Gelweave "M branched vascular graffs: "Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation". Sicua TM grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation". "Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".

Device Description

The design and all other properties of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remain unchanged. The Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers function as vascular grafts manufactured from standard polyester and gelatin sealant technologies.

AI/ML Overview

The provided document describes the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers. This submission (K090987) is for an expanded indication for use of existing devices, not a new device. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the expanded indication does not compromise the safety and effectiveness of the unchanged device.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an expanded indication for an existing device with no changes in design, materials, or manufacturing, the acceptance criteria are not in terms of specific performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria revolve around demonstrating that the device's fundamental performance characteristics (sealing properties) are maintained even with procedures related to the expanded indication.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Maintenance of Sealing Properties	The insertion and manipulation of an endovascular delivery catheter through a side branch of the graft should not alter the sealing properties of the graft or cause structural damage leading to blood leakage. This is within the context of forces and procedures that exceed those expected in an operating room.	For verification, a 26 F introducer was inserted into the 10mm side branch of 21 Gelweave grafts. The introducer and side branch were tied to allow back and forth movement. The graft was then pressurized with citrated horse blood to 120 mm/Hg. During pressurization, the delivery catheter was deliberately pushed into the main body of the Gelweave graft (i.e., forced onto the graft body wall) 10 times over a 2-minute period. This force and number of manipulations far exceeded what a surgeon would use in the operating room. Any blood lost was collected and weighed. Results showed that the insertion of the delivery catheter under these exaggerated conditions did not alter the sealing properties of the graft (i.e., did not cause damage resulting in blood leakage).
Clinical Equivalence to Predicates	The use of the device for debranching and hybrid procedures, as an expanded indication, should be considered standard clinical practice and not introduce new safety or effectiveness concerns compared to existing practices and predicate devices.	A comprehensive review of the literature regarding the clinical use of standard branched polyester vascular grafts for debranching and associated hybrid procedures was provided. The document states that these procedures are considered standard clinical practice and an alternative treatment option for aortic repair, especially for high-risk patients who cannot tolerate conventional open surgical repair. The submission argues that the expanded indication does not change the overall intended use or affect the safety and effectiveness of the device when used as labelled.
No Material/Design Changes	There should be no changes to the design, materials, packaging, sterilization, shelf life, or any other parameters of the device itself.	The submission explicitly states: "There are no other changes to the products i.e. there are no changes to the design, materials, packaging, sterilisation, shelf life or any other parameters. The only change is a request for an expanded indication for use." And "These devices have the same technological characteristics as the predicates i.e. there are no changes to the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers other than the request for an expanded indication."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 21 Gelweave grafts were used for the bench testing.
Data Provenance: The bench testing was conducted by Vascutek Ltd. (Scotland, United Kingdom). The clinical information provided was a "comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts," implying retrospective data from published studies and clinical opinions globally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated as a defined number of individual experts for establishing a ground truth. Instead, the submission relies on "clinical opinion" and "available literature" for the clinical context of the expanded indications.
Qualifications of Experts: Not specified. It refers to "clinical opinion" generally, implying established consensus within the surgical community regarding debranching and hybrid procedures.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the context of this submission. The bench testing involved objective measurement of blood leakage, not a qualitative assessment requiring adjudication. The clinical justification relied on a literature review, not individual case adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This submission focuses on expanding the indications for an existing physical device, not on the performance of a diagnostic algorithm or a device requiring human reader interpretation.

6. If a Standalone Study Was Done

Yes, a standalone bench test was done to assess the physical integrity and sealing properties of the device under conditions related to the expanded indication. This test measured blood leakage after mechanical manipulation of a delivery catheter through the graft's side branch.
The clinical justification was a standalone literature review, not a clinical study involving human subjects for this specific submission.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was quantifiable physical measurement (weight of blood lost) to determine if the graft's sealing properties were maintained.
For the clinical justification, the "ground truth" was established by expert consensus and outcomes data as reflected in the "available literature and clinical opinion" regarding the standard practice of debranching and hybrid procedures with similar grafts.

8. The Sample Size for the Training Set

Not applicable. This submission is for an expanded indication of an existing physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI/ML algorithm submission.

Summary

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K090987
VASQUTEK

PERUNO

JUN 19 2009

VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan Renfrewshire, PA4 9RR Scotland

Tel: {+44) (0)141 812 5555 Fax: (+44) (0)141 812 7650 www.vascutek.com

510(k) SUMMARY

VASCUTEK GELWEAVE™ BRANCHED VASCULAR GRAFTS (K952293) AND GELWEAVE SIENA " VASCULAR GRAFTS WITH (K060142) AND WITHOUT (K040829) RADIOPAQUE MARKERS

Date prepared: 2nd of June 2009

Prepared in accordance with CFR21 Part 807, Sec. 807.92: Content and format of a 510(k) summary.

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Prosthesis, vascular graft Common/Usual Name :

Proprietary Name(s) : Vascutek Gelweave 10 branched vascular grafts and Gelweave Siena M vascular grafts with and without radiopaque markers

Prosthesis, vascular graft, of 6mm and greater diameter Classification Name :

Classification :

The Food and Drug Administration has classified these devices 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

Phone: +44 (141) 814 5527 Fax: +44 (141) 814 3431

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Device Predicates:

Predicate Device Name	FDA Clearance Date	510(k)
Gelweave™ grafts	19th December 1995	K952293
Gelweave Siena™ grafts withoutradioopaque markers	20th May 2004	K040829
Gelweave Siena™ grafts with radiopaquemarkers	6th February 2006	K060142

NOTE: Gelweave Branched Grafts - Documentation submitted to Dorothy Abel, FDA, dated 21° November 2001, regarding Vascutek's decision not to submit a 510k for branched Gelweave grafts. This decision ultilised FDA Guidance document (K97-1) "Deciding when to submit a 510k for an existing device".

Device Description:

Additional images and information are provided in the catalogue number table presented in Table 3 of this 510(k) submission.

Vascutek Gelweave™ vascular grafts were cleared by FDA on the 19th of December 1995 (K952293). The cleared indications for use were "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation".

The branched versions of the Gelweave™ vascular grafts were later made available to also accommodate reconstruction of the associated side vessels and allow intra-operative attachment to cardiopulmonary bypass. This is information clearly detailed in the product Instructions for Use.

In 2004 Vascutek received 510(k) clearance for the Siena™ grafts without radiopaque markers, followed by Siena™ grafts with radiopaque markers in 2006. The intention of the radiopaque markers was to aid in vivo visualisation. The branches present on the Gelweave grafts, like all other Gelweave™ branched grafts was to accommodate Siena™M reconstruction of the associated branch vessels and also intra-operative aftachment to cardiopulmonary bypass. The cleared indications for use were; "Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarchation". This is clearly detailed in the 510(k) cleared product Instructions for Use.

As stated, the presence of side branches allows accommodation of aortic side vessel reconstruction as well as the ability to attach the patient to cardiopulmonary bypass. It is evident from the available literature and clinical opinion that it is also considered standard practice to use branched polyester vascular grafts to undertake debranching and associated Hybrid procedures. These procedures allow reconstruction of the aortic side vessels at the same time as repair of the aortic aneurysm by using standard polyester vascular grafts in combination with endovascular devices, usually in a single procedure.

Vascutek are therefore requesting FDA clearance to make reference to debranching and vasociated Hybrid procedures for the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena " yascular grafts with and without radiopague markers in the product labelling, specifically the indications for use, product Instructions for Use and associated marketing literature.

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There are no other changes to the products i.e. there are no changes to the design, materials, packaging, sterilisation, shelf life or any other parameters. The only change is a request for an expanded indication for use. The grafts remain as finished products, provided sterile for single use only.

Intended Use:

The intended use for the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers is currently;

Gelweave " branched vascular grafts:

"Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation".

Gelweave Siena™ vascular grafts with and without radiopaque markers:

"Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation".

The subject of this 510(k) is to request FDA clearance to expand this intended use as follows:

"Gelweave" branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".

Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.

As stated, it is evident from the literature and clinical opinion that it is considered standard practice to use branched polyester vascular grafts to undertake debranching and associated Hybrid procedures. These procedures do not change the overall intended use of the grafts, which are still used in open heart surgery to repair or replace a diseased and damaged aorta and associated vessels.

The difference is therefore not critical to the intended therapeutic, diagnostic, prosthetic 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:

Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers are used to repair or replace a diseased and damaged in aorta and associated vessels.

Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers are intended only for use in the hospital operating room by suitably qualified surgeons.

Vascutek Gelweave™ pranched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers provided sterile by ethylene oxide for single use only.

There devices have the same technological characteristics as the predicates i.e. there are no
changes to the Vascutek Gelweave" branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers other than the request for an expanded indication.

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Performance: The performance of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remains unchanged. The grafts are still used in open heart surgery to repair or replace a diseased and damaged aorta and associated vessels.

Bench Testing: For verification purposes testing was undertaken to demonstrate that there was no change in the sealing properties of the Gelweave™ branched vascular grafts as a result of introduction and manipulation of an endovascular delivery catheter via a side branch. A 26 F introducer was inserted into the 10mm side branch of 21 Gelweave grafts. The introducer and side branch were tied to allow movement back and forth within the side branch. After this process, the graft was pressurised with the citrated horse blood to 120 mm/Hg. During this pressurisation process, the delivery catheter was deliberately pushed into the main body of the Gelweave graft, i.e. it was forced onto the graft body wall. The force used to push the delivery catheter into the graft wall far exceeded that which a surgeon would use in the operating room. The delivery catheter was pushed onto the graft body wall 10 times over a 2 minute period. This is again in excess of what would be undertaken in the operating room during this procedure. Any blood lost from the graft due to this manual action of the delivery catheter was collected on a pre-weighed absorbent tissue. This was reweighed after the test and the total weight of blood lost from the graft calculated. The results have shown that the insertion of a 26 F endovascular delivery catheter through a 10mm side branch of a standard Gelweave graft does not alter the sealing properties of the ronft i.e. does not cause damage to the structure of the graft, which would result in blood leakage.

Clinical Information: No clinical testing has been undertaken, however a comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts in relation to performance of debranching and associated hybrid procedures is provided. These procedures are considered standard clinical practice in light of current endovascular procedures and allow surgeons to undertake repair of aortic vessels and aneurysm in either a single or two-stage procedure.

Debranching and hybrid procedures are considered an alternative treatment in the light of current endovascular procedures as they allow the surgeon to undertake repair of aortic vessels and aortic aneurysms in a less invasive approach; the gold standard of aortic arch aneurysm and thoracoabdominal aneurysm, still remains conventional open surgical repair. Since open surgical repair is a rather invasive approach and the surgical insult is often intolerable for high risk elderly patients, other alternative treatments options have emerged. As discussed, these new treatment options include hybrid procedures and also branched endovascular stent grafts.

Gonclusion: In conclusion, the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopague markers 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:

Substantial Lquivalence: " branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers are substantially equivalent in overall intended use, design and materials, performance, principles of operation and technology to the predicate This is shown comprehensively in Table 2, Section 10 of this pre-market devices. notification.

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There are no changes to the Vascutek Gelweave™ branched vascular grafts and Gelweave There and the one of a crown of thout radiopaque markers other than the request for an
expanded indication.

Karai Leto

Signature

.............................................................................................................................................................................. Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a double helix-like design.

Public Health Service

JUN 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascutek, Ltd. c/o Ms. Karen Kelso Regulatory Affairs Manager Newmains Avenue Inchinnan Industrial Estate Renfrewshire, Scotland PA4 9RR, United Kingdom

Rc: K090987

Trade Nmae: Vascutek Gelweave™ branched vascular grafts and

Gelweave SienaTM vascular grafts with and without radiopaque markers Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: June 2, 2009

Received: June 9, 2009

Dear Ms. 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.

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Page 2 - Ms. 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 (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to -http://www.fda.gov/cdrh/mdr/. _______________________________________________________________________________________________________________________________________________

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 (240) 276-3150 or at its Internet addresshttp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dmina R. Vachner

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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Indications for Use

510(k) Number (if known):

K. 09.0987

Device Name:

Gelweave™ Branched Vascular Grafts Vascutek including Gelweave Siena™ Vascular Grafts with and without Radioapaque Markers

Indications For Use:

Gelweave "M branched vascular graffs:

"Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation".

Sicua TM grafts vascular with and without Gelweave radiopaque markers:

"Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation".

"Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".

Prescription Use (Part 21 CFR 80L 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)

地边流!

Donna R. Richter
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K09

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Regulation Number and Section

§ 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.”