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

K990213 · Gyrus Ent LLC · EOB · Feb 2, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K990213
• Device Name: HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
• Applicant: Gyrus Ent LLC
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

HydraClear System is a rotary peristaltic pump and sheath assembly; provides irrigation and cleaning during endoscopic sinus surgery. Device operates by pumping fluid to irrigate surgical site and clear sinuscope lens of blood/tissue deposits. Used in clinical settings by surgeons. Output is physical irrigation flow; assists visualization by maintaining lens clarity. Benefits patient by facilitating surgical procedure through improved visibility.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rotary peristaltic pump and sheath assembly. Materials meet ISO 1099-1. Electrical safety standards: UL2601-1, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-1-2.

Indications for Use

Indicated for use during endoscopic sinus surgery to irrigate the surgical site and remove blood and tissue deposits from the sinuscope lens surface.

Regulatory Classification

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.

Predicate Devices

• ENTire Irrigating Pump (K973286)
• Accessories to Endoscope (K932988)

Submission Summary (Full Text)

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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

1

#### 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: [phone]

Telefax: [phone]

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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)