(90 days)
Not Found
Not Found
No
The summary describes a synthetic vascular graft made of ePTFE and details bench and biocompatibility testing. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of AI/ML technology.
Yes
The device is designed to repair or replace peripheral arteries, which is a therapeutic intervention aimed at restoring physiological function or preventing further deterioration.
No
This device is a vascular graft, which is an implant used for repair or replacement of arteries. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a synthetic vascular graft constructed of expanded polytetrafluoroethylene (ePTFE), which is a physical material, not software. The performance studies also focus on physical properties and testing of the graft material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair or replace peripheral arteries" and "provide vascular access." This describes a surgical implant used directly in the body for treatment or access, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The device is a "synthetic vascular graft constructed of expanded polytetrafluoroethylene (ePTFE)." This is a physical implant, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests outside the body, or providing diagnostic information about a patient's condition.
Therefore, this device falls under the category of a surgical implant or medical device used for treatment and access, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access. Thin Wall Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE). EXXCEL™ Soft ePTFE Vascular Grafts feature a GUIDELINE® stripe to facilitate proper graft alignment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal)
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The device was qualified through the following tests:
- Kink Diameter .
- Longitudinal Tensile Strength .
- Wall Thickness .
- Oblique Suture Retention Strength ●
- Longitudinal Suture Retention Strength .
- Relaxed Internal Diameter .
- Usable Length .
- Water Entry Pressure (WEP) .
- Radial Burst Strength (Burst Pressure) .
- Strength After Repeated Puncture .
- Pressurized Internal Diameter .
- Biocompatibility Testing .
o Cytotoxicity
o Hemolysis
The results of these non-clinical tests met the specified acceptance criteria and were substantially equivalent to the predicate device.
No new safety or performance issues were raised during the testing regimen.
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.
EXXCEL™ Soft ePTFE Vascular Grafts
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
§ 870.3450 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.”
0
JAN 1 7 2012
MAQUET GETINGE GROUP
510(k) Summary (as required by 21 CFR 807.92)
| 510(k) Number: | K113101 |
|---|---|
| Date Prepared: | November 28, 2011 |
| Device Owner: | MAQUET Cardiovascular LLC |
| 45 Barbour Pond Drive | |
| Wayne, New Jersey 07470 | |
| Contact Personnel: | Susan Eichler-Huston |
| Title: | Director, Regulatory Affairs |
| Email: | susan.eichler-huston@maquet.com |
| Phone: | 973-709-7487 |
| Fax: 973-709-6522 | |
| Trade Name: | EXXCEL™ Soft ePTFE Vascular Grafts |
| Device Generic Name: | Vascular Graft Prosthesis |
| Classification: | According to Section 513 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, Performance | |
| Standards. | |
| Predicate Device: | EXXCEL™ Soft ePTFE Vascular Grafts |
| Device Description: | EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vascular |
| grafts constructed of expanded polytetrafluoroethylene | |
| (ePTFE). EXXCEL™ Soft ePTFE Vascular Grafts feature a | |
| GUIDELINE® stripe to facilitate proper graft alignment. | |
| Indications for Use: | Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts are |
| designed to repair or replace peripheral arteries (iliac, femoral, | |
| popliteal, infrageniculate vessels, axillary, renal) and to provide | |
| vascular access. Thin Wall Exxcel™ Soft ePTFE Vascular | |
| Grafts are designed to repair or replace peripheral arteries | |
| (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal). | |
| Technological | |
| Characteristics | The proposed Exxcel Soft ePTFE Vascular Graft and the |
| predicate Exxcel Soft ePTFE Vascular Graft are similar | |
| with respect to the following: | |
| Equivalent finished device characteristicsEquivalent indication for useEquivalent packaging, sterilization and shelf life | |
| The proposed Exxcel Soft ePTFE Vascular Graft and the | |
| predicate Exxcel Soft ePTFE Vascular Graft, are different |
1
with respect to the following:
- The proposed device utilized a PTFE resin . manufactured using a non-PFOA surfactant as a process aid.
This difference is not considered a technological difference and is substantially equivalent to the predicate Exxcel Soft ePTFE Vascular Graft.
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The device was qualified through the following tests:
- Kink Diameter .
- Longitudinal Tensile Strength .
- Wall Thickness .
- Oblique Suture Retention Strength ●
- Longitudinal Suture Retention Strength .
- Relaxed Internal Diameter .
- Usable Length .
- Water Entry Pressure (WEP) .
- Radial Burst Strength (Burst Pressure) .
- Strength After Repeated Puncture .
- Pressurized Internal Diameter .
- Biocompatibility Testing .
- o Cytotoxicity
- o Hemolysis
The results of these non-clinical tests met the specified acceptance criteria and were 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 safety and performance testing, the EXXCEL™ Soft ePTFE Vascular Graft has been shown to be substantially equivalent to the predicate device.
Safety and Performance:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 7 2012
MAQUET Cardiovascular LLC c/o Ms. Susan Eichler-Huston Director, Regulatory Affairs 45 Barbour Pond Drive Wayne. NJ 07470
Re: K113101
:
Trade/Device Name: EXXCEL Soft ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: October 14, 2011 Received: October 19, 2011
Dear Ms. Eichler-Huston:
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.
3
Page 2 – Ms. Susan Eichler-Huston
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K113101 510(k) Number (if known):
Device Name: EXXCEL™ Soft ePTFE Vascular Graft
Indications for Use:
Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access.
Thin Wall Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).
(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
OR
X Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Confidential