exGraft, exGraft Carbon ePTFE Vascular Grafts
Device Facts
| Record ID | K180957 |
|---|---|
| Device Name | exGraft, exGraft Carbon ePTFE Vascular Grafts |
| Applicant | Peca Labs |
| Product Code | DSY · Cardiovascular |
| Decision Date | Aug 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3450 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
Device Story
exGraft and exGraft Carbon are single-use, sterile ePTFE vascular grafts; intended for subcutaneous arteriovenous access, bypass, or peripheral arterial reconstruction. Devices feature radiopaque ink on outer surface for visualization; exGraft Carbon variant includes carbon coating on inner graft wall. Grafts implanted by surgeons in clinical settings. Radiopaque ink allows for identification/positioning; carbon coating aims to improve hemocompatibility. Performance verified via bench testing (burst strength, suture retention, tensile strength, porosity, kink radius, ink wear) and biocompatibility assessments (ISO 10993).
Clinical Evidence
No clinical data. Substantial equivalence supported by biocompatibility evaluation (ISO 10993-1) and extensive bench testing, including probe burst strength, suture retention, tensile strength, water entry pressure, porosity, puncture strength, kink radius, ink thickness/wear, and MRI safety.
Technological Characteristics
Materials: ePTFE, radiopaque ink, carbon coating. Form factor: tubular vascular graft. Sterilization: same as predicate. Connectivity: N/A (mechanical implant).
Indications for Use
Indicated for patients requiring vascular prostheses for subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
Submission Summary (Full Text)
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August 21, 2018
PECA Labs Doug Bernstein Chief Executive Officer 4424 Penn Ave. Suite 201 Pittsburgh, Pennsylvania 15224
Re: K180957
Trade/Device Name: exGraft and exGraft Carbon ePTFE Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: July 13, 2018 Received: July 16, 2018
Dear Doug Bernstein:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Brian D. Pullin -S
for 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) K180957
Device Name
exGraft and exGraft Carbon ePTFE Vascular Grafts
### Indications for Use (Describe)
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## K180957
### 510(k) Summary
(as required by 21 CFR 807.92)
#### l. SUBMITTER
PECA Labs, Inc. 4424 Penn Avenue Suite 201 Pittsburgh, PA 15224
Phone: (412) 482-3755
Contact Person: Doug Bernstein, Chief Executive Officer Date Prepared: August 16, 2018
- II. DEVICE
| Name of Device: | exGraft and exGraft Carbon ePTFE Vascular Grafts |
|-----------------------|----------------------------------------------------------|
| Common or Usual Name: | Vascular Graft |
| Classification Name: | 21 CFR 870.3450 |
| | Prosthesis, Vascular Graft, of 6 mm and Greater Diameter |
| Regulatory Class: | Class II |
| Product Code: | DSY |
#### III. PREDICATE DEVICE
Impra Carboflo ePTFE Vascular Grafts, K004011 and Impra ePTFE Vascular Grafts, K954582
The predicates have not been subject to a design-related recall.
#### IV. DEVICE DESCRIPTION
The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the outer surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
- V. INDICATIONS FOR USE
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
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The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed exGraft and exGraft Carbon and the predicate devices Impra Carboflo and Impra ePTFE vascular graft have the following similarities:
- Same basic design and material
- . Sterilized using the same material and processes
- Same packaging material and construction
- Carbon impregnated and non-carbon impregnated
The proposed exGraft and exGraft Carbon and the predicate devices Impra Carboflo and Impra ePTFE vascular graft have the following differences:
- exGrafts include radiopaque ink applied to the outer surface
The radiopaque ink is considered a technological difference. However, there are no new questions of safety and effectiveness raised by the addition of the ink.
### VII. PERFORMANCE DATA
Biocompatibility and bench testing were performed to demonstrate substantial equivalence to the predicate device.
### Biocompatibility Evaluation
The biocompatibility evaluation for the exGraft and exGraft Carbon was conducted in accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" issued on June 16, 2016 and International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogen Testing
- . Implantation
- Hemocompatibility ●
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Chemical characterization and toxicological risk assessment were used to address the following endpoints:
- Subacute/Subchronic Systemic Toxicity
- . Chronic Systemic Toxicity
- Genotoxicity
- Carcinogenicity
The exGraft and exGraft Carbon are single use devices and are considered blood contact implant devices with a contact duration of permanent (greater than 30 days).
### Bench Testing
Bench testing of the exGraft and exGraft Carbon included the following tests:
- Probe Burst Strength
- Suture Retention Strength
- Longitudinal Tensile Strength ●
- Circumferential Tensile Strength
- Water Entry Pressure
- . Microscopic Porosity (Upper and Lower Limit)
- Strength After Repeated Puncture
- Kink Radius
- Ink Thickness ●
- Accelerated Ink Wear ●
- MRI Safety Evaluation
### CONCLUSION
The exGraft and exGraft Carbon ePTFE Vascular Grafts are substantially equivalent to the currently marketed Impra Carboflo ePTFE Vascular Graft (K004011) and Impra ePTFE Vascular Graft (K954582).
