(196 days)
No
The description focuses on a mechanical device for creating surgical connections and does not mention any AI/ML components or functionalities.
No.
The device facilitates a surgical procedure (creating an anastomosis) but does not directly treat a disease or condition itself. It is a surgical aid, not a therapeutic agent.
No
This device is a mechanical connector used to facilitate surgical anastomosis, not diagnose medical conditions. Its purpose is to replace sutures during a procedure, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "mechanical device" consisting of an "implantable connector and delivery system," indicating it is a hardware-based medical device.
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 on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a "mechanical device used to facilitate an aortic vein graft anastomosis." This further reinforces its role in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.
Product codes
FZP
Device Description
The Aortic Connector 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 Symmetry Aortic Connector System consists of a self expanding implantable connector and 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)
Mechanical, In Vitro, and animal, testing has been conducted which demonstrates that the performance of the Aortic Connector System is equivalent to standard suture anastomoses.
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
MAY 21 2001
K00344651
510(k) Summary
Aortic Connector System
Common/Classification Name: Implantable Clip and delivery system as classified under 21 CFR 878.4300 and 4800
St. Jude Medical Anastomotic Technology Group 6500 Wedgwood Rd. Maple Grove, MN 55311
Telephone: (763) 383-2559 (763) 383-2771 Fax: Contact: Milana Solganik, Director of Regulatory Affairs
Prepared: November 1, 2000
A. Legally Marketed Predicate Devices
The Aortic Connector System is substantially equivalent to the U.S. Surgical AutoSuture Vascular Anastomosis Clip Cartridge and Applier (K970793).
B. Device Description
The Aortic Connector 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 Symmetry Aortic Connector System consists of a self expanding implantable connector and delivery system.
C. Indications for Use
The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.
D. Substantial Equivalence Summary
Both devices are intended to be used in creating vascular anastomoses. The St. Jude Medical Anastomotic Technology Group Mechanical Anastomosis Connector is made of a Nickel Titanium alloy (Nitinol) in a "U" shape with rounded ends. The U.S. Surgical clip is made of Titanium in a "C" shape with blunted ends. The ends of both clips pinch the edges of the vessels together without penetrating the vessel wall.
The primary difference between the devices is the delivery method. The U.S. Surgical applier fires the clips one at a time, and the applier must be manually moved circumferentially around the anastomosis site. The St. Jude Medical Anastomotic
1
K003446S1
Technology Group Mechanical Anastomosis Connector is a unitary device with all clipping elements being deployed simultaneously around the circumference.
E. Technological Characteristics
See Device Description above.
F. Testing
Mechanical, In Vitro, and animal, testing has been conducted which demonstrates that the performance of the Aortic Connector System is equivalent to standard suture anastomoses.
G. Conclusion
St. Jude Medical has demonstrated through its comparison of performance with standard suture anastomoses that the Aortic Connector System is equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
MAY 2 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Al Flory Vice President, Clinical and Regulatory Affairs St. Jude Medical Cardiac Surgery Division Anastomotic Technology Group 6500 Wedgwood Road Maple Grove, Minnesota 55311
Re: K003446
Trade/Device Name: Symmetry Aortic Clip System Regulation Number: 878.4300 Regulatory Class: II Product Code: FZP Dated: February 16, 2001 Received: February 20, 2001
Dear Mr. Sheridan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Robert L. Sheridan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
Sincerely yours.
Mude M. Mulle
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K@@344651
Page _ of _1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K003446
Device: Mechanical Anastomosis System
Indications for Use:
The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Mark N. Mellman
ivision of General, Restorative and Neurological Devices
510(k) Number K003446