(259 days)
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Not Found
No
The summary describes a physical vascular graft made of ePTFE and its intended use and performance testing. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is a vascular graft used for arterial vasoreconstruction and arteriovenous shunts, which are therapeutic interventions.
No
This device is a vascular graft, primarily used for arterial vasoreconstruction and as an arteriovenous shunt prosthesis. Its function is to replace or bypass damaged blood vessels, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a tube composed of expanded polytetrafluoroethylene (ePTFE), 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 describes the device as a vascular graft for arterial vasoreconstruction and arteriovenous shunt prostheses. This is a surgical implant used directly within the body to replace or bypass blood vessels.
- Device Description: The device is described as a tube made of ePTFE, designed to be implanted.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of the Jotec FlowLine Bipore ePTFE Vascular Graft does not involve any testing of samples or analysis of biological markers.
Therefore, the Jotec FlowLine Bipore ePTFE Vascular Graft is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstruction - femorofemoral and axillofemoral. Standard wall FlowLine BiporeePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
Product codes
DSY
Device Description
The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular region, femorofemoral, axillofemoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing, as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions demonstrated through mechanical testing and material analysis that the Jotec FlowLine Bipore ePTFE Vascular Graft is substantially equivalent to the predicate devices.
Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FlowLine Bipore ePTFE Vascular Graft and predicate Gore-Tex® and Impra, Inc, ePTFE vascular grafts are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Impra and Gore-Tex® and ePTFE vascular grafts.
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.”
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JAN 2 4 2003
510 (k) Summary
| Submitter: | Jotec GmbH
Lotzenacker 23 Hechingen, Germany 72379
Phone: 49-7471-922-0
Fax: 49-7471-922-100 |
|----------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Ralf Kaufmann |
| Date Summary Prepared: | May 9th, 2002 |
| Trade or Proprietary Name: | Jotec® FlowLine™ Bipore ePTFE Vascular Graft |
| Common or Usual Name: | ePTFE Vascular Graft |
| Classification Name: | Prosthesis, vascular graft of 6 millimeters or greater
diameter |
| Predicates: | Impra and Gore-Tex® and ePTFE vascular grafts. |
Device Description:
The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.
The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.
Non-clinical bench testing, as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions demonstrated through mechanical testing and material analysis that the Jotec FlowLine Bipore ePTFE Vascular Graft is substantially equivalent to the predicate devices.
Statement of Intended Use:
The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstruction - femorofemoral and axillofemoral. Standard wall FlowLine BiporeePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
1
Substantial Equivalence Conclusion:
Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FlowLine Bipore ePTFE Vascular Graft and predicate Gore-Tex® and Impra, Inc, ePTFE vascular grafts are substantially equivalent.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jotec GmbH c/o Mr. Bruce Ruefer Bridger Biomed 2430 N. 7th Avenue, Suite 4 Bozeman, MT 59715
Re: K021547
Jotec GmbH Flowline™ Bipore ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: November 5, 2002 Received: November 6, 2002
Dear Mr. Ruefer:
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. Iisting 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.
3
Page 2 - Mr. Bruce Ruefer
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) 594-4646. 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.qov/cdrh/dsma/dsmamain.html
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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Image /page/4/Picture/0 description: The image shows the text "510(K): K 021547" written in black ink on a white background. The text appears to be handwritten. The "K" in "510(K)" is in parentheses. The number following the second "K" is "021547".
10 Statement of Indication for Use
Indication for Use:
The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral.
Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
ason Devices
510(k) Number: K021547
Prescription Use_X (Per 21 CFR 801.109)