PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

Device Description

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1, 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

AI/ML Overview

The provided text is a 510(k) summary for the PuraStat device. It states that the subject device (K242250) is identical to the predicate device (K222481) except for the final sterilization method. The document explicitly states that the "device is identical to the predicate device and has the same intended use."

Therefore, the performance data provided is to demonstrate equivalence to the predicate device, not to establish new performance criteria for the subject device. It relies on the predicate's performance to establish substantial equivalence.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this specific document:

A table of acceptance criteria and the reported device performance
- This document does not provide a table of acceptance criteria and reported device performance for the new device in the general sense of clinical performance or accuracy for an AI/diagnostic device.
- Instead, it states, "The subject device is identical to the predicate device...an equivalence demonstration was performed following the final sterilization change. The bench testing and biocompatibility testing provided in this submission assess the equivalence demonstration."
- The "acceptance criteria" here are to show that the change in sterilization does not alter the device's fundamental properties or safety, ensuring it performs identically to the predicate device. Specific numerical performance metrics for hemostasis are not detailed in this filing, as they would have been established and accepted for the predicate device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in this 510(k) summary. The testing mentioned (bench testing and biocompatibility) is related to the change in sterilization, not a clinical trial to establish new efficacy for the device's intended use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable and is not mentioned. The device is a hemostatic gel, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/diagnostic device based on expert interpretation.
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
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical hemostatic gel, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/diagnostic ground truth. The "ground truth" for this filing is that the subject device, with its new sterilization, is functionally identical and safe compared to the predicate through bench and biocompatibility testing. Clinical efficacy would have been established for the predicate device, likely through clinical studies demonstrating hemostatic success (e.g., control of bleeding, resolution of bleeding events), which would have served as the "ground truth" for its performance.
The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI device that requires a training set.

Summary of Relevant Information from the Document:

Device Name: PuraStat
Intended Use: Hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. Not indicated for arterial Forrest 1a bleeding.
Key Change from Predicate: Final sterilization method (replaced by gamma radiation sterilization).
Performance Data Provided: Bench testing and biocompatibility testing to demonstrate equivalence between the subject device (with new sterilization) and the predicate device.
Conclusion: The subject device is substantially equivalent to the predicate (K222481) as the change in sterilization does not raise any new questions of safety and effectiveness, and the device remains identical in material, formulation, manufacturing, and final product specifications. The performance of the predicate device is implicitly relied upon.

Summary

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October 22, 2024

3-D Matrix Europe SAS Audrey Vion RAQA Manager 11 Chemin des Petites Brosses Caluire et Cuire, Rhone 69300 France

Re: K242250

Trade/Device Name: PuraStat Regulation Number: 21 CFR 878.4456 Regulation Name: Hemostatic Device For Intraluminal Gastrointestinal Use Regulatory Class: Class II Product Code: OAU Dated: July 31, 2024 Received: July 31, 2024

Dear Audrey Vion:

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.

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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).

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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

Tek N.
Lamichhane -S

Digitally signed by
Tek N. Lamichhane -S
Date: 2024.10.22
12:53:13 -04'00'

Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)
------------------------------	--

K242250

Device Name

PuraStat

Indications for Use (Describe)

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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.

SUBMITTER 1.

3-D Matrix Europe SAS 11 chemin des Petites Brosses 69300 Caluire et Cuire - FRANCE

Contact Person: Audrey VION Phone: +33 (0) 627 635 514 Email: avion@puramatrix.com

Date Prepared: July 31, 2024

2. DEVICE

Name of Device: PuraStat Common Name: Hemostatic device for intraluminal gastrointestinal use Classification Regulation: 21 CFR 878.4456 Regulatory Class: II Product Code: QAU Panel: General & Plastic Surgery

3. PREDICATE DEVICE

Predicate Device: 3-D Matrix, Inc.'s PuraStat (K222481).

4. DEVICE DESCRIPTION

PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

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5. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The subject device is identical to the PuraStat predicate (K222481) except for the final sterilization, which is replaced by gamma radiation sterilization. The final product specifications are unchanged.

PuraStat comprises of a synthetic repeating 16-amino acid (RADA-16) oligopeptide in sterile water for injection. In the presence of a bleeding wound, the peptides assemble into a scaffold structure that forms a mechanical barrier over the bleeding site. The solution is filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel. The device is terminally sterilized, and the resorbable gel is delivered to the intended application site(s) via a commercially available adapter connected to a commercially available catheter. The device is delivered endoscopically via a catheter to the patient.

7. PERFORMANCE DATA

The subject device is identical to the predicate device. The intended use of the predicate device is identical to the intended use of the predicate device K222481. The indications for use of the subject device are identical to the predicate's indications for use.

The subject device is identical to the predicate device and has the same intended use, and an equivalence demonstration was performed following the final sterilization change. The bench testing and biocompatibility testing provided in this submission assess the equivalence demonstration.

Overall, the difference in technological characteristics (Final sterilization) of the subject and the predicate device 3-D Matrix Inc. - PuraStat do not raise any new questions of safety and effectiveness.

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8. CONCLUSIONS

The subject PuraStat has identical intended use and indications as the predicate PuraStat (K22481).

Technological characteristics between the subject PuraStat (K222481) and the subject device are identical, with the exception of the final sterilization. This difference do not raise any questions of safety or effectiveness. PuraStat is identical in material, formulation and manufacturing, and so final product specification to the predicate PuraStat (K222481)

PuraStat complies with the special controls for a hemostatic device for intraluminal gastrointestinal internal use.

In conclusion, PuraStat is substantially equivalent to the predicate (K222481).

Regulation Number and Section

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.

(a)
Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance data must support the sterility and pyrogenicity of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
(i) The ability to deliver the hemostatic material to the bleeding site;
(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
(6) Labeling must include:
(i) Information identifying and explaining how to use the device and its components; and
(ii) A shelf life.