(88 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a PTFE graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "expanded polytetrafluoroethylene (PTFE) graft" intended for "creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels." These actions directly treat or modify the body for therapeutic purposes.
No
This device is a graft intended for surgical repair and reconstruction of blood vessels, not for diagnosing medical conditions.
No
The device description clearly describes a physical graft made of PTFE and gelatin, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the creation of subcutaneous arteriovenous conduits, bypass, or reconstruction of blood vessels. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical graft made of PTFE and gelatin, designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the living body) to analyze samples. This device is an implantable medical device used in vivo.
N/A
Intended Use / Indications for Use
Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo- femoral/bifemoral bypass reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
The device is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. Similar devices have been used clinically since the 1970's with few reported complications or material failures. PTFE typically is used as a synthetic conduit to replace natural vessels or as a shunt for AV/dialysis access. The mechanical properties of Sulzer Vascutek PTFE material such as strength, suture retention, and handling are substantially equivalent to products currently in commercial distribution.
The PTFE material has been impregnated with an absorbable mammalian gelain that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
systemic arteries
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)
In vitro testing conducted on the Sulzer Vascutek SEALPTHE™ graft line shows it to be substantially equivalent to Impra commercial grafts. Results from animal studies demonstrate that the Sulzer Vascutek standard wall grafts to be equivalent to Impra standard wall grafts. Results from biomaterial that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Sulzer Medica, a medical technology company. The text "SULZER MEDICA" is displayed in a bold, sans-serif font. Above the logo, there is a handwritten code "K993667".
JAN 2 8 2000
510(k) SUMMARY
SULZER VASCUTEK SEALPTFE™ VASCULAR PROSTHESIS
Sulzer Carbomedics Inc.
1300 East Anderson Lane Austin, Texas 78752-1793
Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada)
The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is substantially equivalent to devices in commercial distribution by Impra, a division of C. R. Bard. All devices referenced under this application are 6mm in diameter or greater and are used to treat diseased or occluded systemic arteries and for A/V access. In addition, the application covers externally supported graft designs.
The device is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. Similar devices have been used clinically since the 1970's with few reported complications or material failures. PTFE typically is used as a synthetic conduit to replace natural vessels or as a shunt for AV/dialysis access. The mechanical properties of Sulzer Vascutek PTFE material such as strength, suture retention, and handling are substantially equivalent to products currently in commercial distribution.
The PTFE material has been impregnated with an absorbable mammalian gelain that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.
Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral bypass and femoralpopliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.
In vitro testing conducted on the Sulzer Vascutek SEALPTHE™ graft line shows it to be substantially equivalent to Impra commercial grafts. Results from animal studies demonstrate that the Sulzer Vascutek standard wall grafts to be equivalent to Impra standard wall grafts. Results from biomaterial that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.
In summary, all testing demonstrates that the Sulzer Vascutek SEALPTFE™ graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access.
| Common name of the Device: | Vascular Graft | |
|---|---|---|
| Trade name of Proprietary Name: | Sulzer Vascutek SEALPTFE™ Vascular Prosthesis | |
| Submitter and Contact Person:Edward E. Newton | ||
| Regulatory Affairs Manager | ||
| 1300 E. Anderson Lane, Austin, TX 78752 | ||
| Phone: (512) 435-3407 Fax: (512) 435-3350 | ||
| Submission Submitted on: | October 29, 1999 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
JAN 2 8 2000
Mr. Edward E. Newton Regulatory Affairs Manager Sulzer Medica 1300 East Anderson Lane Austin, TX 78752
Re: K993667
Sulzer Vascutek SEALPTFE™ Vascular Prosthesis Requlatory Class: II Product Code: DSY Dated: October 29, 1999 Received: November 1, 1999
Dear Mr. Newton:
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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2
Page 2 - Mr. Edward E. Newton
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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ta data de Emissão
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE STATEMENT
| 510(K) Number (if known): | Unknown |
|---|---|
| Device Name: | Sulzer Vascutek SEALPTFE™ Vascular Prosthesis |
| Indications for Use: | Sulzer Vascutek SEALPTFE™ grafts are intended for the |
| creation of subcutaneous arteriovenous conduits for blood | |
| access, bypass, or reconstruction of occluded or diseased | |
| arterial blood vessels. Typical applications for standard | |
| wall grafts include systemic vascular repair, primarily for | |
| axillo-femoral/bifemoral bypass and femoral-popliteal | |
| reconstruction. Typical applications for thin wall grafts | |
| include systemic vascular repair, but not for axillo- | |
| femoral/bifemoral bypass reconstruction. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bess R. Lamphere
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ K 993667
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use
(Optional Format 1-2-96)