(279 days)
No
The device description and performance studies focus on the material properties and physical performance of a vascular graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the repair or replacement of damaged and diseased thoracic aorta, which are therapeutic interventions.
No
Explanation: This device is a vascular prosthesis intended for surgical repair or replacement of the thoracic aorta, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "gelatin-sealed, woven polyester graft," which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair or replacement of damaged and diseased thoracic aorta. This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a vascular prosthesis, a physical implant used to replace or repair a blood vessel. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Product codes
DSY
Device Description
The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic aorta
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)
Subject device: Sulzer Vascutek Gelweave Valsalva™ Vascular Prosthesis
Test Description: In vitro testing which evaluated Base Graft Water Porosity, Blood Porosity, Burst Strength, Tensile Strength, Suture Retention, and Hydrodynamic testing was performed on the Sulzer Vascutek Gelweave Valsalva™. In addition, flow visualization, biocompatibility and animal testing are referenced.
Key results: The testing demonstrated that the Gelweave Valsalva™ is substantially equivalent to the Gelweave™ graft predicate 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
§ 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
KOI3022
Image /page/0/Picture/2 description: The image shows the logo for Sulzer Medica. The text "SULZER" is in bold, block letters, followed by "MEDICA" in a slightly smaller font. The logo appears to be for a medical company, given the name Medica.
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) www.sulzercarbomedics.com
510(k) SUMMARY
per 21 CFR §807.92
| Submitter | Contact |
|---|---|
| Sulzer Carbomedics Inc. | Lisa Peterson |
| 1300 East Anderson Lane | Regulatory Affairs Associate |
| Austin, Texas 78752-1793 | Telephone: (512) 435-3523 |
| Facsimile: (512) 435-3350 | |
| E-mail: lpeterson@carbomedics.com |
Date of Summary: Common Name: Proprietary Name:
September 5, 2001 Vascular Graft Sulzer Vascutek Gelweave Valsalva™ Vascular Prosthesis
Description of Device: The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.
Statement of Intended Use: The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Technological Comparison: For purposes of this submission, the Sulzer Vascutek Gelweave Valsalva™ Vascular Prosthesis was compared to the following predicate devices:
- � Sulzer Vascutek Gelweave™ Vascular Prosthesis: K952293 (Straight)
Testing: In vitro testing which evaluated Base Graft Water Porosity, Blood Porosity, Burst Strength, Tensile Strength, Suture Retention, and Hydrodynamic testing was performed on the Sulzer Vascutek Gelweave Valsalva™. In addition, flow visualization, biocompatibility and animal testing are referenced. The testing demonstrated that the Gelweave Valsalva™ is substantially equivalent to the Gelweave™ graft predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of health, well-being, and service.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Sulzer Carbomedics, Inc. c/o Ms. Lisa Peterson Regulatory Affairs Associate 1300 East Anderson Lane Austin, TX 78752-1793
Re: K013022
Trade Name: Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: March 13, 2002 Received: March 15, 2002
Dear Ms. Peterson:
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.
2
Page 2 - Ms. Lisa Peterson
. 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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely yours,
N. O'Dell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
.
.
| 510(K) Number: | Unknown |
|---|---|
| Device Name: | Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis |
| Indications for Use: | The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K013022 |