(91 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a knitted polyester vascular patch, with no mention of AI or ML.
Yes
The device is a vascular patch indicated for grafting, which is a therapeutic intervention to repair or replace damaged tissue within the body.
No
The 'Intended Use' section states the device is "indicated for cardiac and vascular patch grafting," which is a treatment or repair function, not a diagnostic one. The performance studies also focus on physical properties relevant to a medical implant rather than diagnostic accuracy.
No
The device description clearly states it is a knitted polyester fabric, which is a physical material, 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 "cardiac and vascular patch grafting." This describes a surgical implant used in vivo (within the body) to repair or replace tissue.
- Device Description: The description details a "knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent." This is a material designed to be surgically implanted.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens outside the body.
Therefore, the AlboSure Polyester Vascular Patch is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Following tests have been performed: Tensile Strength, Burst Strength, Wall Thickness, Suture Retention Strength, Water Permeability. The biocompatibility of the device was tested per ISO10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
K101740
SECTION 5: 510(K) Summary
| Submitter: | LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA 01803
SEP 20 2010 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vic Zhang
Regulatory Affairs Specialist
Phone: 781-221-2266 x162
Fax: 781-425-5049
Email: xzhang@lemaitre.com |
| Date Prepared: | June 18, 2010 |
| Trade Name: | AlboSure™ Cardiovascular Patch |
| Common Name: | Cardiovascular Patch |
| Classification Name: | Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene |
| Predicate Device: | Hemashield Finesse Knitted Cardiovascular Patch (K962342) |
| Device Description: | AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent. |
| Intended Use: | The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. |
| Summary of Technological Characteristics: | AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent. |
| Summary of Product Testing: | Following tests have been performed:
Tensile Strength, Burst Strength, Wall Thickness, Suture Retention Strength, Water Permeability. |
| Summary of Pre-clinical Study: | The biocompatibility of the device was tested per ISO10993-1. |
| Conclusion: | LeMaitre Vascular has demonstrated that the AlboSure Polyester Vascular Patch is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology. |
.
.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LeMaitre Vascular, Inc. c/o Mr. Vic Zhang Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803
SEP 2 0 2010
Re: K101740
Trade/Device Name: AlboSure™ Polyester Vascular Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II Product Code: DXZ Dated: June 18, 2010 Received: June 21, 2010
Dear Mr. Zhang:
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 I varial 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 If your device 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.
2
Page 2 - Mr. Vic Zhang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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,
ram D. Zugkerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number (if known): _
101740
Device Name: AlboSure™ Polyester Vascular Patch
SEP 2 0 2010
Indications for Use:
The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Prescription Use______________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Siam Off) Division of Cardiovasculo 510(k) Number