SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR

K081946 · Quantel Medical · HQF · Mar 25, 2009 · Ophthalmic

Device Facts

• Record ID: K081946
• Device Name: SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
• Applicant: Quantel Medical
• Product Code: HQF · Ophthalmic
• Decision Date: Mar 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532mm is intended to retinal photocoagulation in the following conditions: With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectorny surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractig ral getinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy. With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments. 810 nm Intended Use: The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810nm is intended to be used for : Phocoagulation or ablation of pigmented tissue within the eye, Transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), Limited and pan-retinal photocoagulation. Transpupillary photocoagulation, Endophotocoagulation, Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbentopations), transpupillary photocoagulation of choroidal neovasculature, and Age related macular desencerative (AMD) treatments.

Device Story

Supra Twin is an Nd:YAG ophthalmic laser system using a KTP crystal to deliver 532 nm and 810 nm wavelengths. Device delivers laser energy via slit lamp, indirect ophthalmoscope, or endocular probe for photocoagulation or ablation of ocular tissues. Operated by physicians in clinical settings. Output consists of controlled laser energy for treating retinal conditions, glaucoma, and choroidal neovascularization. System is a modification of existing Quantel Supra and Viridis Twin platforms. Benefits include precise tissue photocoagulation to manage sight-threatening conditions like diabetic retinopathy and retinal detachments.

Clinical Evidence

No clinical data. Bench testing only; device validated through non-clinical testing of laser performance and software.

Technological Characteristics

Nd:YAG laser with KTP crystal; dual wavelengths 532 nm and 810 nm. Delivery via slit lamp, indirect ophthalmoscope, or endocular probe. Class II ophthalmic laser. Software-controlled operation.

Indications for Use

Indicated for patients requiring retinal photocoagulation, including those with proliferative diabetic retinopathy, retinal detachments, proliferative vitreoretinopathy, choroidal neovascularization secondary to AMD, and macular degeneration. 810nm wavelength indicated for pigmented tissue ablation and transscleral ciliary body ablation in patients with chronic glaucoma unresponsive to conventional treatments.

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

• Quantel Supra (K070776)
• Quantel Viridis Twin (K023464)

Submission Summary (Full Text)

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# Quantel Medical Special 510(k) Supra Twin Ophthalmic Laser

510(k) Summary K081946

# (1) Submitter Information

Name: Quantel Medical

Address:

21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France

Telephone Number: 33-1-69-29-17-00

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: March 23, 2009

(2) Name of Device

Trade Name: Supra Twin Common Name: Ophthalmic Laser Classification name: Laser, ophthalmic

(3) Equivalent legally-marketed devices.

- 1. Quantel Supra (K070776)
- 2. Quantel Viridis Twin (K023464)

# (4) Description

The Quantel Supra Twin is a modification of the Quantel Supra (K070776) and the Quantel Viridis Twin (K023464). The SUPRA Twin laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery of itraocular

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endoprobe delivery. Both lasers are Nd: YAG laser using a KTP crystal at wavelengths of 532 nm. and 810 nm. Its basic improvement is the laser. Controls, indications, and methods of use are basically the me,

(5) Intended Use

The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532mm is intended to retinal photocoagulation in the following conditions:

With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.

With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectorny surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractig ral getinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.

With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.

810 nm Intended Use:

The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810nm is intended to be used for :

Phocoagulation or ablation of pigmented tissue within the eye,

Transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),

Limited and pan-retinal photocoagulation.

Transpupillary photocoagulation,

Endophotocoagulation,

Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbentopations), transpupillary photocoagulation of choroidal neovasculature, and Age related macular desencerative (AMD) treatments.

(6) Performance Data

(a) Non-clinical tests

Supra Twin has been extensively validated, both the laser itself and the software.

(b) Clinical tests

Clinical tests are not necessary, since Supra Twin uses the same technology as the predicate device,

(c) Conclusions

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Supra Twin is equivalent in safety and efficacy to the legally-marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stars above it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2.5 2009

Quantel Medical c/o Mr. George Myers, Sc.D. Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K081946

Trade/Device Name: Supra Twin Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: February 27, 2009 Received: March 3, 2009

Dear Mr. Myers:

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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## Page 2 - Mr. George Myers, Sc.D.

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. Eggleston, wid

Malvina B. Evdelman. 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

510(k) Number (if known):

Device Name: Supra Twin Ophthalmic Laser

532 nm Indications For Use:

The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm is indicated for retinal photocoagulation in the following conditions:

With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.

With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.

With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.

810 nm Indications For Use:

The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810mm is indicated for use for :

Phocoagulation or ablation of pigmented tissue within the eye,

Transcleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),

Limited and pan-retinal photocoagulation,

Transpupillary photocoagulation,

Endophotocoagulation.

Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choroidal neovasculature, and Age related macular degeneration (AMD) treatments.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices

510(k) Number k081946