K Number
K080423
Device Name
INTEGRE, MODEL LP581
Date Cleared
2008-03-11

(25 days)

Product Code
Regulation Number
886.4390
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ellex Integre is indicated for use in 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; - branch retinal vein occlusion; - 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 Description
The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
More Information

No
The device description focuses on the laser technology and optical components, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Yes
The device is used for photocoagulation of various eye conditions, which is a medical treatment designed to treat or alleviate diseases.

No

The device is described as a photocoagulator used for treatment (photocoagulation, iridotomy, iridectomy, suturelysis, and trabeculoplasty), not for diagnosing conditions.

No

The device description clearly describes a hardware device (ophthalmic photocoagulator) that produces laser pulses for treatment. It is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Ellex Integre is a photocoagulator that uses focused laser light to treat conditions within the eye. It directly interacts with the patient's eye for therapeutic purposes.
  • Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient. Its function is to deliver laser energy to specific anatomical sites within the eye.

Therefore, the Ellex Integre falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Ellex Integre is indicated for use in 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; -
    • branch retinal vein occlusion; ।
    • age-related macular degeneration;
    • retinal tears and detachments: -
    • retinopathy of prematurity; -
  • Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open . angle glaucoma

Product codes

HQF, GEX

Device Description

The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.

The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.

The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output.

The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea.

As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eye, retina, choroid

Indicated Patient Age Range

Not Found

Intended User / Care Setting

ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052777, K022181, K974732, K042785

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

MAR 1 1 2008

Image /page/0/Picture/1 description: The image shows a logo with the word "ellex" in white letters against a textured, dark circular background. The texture of the background appears to be made up of many small, closely spaced lines or dots, giving it a slightly rough or grainy appearance. The font used for "ellex" is simple and sans-serif, making the word easily readable despite the busy background.

82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 3 8104 5200 +61 8 3221 5551

Attachment 5: 510(k) Summary *Submitter's Name:

Submitter's Address:

Contact Person:

Contact Details:

Date Summary Prepared:

Trade Name of Modified Device: (For which this Special 510(k) is being submitted)

Common Name of Modified Device: (For which this Special 510(k) is being submitted)

Classification of Device:

Trade Name of Predicate Device:

Common of Predicate Device:

Classification of Device:

Description of the Device:

Special 510(k)

K080423

Ellex Medical Pty. Ltd. *Manufacturing and packaging.

82 Gilbert Street Adelaide, South Australia, 5000 AUSTRALIA

Kevin Howard, Senior Regulatory Officer

Tel +61 8 8104 5200 Fax +61 8 8221 5645 Email: khoward@ellex.com

December 13, 2007

Integre LP561

Photocoagulator Ophthalmic Laser

Class II, HQF; GEX, Ophthalmic Laser

Ellex Integre Duo LP1RG

Photocoagulator Ophthalmic Laser

Class II, Ophthalmic Laser

The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.

The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.

The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output.

The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the

1

Image /page/1/Picture/0 description: The image shows a logo for "ellex" inside of a circle. The word "ellex" is written in white, sans-serif font. The circle surrounding the word is black and white and appears to be made of many small lines. The logo is simple and modern.

82 Giberi Street Adelaide SA, 5000 Australia ���������� +61 8 2104 5200 +61 8 8221 5651

penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea.

As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.

The Integre Duo is a ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye. It is expected that the user is trained in operation of the instrument. This is the same intended use as previously cleared for Integre Duo laser 510(k) K052777

The Indications for Use statement can be found in Attachment 2

Refer to the following tables for a comparison of the Integre LP561 with the Integre Duo LP1RG and other commercially available predicate devices

Intended Use:

Comparison of Technological Characteristics:

2

| Characteristic compared | Integre LP561 | Integre Duo LP1RG;
510(k) K052777 | Lumenis Novus Varia;
510(k) K022181 | Nidek MC-7000;
510(k) K974732 | Nidek MC-300;
510(k) K042785 |
|-----------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------|
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG |
| Laser Wavelength | 561 nm (yellow) | 532 nm (green)
670 nm (red) | 532 nm (green)
561 nm (yellow)
659 nm (red) | 520.8-530.9 nm (green)
568.2 nm (yellow)
647.1 nm (red) | 532 nm (green)
561 nm (yellow)
659 nm (red) |
| Laser Power | 50-1500 mW (yellow) | 50-2000 mW (green)
50-1500 mW (red) | 50-1500 mW (green)
50-600 mW (yellow)
50-600 mW (red) | 50-900 mW (green)
50-1500 mW (yellow/green)
50-1000 mW (red) | 50-2000 mW (green)
50-700 mW (yellow)
50-700 mW (red) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 3.0 seconds adjustable in variable increments | 0.02 seconds to continuous adjustable in 21 increments | 0.01 to 3.0 seconds adjustable in variable increments |
| Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds | 0.05 to 3.0 | 0.2 to 1.0 seconds | 0.2 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV | 4/IV | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm parfocal, 1000 to 2000 um defocused | 50 to 900 µm |

3

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82 Gilbert Bireet
Adalalde SA, 6000 Australia
elleralde SA, 6000 Australia

-ﺴﺎ T, -

Characteristic comparedComparison Table - Aiming lasers of devices
Integre LP561Integre Duo LP1RGLumenis Novus VariaNidek MC-7000Nidek MC-300
Aiming Laser TypeSemi conductor laser diodeSemi conductor laser diodeSemi conductor laser diodeSemi conductor laser diodeDiode pumped solid-state
Aiming Laser Power