(14 days)
The HEMASHIELD Vascular Grafts are 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 Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.
HEMASHIELD Woven Vascular Grafts - Acceptance Criteria and Study Details
The provided document describes the acceptance criteria and study performed to demonstrate substantial equivalence for the HEMASHIELD Woven Vascular Grafts. As this is a 510(k) submission for a predicate device modification, the focus is on non-clinical bench testing rather than clinical trials with human readers or AI algorithms.
1. Acceptance Criteria and Reported Device Performance
The document states that the results of non-clinical tests meet the specified acceptance criteria and are substantially equivalent to the predicate device. However, the exact quantitative acceptance criteria for each test and the reported numerical performance values for the proposed device are not explicitly provided in the given text. The tests performed are listed as:
| Acceptance Criteria (Explicit values not provided) | Reported Device Performance |
|---|---|
| Water Permeability | Met acceptance criteria |
| Longitudinal Tensile Strength | Met acceptance criteria |
| Factory Anastomotic Strength | Met acceptance criteria |
| Burst Strength | Met acceptance criteria |
| Usable Length | Met acceptance criteria |
| Relaxed Internal Diameter | Met acceptance criteria |
| Pressurized Internal Diameter | Met acceptance criteria |
| Wall Thickness | Met acceptance criteria |
| Suture Retention Strength (Suture Pull Out) | Met acceptance criteria |
| Guideline | Met acceptance criteria |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify the exact sample size (number of grafts) used for each of the bench tests.
- Data Provenance: The data is from bench testing conducted by MAQUET Cardiovascular LLC. The context of a 510(k) submission implies this testing was done internally by the manufacturer to support regulatory submission. No country of origin is explicitly stated, but the company address is in Wayne, New Jersey, USA. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device against predetermined criteria.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not Applicable. This study is a non-clinical bench test evaluating physical properties of a vascular graft, not a diagnostic or AI device that requires expert review for ground truth establishment.
4. Adjudication Method for Test Set
- Not Applicable. As this is a non-clinical bench test, there is no need for expert adjudication of results. Each test would have objective measurement outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not performed. This type of study is relevant for diagnostic devices involving human readers and potentially AI assistance, which is not the nature of this vascular graft evaluation.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an AI algorithm or software-only device. The evaluation focuses on the physical properties of a medical implant.
7. Type of Ground Truth Used
- The "ground truth" for the bench tests would be the objective measurements obtained from established testing standards and methodologies (e.g., ISO or ASTM standards, or equivalent internal validated methods). The results of these measurements were then compared against predetermined acceptance criteria, likely derived from the predicate device's performance or relevant standards.
8. Sample Size for Training Set
- Not Applicable. This is a non-clinical bench test, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
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K122612 Page 1 of 2 GETINGE GROUP
SEP 1 0 2012
510(k) Summary (as required by 21 CFR 807.92)
510(k) Number:
Date Prepared:
Device Owner:
Contact Personnel: Title: Email: Phone:
Trade Name:
Device Generic Name:
Classification:
Predicate Device:
Device Description:
Indications for Use:
Technological Characteristics Unknown
August 23, 2012
MAQUET Cardiovascular LLC 45 Barbour Pond Drive Wayne, New Jersey 07470
Marylou Insinga Regulatory Affairs Specialist II marylou.insinga@maquet.com Fax: 973-807-1658 973-709-7442
HEMASHIELD Woven Vascular Grafts
Vascular Graft Prosthesis
According to Section 513 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards.
HEMASHIELD Woven Vascular Grafts
The HEMASHIELD Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.
The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prostheses are also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
The proposed HEMASHIELD Vascular Grafts and the predicate HEMASHIELD Vascular Grafts are similar with respect to the following:
- Identical materials and finished device characteristics �
- Identical indication for use 0
- Identical packaging, sterilization and shelf life 0
{1}------------------------------------------------
The proposed HEMASHIELD Vascular Grafts and the predicate HEMASHIELD Vascular Grafts are different with respect to the following:
- An alternate method for the collagen coating process was o used in manufacturing the proposed devices.
This difference is not considered a technological difference and is substantially equivalent to the predicate HEMASHIELD Vascular Grafts.
Bench testing was performed to support a determination of substantial equivalence. The device was qualified through the following tests:
- o Water Permeability
- Longitudinal Tensile Strength 0
- Factory Anastomotic Strength o
- Burst Strength o
- Usable Length 0
- Relaxed Internal Diameter 0
- o Pressurized Internal Diameter
- o Wall Thickness
- o Suture Retention Strength (Suture Pull Out)
- 0 Guideline
The results of these non-clinical tests meet the specified acceptance criteria and are substantially equivalent to the predicate device.
No new safety or performance issues were raised during the testing regimen.
Conclusion:
Based on the Indication for Use; technological characteristics and performance testing, the HEMASHIELD Vascular Grafts have been shown to be substantially equivalent to the predicate device.
Safety and Performance:
00 7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
10 2012
Maquet Cardiovascular, LLC % Marylou Insinga 45 Barbour Pond Dr. Wayne, NJ 07470
Re: K122612
Trade/Device Name: Hemashield Woven Double Velour Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: MAL Dated: August 23, 2012 Received: August 27, 2012
Dear Marylou Insinga:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Marylou Insinga
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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HEMASHIELD Vascular Grafts 510(k)
August 2012
Indications for Use
510(k) Number (if known): K122612
Device Name: HEMASHIELD Vascular Grafts
Indications For Use:
The HEMASHIELD Vascular Grafts are 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 × (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122612
§ 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.”