(59 days)
No
The summary describes a physical vascular graft made of ePTFE and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is a vascular graft intended for replacement or bypass of diseased vessels, which directly treats or alleviates a disease or condition.
No
The device is described as a vascular graft, intended for use as a prosthesis for replacement or bypass of diseased vessels. It is a treatment device, not a diagnostic one.
No
The device description explicitly 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 "replacement or bypass of diseased vessels." This is a surgical implant used directly in the body.
- Device Description: The description details the physical construction of the graft (ePTFE with radiopaque ink and carbon coating). This is a physical device, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used to replace or bypass 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
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
Not Found
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)
The proposed exGraft and exGraft Carbon ePTFE Vascular Grafts utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K202471.
Additional nonclinical data related to packaging, shelf life and sterilization was provided to support substantial equivalence.
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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August 4, 2022
PECA Labs Doug Bernstein Chief Executive Officer 4424 Penn Ave, Suite 201 Pittsburgh, Pennsylvania 15224
Re: K221628
Trade/Device Name: exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY Dated: June 3, 2022 Received: June 6, 2022
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
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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 devices or postmarketing safety reporting (21 CFR 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 (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 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,
for Carmen Johnson, PhD 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
Enclosure
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Indications for Use
510(k) Number (if known) K221628
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.
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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K221628 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: 3 June 2022
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 |
| Regulatory Class: | Class II |
| Product Code: | DSY |
III. PREDICATE DEVICE
exGraft and exGraft Carbon ePTFE Vascular Grafts [K202471]
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
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
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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 [K202471]:
The proposed exGraft and exGraft Carbon have the following similarities:
- Same design and material
- Same configurations ●
- Sterilized using the same sterilant agent
- Same packaging materials and basic design
- 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 sterilization location and process
- Change in shelf life
- Change in packaging location ●
- Minor modifications to the packaging design
VII. PERFORMANCE DATA
The proposed exGraft and exGraft Carbon ePTFE Vascular Grafts utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K202471.
Additional nonclinical data related to packaging, shelf life and sterilization was provided to support substantial equivalence.
VIII. 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 K202471.