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 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.

AI/ML Overview

The provided text is for a medical device called "exGraft and exGraft Carbon ePTFE Vascular Grafts," which is a vascular prosthesis. This type of device is a physical product, not a software or AI-based diagnostic tool. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined by the prompt (which implies performance metrics like sensitivity, specificity, or human reader improvement for AI/software) does not directly apply here.

The "performance data" section in the document refers to engineering and material testing rather than clinical study data involving humans reading images or making diagnoses.

However, I can extract the information provided in the document and present it in a format that aligns with the spirit of the prompt, reinterpreting "acceptance criteria" as the engineering and material performance requirements for this physical device.

Reinterpretation for a Physical Device:

Acceptance Criteria: These are the established performance specifications for the physical properties of the vascular graft (e.g., kink radius, microscopic porosity, water entry pressure, MRI safety).
Reported Device Performance: The results of the tests conducted on the exGraft and exGraft Carbon ePTFE Vascular Grafts to demonstrate that they meet these specifications.
Study Proving Acceptance: The testing performed to support substantial equivalence to the predicate device.

Analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not provide specific numerical acceptance criteria or the exact numerical reported performance for each criterion. Instead, it states that "the exGraft and exGraft Carbon are substantially equivalent to the predicate device" based on historical data and performance testing. The "performance testing" lists the types of tests conducted.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Physical Device):

Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
Kink Radius	Testing performed; results support substantial equivalence.
Microscopic Porosity (Upper Limit)	Testing performed; results support substantial equivalence.
Microscopic Porosity (Lower Limit)	Testing performed; results support substantial equivalence.
Water Entry Pressure	Testing performed; results support substantial equivalence.
MRI Safety Evaluation	Testing performed; results support substantial equivalence.

Note: The document explicitly states that the technological differences "do not raise different questions of safety and effectiveness" and "can be evaluated with performance testing," and that the device "leverages historical data from the predicate and reference devices." This implies that the 'acceptance criteria' are met if the new device's performance is comparable to or within acceptable limits of the predicate device for these physical characteristics.

Study Details:

Given that this is a physical medical device (vascular graft) and not an AI/software product, many sections of your prompt (e.g., ground truth, experts, MRMC studies, training/test sets) are not applicable in their traditional sense for this type of device. I will address the relevant parts and explicitly state when a section is not applicable (N/A) based on the provided text for this physical device.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated in terms of the number of graft samples tested for each criterion. The document refers to "testing" being performed.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would have been conducted by the manufacturer, PECA Labs, Inc., in the U.S.
- Nature of Data: This refers to physical and material property measurements, not clinical patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: For a physical device like a vascular graft, "ground truth" is established through standardized engineering and material testing protocols, not by expert consensus on clinical images or diagnoses. The "truth" is the measured physical property.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: Not relevant for material property testing of a physical device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A: This is a physical device, not an AI or diagnostic imaging tool. No human reader studies (MRMC) would be relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Physical Property Measurements: The "ground truth" for this device is the objective, measurable physical properties (kink radius, porosity, water entry pressure, MRI safety) determined through standardized laboratory testing. It is not based on expert consensus, pathology, or clinical outcomes data described in this document, though clinical performance would be evaluated separately post-market or in later clinical trials if required.
The sample size for the training set:
- N/A: There is no "training set" in the context of a physical medical device submission like this. The device is not learning from data. It's manufactured to specifications. "Historical data from the predicate and reference devices" are used for comparison, not for "training."
How the ground truth for the training set was established:
- N/A: See point 7.

Summary

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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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (412) 482-3755 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

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.

Regulation Number and Section

§ 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.”