(279 days)
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.
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.
The provided document, K013022, pertains to a 510(k) premarket notification for a medical device: Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis. This document describes substantial equivalence to a predicate device, not, a study against specific acceptance criteria for performance metrics that would typically apply to software or AI-based devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device submission.
However, I can extract the information related to device testing and comparison to a predicate device, which serves a similar purpose in the context of a 510(k) submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate device (Sulzer Vascutek Gelweave™ Vascular Prosthesis: K952293) and the results of the in-vitro testing demonstrating substantial equivalence. The document doesn't list explicit numerical acceptance criteria for each test but rather states that the new device demonstrated substantial equivalence.
| Test Performed | Implied Acceptance Criteria (via predicate) | Reported Device Performance (Gelweave Valsalva™) |
|---|---|---|
| Base Graft Water Porosity | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Blood Porosity | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Burst Strength | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Tensile Strength | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Suture Retention | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Hydrodynamic Testing | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Flow Visualization | Reference made | Referenced, implies satisfactory performance. |
| Biocompatibility | Reference made | Referenced, implies satisfactory performance and safety. |
| Animal Testing | Reference made | Referenced, implies satisfactory performance and safety. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the publicly available 510(k) summary. For in-vitro testing of medical devices like vascular grafts, the sample size would typically be determined by statistical methods for materials testing, but the summary does not detail these.
- Data Provenance: The document implies the data was generated through in vitro testing performed by Sulzer Carbomedics Inc. and possibly by reference to prior animal testing and biocompatibility studies for the Gelweave™ series. The country of origin for the data is implicitly the USA (Austin, Texas) where the submitter is located. The testing is essentially prospective in the sense that it was conducted specifically to support this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to diagnostic or prognostic accuracy for imaging or AI devices. For this device, performance is established through physical properties testing, biocompatibility, and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments or disagreements in data labeling/ground truth establishment, which isn't relevant for the objective measurements of physical properties of a vascular graft.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI or imaging device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on objective measurements of physical properties (e.g., water porosity, burst strength) and biological evaluations (biocompatibility, animal testing) against established standards and the performance of a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
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KOI3022
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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.
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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.
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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
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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 |
§ 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.”