(51 days)
No
The summary describes a physical vascular graft made of ePTFE and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vascular prosthesis intended for replacement or bypass of diseased vessels, which serves to treat medical conditions.
No
The device is described as a vascular graft, which is a prosthetic device used for replacement or bypass of diseased vessels. Its function is to replace or assist the function of a vessel, not to diagnose a condition.
No
The device description explicitly states it is a physical vascular graft constructed of ePTFE, which is a hardware component. The performance studies also focus on physical properties of the graft.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use as vascular prostheses for replacement or bypass of diseased vessels, trauma patients, and dialysis access. This is a surgical implant used directly in the body.
- Device Description: The device is a vascular graft constructed of ePTFE. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a replacement for blood vessels.
N/A
Intended Use / Indications for Use
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
Product codes
DSY, DYF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
There have been no changes to the exGraft Carbon ePTFE Vascular Grafts and thus those configurations utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K221628.
For the exGraft ePTFE Vascular Grafts (Non-Carbon) additional performance data been included within the submission and its appendices, including
- Burst Strength
- Strength after Repeated Puncture
- Tensile Strength
- Suture Retention Strength
- Kink Radius
- Water Entry Pressure
- Microscopic Porosity
- Wall Thickness Eccentricity
- Wall Thickness
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K004012, K004011, K954582, K830543
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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January 17, 2024
PECA Labs, Inc. Doug Bernstein Chief Executive Officer 4424 Penn Ave., Ste 201 Pittsburgh, Pennsylvania 15224
Re: K233783
Trade/Device Name: exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY, DYF Dated: November 24, 2023 Received: November 27, 2023
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 (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" (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).
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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, Rohini Retarekar -S
- Carmen Gacchina Johnson, PhD for Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233783
Device Name
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
Indications for Use (Describe)
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
| 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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Image /page/3/Picture/0 description: The image shows the word "PECA" in large, bold, purple letters, followed by the word "labs" in smaller, thinner, purple letters. The letters are all in a sans-serif font. The word "PECA" is much larger than the word "labs", and the two words are separated by a small space.
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
Doug Bernstein, Chief Executive Officer Contact Person: Date Prepared: 16 January 2024
- II. DEVICE
| Name of Device: | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft |
|---|---|
| Common or Usual Name: | Vascular Graft |
| Classification Name: | 21 CFR 870.3450 Prosthesis, Vascular Graft, of 6mm and Greater |
| Diameter | |
| 21 CFR 870.3450 Prosthesis, Vascular Graft, of less than 6mm | |
| Diameter | |
| Regulatory Class: | Class II |
| Product Code: | DSY, DYF |
III. PREDICATE DEVICE
exGraft and exGraft Carbon ePTFE Vascular Grafts [K221628]
Impra Carboflo ePTFE Vascular Grafts [K004012 and K004011], Impra ePTFE Vascular Grafts [K954582 and K830543], are used as reference devices.
The predicates and references 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 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
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The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
Compared to the predicate device exGraft and exGraft Carbon ePTFE Vascular Grafts [K221628]:
The proposed exGraft and exGraft Carbon have the following similarities:
- Same design and material
- Same sterilization processes and method
- Same packaging materials, processes, design and location
- Available in Carbon and Non-Carbon configurations
- Same radiopaque ink on the outer (abluminal) surface
The proposed exGraft and exGraft Carbon have the following differences:
- Change in conduit manufacturing supplier for Non-Carbon configurations ●
- . Change in the wall thickness of some configurations for Non-Carbon configurations
- Reduction of blue lines on the graft from two to one for Non-Carbon configurations
VII. PERFORMANCE DATA
There have been no changes to the exGraft Carbon ePTFE Vascular Grafts and thus those configurations utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K221628.
For the exGraft ePTFE Vascular Grafts (Non-Carbon) additional performance data been included within the submission and its appendices, including
- Burst Strength
- Strength after Repeated Puncture
- Tensile Strength
- Suture Retention Strength
- Kink Radius
- Water Entry Pressure
- Microscopic Porosity ●
- Wall Thickness Eccentricity
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Image /page/5/Picture/0 description: The image shows the text "PECA labs" in a bold, purple font. The letters are evenly spaced and the text is aligned horizontally. The word "labs" is smaller than the word "PECA".
- Wall Thickness .
CONCLUSION
The exGraft and exGraft Carbon ePTFE Vascular Grafts are substantially equivalent to the predicate devices exGraft and exGraft Carbon ePTFE Vascular Graft cleared under K221628.