(134 days)
Purastat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
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 mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. 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.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies for medical devices.
Instead, this document is an FDA 510(k) clearance letter and an associated 510(k) Summary. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (PuraStat-RM, K213552). The key assertion is that the subject device (PuraStat) is identical to the predicate device in most aspects, with the only exception being the final sterilization method (gamma radiation sterilization).
Therefore, the "performance data" referred to in the document is not a clinical study to prove new performance criteria but rather:
- Bench testing: To demonstrate that the change in sterilization method does not alter the physical or functional properties of the device.
- Biocompatibility testing: To ensure that the modified sterilization method does not introduce new biocompatibility concerns.
The document explicitly states: "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."
Given this, the requested information elements related to a and clinical study with performance metrics, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not available in this document. The document relies on the predicate device's prior clearance to establish safety and effectiveness.
Here's what can be extracted based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics for the subject device based on a new study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance reported is that the subject device is "identical in material, formulation and manufacturing, and so final product specification" to the predicate, with the exception of the sterilization method.
| Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance |
|---|---|
| Maintain material, formulation, manufacturing, and final product specifications as the predicate device. | "PuraStat is identical in material, formulation and manufacturing, and so final product specification to the predicate PuraStat-RM (K213552)." |
| No new questions of safety and effectiveness due to the change in sterilization method. | "The difference in technological characteristics (Final sterilization) of the subject and the predicate device... do not raise any new questions of safety and effectiveness." |
| Biological compatibility is maintained after sterilization change. | Biocompatibility testing was performed. (Specific results not detailed here). |
| Physical/functional properties are maintained after sterilization change. | Bench testing was performed. (Specific results not detailed here). |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this document as it pertains to a new clinical performance study. The "test set" in this context refers to the samples used for bench and biocompatibility testing, but their specific sizes and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This type of information is typically for clinical performance studies, which were not the basis for this 510(k) clearance beyond the predicate's original clearance.
4. Adjudication method for the test set
Not applicable/Not provided.
5. 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 device is a medical product (a gel) for symptomatic management, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
Not applicable in the context of a new clinical performance study. For the equivalence demonstration, the "ground truth" (or reference) is the established safety and effectiveness profile of the predicate device previoiusly cleared by the FDA. The current submission's "truth" is that the modified device remains functionally and biologically equivalent to that predicate.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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January 15, 2025
3-D Matrix Europe SAS Audrey Vion RAQA Manager 11 Chemin des Petites Brosses Caluire et Cuire, 69300 France
Re: K242634 Trade/Device Name: PuraStat Regulatory Class: Unclassified Product Code: PHN Dated: December 18, 2024 Received: December 18, 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.
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 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 Rue"). 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.
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For comprehensive regulatory information about medical devices and radiation-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,
Anthony Lee -S
Anthony Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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)
Device Name
PuraStat
Indications for Use (Describe)
Purastat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
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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Page 1 of 3
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: September 2, 2024
2. DEVICE
Name of Device: PuraStat Common Name: Mucoadhesive Application for the Protective Coating of the Rectal Mucosa Classification Regulation: Unclassified Regulatory Class: Unclassified Product Code: PHN Panel: Gastroenterology / Urology
PREDICATE DEVICE 3.
Predicate Device: 3-D Matrix, Inc.'s PuraStat-RM (K213552).
DEVICE DESCRIPTION 4.
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 mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. 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.
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5. INDICATIONS FOR USE
PuraStat is intended to be used for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The subject device is identical to the PuraStat-RM predicate (K213552) 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 physiological pH (blood or tissue), the peptides assemble into a scaffold structure that results in the formation of a protective coating over the rectal mucosa.. The solution is filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a highdensity 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 subject device is identical to the intended use of the predicate device K213552. 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-RM 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-RM (K213552).
Technological characteristics between the predicate PuraStat-RM (K213552) 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-RM (K213552)
In conclusion, PuraStat is substantially equivalent to the predicate (K213552).
N/A