a medical condition.
No
The device description clearly outlines physical components like a handle, subassemblies, and clips, indicating it is a hardware device, not software-only.
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 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 system that delivers clips to create a physical connection between vessels. This is a surgical tool used during a procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM does not involve the analysis of any biological specimens.
Therefore, the Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FZP
Device Description
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.
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® 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cardica® C-Port® xA™ Anastomosis System (#K063644)
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
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 |
| 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: Clip, Implantable |
| Regulation Number: 21 CFR §878.4300 | |
| Trade Name: Cardica® C-PORT® X-CHANGE™ Anastomosis System | |
| Common Name: Cardiovascular Surgical Instruments | |
| Predicate Device(s) | Cardica® C-Port® xA™ Anastomosis System (#K063644) |
| Device Description | 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. |
1
F
Cardica, Inc.
7
| Intended Use | The 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. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Device | The Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS
SYSTEM is substantially equivalent to the Cardica® C-Port®
xA™Anastomosis System (#K063644, 21 CFR §878.4300).
The subject device is substantially equivalent to the predicate
device with regard to 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® 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. |
| Substantial
Equivalence
Summary | Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM
has the same indications for use and the same technological
characteristics as the predicate device (#K063644). 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. |
Cardica® and C-Port® are registered trademarks of Cardica, Inc.
.
2
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.
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 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
4
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™ 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)
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) |
|---|
| (Division Sign-Off) |
| Division of Cardiovascular |
| 510(k) Number K073304 |
Indications for Use Statement
Pg. 1 of 1