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

Device Description

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.

AI/ML Overview

The SOLX 790 Titanium Sapphire Laser is a medical device intended for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty. The device's performance was assessed through preclinical and clinical investigations to demonstrate substantial equivalence to a legally marketed predicate device, the COHERENT (LUMENIS) Ultima 2000 Argon Laser (K913127).

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the SOLX 790 Titanium Sapphire Laser are based on demonstrating substantial equivalence to the predicate device, K913127, in terms of intended use, safety, and effectiveness. The table below compares the key features and performance parameters of the SOLX 790 with the predicate device. The "Reported Device Performance" column reflects the specifications of the SOLX 790, which are deemed acceptable by showing equivalence or demonstrating that differences do not raise new questions of safety or effectiveness.

Feature / Performance Parameter	Predicate Device (Coherent Ultima 2000) Performance/Specification	Acceptance Criteria (Implied by Predicate Equivalence)	SOLX 790 Titanium Sapphire Laser Performance
Indications for Use	Treatment of ocular pathology including trabeculoplasty in open-angle glaucoma	Equivalent/Same Indications for Use	Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty
Clinical Treatment Power/Energy	50-1750 mW	Safe and effective range for trabeculoplasty	30-80 mJ
Pulse Duration	0.01-1.0 sec	Safe and effective for trabeculoplasty	7 +/- 2 microseconds
Laser Media	Argon	Different media is acceptable if demonstrated safe and effective	Titanium Sapphire
Wavelength	488/514 nm (blue-green)	Different wavelength is acceptable if demonstrated safe and effective	790 nm +/- 5 nm
Mode of Operation	CW (Continuous Wave)	Different mode is acceptable if demonstrated safe and effective	Pulsed
Spot Size	50-1000 µm	Safe and effective range for trabeculoplasty	200 um
Aiming Beam	Diode, variable intensity from barely visible to 1.5 mW	Visible and safe for eye targeting	Diode, variable intensity to < 5 mW
Laser Actuation	Footswitch	Standard and safe actuation method	Footswitch
Slit Lamp/Adapters	Laser compatible slit lamps	Compatible with standard ophthalmic equipment	Laser compatible slit lamp
Cooling System	Air cooled	Safe and effective cooling	Internal water cooled
Dimensions	47 cm x 20 cm x 60 cm (h x w x d) (18.5" x 8" x 24")	Practical and manageable size	Height: 38" (96 cm), Width: 16" (40 cm), Depth: 27" (68 cm) including cord wrap
Weight	30 kg (65 lbs)	Manageable weight	140 lbs (81 kg)
Electrical Requirements	100-120 VAC; 15-20 A, 220-240 VAC; 10 A, 50/60 Hz	Standard electrical compatibility	120 VAC/15 Amps (can also be run from 200-240 VAC service), approximately 500 Watts, 50-60 Hz

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states that "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." The overarching study design is one of demonstrating substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set of the clinical investigation, nor does it specify the country of origin of the data or whether the study was retrospective or prospective. It only broadly refers to "clinical investigations."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical investigation mentioned.

4. Adjudication Method:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth within the clinical investigation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The provided information does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The comparison is primarily between the new device's specifications and the predicate device's specifications, along with general statements about clinical data demonstrating safety and efficacy without a direct human reader comparison in the context of AI.

6. Standalone (Algorithm Only) Performance Study:

This device is a physical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The performance is of the laser system itself, operated by a physician.

7. Type of Ground Truth Used:

The ground truth for demonstrating the safety and effectiveness of the SOLX 790 Titanium Sapphire Laser would be based on clinical outcomes data related to intraocular pressure reduction and safety profiles in patients undergoing laser trabeculoplasty. This means the actual physiological changes and patient responses observed in the clinical investigation.

8. Sample Size for the Training Set:

This device is a hardware system, not an AI algorithm that requires a "training set" in the conventional machine learning sense. Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established:

As explained above, the concept of a "training set" and associated ground truth establishment is not relevant to this type of medical device submission.

Summary

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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) andCFR 878.4810 Product code GEX (laser surgicalinstrument).
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:

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 .

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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 toreduce intraocular pressure inpatients with poorlycontrolled intraocularpressure on maximallytolerated medical therapy orprior failed lasertrabeculoplasty	*Indicated for use in thetreatment of ocularpathology includingtrabeculoplasty in open-angle glaucoma
Clinical TreatmentPower/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, variableintensity to < 5 mW	Diode, variable intensity frombarely visible to 1.5 mW
Laser Actuation	Footswitch	Footswitch
Slit Lamp/Slit LampAdapters	Laser compatibleslit lamp	Laser compatible slitlamps
Cooling System	Internal watercooled	Air cooled
Dimensions	Height: 38" (96 cm)Width: 16" (40 cm)Depth: 27" (68 cm),including cord wrap	47 cm x 20 cm x 60 cm(18.5" x 8" x 24")(h x w x d)
Weight	Weight: 140 lbs(81 kg)	30 kg (65 lbs)
ElectricalRequirements	120 VAC/ 15 Amps- It can also be runfrom 200-240 VACservice.The system drawsapproximately 500Watts.50-60 Hz	100-120 VAC; 15-20 A220-240 VAC; 10 A50/60 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

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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.

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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.

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

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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)

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Division of Ophthalmic Ear, Nose and Throat Devises

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
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.(b)
Classification. Class II.