(131 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a vascular graft, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a vascular graft, intended for the reconstruction or bypass of blood vessels, which directly addresses a medical condition or health problem.
No
The device is a vascular graft, intended for use as a prosthesis for blood access, bypass, or reconstruction of blood vessels. It is not designed to diagnose a medical condition.
No
The device description clearly states it is a physical vascular graft constructed of ePTFE, which is a hardware component.
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 device is a "vascular prosthesis" for use as "subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels." This describes a device that is implanted or used directly within the body for a therapeutic purpose.
- Device Description: The description details the physical construction of the graft (ePTFE with radiopaque ink and carbon coating). This is a physical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The performance studies focus on the physical and biological compatibility of the graft itself, not on its ability to detect or measure substances in a sample.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DSY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Chemical characterization and toxicological risk assessment were used to address the following endpoints:
- Subacute/Subchronic Systemic Toxicity
- Chronic Systemic Toxicity
- Genotoxicity
- Carcinogenicity
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
Key results: 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).
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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
2
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) | |
|---|---|
| ☑ 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
Image /page/3/Picture/0 description: The image shows the logo for PECA Labs. The logo is in a dark purple color. The word "PECA" is in a bold, sans-serif font, while the word "labs" is in a lighter, sans-serif font.
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.
4
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 ●
5
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).