(128 days)
Not Found
No
The description focuses on a mechanical device for creating surgical anastomoses and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate an aortic vein graft anastomosis and replaces sutures to create a secure, patent, and reproducible anastomosis, which is a therapeutic intervention.
No
Explanation: The device description states that the system is used to create an aortic anastomosis and facilitates an anastomosis, replacing sutures. This describes a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is a "mechanical device" and consists of a "connector and a delivery system," indicating 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 to "create the aortic anastomosis of aortic autologous vein grafts." This is a surgical procedure performed in vivo (within the living body) to connect blood vessels.
- Device Description: The device is described as a "mechanical device used to facilitate an aortic vein graft anastomosis" that "replaces sutures." This further confirms its use in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body, while this device is used directly on the body during surgery.
N/A
Intended Use / Indications for Use
The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.
Product codes
FZP
Device Description
The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic
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 PAS-Port' Proximal 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)
St. Jude Medical Aortic Connector System (#K003446)
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
SEP - 5 2008 S•Port® Proximal Anastomosis System Cardica, Inc. Traditional 510(k) Premarket Notification
510(k) Summary
PAS•Port™ Proximal Anastomosis System
| 510(k) Number | |
|---|---|
| Date Prepared | 28 April, 2008 |
| 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® PAS•Port® Proximal | |
| Anastomosis System | |
| Common Name: Cardiovascular Surgical Instruments | |
| Legally Marketed | |
| Predicate Device(s) | St. Jude Medical Aortic Connector System (#K003446) |
| Device Description | The Cardica® PAS•Port® Proximal Anastomosis System is a |
| mechanical device used to facilitate an aortic vein graft | |
| anastomosis. The connector replaces sutures to create a | |
| secure, patent and reproducible anastomosis. The PAS•Port® | |
| Proximal Anastomosis System consists of a connector and a | |
| delivery system. | |
| Indications for Use | The PAS-Port' System is intended to create the aortic |
| anastomosis of aortic autologous vein grafts. | |
| Comparison to | |
| Predicate Device | The PAS•Port® Proximal Anastomosis System is substantially |
| equivalent to the St. Jude Medical Aortic Connector System | |
| (#K003446, 21 CFR $878.4300). | |
| Device Testing | |
| Results and | |
| Conclusion | All necessary in vitro and in vivo testing has been performed |
| on the PAS-Port' Proximal Anastomosis System and its | |
| packaging to ensure substantial equivalence to the predicate | |
| device, and to ensure the safety and effectiveness of the | |
| device. | |
| Technological | |
| Characteristics | See Device Description above. |
| Substantial | |
| Equivalence | |
| Summary | Both, the Cardica® PAS-Port' Proximal Anastomosis System |
| and the St. Jude Aortic Connector System are intended for | |
| creation of the aortic anastomoses made of aortic autologous | |
| vein grafts. Both devices include a metal implant and a | |
| delivery system. With both devices, a graft vessel is loaded | |
| onto an implant and the delivery device is used to form the | |
| implant into a circular grommet-like structure that seals the vein | |
| graft to the aorta. | |
| The primary difference between the two devices is the material | |
| used for the implant. The PAS-Port' Proximal Anastomosis | |
| System implant is made of a medical grade 316L Stainless | |
| Steel whereas the St. Jude Symmetry device is made from | |
| nitinol, i.e., a nickel-titanium alloy. | |
| Conclusions | This Traditional 510(k) Premarket Notification submission has |
| demonstrated Substantial Equivalence with the St. Jude Aortic | |
| Connector System (#K003446) 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
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Cardica. Inc. c/o Ms. Iskra Mrakovic VP, Clinical Affairs Manager, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K081225
PAS-Port Proximal Anastomosis System Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: II (two) Product Code: FZP Dated: August 15, 2008 Received: August 18, 2008
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
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/cdrl/industry/support/index.html.
Sincerely yours.
Duna R. Vicher
Image /page/3/Picture/4 description: The image contains a symbol that resembles a stylized letter 'S' or a flourish. It is drawn with a single, continuous line that curves and loops back on itself. The line starts at the top, curves down and to the left, then loops back up and to the right before ending with a small curl at the bottom.
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) | K081225 |
|---|---|
| Device Name: | Cardica® PAS•Port® Proximal Anastomosis System |
| Indications for Use: | The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts. |
Prescription Use X (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)
sumar D. V. V. Luis
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko81225
Indications for Use Statement
Pg. 1 of 1