MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL

K974469 · Mentor Corp. · HQC · Feb 24, 1998 · Ophthalmic

Device Facts

• Record ID: K974469
• Device Name: MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
• Applicant: Mentor Corp.
• Product Code: HQC · Ophthalmic
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2

Intended Use

The Mentor® Phacoemulsification SISTem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SISTem from a distance.

Device Story

Hand-held remote control accessory for Mentor Phacoemulsification SIStem; enables remote operation of system functions including IV pole height, memory access, mode changes, and parameter adjustments. Operates via wireless infrared (IR) signals (battery-powered) or hard-wired connection (console-powered). Used by operating room personnel in clinical settings to facilitate phacoemulsification procedures. Provides convenience and flexibility for the surgeon or staff by allowing control of the main console from a distance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hand-held remote control; wireless infrared (IR) transmission and hard-wired electrical connection; battery or console-powered; interfaces with Mentor Phacoemulsification SIStem console.

Indications for Use

Indicated for use by operating room personnel to control main functions of the Mentor Phacoemulsification SIStem from a distance.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• Alcon Series 2000 Legacy phacoemulsification system (K952213)
• Chiron Vision Catalyst phacoemulsification system (K925828)

Submission Summary (Full Text)

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K174464

MENTOR CORPORATION

Executive Offices

5425 Hollister Avenue

Santa Barbara, CA 93111

[phone]

# 510(k) SUMMARY

FEB 24 1998

Date: February 3, 1998

Submitter: Donna A. Crawford
Manager, Corporate Regulatory Affairs
Mentor Corporation
5425 Hollister Avenue
Santa Barbara, CA 93111
Phone: [phone]
Fax: [phone]

Trade or Proprietary
Name: Mentor® Phacoemulsification SIStem Remote Control

Common or usual name: Remote Control

Classification name: Phacofragmentation system (accessory), 21 CFR 886.4670

Description and Intended Use of Device:

The Mentor® Phacoemulsification SIStem Remote Control is an accessory to the Mentor Phacoemulsification SIStem. It is a combination wireless and hard-wired hand-held device that allows the operator to control certain aspects of the Mentor Phacoemulsification SIStem's operation from a distance. When using the remote in a wireless mode, signals are transmitted to the console via IR (infrared) signals. When using the remote in the hard-wired mode, signals are transmitted to the console directly through the wire. The remote can be powered either by battery (when used in the wireless mode) or from the SIStem console itself (when the hard-wired mode is used).

The Mentor Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.

Substantial Equivalence:

The Mentor Phacoemulsification SIStem Remote Control has the same intended use and the same technological characteristics, and is therefore substantially equivalent to, the remote controls used with the Alcon Series 2000 Legacy

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phacoemulsification system and the Chiron Vision Catalyst phacoemulsification system. The Alcon Legacy remote control and the Chiron Vision Catalyst remote control are full function, wireless, infrared remote controls. Please see the comparison table below.

COMPARISON TABLE

| Feature | Alcon Legacy Remote Control 510(k) K952213 | Chiron Vision Catalyst Remote Control 510(k) K925828 | Mentor Phacoemulsification SISTem Remote Control |
| --- | --- | --- | --- |
| Wireless Infrared Remote Control | YES | YES | YES, also may be hard-wired |
| Controls I.V. Pole Height | YES | YES | YES |
| Memory Access | YES | ? | YES |
| Mode Changes | YES | YES | YES |
| Performance Parameter Adjustments | YES | YES | YES |
| Hand motion sensor which initiates remote backlight for visibility in the dark | YES | ? | NO |
| Optional sterile cover | YES | ? | NO |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 24 1998

Donha A. Crawford
Manager, Corporate Regulatory Affairs
Mentor Corporation
5425 Hollister Ave.
Santa Barbara, Ca 93111

Re: K974469
Trade Name: Mentor Phacoemulsification SIStem Remote Control Regulatory Class: II
Product Code: 86 HQC
Dated: November 24, 1997
Received: November 26, 1997

Dear Ms. Crawford:

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 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 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Donna Crawford

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 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/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(K) Number: K974469

Device Name:
Mentor® Phacoemulsification SISTem Remote Control

Indications for Use:
The Mentor® Phacoemulsification SISTem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SISTem from a distance.

Prescription Use ☑
(Per 21 CFR 801.109)

Mareka L. Dusk, Director
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974469

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