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:

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.
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.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm/AI device.
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.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
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.

Summary

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K990213

Food and Drug Administration Special 510(k) - HydraClear System January 21, 1999

ENT Division Smith & Nephew. Inc 2925 Appling Rd., Bartlett, TN 38133 U.S. 901-373-0200, Toll Free: 1-800-262

Smith - Neph

FEB 2 1999

Exhibit H

510(k) Summary of Safety and Effectiveness

	Trade Name:
--	-------------

HydraClear™ Irrigating System Modification to the ENTire™ Irrigating Pump (K973286) and Accessories to Endoscope (K932988)

Common Name: Electrical Irrigating Pump and Accessories to Endoscopes

Classification Name: Nasopharyngoscope (flexible or rigid) and Accessories (21 CFR 874.4760)

Official Contact: Jeff Cobb
Director R.A.\C.A.\Q.A. Smith & Nephew, INC. ENT Division 2925 Appling Road Bartlett, TN 38133

Telephone: (901) 373-0200

Telefax: (901) 373-0242

Date Prepared: January 21, 1999

The HydraClear System is substantially equivalent to the ENTire Irrigating Pump and the Suction/Irrigation Sheaths.

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

The HydraClear Irrigating Pump's intended use is for providing both cleaning and irrigation during endosopic surgery to irrigate the surgical site and to remove blood and tissue deposits from the surface of the sinuscope lens.

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The power instrumentation technology utilized in the system is equivalent to the ENTire Irrigating Pump. The HydraClear Irrigating Pump is designed to meet UL2601-1, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-1, and IEC 601-1-2 requirements.

The HydraClear Sheaths, which meet the ISO 1099-1 requirements, are equivalent to the previously cleared Suction/Irrigation sheaths.

Differences between the HydraClear Irrigating Pump and Sheaths and the predicate devices should not affect the safety or effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1999

Jeff Cobb Director, R.A.\C.A.\Q.A. Smith & Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133

Re:

K990213

The HydraClear™ System Dated: January 21, 1999 Received: January 22, 1999 Regulatory class: II 21 CFR 874.4760/Procode: EOB

Dear Mr. Cobb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bert David C. Ostfeld, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit D

Indications for Use Statement

510(k) Number: HydraClear™ System Device Name

The HydraClear System is intended for endoscopic sinus surgery, to irrigate the Indications for The HydraClear System is intended for endostopic and tissue deposits from the surface Use of the sinusope lens.

Thind h. Segerson
(Division Sign-Off)

lvision of Reproductive, Abdominal, E and Radiological Do 510(k) Number

Prescription Use _ V (Per 21 CFR 801.109)

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.