Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow

K142398 · Ellex Medical Pty, Ltd. · HQF · Jul 14, 2015 · Ophthalmic

Device Facts

• Record ID: K142398
• Device Name: Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
• Applicant: Ellex Medical Pty, Ltd.
• Product Code: HQF · Ophthalmic
• Decision Date: Jul 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ellex Integre Pro Scan is indicated for use photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - retinal vein occlusion; - wet age-related macular degeneration; - retinal tears and detachments; - retinopathy of prematurity; - Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Device Story

Integre Pro Scan is an ophthalmic laser system for photocoagulation of anterior and posterior eye segments. Device delivers laser energy to treat vascular and structural retinal/choroidal abnormalities and glaucoma-related conditions. Operated by ophthalmologists in clinical settings. System utilizes scanning technology to facilitate precise laser delivery. Output is controlled laser energy; assists clinicians in performing therapeutic procedures to manage retinal diseases and glaucoma. Benefits include non-invasive or minimally invasive treatment of ocular pathologies.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ophthalmic laser system; utilizes scanning technology for laser delivery. Designed for anterior and posterior segment photocoagulation. System architecture includes laser source, delivery optics, and scanning mechanism. Complies with applicable ophthalmic laser safety standards.

Indications for Use

Indicated for patients requiring photocoagulation of anterior and posterior eye segments, including those with diabetic retinopathy, choroidal neovascularization, retinal vein occlusion, wet age-related macular degeneration, retinal tears/detachments, retinopathy of prematurity, and glaucoma (angle closure or open angle).

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

• Ellex Integre Pro (K113566)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 14, 2015

Ellex Medical Pty Ltd Dr. Merricc Edgar-Hughes Regulatory Affairs Officer 82 Gilbert St., Adelaide, SA 5000 Australia

Re: K142398

> Trade/Device Name: Integre Pro Scan Ophthalmic Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: May, 29, 2015 Received: June 3, 2015

Dear Dr. Edgar-Hughes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman 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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510(k) Number (if known): __ K142398

Device Name: Integre Pro Scan

Indications for Use:

The Ellex Integre Pro Scan is indicated for use photocoagulation of both anterior and posterior segments of the eye including:

- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural . abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization; .
- retinal vein occlusion; - -
- wet age-related macular degeneration; :
- retinal tears and detachments; -
- retinopathy of prematurity; -
- Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle . glaucoma

X Prescription Use _ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (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)

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