SOLX 790 TITANIUM SAPPHIRE LASER

K081774 · Solx, Inc. · HQF · Sep 12, 2008 · Ophthalmic

Device Facts

• Record ID: K081774
• Device Name: SOLX 790 TITANIUM SAPPHIRE LASER
• Applicant: Solx, Inc.
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty

Device Story

SOLX 790 Titanium Sapphire Laser is a flashlamp-pumped ophthalmic laser for trabeculoplasty. System components include electronics module, laser optical head, control panel, slit lamp, and footswitch. Physician operates device in clinical setting; uses Goldman goniolens to visualize trabecular meshwork. Device delivers 790 nm pulsed laser energy (30-80 mJ, 8 microsecond duration) via optical fiber to slit lamp. Visible diode aiming beam assists physician in targeting. Laser energy application reduces intraocular pressure in patients with poorly controlled glaucoma. Internal water cooling system manages thermal output.

Clinical Evidence

Preclinical and clinical data provided to support safety and effectiveness for trabeculoplasty in patients with poorly controlled intraocular pressure or prior failed laser trabeculoplasty. Hazard analysis also performed.

Technological Characteristics

Flashlamp-pumped Titanium Sapphire laser; 790 nm wavelength; pulsed operation; 30-80 mJ energy; 8 microsecond pulse duration; 200 micron spot size; internal water cooling; footswitch actuation; slit lamp delivery; 120/240 VAC power.

Indications for Use

Indicated for patients with poorly controlled intraocular pressure despite maximally tolerated medical therapy or those with prior failed laser trabeculoplasty.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• ULTIMA 2000 ARGON LASER (K913127)

Submission Summary (Full Text)

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

K081774

## Revised August 11, 2008

SEP 1 2 2008

#### 510(k) Summary of safety and effectiveness

| APPLICANT | SOLX, Inc. |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| TRADE NAME: | SOLX 790 Titanium Sapphire Laser |
| COMMON NAME: | Ophthalmic Laser |
| CLASSIFICATION NAME: | Ophthalmic lasers for use in laser trabeculoplasty |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | CFR 886.4390 Product code HQF (laser, ophthalmic) and<br>CFR 878.4810 Product code GEX (laser surgical<br>instrument). |
| PREDICATE DEVICE: | ULTIMA 2000 ARGON LASER K913127 |

USER FEE PAYMENT ID:

## SUBSTANTIALLY EQUIVALENT TO:

| COHERENT (LUMENIS) | Ultima 2000 Argon Laser | K913127 |
|--------------------|-------------------------|---------|
|--------------------|-------------------------|---------|

The SOLX 790 Titanium Sapphire Laser is substantially equivalent in intended of action to the Coherent/Lumenis Ultima 2000 Argon Laser approved under K913127.

# 5.1 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SOLX 790 Titanium Sapphire system is a flashlamp-pumped laser intended for use in performing laser trabeculoplasty. The laser operates at a wavelength of 790 nanometers (nm), and delivers user-selectable pulse energies of 30-80 millijoules (mJ), with nominal pulse duration of 8 microseconds (7+2usec) and a nominal spot size of 200 microns (um). A footswitch activates the laser to deliver pulses of laser energy through an optical fiber to a slit lamp. A trained physician then directs the laser pulses exiting the slit lamp to the desired regions of the trabecular meshwork inside the eye using a Goldman goniolens. A low power, visible aiming beam allows the physician to direct the treatment laser pulses.

#### PRODUCT INFORMATION

The laser is comprised of the following functional components:

- Electronics Module .
- Laser Optical Head
- Control Panel .
- Slit Lamp/Slit Lamp Table ●
- Covered Footswitch .

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

Table A Comparison of SOLX 790 Titanium Sapphire Laser and Predicate Device

| | SOLX | Coherent Ultima 2000 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | 790 Titanium | Argon Ophthalmic Laser |
| | Sapphire | K913127 |
| | Ophthalmic Laser | |
| Indications for Use | Laser trabeculoplasty to<br>reduce intraocular pressure in<br>patients with poorly<br>controlled intraocular<br>pressure on maximally<br>tolerated medical therapy or<br>prior failed laser<br>trabeculoplasty | *Indicated for use in the<br>treatment of ocular<br>pathology including<br>trabeculoplasty in open-<br>angle glaucoma |
| Clinical Treatment<br>Power/Energy | 30-80mJ | 50-1750 mW |
| Pulse duration | 7±2 microseconds | 0.01-1.0 sec |
| Laser Media | Titanium Sapphire | Argon |
| Wavelength | 790 nm ± 5 nm | *488/514 nm (blue-green) |
| Mode of Operation | pulsed | CW |
| Spot Size | 200 um | *50-1000 µm |
| Aiming Beam | Diode, variable<br>intensity to < 5 mW | Diode, variable intensity from<br>barely visible to 1.5 mW |
| Laser Actuation | Footswitch | Footswitch |
| Slit Lamp/Slit Lamp<br>Adapters | Laser compatible<br>slit lamp | Laser compatible slit<br>lamps |
| Cooling System | Internal water<br>cooled | Air cooled |
| Dimensions | Height: 38" (96 cm)<br>Width: 16" (40 cm)<br>Depth: 27" (68 cm),<br>including cord wrap | 47 cm x 20 cm x 60 cm<br>(18.5" x 8" x 24")<br>(h x w x d) |
| Weight | Weight: 140 lbs<br>(81 kg) | 30 kg (65 lbs) |
| Electrical<br>Requirements | 120 VAC/ 15 Amps<br>- It can also be run<br>from 200-240 VAC<br>service.<br>The system draws<br>approximately 500<br>Watts.<br>50-60 Hz | 100-120 VAC; 15-20 A<br>220-240 VAC; 10 A<br>50/60 Hz |

## 5.2 INDICATION FOR USE: SOLX 790 TITANIUM

Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.

## 5.3 RATIONALE FOR SUBSTANTIAL EQUIVALENCE

The Titanium Sapphire Laser shares the same indications for use and similar design features (treatment area, aiming beam, delivery system, similar cooling system, and control system) as the predicate device. The Titanium Sapphire Laser has different functional features from the predicate device, including energy delivered and spot size. The effects of the new functional

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

features in performing trabeculoplasty have been assessed through preclinical and clinical investigations. The data obtained from these investigations demonstrate that the Titanium Sapphire Laser is substantially equivalent to the predicate laser system.

## 5.4 SAFETY AND EFFECTIVENESS INFORMATION

Preclinical and clinical data was provided to demonstrate that the Titanium Sapphire is safe and effective for use in trabeculoplasty to reduce intraocular pressure in patients with poorly controlled or elevated intraocular pressure or prior failed laser trabeculoplasty.

In addition, hazard analysis information was provided.

## 5.5 CONCLUSION

The Titanium Sapphire Laser is substantially equivalent to currently marketed predicate laser device. The device shares the same intended use/indications for use and other basic system characteristics as the predicate laser system. Preclinical study results demonstrate the substantial equivalence as well as the safety and effectiveness of the Titanium Sapphire Laser for use in trabeculoplasty.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

SOLX, Inc. c/o Mr. Doug Adams President SOLX, Inc. 890 Winter Street, Suite 115 Waltham, MA 02451

Re: K081774

Trade/Device Name: SOLX 790 Titanium Sapphire Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: June 19, 2008 Received: June 26, 2008

Dear Mr. Adams:

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.

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

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 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), 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 Postmarket 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 at 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,

Malvina B. Edwards, and

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

{5}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): _ 130 Ko 8/774

Device Name: SOLX 790 Titanium Sapphire Laser

Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joe Calloway
(Division Sign-Off)

Page *_ of _*

Division of Ophthalmic Ear, Nose and Throat Devises

Page *_ of _*

510(k) Number_________________________________________________________________________________________________________________________________________________________________