(254 days)
PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing.
Manages pain of, for example:
- All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa
- Canker sores and cold sores
- Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
- Soft tissue pain from orthodontics
- Aphthous ulcers
- Extraction site pain
- Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)
PuraStat-OM 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 an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process.
PuraStat-OM is completely non-animal and non-plant derived and contains no drugs or biologics 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.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:
Device: PuraStat-OM (an oral hydrogel wound dressing)
Predicate Device: McMerlin Dental Company's SOCKIT!® Oral Hydrogel Wound Dressing (K063148)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the purpose of demonstrating substantial equivalence. Instead, it describes a comparison of technological characteristics and performance data between the subject device (PuraStat-OM) and the predicate device (SockIt!® Gel) to argue for their substantial equivalence. The "criteria" are implicitly defined by the properties measured and compared.
| Characteristic Measured/Compared | Acceptance Criteria (Implicit) | Reported Device Performance (PuraStat-OM) | Reported Predicate Performance (SockIt!® Gel) | Conclusion/Implication (PuraStat-OM vs. Predicate) |
|---|---|---|---|---|
| Biocompatibility | No toxic, sensitizing, irritating, acute systemic, subchronic/subacute, or material-mediated pyrogenic effects; normal inflammatory response resolving to capsular fibrosis. (Based on ISO 10993-1 and FDA Guidance) | Met all biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic / Subacute Toxicity, Implantation, Material-Mediated Pyrogenicity). Device deemed to not give rise to toxic effects. | Not directly tested for this submission (predicate is already cleared), but the predicate is also a medical device with established biocompatibility. | Device does not raise different questions of safety; it performs adequately in biocompatibility. |
| Primary Mode of Action | Adheres to wound, forms protective barrier, conforms to contours, prevents contamination/irritation, provides moist wound environment. | Adheres to wound surface, conforms to contours, forms protective barrier, provides moist wound environment. | Adheres to wound surface, conforms to contours, forms protective barrier, provides moist wound environment. | Same primary mode of action. |
| Complex Modulus (Simulated Body Fluid) | Should demonstrate sufficient physical strength to form an effective physical barrier, comparable to or greater than the predicate. | Greater than the predicate device. | Lower than the subject device. | PuraStat-OM forms a physical barrier that is as at least as effective as the predicate due to its increased physical strength. |
| Complex Viscosity (Simulated Body Fluid) | Should demonstrate sufficient physical strength to form an effective physical barrier, comparable to or greater than the predicate. | Greater than the predicate device. | Lower than the subject device. | PuraStat-OM forms a physical barrier that is as at least as effective as the predicate due to its increased physical strength. |
| Viscosity | Needs to allow for easy injection onto the wound, potentially lower than predicate for ease of use. | Lower than SockIt!® Gel. | Higher than PuraStat-OM. | Easier to inject the product onto the wound site. |
| Injection Force | Should be manageable for clinical use, comparable to or lower than the predicate for ease of use. | Required less force than the predicate SockIt!® Gel. | Required more force than PuraStat-OM. | Easier to use/inject. |
| pH (after 10 min in human saliva) | Biocompatible pH range, comparable to predicate. | 6.2 | 7.7 | Comparable pH after exposure to physiological fluids, indicating similar physiological interaction. |
| pH (after 10 min in human blood) | Biocompatible pH range, comparable to predicate. | 6.0 | 7.6 | Comparable pH after exposure to physiological fluids, indicating similar physiological interaction. |
2. Sample Size Used for the Test Set and Data Provenance
The study described is nonclinical performance (bench testing) and GLP biocompatibility testing.
- Sample Size for Test Set: Not explicitly stated with a specific number of units for each test. The document refers to "PuraStat-OM" and "SockIt!® Gel" being tested, implying samples of each device were used. For biocompatibility, testing is typically done on multiple samples.
- Data Provenance: The biocompatibility testing was conducted as per ISO 10993-1 and consistent with FDA Guidance, indicating standard laboratory practices. The bench testing (complex modulus, viscosity, pH, etc.) was a "side-by-side comparison" of the subject and predicate devices. This is retrospective in the sense that it compares a new device to an already marketed predicate, but the testing itself would have been conducted prospectively for the submission. The origin of the data is laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This document describes nonclinical, laboratory-based performance testing and biocompatibility assessments, not a study requiring human readers or expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
N/A. Not applicable to nonclinical performance or biocompatibility testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not mentioned as this submission focuses on nonclinical and bench testing to demonstrate substantial equivalence based on technological characteristics and biocompatibility, not comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This is a physical medical device (hydrogel), not an imaging/AI algorithm.
7. The Type of Ground Truth Used
For the biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation), the "ground truth" is defined by established biological safety standards and methodologies (ISO 10993-1). For the bench tests (e.g., Complex Modulus, Viscosity, pH), the "ground truth" is the measured values obtained using validated laboratory methods and instruments. These are objective physical and chemical properties.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable.
N/A