(35 days)
Not Found
No
The summary describes a physical vascular graft and a change to the ink used for printing on it. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vascular graft, which is used to bypass or reconstruct diseased or occluded blood vessels, directly addressing a health issue.
No
Explanation: The device is a vascular graft, which is a prosthetic device used for the reconstruction or bypass of blood vessels. It is not designed to diagnose diseases or conditions.
No
The device is a physical vascular graft made of expanded PTFE, not software. The 510(k) is for a change in the ink used for printing on the graft.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "vascular prosthesis" for bypass or reconstruction of blood vessels and arteriovenous shunts. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implant made of PTFE, not a reagent, instrument, or system intended for in vitro use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used directly within the body for structural support and blood flow.
N/A
Intended Use / Indications for Use
The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
Product codes
DSY
Device Description
LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped and tapered grafts have a small diameter end and a large diameter end. All models of the graft have a printed black orientation line consisting of "LeMaitre LifeSpan" printed repeatedly along the length of the graft. This 510k is to add an alternative ink for the printing the orientation line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diseased or occluded blood vessels
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)
Biocompatibility test was performed for the alternative new ink. The biocompatibility of the device was tested per ISO10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K933590, K944844, K944858, K032900
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1130016
SECTION 5: 510(K) Summary
・
FEB 0 5 2013
| Submitter: | LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA 01803 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Xiang Zhang
Director of Regulatory Affairs
Phone: 781-425-1729
Fax: 781-425-5049
Email: xzhang@lemaitre.com |
| Date Prepared: | January 2, 2013 |
| Trade Name: | LifeSpan ePTFE Vascular Graft |
| Common Name: | Vascular graft prosthesis |
| Classification Name: | Prosthesis, Vascular Graft |
| Predicate Devices: | Baxter reinforced expanded PTFE vascular graft
(K933590); Baxter reinforced expanded PTFE stepped
vascular graft (K944844); Baxter ePTFE externally
supported vascular grafts (K944858); LifeSpan reinforced
ePTFE straight, externally supported, stepped vascular
grafts (K032900) |
| Device Description: | LifeSpan Vascular Grafts are consisting of a base tube of
expanded PTFE that is wrapped with PTFE tape for
better strength. Externally supported grafts have a
monofilament of PTFE wrapped over the tape for added
crush and kink resistance. The stepped and tapered grafts
have a small diameter end and a large diameter end.
All models of the graft have a printed black orientation
line consisting of "LeMaitre LifeSpan" printed repeatedly
along the length of the graft. This 510k is to add an
alternative ink for the printing the orientation line. |
1
• The LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access. The physician must evaluate each alternative method of treatment, discuss the risks and benefits with each patient, and decide whether to use a prosthetic vascular graft based upon all available factors.
· Grafts with removable external monofilament support over the length of the graft are used in bypass or reconstruction of occluded or diseased vessels, where compression or kinking could jeopardize patency.
· Grafts with external monofilament support in the middle of the graft may be used for the creation of an arteriovenous shunt for blood access; however, the graft must not be cannulated in the area of the external monofilament support.
· Stepped and tapered grafts are used for the creation of arteriovenous shunts for blood access. Stepped and tapered configurations may reduce the risk of steal syndrome and high cardiac output.
LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped and tapered grafts have a small diameter end and a large diameter end.
Biocompatibility test was performed for the alternative new ink.
The biocompatibility of the device was tested per ISO10993-1.
LeMaitre Vascular has demonstrated that the LifeSpan ePTFE Vascular Graft printed with the new ink is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology.
Technological Characteristics:
Summary of
Summary of Product Testing:
Summary of Pre-clinical Study:
Conclusion:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 0 5 2013
LeMaitre Vascular, Inc. C/O Xiang Zhang, Director of Regulatory Affairs 62 Second Avenue Burlington, MA 01803
Re: K130016
Trade/Device Name: LifeSpan ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: January 2, 2013 Received: January 3, 2013
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 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.
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
3
Page 2 - Mr. Xiang Zhang
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,
Matthew G. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LifeSpan ePTFE Vascular Graft
Indications for Use:
The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
Prescription Use X
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)
izhill
vision of Cardiovascular Devices
Lisoolb 510(k) Number