(78 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a vascular graft, with no mention of AI or ML technology.
Yes
The device is a vascular graft intended for bypass or reconstruction of diseased or occluded blood vessels, which serves a therapeutic purpose by restoring blood flow or providing access for medical procedures.
No
The device description indicates it is a vascular graft used for bypass or reconstruction of blood vessels, or for arteriovenous shunts. Its intended use is as a physical prosthesis, not to diagnose a condition or disease.
No
The device description clearly states it is a vascular graft made of expanded PTFE, which is a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "vascular prosthesis" for "bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access." This describes a device that is implanted or used directly within the body to treat a medical condition.
- Device Description: The description details a physical graft made of expanded PTFE, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Edwards Lifespan ePTFE Vascular Grafts are a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Edwards 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 (comma separated list FDA assigned to the subject device)
DSY, DYF
Device Description
The subject devices are vascular grafts 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 grafts have a 4 mm diameter end with a step up to the 7 mm diameter end. All models of the graft have a printed black orientation line consisting of "Edwards Lifesciences" printed repeatedly along the length of the qraft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
In vitro performance testing and biocompatibility evaluations were conducted on the subject devices. Test specific to vascular grafts included burst pressure, suture retention, internodal distance and water entry pressure. Additionally, the printing was checked for legibility at the time of printing and after sterilization and aging. All testing demonstrated that the subject device met its acceptance criteria. No clinical tests specific to the subject device have been conducted. The subject devices are expected to have a risk to benefit ratio similar to the predicate devices.
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
§ 870.3450 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
Food and Drug Administration
510(k) Summary APPENDIX I
510(k) Notification
A. Submitter Information
Daun Putnam, Regulatory Specialist Edwards Lifesciences One Edwards Way Irvine, CA 92614-5686 Phone Number: (949) 250-2217 Fax Number: (949) 250-3579 Email address: daun_putnam@edwards.com
B. Device Information
-
- Trade Name:
Edwards Lifespan Reinforced Expanded PTFE Vascular Graft
- Trade Name:
Edwards Lifespan Reinforced Expanded PTFE Externally Supported Vascular Grafts Edwards Lifespan Reinforced Expanded PTFE Stepped Vascular Graft
-
- Common or Usual Name:
Vascular Graft Prosthesis
- Common or Usual Name:
-
- Device Classification and Classification Name:
Class II (DSY, 21 CFR 870.3460, vascular graft of 6 mm diameter or greater)
- Device Classification and Classification Name:
Class II (DYF, 21 CFR 870.3450, vascular graft of less than 6 mm diameter)
1
-
Predicate Device Identification: 4.
Baxter Reinforced Expanded PTFE Vascular Graft (K933590) Baxter Reinforced Expanded PTFE Stepped Vascular Graft (K944844) Baxter Reinforced Expanded PTFE Externally Supported Vascular Grafts (K944858) -
- Device Description:
The subject devices are vascular grafts 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 grafts have a 4 mm diameter end with a step up to the 7 mm diameter end. All models of the graft have a printed black orientation line consisting of "Edwards Lifesciences" printed repeatedly along the length of the qraft.
- Device Description:
-
- Intended Use:
- The Edwards 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 diseased
2
or occluded blood vessels, where compression or kinking could jeopardize patency.
- Grafts with external monofilament supporting 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 grafts are used for the creation of arteriovenous shunts for . blood access. Stepped configurations may reduce the risk of steal syndrome and high cardiac output.
-
- Technological Comparison of Subject Device to Predicate Device:
The physical characteristics, the intended use and the mode of use of the subject device are very similar to the predicate devices.
-
- Summary of Non-Clinical Tests and Conclusions:
In vitro performance testing and biocompatibility evaluations were conducted on the subject devices. Test specific to vascular grafts included burst pressure, suture retention, internodal distance and water entry pressure. Additionally, the printing was checked for legibility at the time of printing and after sterilization and aging. All testing demonstrated that the subject device met its acceptance criteria.
- Summary of Non-Clinical Tests and Conclusions:
-
- Summary of Clinical Tests and Conclusions:
No clinical tests specific to the subject device have been conducted. The subject devices are expected to have a risk to benefit ratio similar to the predicate devices.
- Summary of Clinical Tests and Conclusions:
3
C. Submitter's Signature and Date of Summary Preparation
Daun S. Putnam only 9/15/56
Daun Putnam Regulatory Specialist
Date
4
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2003
Edwards Lifesciences, LLC. c/o Ms. Daun Putnam One Edwards Way Irvine, CA 92614
Re: K032900
Lifespan Reinforced ePTFE Straight Vascular Graft Regulation Number: 21 CFR 807.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: September 15, 2003 Received: September 17, 2003
Dear Ms. Putnam:
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 indicetions 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, Drig, 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, ilsting 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.
5
Page 2 - Ms. Daun Putnam
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 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ashley B. Bevan
for
Bram D. Zuckenman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K032900
Device Name: Lifespan™ Reinforced ePTFE Vascular grafts
Indications For Use:
The Edwards 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 × (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)
Ashley B. Boone
510(K) Number
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