(282 days)
Not Found
No
The summary describes a physical vascular prosthesis made of knitted polyester and sealed with gelatin. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on physical and biocompatibility testing, not algorithmic performance.
Yes
The device is indicated for replacement or bypass in aneurysmal and occlusive disease of arteries, which are conditions that require therapeutic intervention to restore normal function or mitigate disease progression.
No
Explanation: The device, a vascular prosthesis, is indicated for replacement or bypass of diseased arteries, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "gelatin sealed knitted polyester prostheses," indicating it is a physical hardware 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 that the devices are for "replacement or bypass of abdominal arteries" and "abdominal and peripheral vascular repair." This describes a surgical implant used directly within the body to treat a disease.
- Device Description: The description confirms they are "gelatin sealed knitted polyester prostheses, designed for vascular repair." This further reinforces their nature as implantable medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Gelseal, Gelsoft, and Gelsoft Plus Vascular Prostheses are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Gelseal™ Vascular Grafts: "Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease."
Gelsoft™ Vascular Grafts: "Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries."
Gelsoft™ Plus Vascular Grafts: "Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries."
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
Gelseal. Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, designed for vascular repair.
The Vascutek Gelseal, Gelsoft and Gelsoft Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal arteries, abdominal and peripheral vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The nonclinical testing performed, including physical and biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent 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.
P890045, P890045/S001, K990503, K955230
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Vascutek Ltd. Mr. Neil McLachlan Head of Regulatory Affairs Newmains Avenue Inchinnan Renfrewshire, PA4 9RR United Kingdom
Re: K162803
Trade/Device Name: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: June 15, 2017 Received: June 16, 2017
Dear Mr. Neil McLachlan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162803
Device Name Gelseal™ Vascular Grafts
Indications for Use (Describe)
Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K162803
Device Name Gelsoft™ Vascular Grafts
Indications for Use (Describe)
Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K162803
Device Name Gelsoft™ Plus Vascular Grafts
Indications for Use (Describe)
Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510 (k) Summary
This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.
| Submitter: | Vascutek Ltd
Newmains Avenue
Inchinnan
Renfrewshire
PA4 9RR
Scotland, UK |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| | Tel: +44 (0) 141 812 5555 |
| Contact: | Neil McLachlan
Head of Regulatory Affairs
Tel: +44 (0) 141 812 5555
Email: N.McLachlan@vascutek.com |
| Date of Preparation: | 04 July 2017 |
| Trade Name: | Vascutek Gelseal™ Vascular Grafts
Vascutek Gelsoft™ Vascular Grafts
Vascutek Gelsoft™ Plus Vascular Grafts |
| Common or Usual Name: | Vascular Prosthesis |
| Classification Name: | Vascular Graft Prosthesis |
| Product Code: | DSY |
| Regulation Number: | 21 CFR 870.3450 |
| Device Class: | II |
6
ldentification of the legally marketed device to which equivalence is being
claimed: Vascutek Ltd. are claiming equivalence to the following legally marketed devices:
- . Gelseal™ Vascular Graft (P890045)
- Gelsoft™ Vascular Prosthesis (Abdominal Repair Indication) (P890045/S001)
- Gelsoft™ Vascular Prosthesis (Peripheral Repair Indication) (K990503) ●
- Gelsoft™ Plus Vascular Graft (K955230) .
Device Description
Gelseal. Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, designed for vascular repair.
The Vascutek Gelseal, Gelsoft and Gelsoft Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.
Indications for Use
The indications for use for each model are identical to each predicate and are described below:
Gelseal™ Vascular Prostheses: "Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease."
Gelsoft™ Vascular Prostheses: "Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries."
Gelsoft™ Plus Vascular Prostheses: "Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries."
Technological Characteristics
Equivalency is based on identical design, technology, construction and intended use,
The only change is that the gelatin used to seal the grafts will be purchased from a new supplier.
The nonclinical testing performed, including physical and biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent the predicate devices.