(75 days)
No
The summary describes a physical medical device (vascular graft) and its manufacturing process, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a vascular graft intended for bypass or reconstruction of peripheral arterial blood vessels, which directly treats or alleviates a medical condition.
No
Explanation: The device is described as an ePTFE vascular graft used for bypass or reconstruction of peripheral arterial blood vessels, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical vascular graft made of ePTFE, which is a hardware component. There is no mention of any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Bypass or reconstruction of peripheral arterial blood vessels." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a vascular graft, which is an implantable medical device used to replace or bypass damaged blood vessels.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to diagnose diseases or other conditions. This device does not perform any such testing.
The device is a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
"bypass or reconstruction of peripheral arterial blood vessels".
The Vascutek Cobrahood™ vascular grafts are still intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels".
All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528).
All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts.
The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital operating room by suitably qualified surgeons.
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: For verification purposes, physical testing was undertaken on Cobrahood™ grafts and both predicate grafts, MAXIFLO™ Wrap and Distatio. All samples tested passed the relevant acceptance criteria. Results have demonstrated that the Cobrahood 10 ePTFE vascular grafts are substantially equivalent to the predicate devices.
Clinical Information; No clinical testing has been undertaken on the Cobrahood™ ePTFE vascular grafts, which have been shown to be substantially equivalent to the predicate devices. However, a review of the literature in relation to clinical use of the predicate Distaflo grafts is provided, which has been available commercially in the USA since 1998. It is also demonstrated that clinical use of comparable techniques is an established concept.
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.”
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Image /page/0/Picture/0 description: The image shows the number 5091778 at the top. Below that is the word "VASCUTEK" in a stylized font, with a logo to the left of the word. Underneath that is the word "TERUMO".
VASCUTEK L a TERUMO Company Newmains Avenue Renfrewshire Scotland
Tel: (+44) (0)141 812-5555 Fax: (+44) (0)141 812 7650 www.vascutek.com
510(k) SUMMARY
VASCUTEK COBRAHOOD™ ePTFE VASCULAR GRAFTS
Date prepared: 12th of June 2009
Prepared in accordance with CFR21 Part 807, Sec. 807.92; Content and format of a 510(k) summary.
Page 1 of 3
Common/Usual Name : Prosthesis, vascular graft
Vascutek Cobrahood™ ePTFE vascular grafts Proprietary Name(s) :
Classification Name : Prosthesis, vascular graft, of 6mm and greater diameter
The Food and Drug Administration has classified these devices Classification : as Class II devices under classification 21 CFR 870.3450. Classification, DSY.
Applicant and : 510(k) submitter/ contact -
Karen Kelso Regulatory Affairs Manager Vascutek Ltd. Newmains Avenue Inchinnan Industrial Estate Renfrewshire, Scotland PA4 9RR, United Kingdom
+44 (141) 814 5527 Phone: +44 (141) 814 3431 Fax:
AUG 8 1 2009
1
Device Predicates:
| Predicate Device Names | FDA Clearance Date | Original 510(k) |
|---|---|---|
| Vascutek MAXIFLOTM Wrap Grafts | ||
| ePTFE wrapped ePTFE vascular grafts * | 14th September 2004 | K041528 |
| NOTE: *PTFE external support cleared under K043552 on 5th January 2005 for | ||
| wrapped grafts (K041528) | ||
| IMPRA Inc. Distaflo Bypass Grafts | ||
| ePTFE wrapped ePTFE vascular grafts | ||
| with flared distal end | 24th November 1998 | K983861 |
Device Description:
Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels".
All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528).
All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts.
The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.
Intended Use:
The subject of this 510(k) is to request FDA clearance for the Cobrahood™ ePTFE vascular grafts, which have the following indication for use;
"bypass or reconstruction of peripheral arterial blood vessels".
The Vascutek Cobrahood 10 vascular grafts are still intended for prescription use only.
2
The difference in design of the Vascutek Cobrahood™ vascular grafts, i.e. the presence of the flared outflow is not critical to the intended therapeutic, diagnostic, prosthelic or surgical use of the devices. The difference also does not affect the safety and effectiveness of the device when used as labelled.
Principles of Operation and Technology:
The performance of the Vascutek Cobrahood™ ePTFE vascular grafts remains unchanged. The grafts are still used in surgery in the same manner as standard ePTFE vascular grafts.
Vascutek Cobrahood MePTFE vascular grafts are intended only for use in the hospital operating room by suitably qualified surgeons.
Vascutek Cobrahood M ePTFE vascular grafts are provided sterile by Ethylene Oxide for single use only.
The devices have the same technological characteristics as the predicates i.e. there are no changes to the materials of construction, sterilization, packaging or shelf life.
Performance: The performance of the Vascutek Cobrahood ™ ePTFE vascular grafts remains unchanged. The grafts are still used in surgery in the same manner as standard ePTFE vascular grafts.
Bench Testing: For verification purposes, physical testing was undertaken on Cobrahood™ grafts and both predicate grafts, MAXIFLO™ Wrap and Distatio. All samples tested passed the relevant acceptance criteria. Results have demonstrated that the Cobrahood 10 ePTFE vascular grafts are substantially equivalent to the predicate devices.
Clinical Information; No clinical testing has been undertaken on the Cobrahood™ ePTFE vascular grafts, which have been shown to be substantially equivalent to the predicate devices. However, a review of the literature in relation to clinical use of the predicate Distaflo grafts is provided, which has been available commercially in the USA since 1998. It is also demonstrated that clinical use of comparable techniques is an established concept.
Conclusion: In conclusion, the Vascutek Cobrahood™ ePTFE vascular grafts are substantially equivalent to the predicate devices in commercial distribution and results of non-clinical tests and supporting information from the literature demonstrates that the devices continue to be safe, effective and perform as well as the predicate devices.
Substantial Equivalence:
The Vascutek Cobrahood™ ePTFE vascular grafts are substantially equivalent in overall intended use, design and materials, performance, principles of operation and technology to the predicate devices. This is shown comprehensively in Table 2, Section 10 of this pre-market notification.
There are no other design changes to the Vascutek Cobrahood™ ePTFE vascular grafts other than the presence of the flared graft portion.
Harsh Kothari
Signature
.............................................................................................................................................................................. Date
्र के
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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 3 1 2009
Vascutek Ltd. c/o Dr. Karen Kelso Regulatory Affairs Manager Newmains Avenue Inchinnan Renfrewshire, PA4 9PR Scotland
Re: K091778
Vascutek Cobrahood™ ePTFE Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: June 12, 2009 Received: June 17, 2009
Dear Dr. Kelso:
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.
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.
4
Page 2 - Dr. Karen Kelso
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 (OS) 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/ResourcesforYou/Industry/default.htm
Sincerely yours,
Dana R. Wachner
Image /page/4/Picture/8 description: The image shows a close-up of a handwritten signature or symbol. The lines are dark and bold, creating a flowing, abstract shape. The overall impression is that of a stylized mark, possibly representing initials or a unique identifier.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Vascutek Cobrahood™ cPTFE vascular grafts
Indications For Use:
Bypass or reconstruction of peripheral arterial blood vessels
Prescription Use X (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)
una R. lehner
Page \ of I
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kog) 7 4 g