(133 days)
ProctiGard™ is indicated for the symptomatic management of rectal mucositis.
ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.
This 510(k) premarket notification is for ProctiGard™, a device indicated for the symptomatic management of rectal mucositis. The submission asserts substantial equivalence to a predicate device, MuGard® Mucoadhesive Oral Wound Dressing (K062795).
Here is an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Acceptance Criterion for Substantial Equivalence: Device formulation is identical to a legally marketed predicate device, ensuring similar safety and efficacy profile. | ProctiGard™'s liquid hydrogel formulation is identical to that of MuGard® Mucoadhesive Oral Wound Rinse (K062795). Both devices utilize a mixture of film-forming polymers, pharmaceutical aids, and preservatives. |
| Biocompatibility: Meet ISO 10993 standards for in vitro cytotoxicity, sensitization, and mucosal irritation. | Safety has been established through biocompatibility testing of the hydrogel liquid according to ISO 10993, including in vitro cytotoxicity tests, sensitization testing in guinea pigs, and mucosal irritation testing in rabbits. |
| Mode of Action: Achieve a protective layer over the relevant mucosa. | The mode of action of ProctiGard™ is achieved in an identical manner to MuGard® (i.e., formation of a protective layer over the mucosa), but specifically over the rectal mucosa. |
| Intended Use: Symptomatic management of mucositis. | ProctiGard™ is indicated for the symptomatic management of rectal mucositis, similar in function to MuGard®'s indication for oral mucositis. |
| Material Composition: Identical to predicate device. | The composition of the liquid hydrogel of ProctiGard™ is identical to that of MuGard®. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not describe a clinical "test set" or a clinical study involving human subjects for ProctiGard™. The device's substantial equivalence is primarily based on the identical composition and analogous mode of action to its predicate device, MuGard®, along with preclinical biocompatibility testing. The data provenance for the biocompatibility tests (guinea pigs, rabbits) is not specified geographically or as retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set is described.
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. ProctiGard™ is a medical device (a protective coating), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. ProctiGard™ is a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's claims of safety and effectiveness relies on:
- Identity of Formulation: The chemical and physical composition of ProctiGard™ is stated to be identical to the legally marketed predicate device, MuGard®.
- Biocompatibility Standards: Compliance with ISO 10993 standards (in vitro cytotoxicity, sensitization, mucosal irritation in animal models) serves as the "ground truth" for safety.
- Analogous Mode of Action: The understanding that a protective layer over mucosa provides symptomatic relief, which was established for the predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The basis for approval is substantial equivalence to a predicate, supported by preclinical biocompatibility testing and identical formulation.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
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