(110 days)
The Davol® Hysteroscopy Pouch Drape and Tubing Set is intended for the collection of distention and irrigation fluids during diagnostic or operative hysteroscopy.
The Davol Hysteroscopy Pouch Drape and Tubing Set consists of a Drape and Fluid Collection Tubing. The Drape is a blue polyethylene under-buttocks sheet with a clear, funnelshaped polyethylene fluid collection pouch. The sheet has a patient adhesive strip located at the edge closest to the pouch, as well as hand cuffs to facilitate placement under the patient. The cuffs are identified as left and right. The pouch is held open by a malleable wire support located at the top outside edge and it contains a spunbonded nylon fabric filtration screen to catch large tissue debris or surgical gauze, which prevents clogging the drainage port. The drainage port, located at the bottom of the pouch, has a hinged cap. The Fluid Collection Tubing includes a Drape Suction Set and an Outflow Tubing Set. The Drape Suction Set is supplied in a Y-configuration manufactured from three pieces of polyvinylchloride (PVC) tubing joined by a PVC Y-Connector. The Ouflow Tubing Set includes an anti-siphon feature which allows air to vent into the fluid path of the outflow tubing.
The provided text describes a 510(k) premarket notification for the Davol® Hysteroscopy Pouch Drape and Tubing Set. The submission focuses on establishing substantial equivalence to a predicate device, rather than providing a performance study with detailed acceptance criteria and results as typically found for novel device validations.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" as typically seen in a performance study (e.g., accuracy, sensitivity, specificity, or objective metrics) is not applicable in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to a previously marketed predicate device. The "performance" is implicitly deemed equivalent if the technological characteristics and intended use are the same.
The comparison is presented in a "Comparison Chart" (Attachment 6-1) which lists features and whether both the new device (Davol Drape) and the predicate device (Microtek Drape) possess them. This serves as the basis for the "acceptance" of substantial equivalence.
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance (Davol Drape) |
|---|---|---|
| Intended use for collection of distention and irrigation fluids during diagnostic/operative hysteroscopy | Must be identical to predicate device | Yes |
| Can be connected to suction | Must be identical to predicate device | Yes |
| Blue Polyethylene Under Buttocks Sheet | Must be identical to predicate device | Yes |
| Clear Funnel-Shaped Polyethylene Fluid Collection Pouch | Must be identical to predicate device | Yes |
| Malleable wire support on the top outside edge of the pouch to keep pouch open during the procedure | Must be identical to predicate device | Yes |
| Spunbonded nylon fabric filtration screen inside the Fluid Collection Pouch | Must be identical to predicate device | Yes |
| Drainage Port w/Hinged Cap | Must be identical to predicate device | Yes |
| Hand Cuffs to aid in positioning the Drape | Must be identical to predicate device | Yes |
| Patient Adhesive Strip | Must be identical to predicate device | Yes |
Note: The "acceptance criteria" here are implicitly that the Davol Drape must possess the same features and intended use as the predicate Microtek Drape to establish substantial equivalence. The document explicitly states: "The Drape subject of this submission and the predicate product are identical as summarized in the Comparison Chart, Attachment 6-1."
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This submission is not a clinical performance study using a test set of patient data. It is a regulatory submission focused on comparing the design and intended use of a new device to a predicate device. Therefore, there is no "test set" in the context of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. As there is no "test set" of clinical data being evaluated for performance, there are no experts establishing ground truth in that sense. The comparison of the device features was a direct comparison of physical and functional characteristics.
4. Adjudication Method for the Test Set
Not Applicable. No test set requiring expert adjudication was used.
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 surgical drape and tubing set, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is a physical medical device (surgical drape and tubing) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the known characteristics and intended use of the legally marketed predicate device (Microtek Medical, Inc. Under Buttocks Drape and Fluid Collection Pouch). The new Davol Drape was compared directly against these known characteristics.
8. The Sample Size for the Training Set
Not Applicable. This submission does not involve a "training set" in the context of machine learning or algorithm development. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an algorithm, 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.