(73 days)
Not Found
No
The summary describes a vascular graft made of standard materials and does not mention any computational or analytical functions that would suggest the use of AI/ML. The performance studies are bench tests focused on the physical properties of the graft.
Yes
The device is a vascular graft used for the "Repair or replacement of damaged and diseased vessels," which is a therapeutic intervention.
No
Explanation: The device is a vascular graft used for the repair or replacement of damaged or diseased blood vessels. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a vascular graft manufactured from polyester and gelatin, which are physical materials, not software. The performance studies also describe bench testing on the physical graft.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta". This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is described as a "vascular graft manufactured from standard polyester and gelatin sealant technologies". This is a medical implant, not a diagnostic reagent or instrument used for testing.
- Anatomical Site: The device is used in the "abdomen and thoracic aorta", which are internal anatomical sites.
- Intended User / Care Setting: The device is used in a "hospital operating room by suitably qualified surgeons", indicating a surgical intervention setting.
- Performance Studies: The performance studies described are "Bench Testing" related to the physical properties and sealing of the graft, and a "comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts". These studies focus on the device's function as a vascular implant, not its ability to diagnose a condition.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to repair blood vessels.
N/A
Intended Use / Indications for Use
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". Siena™ grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation". "Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".
Product codes (comma separated list FDA assigned to the subject device)
DSY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and thoracic aorta
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 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.
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
K090987
VASQUTEK
PERUNO
JUN 19 2009
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.
Page 1 of 5
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
1
Device Predicates:
| Predicate Device Name | FDA Clearance Date | 510(k) |
|---|---|---|
| Gelweave™ grafts | 19th December 1995 | K952293 |
| Gelweave Siena™ grafts without | ||
| radioopaque markers | 20th May 2004 | K040829 |
| Gelweave Siena™ grafts with radiopaque | ||
| markers | 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:
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.
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.
2
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.
3
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.
4
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
5
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.
6
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
7
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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