(22 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 analysis that would indicate the use of such technologies.
Yes.
The device is used for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures, which is a surgical treatment.
No
Explanation: The device description states its purpose is to create anastomoses using stainless steel clips, which is a surgical or interventional procedure, not a diagnostic one. It does not mention any function for identifying or characterizing diseases or conditions.
No
The device description clearly states it is a sterile, single-use device that includes 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® XATM PLUS™ Distal Anastomosis System is not an In Vitro Diagnostic (IVD) device.
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 that uses stainless steel clips to create the anastomosis. This is a surgical instrument used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or any diagnostic purpose.
Therefore, the Cardica® C-Port® XATM PLUS™ Distal Anastomosis System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardica® C-Port® XATM PLUS™ 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® xATM PLUSTM 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® XATM PLUS™ Distal Anastomosis System 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)
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
C-Port® xA Distal Anastomosis System
510(k) Summary
r
APR 2 1 2009
10F2
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 | March 26, 2009 | |
| Applicant | ||
| Information | Cardica, Inc. | |
| 900 Saginaw | ||
| Redwood City, California 94063 | ||
| Main: 650-364-9975 | ||
| Fax: 650-331-7195 | ||
| Contact Person | Kimberlee Leon | |
| Office: 650-331-7119 | ||
| Fax: 650-331-7195 | ||
| e-mail: leon@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® xATM PLUSTM Distal | ||
| Anastomosis System | ||
| Cardiovascular Surgical Instruments | ||
| Predicate Device(s) | Cardica® C-Port® xATM Distal Anastomosis System (K063644) | |
| Device Description | The Cardica® C-Port® xATM PLUSTM 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® XATM PLUS™ 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® XATM PLUS™ Distal Anastomosis | |
| System is substantially equivalent to the Cardica® C-Port® XATM | ||
| Distal Anastomosis System (K063644, 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® XATM PLUS™ Distal Anastomosis System to | ||
| ensure substantial equivalence to the predicate device, and to | ||
| ensure the safety and effectiveness of the device. | ||
| Substantial | ||
| Equivalence | ||
| Summary | Cardica® C-Port® XATM PLUS™ Distal 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. | ||
| 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
K090872
C-Port® xA Distal Anastomosis System
20F2
Cardica and C-Port are registered trademarks of Cardica, Inc.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, a symbol of medicine and health.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 2009
Cardica®, Inc. c/o Ms. Kimberlee Leon Manager, Quality Systems 900 Saginaw Drive Redwood City, CA 94063
Re: K090872
C-Port® xATM PLUS Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable and Delivery System Regulatory Class: Class II Product Code: FZP Dated: March 26, 2009 Received: March 30, 2009
Dear Ms. Leon:
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 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. Kimberlee Leon
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
iana R. Vachner
Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
.
.
:
| 510(k) Number: (if known) | K090872 |
|---|---|
| Device Name: | Cardica ® C-Port ® XA ™ PLUS ™ Distal Anastomosis System |
| Indications for Use: | The Cardica ® C-Port ® XA ™ PLUS ™ 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
X
OR Over-The-Counter Use
(Part 21 CFR§801.109)
(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 Devices
| Indications for Use Statement | 510(k) Number K090872 Pg. 1 of 1 |
|---|---|
| ------------------------------- | ---------------------------------- |