HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET

• K Number: K990213
• Device Name: HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
• Manufacturer: GYRUS ENT L.L.C.
• Date Cleared: 1999-02-02 ( 11 days)
• Product Code: EOB
• Regulation Number: 874.4760
• Type: Special
• Panel: EN
• Reference & Predicate Devices: K973286 , K932988
• Predicate For: N/A

Intended Use

The HydraClear System is intended for endoscopic sinus surgery, to irrigate the surgical site and to remove blood and tissue deposits from the surface of the sinuscope lens.

Device Description

The HydraClear System is a rotary peristaltic pump and sheath assembly that provides both irrigation and cleaning.

AI/ML Overview

The provided text describes a 510(k) submission for the HydraClear System, which is a modification to an existing irrigating pump and accessories. However, it does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and adherence to established safety standards, rather than showing a new performance metric or improvement over a baseline.

Therefore, I cannot extract the specific details requested in your prompt for acceptance criteria and a study proving device performance in the context of an AI/ML device.

Here's why and what information is available:

• No Acceptance Criteria or Reported Device Performance Table: The document doesn't define quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the HydraClear System's performance and then report its achievement of those criteria. Its primary "performance" claims are related to its function of irrigation and cleaning, and its safety equivalence to existing devices.
• No Clinical Study Details: This 510(k) summary does not describe any clinical study or controlled experiment designed to measure the HydraClear System's performance in terms of effectiveness or an AI algorithm's capabilities. It relies on the substantial equivalence argument, assuming that if the new device is similar enough to existing, legally marketed devices, it will be safe and effective.
• Focus on Standards Compliance: The text mentions that the HydraClear Irrigating Pump is "designed to meet UL2601-1, CSA 22.2 No. 601-1, IEC 601-1, and IEC 601-1-2 requirements" and the sheaths "meet the ISO 1099-1 requirements." These are safety and electrical standards, not performance metrics for an AI system.

Summary of what can be inferred or is directly stated, with the caveat that it does not fit the AI/ML performance study context:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied - Regulatory/Safety):
     • Compliance with UL2601-1, CSA 22.2 No. 601-1, IEC 601-1, and IEC 601-1-2 (for pump)
     • Compliance with ISO 1099-1 (for sheaths)
     • Substantial equivalence to predicate devices (ENTire™ Irrigating Pump, Suction/Irrigation Sheaths) in terms of safety and effectiveness.
   • Reported Device Performance: The document states the device is designed to meet these standards and that differences to predicates should not affect safety or effectiveness. This is a design and regulatory compliance statement, not a measurement of clinical performance.

2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is not a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI system, and no MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm/AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. There is no ground truth established for performance in the context of an AI/ML device. The "ground truth" for this submission is regulatory compliance and substantial equivalence to legally marketed devices.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text details a standard 510(k) submission for a non-AI medical device, focusing on substantial equivalence and compliance with established safety standards, rather than clinical performance studies with specific acceptance criteria that would typically be seen for AI/ML device submissions.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.