(5 days)
Not Found
Not Found
No
The summary describes a physical vascular graft and its clinical performance, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is a vascular graft used for the repair or replacement of damaged vessels, which is a therapeutic intervention for diseases like aneurysmal or occlusive disease.
No
The device is a vascular graft for replacing damaged blood vessels, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "vascular graft" made of "polyester terephthalate knitted fiber graft coated with modified cross linked gelatin," which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states the Uni-Graft K DV is a vascular graft intended for repair or replacement of damaged and diseased vessels within the body. This is an implantable device used in vivo (within the living organism).
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Uni-Graft K DV is indicated for use in repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, thoracic, and larger peripheral arterial reconstruction / damaged and diseased vessels of the abdomen
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)
A definitive clinical trial comparing the Uni-graft@ to historical coated graft controls was conducted in Japan on 100 patients from 1990 - 1993. This clinical study showed no bleeding, negative collagen antibody testing or complications specifically associated with the Uni-graft® prosthesis at the 6 month study period. The cumulative patency rate was 98.8%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Patency rate: 98.8%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Meadox Hemashield, Vascutek Gelseal, Gelsoft
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
99/8/3
Section 2 - Summary & Certification
| Date: | September 5, 1996 |
|---|---|
| Submitter's Name: | Ted Karwoski, VP R&D/Operations |
| Atrium Medical Corporation | |
| Address: | 5 Wentworth Drive |
| Hudson, NH 03051 | |
| Telephone No.: | (603)880-1433 |
| Trade Name: | Uni-graft® K DV |
| Vascular Graft 6mm and larger |
Safety and Effectiveness Summary
This device is a vascular graft intended for use as a replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction. Reconstruction is required because of - 1) aneurysmal disease or potential rupture, and 2) occlusive disease or blockage of the natural vessel.
It is substantially equivalent to the Meadox Hemashield and Vascutek Gelseal and Gelsoft. It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall. Minimizing blood loss is extremely important in large diameter conduits such as the aorta.
Implantation of all vascular grafts have potential adverse patient effects or complications. These involve surgical risk from the operation, graft occlusion (which include thrombosis, technical errors in surgery or anatomic positioning) coagulopathy, infection, thromboembolic episodes (downstream clotting), aneurysm, hyperplasia, leaking or weeping of blood or serous fluid (seroma). In addition, coated grafts can cause immunological (allergic) reactions, delayed healing. Any, and all of these complications can lead to amputation which is the undesirable event the synthetic vascular graft was intended to ameliorate.
Patients undergoing implantation of the Uni-graft® K DV experience no increase in any risk over that of an uncoated polyester prosthesis based upon study results or implantation history of this product in the world marketplace.
The benefits of a gelatin coated product as a vascular replacement are significant in that it does not require preclotting, minimizes blood loss, operative time, substitute blood product exposure, and anesthesia.
All pertinent structural and biological testing such as burst strength, compliance, etc., parameters detailed in the Vascular graft prostheses guidance and tripartite documents have been completed. The results show equivalent strength and long term structural stability of this product compared to existing devices.
Over 200,000 implants worldwide of the Uni-graft@ product have occurred with an exemplary record of success. Various human and animal reports are included in this submission for review. A definitive clinical trial comparing the Uni-graft@ to historical coated graft controls was conducted in Japan on 100 patients from 1990 - 1993. This clinical study showed no bleeding, negative collagen antibody testing or complications specifically associated with the Uni-graft® prosthesis at the 6 month study period. The cumulative patency rate was 98.8%. This study as well as the other information provided demonstrates this product to be safe and effective with performance as well as or better than the predicate devices.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
1 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph P. DePaolo Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re : K991813 Uni-Graft® K DV Gelatin Coated Vascular Graft Regulatory Class: II (Two) Product Code: DSY Dated: April 20, 1999 Received: May 18, 1999
Dear Mr. DePaolo,
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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.
2
Page 2 - Mr. Joseph P. DePaolo
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) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1_of_1_
510(k) Number (if known):_ K991813
Device Name:__Uni-Graft K DV Vascular Graft
Indications For Use:
The Uni-Graft K DV is indicated for use in repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)