(78 days)
InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum
The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.
The provided text describes a 510(k) submission for a rectal suppository applicator called "InsertEase™". The core of the submission revolves around demonstrating substantial equivalence to already legally marketed predicate devices, primarily vaginal applicators.
Here's an analysis of the acceptance criteria and the study as described in the document, keeping in mind that the primary "study" is a comparison to predicate devices rather than a traditional clinical trial:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, the acceptance criteria are met if the device demonstrates equivalent:
| Acceptance Criteria Category | Predicate Device (Vaginal Applicator) | InsertEase™ (Rectal Suppository Applicator) | Outcome / Performance |
|---|---|---|---|
| Intended Use | Insertion of medication into the vagina. | Insertion of suppositories into the rectum. | Equivalent Function: The document argues that the only difference is the anatomical orifice, and the function of inserting a suppository is the same. |
| Design | Two-piece, plunger within a barrel, open end to hold suppository. | Two-piece, plunger within a barrel, open end to hold suppository. | Equivalent Design: Described as "substantially equivalent" design. |
| Materials | Plastic (medical grade) | Plastic (medical grade) | Equivalent Materials: Both are plastic applicators to be extruded using medical grade plastic. |
| Sterility | Non-sterile (implied for common applicators) | Non-sterile | Equivalent Status: Both are non-sterile. |
| Single Use | Single use (implied for common applicators) | Single use | Equivalent Status: Both are single use. |
| Function/Movement | Inserts vaginal suppositories/tampons by pushing plunger. | Inserts rectal suppositories by pushing plunger. | Equivalent Function: "functions in the same way and manner". |
| Manufacturing Facility | FDA approved manufacturing facility | FDA approved manufacturing facility | Equivalent Compliance: Will be manufactured in an FDA approved facility. |
| Safety and Effectiveness | Demonstrated by predicate devices. | Not questioned when used as labeled, based on predicate equivalence. | Equivalent Assumed: Safety and effectiveness are not in question due to the similarity in function to established predicate devices. |
| Classification | Class I (Rectal Applicator, Vaginal Applicator) | Class I | Equivalent Classification: Both are Class I devices. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) based on substantial equivalence to a physical device. There wasn't a "test set" of performance data generated, but rather a comparison of technical characteristics and intended use.
- Data Provenance: The "data" primarily comes from the established regulatory classifications and descriptions of existing predicate devices marketed in the United States (implied by FDA regulation). This is retrospective in the sense that it relies on the known characteristics and regulatory history of pre-existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert review of performance, was not established for InsertEase™ using a test set. The "ground truth" for the substantial equivalence claim relies on the established regulatory framework and common understanding of how such applicators function, and their safety/effectiveness as previously determined by the FDA for similar devices.
4. Adjudication method for the test set
Not applicable, as there was no test set or expert adjudication process described for performance evaluation.
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 is a medical device for physical application, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study was conducted or relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Predicate Device Characteristics: The established design, materials, intended use, and functional principles of legally marketed vaginal applicators (Product Code: 884.4520(7)) and other relevant devices like Enema Kits (876.5210) and Rectal Dilators (876.5450), and the precedent set by the FDA regarding the Rectal Speculum vs. Vaginal Speculum.
- Regulatory Precedent: The FDA's prior determination of substantial equivalence for devices with similar function but different anatomical sites (e.g., vaginal vs. rectal speculums).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.