IRIDIS OPHTHALMIC PHOTOCOAGULATOR

K023094 · Quantel Medical · HQF · Dec 17, 2002 · Ophthalmic

Device Facts

• Record ID: K023094
• Device Name: IRIDIS OPHTHALMIC PHOTOCOAGULATOR
• Applicant: Quantel Medical
• Product Code: HQF · Ophthalmic
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation 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 (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

Device Story

Iridis Ophthalmic Photocoagulator is an 810 nm diode laser system; consists of main console, controls, and foot switch. Device delivers coherent light energy to ocular tissue via independent delivery systems (slit lamp adapters, biomicroscopes, endoprobes, indirect ophthalmoscopes). Operated by clinicians in clinical settings. Laser energy causes photocoagulation or ablation of pigmented tissue. Output allows treatment of various retinal and choroidal conditions; aids in managing chronic glaucoma, diabetic retinopathy, and macular degeneration. Benefits include targeted tissue destruction for therapeutic ocular outcomes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

810 nm diode laser; console-based with foot switch control. Compatible with various third-party delivery systems (slit lamp adapters, endoprobes, etc.). Class II device. No specific materials or software algorithm details provided.

Indications for Use

Indicated for patients requiring photocoagulation or ablation of pigmented ocular tissue, including those with chronic glaucoma (refractory to conventional treatment), proliferative diabetic retinopathy, macular degeneration, AMD, and retinal detachments.

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

• Iris Medical OcuLight SL/SLx (K020374)
• Nidek DC-3300 (K013760)

Submission Summary (Full Text)

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# DEC 1 7 2002

#### SECTION 10

023094

#### 510(k) SUMMAR Y

This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Iridis Ophthalmic Photocoagulator is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Quantel Medical Address: QUANTEL MEDICAL 21 rue Newton Z.I. du Br zet 63039 Clermont-Ferrand Cedex 2 FRANCE [phone] [phone] (Fax) Contact Person: Mr. Jean Abascal : ([phone] ([phone] Preparation Date: September 2002 (of the Summary) Device Name: Iridis Ophthalmic Photocoagulator Ophthalmic Laser, 810 nm diode laser Common Name: Laser Surgical Instrument; 810 nm diode laser Classification Ophthalmic laser (see 21 CFR 886.4390) Name: Laser surgical instrument (see: 21 CFR 878.4810). Product Code: HOF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Iris Medical OcuLight SL/SLx (K020374); Nidek DC-3300 (K013760) The predicate lasers utilize several delivery systems, including slit lamp adapters, biomicroscopes, endoprobes, and indirect ophthalmoscopes to deliver the laser energy to the treatment site.

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The delivery systems used with the Iridis Ophthalmic Photocoagulator are the same as or similar to delivery systems supplied with or used with other ophthalmic photocoagulators operating at 810 nm. Quantel Medical has identified model or product numbers of the delivery systems which may be used with the Iridis Ophthalmic Photocoagulator. These devices are independently marketed by their respective manufacturers and are compatible for use with the Iridis Ophthalmic Photocoagulator.

- Device description: The Iridis Ophthalmic Photocoagulator consists of a main console with controls and a foot switch. The laser emits a coherent beam of light at 810 nm. Delivery systems attached to the laser then transmit the beam to treatment sites within the eye. The delivery systems are independent devices, manufactured by independent manufacturers, which attach to the Iridis Ophthalmic Photocoagulator either by direct connection at the laser aperture or through attachments, such as the slit lamp adapter.
- Indications: The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye.

Examples include:

photocoagulation 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 thegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

Performance Data: None required.

- Based on the information in this notification Quantel Medical concludes that the Iridis CONCLUSION: Ophthalmic Photocoagulator is substantially equivalent to the cited legally marketed predicates. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who are responsible for complying with applicable regulations and requirements.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quantel Medical Roger W. Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K023094

Trade/Device Name: IRIDIS Ophthalmic Photocoagulator Regulation Number: 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: September 13, 2002 Received: September 18, 2002

Dear Mr. Barnes:

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

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Page 2 - Mr. Roger W. Barnes

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.

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 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Cilia White

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### SECTION 7

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K023094

Device Name: Quantel Iridis Ophthalmic Photocoagulator_

Indications for Use Statement:

The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye.

Examples include:

photocoagulation 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 (recumbent patients),

transpupillary photocoagulation of choriodal neovasculature, and

age-related macular degeneration (AMD) treatments.

Wht

rev. 12/16/2002

Sign-Off) Division of General, Restorative and Neurological Devices

0230994 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use