(207 days)
The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the DOLPHIN® II Fluid Management System. This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device, rather than providing details of a de novo study proving new acceptance criteria.
Therefore, the input does not contain the information requested in the prompt, such as:
- A table of acceptance criteria and reported device performance.
- Details of a study (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance).
- Information about ground truth (type, establishment).
- Training set details.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This indicates that the approval is based on equivalence to existing devices, not on a new study that establishes a device's performance against specific acceptance criteria for a novel functionality.
§ 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.