(28 days)
The Hemashield Gold ™ Woven Double Velour 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 Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence: Identical indications for use, Identical labeling, Identical manufacturing processes, Identical operating principle, Incorporate identical materials, Have the identical shelf-life (5 years), Are packaged and sterilized using identical packaging materials and processes.
The provided submission for the Hemashield Gold Woven Double Velour Branch Graft is a Special 510(k) for a device modification, focusing on the branch configuration. The document explicitly states that there is "no change to these tests or to their acceptance criteria for the Branch Graft line extension" and that "all testing was done with standard test methods for these parameters". This indicates that the device's performance for these criteria was demonstrated to meet existing standards, rather than new studies being conducted specifically for this modification.
Due to the nature of this submission being a device modification to an already approved device and the stated lack of change in acceptance criteria for the branch graft line extension, detailed new studies with specific sample sizes, ground truth establishment, or multi-reader multi-case analyses are not part of this document. The performance is assumed to be in compliance with the established methods for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection - Stains | $\le$ 0.05mm² | Met (Implied by "Pass" for related categories) |
| Visual Inspection - Foreign Matter | $\le$ 0.03mm² | Met (Implied by "Pass" for related categories) |
| Water Permeability | Accept: if $\le$ 4.0 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$Reject: if > 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$Repeat test if > 4.0 and $\le$ 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$If re-test values are all < 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ then batch is acceptable. | Met |
| Burst | > 399.9 lb/inch² | Met |
| Crimp | 12.0 turns/inch - circular | Met |
| Usable Length | Main Graft - 45 ± 5cmHead Branches - 17.5 ± 2.5cmPerfusion Branch - 22.5 ± 2.5cm | Met |
| Inner Diameter | $\le$ 10.0 mm sizes; nominal diameter ± 0.5 mm> 10.0 mm sizes; nominal diameter ± 1.0 mm | Met |
| Visual Inspection - Sewing | No sewing defects | Met (Implied by "Pass" for related categories) |
| Air Permeability | $\le$ 24.5 - 43.5 l/m (depending upon size) | Met |
| Pyrogenicity: Rabbit Pyrogen | Pass | Pass |
| Acute Systemic Toxicity: Acute Systemic Injection | Pass | Pass |
| Irritation: Acute Intracutaneous Reactivity | Pass | Pass |
| Hemocompatibility: Hemolysis | Pass | Pass |
| Cytotoxicity: ISO L929 MEM Elution | Pass | Pass |
| Mutagenicity: Ames Test (Saline extract) | Pass | Pass |
| Subchronic toxicity: 14 day IV injection in rats | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (2 week) | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (12 week) | Pass | Pass |
| Physiochemical | Pass | Pass |
| Shelf Life Testing | Meets Product Specification after aging | Met Product Specification after aging (Implied by "Pass") |
Information Not Applicable to this Submission:
The following information is not provided in the original text as the submission is for a device modification where existing acceptance criteria and methods were used, rather than a new de novo study with specific performance endpoints outlined in these categories. The emphasis is on substantial equivalence to the predicate device, confirming that the modified device continues to meet the established performance and safety characteristics of the existing product line.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document indicates that "All testing was done with standard test methods for these parameters" and that "There is no change to these tests or to their acceptance criteria for the Branch Graft line extension." This suggests that the established test methods for the predicate device were applied, without specifying new sample sizes or data provenance for this specific modification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device for vascular repair, not an image analysis or diagnostic device requiring expert interpretation for ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a medical device for vascular repair.
- 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 a medical device for vascular repair, not an AI or diagnostic device involving human reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device for vascular repair, not an AI or diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical and biological tests, "ground truth" is established by the specified acceptance criteria for each test (e.g., specific dimensions, permeability rates, "Pass" for biocompatibility).
- The sample size for the training set
- Not applicable. This is a medical device for vascular repair, not a machine learning model requiring a training set.
- How the ground truth for the training set was established
- Not applicable. This is a medical device for vascular repair.
{0}------------------------------------------------
OCT - 2 2001
Special 510(k) - Device Modification Hemashield Gold Woven Double Velour Branch Graft August 31, 2001
Section 5
Summary of Substantial Equivalence
previously in this submission, Summary of As shown the Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Modifications Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those Substantial which received previously received 510(k) concurrence: Equivalence Identical indications for use ● Identical labeling ● Identical manufacturing processes . Identical operating principle . Incorporate identical materials . Have the identical shelf-life (5 years) . Are packaged and sterilized using identical packaging materials ● and processes
In summary, the Branch Graft configuration of the Hemashield Gold Woven Double Velour Vascular Graft product line described in this submission are equivalent to the predicate device.
Continued on next page
{1}------------------------------------------------
Summary of Substantial Equivalence, Continued
Summary of Design Control Activities
The design verification tests below are a combination of standard release tests and in-process functional tests conducted on the Hemashield Woven Double Velour Vascular Graft product line. Also included in this list are biocompatibility and shelf life tests conducted on Hemashield Woven Double Velour Vascular Grafts. There is no change to these tests or to their acceptance criteria for the Branch Graft line extension.
| Test Performed | Acceptance Criteria | |
|---|---|---|
| 1 | Visual Inspection -Stains | $\le$ 0.05mm² |
| 2 | Visual Inspection -Foreign Matter | $\le$ 0.03mm² |
| 3 | Water Permeability | Accept: if $\le$ 4.0 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$Reject: if > 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$Repeat test if > 4.0 and $\le$ 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$If re-test values are all < 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ thenbatch is acceptable. |
| 4 | Burst | > 399.9 lb/inch² |
| 5 | Crimp | 12.0 turns/inch - circular |
| 6 | Usable Length | Main Graft - 45 ± 5cmHead Branches - 17.5 ± 2.5cmPerfusion Branch - 22.5 ± 2.5cm |
| 7 | Inner Diameter | $\le$ 10.0 mm sizes; nominal diameter ± 0.5 mm> 10.0 mm sizes; nominal diameter ± 1.0 mm |
| 8 | Visual Inspection -Sewing | No sewing defects |
| 9 | Air Permeability | $\le$ 24.5 - 43.5 l/m (depending upon size) |
| 10 | Pyrogenicity: RabbitPyrogen | Pass |
| 11 | Acute SystemicToxicity: Acute SystemicInjection | Pass |
| 12 | Irritation: AcuteIntracutaneous Reactivity | Pass |
| 13 | Hemocompatibility:Hemolysis | Pass |
| 14 | Cytotoxicity: ISO L929MEM Elution | Pass |
| 15 | Mutagenicity: Ames Test(Saline extract) | Pass |
Continued on next page
{2}------------------------------------------------
Summary of Substantial Equivalence, Continued
| 16 | Subchronic toxicity: 14day IV injection in rats | Pass |
|---|---|---|
| 17 | Implantation: ISOMuscle Implantation withhistopathology (2 week) | Pass |
| 18 | Implantation: ISOMuscle Implantation withhistopathology (12 week) | Pass |
| 19 | Physiochemical | Pass |
| 20 | Shelf Life Testing | Meets Product Specification after aging |
All testing was done with standard test methods for these parameters. All testing was dono with Stanch Granch Graft configuration is substantially All tooling onews and ate device. No new issues of safety or equivalent to the products echaration of conformity with design controls is included in Attachment 3.
| 510(k)Statement | A 510(k) Summary and Certification can be found in Attachment 4. |
|---|---|
| Truthful andAccuracyStatement | A certification of Truthful and Accuracy can be found in Attachment 5. |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body, facing right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Bolton Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K012952
Hemashield Gold Woven Double Velour Vascular Graft-Branch Graft Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular graft prosthesis of 6 millimeters and greater diameter. Regulatory Class: II Product Code: DSY Dated: August 31, 2001 Received: September 4, 2001
Dear Ms. Bolton:
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.
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
OCT - 2 2001
{4}------------------------------------------------
Page 2 - Ms. Jennifer Bolton
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) This letter wification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated. The aclassification 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 11 you desire specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4586. Additionally, for questions on the promotion and advertising of Compliance at (301) 51 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 Oiler general 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,
James E. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications For Use
| 510(k) Number (if known) | Unknown K012952 |
|---|---|
| Device Name: | Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft |
| Indications for Use | The Hemashield Gold ™ Woven Double Velour 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012952
.
§ 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.”