(269 days)
Not Found
No
The device description focuses on the material composition and physical structure of vascular grafts, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests evaluating physical properties.
Yes
The device is a vascular graft, which is implanted to repair or replace peripheral arteries or for arteriovenous vascular access, directly treating a medical condition (peripheral vascular disease and end-stage renal disease).
No
The device description indicates that Advanta VXT and Flixene vascular grafts are used to repair or replace peripheral arteries or for arteriovenous vascular access. These are interventional procedures, not diagnostic ones.
No
The device description clearly states it is made of expanded polytetrafluoroethylene (ePTFE) and includes physical components like rings, a deployment system, and a sheath, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical repair or replacement of peripheral arteries and the creation of arteriovenous vascular access for dialysis. This is 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 blood vessels.
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
This device is clearly an implantable surgical device, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
Product codes (comma separated list FDA assigned to the subject device)
DSY, DYF
Device Description
Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:
- . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
- . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
- . Tapered end
- . Thin or standard wall thickness
The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arteries
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Surgical Suite
They are intended to be implanted by surgeons trained in the theoretical, technical and clinical aspects of vascular reconstruction, bypass and creation of arteriovenous vascular access. Other potential users include dialysis-related nursing staff and clinicians trained in generic vascular access 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)
Non-clinical bench testing was performed including: Visual Appearance, Water Entry Pressure, Relaxed Internal Diameter, Dynamic Compliance, Pressurized Internal Diameter, Kink Resistance, Wall Thickness, Graft Deployment System Pull Strength, Useable Length, Helix Peel Strength (Advanta VXT only), Graft Surface Architecture, Wrap Properties, Suture Retention Strength, Material Composition and Construction, Radial Tensile Strength, Modification of Length and/or End, Longitudinal Tensile Strength, Print Legibility, Strength after Repeated Puncture, Shelf-life Validation.
Other Non-Clinical Testing included: Sterility Validation, MR Compatibility, Packaging Validation, Biocompatibility Evaluation, Chemical Characterization Analytical Testing, Toxicological Risk Assessment.
There were no clinical studies of the modified device.
The design verification and validation testing established that the Advanta VXT and Flixene Vascular Grafts are substantially equivalent to 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.
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
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March 28, 2024
Atrium Medical Corporation Hannah Scribner Regulatory Affairs Specialist II 40 Continental Blvd. Merrimack, New Hampshire 03054
Re: K231972
Trade/Device Name: Advanta VXT Vascular Graft, Flixene Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY Dated: February 27, 2024 Received: February 28, 2024
Dear Hannah Scribner:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carmen G. Johnson -S
Carmen Gacchina Johnson, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231972/S001
Device Name
Advanta VXT Vascular Graft, Flixene Vascular Graft
Indications for Use (Describe)
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
GETINGE
Atrium Medical Corporation Premarket Notification Traditional 510(k) Advanta VXT Vascular Graft Flixene Vascular Graft
Advanta VXT and Flixene Vascular Grafts 510(k) summary prepared in accordance with 21 CFR part 807.92.
General Information
| Submitter's Name and Address | Atrium Medical Corporation
40 Continental Drive
Merrimack, NH 03054 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 3011175548 |
| Contact Person | Hannah Scribner
Regulatory Affairs Specialist II
Tel: (603) 864-5209
Fax: (973) 629-1325
email: Hannah.scribner@getinge.com |
| Date Prepared | July 5, 2023 |
| Device Information | |
| Trade Name(s) | Advanta VXT Vascular Grafts
Flixene Vascular Grafts |
| Common/Generic Name(s) | Vascular Graft |
| Classification Name | Advanta VXT:
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Flixene:
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Regulation Number | 21 CFR 870.3450 |
| Product Codes | Advanta VXT:
DSY (Prosthesis, Vascular Graft, of 6MM and Greater
Diameter)
DYF (Prosthesis, Vascular Graft, of less than 6MM
Diameter)
Flixene:
DSY (Prosthesis, Vascular Graft, of 6MM and Greater
Diameter) |
| Device Class | The Advanta VXT and Flixene Vascular Grafts are classified
as Class II devices according to 21 CFR 870.3450 |
5
Atrium Medical Corporation Premarket Notification Traditional 510(k) Advanta VXT Vascular Graft Flixene Vascular Graft
Predicate Device Information:
The predicate devices are Atrium Medical Corporation's, Advanta VXT Vascular Graft (K992960: October 01, 1999). Advanta VXT Vascular Graft (K992958: October 01, 1999) and Flixene Vascular Grafts (K071923: August 14, 2007).
Advanta VXT is represented by two (2) predicate 510(k)'s in this submission as K992958 (Product Code: DYF) is specific to grafts 6mm in diameter or less and K992960 (Product Code: DSY) is specific to grafts 6mm in diameter or greater.
The Advanta VXT and Flixene Vascular Grafts, subject of this submission, are substantially equivalent in function and intended use as the predicate devices.
Subject Device Description:
Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:
- . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
- . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
- . Tapered end
- . Thin or standard wall thickness
The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on
6
Atrium Medical Corporation Premarket Notification Traditional 510(k) Advanta VXT Vascular Graft Flixene Vascular Graft
surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.
Subject Device Intended Use:
Advanta VXT and Flixene vascular grafts are intended for use in the replacement or repair of peripheral arteries, and for use as an arteriovenous shunt for vascular access.
Subject Device Indication for Use:
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
Intended Use Environment, User/Operator, Patient population, and Intended Use
The following elements are substantially equivalent between the predicate and subject devices.
| | Predicate Devices
Advanta VXT (K992960 and K992958)
Flixene (K071923) | Subject Devices
Advanta VXT
Flixene |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use
Environment | Surgical Suite | Same as Predicate |
| Intended User/Operator | They are intended to be implanted by surgeons
trained in the theoretical, technical and clinical
aspects of vascular reconstruction, bypass and
creation of arteriovenous vascular access.
Other potential users include dialysis-related
nursing staff and clinicians trained in generic
vascular access use. | Same as Predicate |
| Intended Patient
Population | Advanta VXT and Flixene vascular grafts are
intended for use in adult patients. | Same as Predicate |
| Intended Use | Advanta VXT and Flixene vascular grafts are
intended for use in the replacement or repair of
peripheral arteries, and for use as an
arteriovenous shunt for vascular access. | Same as Predicate |
Intended Use Environment, User/Operator, Patient population, and Intended Use Table 1
7
GETI
Atrium Medical Corporation Premarket Notification Traditional 510(k) Advanta VXT Vascular Graft Flixene Vascular Graft
Image /page/7/Picture/2 description: The image shows a close-up of a medical device, possibly a catheter or similar instrument. The device has a white, flexible tube with dashed lines along its length, and the word "atrium" is printed on the tube. The tube is connected to a metallic connector with a screw-like tip.
Vascular Graft Example Figure 1
Technological characteristics:
Atrium's Advanta VXT and Flixene Vascular grafts, subject of this submission, are technologically different from the predicate devices (K071923, K992960 and K992958) as there are differences in the materials of construction.
Atrium's Advanta VXT and Flixene Vascular grafts, subject of this submission, have the same Device Configuration Options as the predicate devices (K071923, K992960 and K992958).
Major Materials of Construction
The Advanta VXT and Flixene Vascular Grafts, subject of this submission, have different materials of construction then the predicate devices.
Non-clinical Tests
Advanta VXT and Flixene Vascular Grafts comply with the voluntary standards. Atrium Medical's development process required that the following activities be completed during the development of the current configuration of the Advanta VXT and Flixene Vascular Grafts:
| Non-Clinical Bench Testing | |
|---|---|
| Visual Appearance | Water Entry Pressure |
| Relaxed Internal Diameter | Dynamic Compliance |
8
GETI
Atrium Medical Corporation Premarket Notification Traditional 510(k) Advanta VXT Vascular Graft Flixene Vascular Graft
| Non-Clinical Bench Testing | |
|---|---|
| Pressurized Internal Diameter | Kink Resistance |
| Wall Thickness | Graft Deployment System Pull Strength |
| Useable Length | Helix Peel Strength (Advanta VXT only) |
| Graft Surface Architecture | Wrap Properties |
| Suture Retention Strength | Material Composition and Construction |
| Radial Tensile Strength | Modification of Length and/or End |
| Longitudinal Tensile Strength | Print Legibility |
| Strength after Repeated Puncture | Shelf-life Validation |
| Other Non-Clinical Testing | |
| Sterility Validation | MR Compatibility |
| Packaging Validation | Biocompatibility Evaluation |
| Chemical Characterization Analytical Testing | Toxicological Risk Assessment |
Clinical Tests
There were no clinical studies of the modified device.
Conclusion
The Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices in the fundamental scientific technology of the device. The design verification and validation testing established that the Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices.
Based upon the information submitted in this Traditional 510(k) premarket notification, Advanta VXT and Flixene Vascular Grafts subject of this submission are substantially equivalent to the predicate devices Advanta VXT Vascular Graft (K992960 and K992958) and Flixene Vascular Grafts (K071923).