VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551

K080803 · American Optisurgical, Inc. · HQC · Sep 22, 2008 · Ophthalmic

Device Facts

• Record ID: K080803
• Device Name: VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
• Applicant: American Optisurgical, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Sep 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy, a process known as phacoemulsification.

Device Story

Vizual™ Phacoemulsification System is an anterior segment surgical system for cataract removal. It provides irrigation, ultrasonic (U/S) phacoemulsification, irrigation/aspiration (I/A), vitrectomy, and coagulation. System includes phaco unit, U/S handpiece, tubing cartridge, and foot pedal; compatible with standard phaco tips, sleeves, vit cutters, and cautery tools. Features non-invasive vacuum sensing with external tubing cartridge that vents to bottle to minimize contamination. Operated via LCD touch panel; supports up to 24 user profiles. Optional cart with electric I/V pole allows software-controlled bottle height. Used by surgeons in clinical settings to perform phacoemulsification, facilitating cataract extraction and potentially improving patient visual outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

System includes LCD touch screen, peristaltic pump (low pulsation), and external fluid path. Vacuum range: 0-500 mmHg; Aspiration rate: 0-50 cc/min. Modes: Irrigation, Phaco, I/A, Vitrectomy, Coagulation. Features non-invasive vacuum sensing and external tubing cartridge. Software-controlled I/V pole height. Standalone or cart-mounted. Sterilization/biocompatibility assumed via compliance with standard surgical device requirements.

Indications for Use

Indicated for the disruption and extraction of cataractous lens material from the eye via phacoemulsification.

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

• Horizon Phacoemulsification System (K020527)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 2 2 2008

. . . . .

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

:

.

K080803

:

## 510(k) Summary

| 510(k) Submitter/<br>Owner | Herbert Cameron III<br>President<br>American Optisurgical, Inc.<br>Email: [e-mail] |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | David Salzberg<br>Director of Regulatory Affairs<br>American Optisurgical, Inc.<br>Email: [e-mail] |
| Date prepared | 03/20/2008 |
| Trade name | Vizual™ Phacoemulsification System, Model 551 |
| Common name | Phacoemulsification System |
| Classification | Phacofragmentation system (21 CFR 886.4670, Product<br>Code HQC) |
| Predicate device | K020527, Horizon Phacoemulsification System<br>(manufactured by American Optisurgical, Inc.) |
| Device description | The Vizual™ Phacoemulsification system is a complete<br>anterior segment surgical system, offering Irrigation, Phaco<br>or Ultrasonic (U/S), Irrigation/Aspiration (I/A),<br>Vitrectomy, and Coagulation modes of operation. The<br>device can be operated as a standalone unit, or connected to<br>an optional cart with electric I/V pole where bottle height<br>can be controlled by the software.<br>The Vizual™ Phacoemulsification System includes the<br>Phaco unit, U/S handpiece, tubing cartridge, and foot pedal.<br>The device has been designed to work with commercially<br>available (and 510k cleared) components and accessories<br>including Phaco tips and sleeves, vit cutters, cautery<br>pencils, and cautery forceps.<br>The Vizual™ Phacoemulsification System utilizes a non-<br>invasive vacuum sensing system including an external<br>tubing cartridge that vents to the bottle versus air, thus |
| | minimizing the possibility of introducing contamination<br>into the fluid path. The external tubing cartridge design is<br>advantageous as the fluid path is visible to the user, and can<br>be easily installed or removed in a single step. |
| | The Vizual™ Phacoemulsification System uses a LCD<br>touch panel interface to allow access to all modes of<br>operation. The system software allows for storing up to<br>twenty-four different user profiles. |
| Intended use | The Vizual™ Phacoemulsification System is intended for<br>use in the disruption and extraction of cataractous lens<br>material from the eye with ultrasonic energy, a process<br>known as phacoemulsification. |
| Technological<br>characteristics | The Vizual™ Phacoemulsification System has the same<br>technological characteristics as the predicate device cleared<br>under 510(k) K020527. A summary is as follows: |

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

| Device<br>Characteristics | Subject Device | Predicate Device |
|---------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Display | LCD Touch Screen | LCD Touch Screen |
| Pump | Peristaltic, low pulsation | Peristaltic, low pulsation |
| Pump Vacuum<br>Range | 0 to 500 mmHg | 0 to 500 mmHg |
| Aspiration Rate | 0 to 50 cc/min | 0 to 50 cc/min |
| Fluidics | External Fluid Path | External Fluid Path |
| System Tubing | Tubing/Cartridge unit (reusable<br>and disposable models) | Tubing/Cartridge unit (reusable<br>and disposable models) |
| Vent | Fluid Vent | Fluid Vent |
| Modes | Irrigation, Phaco,<br>Irrigation/Aspiration (I/A),<br>Vitrectomy, and Coagulation | Irrigation, Phaco,<br>Irrigation/Aspiration (I/A),<br>Vitrectomy, and Coagulation |
| Programmable User<br>Parameters | Yes | Yes |

Table II – Summary of Device Characteristics

:

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2008

American Optisurgical, Inc. c/o David Salzberg 25501 Arctic Ocean Lake Forest, CA 92630

Re: K080803

Trade/Device Name: Vizual™ Phacoemulsification System, Model 551 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification System Regulatory Class: II Product Code: HQC Dated: August 20, 2008 Received: August 20, 2008

Dear Mr. Salzberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, perror to your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems on 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maling B. Egleston, und

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K080803

Device Name: Vizual™ Phacoemulsification System

Indications for Use: The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K080803

Page 4-1