(19 days)
The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
The Hemashield Platinum WDV grafts are woven double velour vascular grafts impregnated with a highly purified collagen. The Hemashield Platinum WDV grafts minimize bleeding at implant and thereby eliminate the operative preclotting step, including cumbersome autoclave techniques. The collagen is gradually resorbed by the patient. The CONCENTRICRIMP® pleat and GUIDELINE® are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.
The provided document describes a 510(k) premarket notification for a medical device called the "Hemashield Platinum Woven Double Velour TAAA graft configuration." This is a vascular graft used for the replacement or repair of arteries.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission for substantial equivalence, comparing the new device to existing predicate devices.
Specifically, the document states:
- "The Hemashield Platinum WDV TAAA configuration has been tested and compared to the predicate devices. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised."
- "We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule..."
Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a de novo study with defined performance metrics in the way a PMA might. The biocompatibility section mentions ISO 10993 testing, which implies testing was done but doesn't detail the acceptance criteria or results.
Therefore, I cannot fulfill the request to provide acceptance criteria and study details based on this document. The information requested (sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set) are typically found in clinical study reports or more detailed verification and validation documents, which are not present in this summary.
{0}------------------------------------------------
SEP 1 2 2005
52302
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Hemashield Platinum Woven Double Velour TAAA graft configuration |
|---|---|
| Classification Name: Graft, Vascular, Synthetic / Biologic Composite | |
| Name of Predicate Devices | Hemashield Platinum Woven Double Velour Vascular Grafts |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use and Device Description | The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery. The Hemashield Platinum WDV grafts are woven double velour vascular grafts impregnated with a highly purified collagen. The Hemashield Platinum WDV grafts minimize bleeding at implant and thereby eliminate the operative preclotting step, including cumbersome autoclave techniques. The collagen is gradually resorbed by the patient. The CONCENTRICRIMP® pleat and GUIDELINE® are also featured. In addition to collagen, the graft also contains glycerol as a softening agent. |
| Biocompatibility | There have been no changes in materials or manufacturing process flow for this device modification. The Hemashield Vascular Graft product line has been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Summary of Substantial Equivalence | The Hemashield Platinum WDV TAAA configuration has been tested and compared to the predicate devices. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised. |
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Jennifer Bolton Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566
Re: K052302
K052302
Hemashield Platinum Woven Double Velour TAAA Graft Configuration Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prostheses of 6MM and Greater Diameter Regulatory Class: Class II (two) Product Code: MAL Dated: August 22, 2005 Received: August 24, 2005
Dear Ms. Bolton:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regary manced profite Medical Device Amendments, or to commerce prior to May 20, 1970, the characters with the provisions of the Federal Food, Drug, devices that have been recassified in accessful as a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . Th and Cosmetic Act (Act) that do not require appro rar or works) provisions of the Act. The You may, therefore, market the device, secject or tire gentrements for annual registration, listing of general controls provisions of the rict moration required in the manage of the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis exist on the major regulations affecting your device can
may be subject to such additional controls. Existing major regulation may be subject to such adultional controlis. Entroling innitions of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. I be found in the Code of Feach. Its gening your device in the Federal Register.
{2}------------------------------------------------
Page 2 - Ms. Jennifer Bolton
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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Dmna R. Lochner
Image /page/2/Picture/6 description: The image contains a handwritten letter 'B' with a signature mark on the left side of the letter. The letter 'B' is in a serif font and appears to be part of a larger text or document. The signature mark is a series of curved lines, possibly representing initials or a stylized signature.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Hemashield Platinum Woven Double Velour TAAA graft Device Name: confiquration
Indications For Use:
The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. kline 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko52302
§ 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.”