ENDO-SCRUB/ENDO-SCRUB 2

K982594 · Xomed, Inc. · EOB · Aug 27, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982594
• Device Name: ENDO-SCRUB/ENDO-SCRUB 2
• Applicant: Xomed, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Aug 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The Endo-Scrub 2 is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.

Device Story

Endo-Scrub 2 is an AC-powered, microprocessor-controlled pump system designed to maintain visualization during endoscopic sinus surgery. It consists of a pump unit, a foot control (or optional clip-on sheath switch), and an anodized aluminum sheath with an ABS handle. The device functions by performing irrigation and aspiration cycles to clear accumulated debris from the distal end of a rigid rod endoscope without requiring the surgeon to remove the scope from the surgical site. Operated by a surgeon or surgical staff in a clinical or OR setting, the device automates the cleaning process via a 'scrub cycle' initiated by the user. By maintaining a clear view, the device assists the surgeon in performing procedures with mechanical instruments or fiber optic lasers, potentially reducing procedure time and improving surgical outcomes.

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1-1 (General Safety Requirements) and IEC 60601-1-2 (Electromagnetic Compatibility). No clinical data provided.

Technological Characteristics

AC-powered microprocessor-controlled pump. Materials: Anodized aluminum sheath, ABS handle. Connectivity: Foot control or clip-on sheath switch. Standards: IEC 60601-1-1 (1988/1991/1995), IEC 60601-1-2 (1993).

Indications for Use

Indicated for patients undergoing routine diagnostic endoscopic procedures or endoscopic sinus surgery requiring visualization via rigid rod endoscopes, including use with mechanical instruments and lasers.

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

• Xomed Endo-Scrub (K902683/A)

Submission Summary (Full Text)

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XOMED

982594

K 982594

## 510(k) Summary of Safety and Effectiveness

- 1.0 Date Prepared July 23, 1998
### 2.0 Submitter (Contact) Debra B. Cortner Xomed Surgical Products Jacksonville, FL [phone]

### 3.0 Device Name

Proprietary Name:

Common Name(s): Classification Names:

Endo-Scrub/Endo-Scrub 2 (Previously known as ScopeScrubber per K902683/A) Suction/Irrigation device Rigid sinus endoscopes (nasopharyngoscopes) and accessories

### 4.0 Device Classification

Rigid sinus endoscopes and accessories Procode EOB Class II; 21CFR 874.4760

# 00065

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### Performance Standards 5.0

No performance standards have been adopted under Section 514 of the Act . This device will be tested to ensure compliance with the following voluntary standards:

Medical Electrical Equipment - Part 1: IEC 60601-1-1: 1988 General Safety Requirements (Amendment 1:1991; Amendment 2:1995)

IEC 60601-1-2: 1993 Medical Electrical Equipment - Part 1: General Safety Requirements 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests

### Device Description 6.0

The Endo-Scrub 2 Pump is an AC powered microprocessor controlled pump with adjustable irrigation and aspiration cycles. Pump action initiated by depression of the foot control or optional clip-on sheath switch results in a "scrub cycle". The Endo-Scrub 2 Sheath consists of an anodized aluminum sheath attached to an ABS handle with a Luer connector for irrigation tubing.

### 7.0 Intended Use

The Endo-Scrub 2 is intended to clear accumulated debris from the inserted end of the scope without removing the scope from the surgical site, maintaining visualization during the procedures. It is indicated for use with mechanical endoscopic sinus instruments and with fiber optic lasers in endoscopic nasal and sinus surgery

### Comparison of Characteristics to Substantial Equivalence Predicate 8.0

The Endo-Scrub 2 described is otherwise identical to the currently marketed Xomed Endo-Scrub (K902683/A) in general intended use, as well as in general technical characteristics and does not present new issues of safety or effectiveness.

Darlene B. Courtney

ebra B. Cortner Sr. Regulatory Affairs and Quality System Specialist

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Image /page/2/Picture/0 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1998

Debra B. Cortner Senior Regulatory Affairs and Quality System Specialist Xomed Surgical Products 6743 Southpoint Dr. N. Jacksonville, FL 32216-0980

Re:

K982594 Endo-Scrub/Endo-Scrub 2 Dated: July 23, 1998 Received: July 24, 1998 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB

Dear Mr. Cortner:

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 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 (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 cither 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 (OS) for Modical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will vertify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 5100k) 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 device on our labeling regulation (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/cdch/dsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K902683HA= 1/98,9594 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Endo-Scrub 2 Indications for Use:

The Endo-Scrub 2 is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site.

The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

revised 3/97

David C. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De

510(k) Number K982594

Or