exGraft, exGraft Carbon

K183613 · Peca Labs · DSY · Apr 22, 2019 · Cardiovascular

Device Facts

• Record ID: K183613
• Device Name: exGraft, exGraft Carbon
• Applicant: Peca Labs
• Product Code: DSY · Cardiovascular
• Decision Date: Apr 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Single-use sterile vascular grafts; constructed of expanded polytetrafluoroethylene (ePTFE). Carbon-impregnated version features carbon coating on inner graft wall; both versions feature radiopaque ink on outer surface. Used by surgeons for peripheral arterial bypass, reconstruction, or arteriovenous access. Device serves as conduit for blood flow; provides structural support for vascular repair. Performance verified via kink radius, porosity, water entry pressure, and MRI safety testing.

Clinical Evidence

Bench testing only. Performance data included kink radius, microscopic porosity, water entry pressure, and MRI safety evaluation. No clinical data presented.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Features: radiopaque ink on outer surface; carbon-impregnated inner wall (select models). Form factor: tubular vascular graft with varying lengths and diameters. Sterilization: validated process. Non-electronic, mechanical device.

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

• exGraft and exGraft Carbon ePTFE Vascular Grafts (K180957)

Reference Devices

• Impra ePTFE Vascular Grafts (K830543)
• Impra Carboflo ePTFE Vascular Grafts (K004012)
• Impra Carboflo ePTFE Vascular Grafts (K004011)

Submission Summary (Full Text)

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# Indications for Use

510(k) Number (if known) K183613

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> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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April 22, 2019

PECA Labs Doug Bernstein Chief Executive Officer 4424 Penn Ave. Suite 201 Pittsburgh, Pennsylvania 15224

Re: K183613

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: March 11, 2019 Received: March 12, 2019

## 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/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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# K183613

# 510(k) Summary

(as required by 21 CFR 807.92)

#### l. SUBMITTER

PECA Labs, Inc. 4424 Penn Avenue Suite 201 Pittsburgh, PA 15224 Phone: [phone] Establishment Registration Number: 3013718163

Contact Person: Doug Bernstein, Chief Executive Officer Date Prepared: 20 December 2018

#### II. DEVICE

| Name of Device: | exGraft and exGraft Carbon ePTFE Vascular Graft |
|-----------------------|-------------------------------------------------|
| Common or Usual Name: | Vascular Graft |
| Classification Name: | 21 CFR 870.3450 Prosthesis, Vascular Graft |
| Regulatory Class: | Class II |
| Product Code: | DSY |

#### III. PREDICATE DEVICE

exGraft and exGraft Carbon ePTFE Vascular Grafts [K180957]. The predicate has not been subject to a design-related recall.

Impra ePTFE Vascular Grafts [K830543] and Impra Carboflo ePTFE Vascular Grafts [K004012 and K004011] were used as reference devices.

#### 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 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 device exGraft and exGraft Carbon ePTFE Vascular Grafts [K180957] 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
- Radiopaque ink applied to the outer surface

The proposed exGraft and exGraft Carbon and the predicate device exGraft and exGraft Carbon ePTFE Vascular Grafts [K180957] have the following differences:

- Different available length and diameter configurations
The different available length and diameter configurations are considered technological differences but do not raise different questions of safety and effectiveness and can be evaluated with performance testing.

#### VII. PERFORMANCE DATA

The proposed exGraft and exGraft Carbon ePTFE Vascular Grafts leverage historical data from the predicate and reference devices.

In addition, the following testing was performed to support substantial equivalence to the predicate device.

- Kink Radius
- Microscopic Porosity (Upper and Lower Limit)
- Water Entry Pressure ●
- MRI Safety Evaluation

## CONCLUSION

Compared to the predicate device, the exGraft Carbon ePTFE Vascular Grafts has the same intended use and the technological differences do not raise different questions of safety and effectiveness. Based on historical data and performance testing, the exGraft and exGraft Carbon are substantially equivalent to the predicate device.