(73 days)
The HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700).
The HYS-Surgiflator 150P is a hysteroscopic insufflator. It is substantially equivalent to the Hysteroflator OP, K922632/B, manufactured by W.O.M. GmbH. Differences include: reduced max. intrauterine pressure (150 mm Hg), preselection of desired pressure (15 - 150 mm Hg), incorporation of a venting valve for automatic pressure regulation, incorporation of an audible and visible overpressure alarm, and required use of a hydrophobic filter.
The provided text is a 510(k) premarket notification letter for the HYS-Surgiflator 150P, a hysteroscopic insufflator. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria, performance metrics, and sample sizes for a new, independent performance study of the HYS-Surgiflator 150P.
Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone), sample sizes, and ground truth establishment are not present in the provided text. The document primarily relies on the established safety and effectiveness of the predicate device and literature review to support the new device's substantial equivalence.
Here's what can be extracted based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria (Implied/Predicate) | Reported Device Performance (HYS-Surgiflator 150P) |
|---|---|---|
| Intrauterine Pressure Range | Not explicitly stated for predicate in this document, but predicate had a max of 200 mm Hg. | 15 - 150 mm Hg (Allows preselection within this range). This is a reduction from the predicate's max. |
| Max Intrauterine Pressure | 200 mm Hg (Predicate: Hysteroflator OP) | 150 mm Hg (Reduced from predicate) |
| Pressure Regulation | Implied functional regulation (Predicate) | Incorporates a venting valve for automatic pressure regulation, including potential reduction of overpressure. |
| Overpressure Alarm | Implied functional alarm (Predicate) | Incorporates an audible and visible overpressure alarm. |
| Hydrophobic Filter Use | Implied for safe operation (Predicate) | Required by the users manual. |
| Intended Use | Distend the uterus by filling the uterine cavity with gas to facilitate viewing with a hysteroscope. (Predicate: Hysteroflator OP) | Distend the uterus by filling the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700). (Identical to predicate) |
| Safety and Effectiveness | Demonstrated by predicate and literature. | Demonstrated to be substantially equivalent to the predicate, relying on the predicate's established safety and effectiveness. "Utility and safety of hysteroscopic techniques using modern electronic hysteroscopic insufflators is thoroughly reported in the literature." |
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This document is a 510(k) submission for substantial equivalence based on design comparison and literature review, not a new performance study requiring a test set of data samples. The comparison is against a legally marketed predicate device (Hysteroflator OP, K922632/B).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No new test set requiring expert ground truth establishment is described. The device's safety and effectiveness are supported by existing literature and the predicate device's history.
4. Adjudication method for the test set:
- Not applicable/Not provided. No test set requiring adjudication is mentioned.
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:
- No. This is a medical device (hysteroscopic insufflator), not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study and AI-related metrics are irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not an algorithm. Standalone performance as described (algorithm only without human-in-the-loop) is not relevant.
7. The type of ground truth used:
- Existing literature and the performance of the legally marketed predicate device (Hysteroflator OP, K922632/B). The 510(k) submission states, "The utility and safety of hysteroscopic techniques using modern electronic hysteroscopic insufflators is thoroughly reported in the literature..." and details specific references for this.
8. The sample size for the training set:
- Not applicable/Not provided. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no training set, this question is not relevant.
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.