(55 days)
Not Found
No
The document describes a laser delivery system for medical procedures and does not mention any AI or ML capabilities.
Yes.
The device is intended for incision, coagulation, vaporization, ablation, and vessel hemostasis in various medical specialties, including ophthalmology, ENT, and dermatology, and is used to treat conditions such as diabetic retinopathy, glaucoma, and vascular lesions. These applications definitively classify it as a therapeutic device.
Yes
The "Device Description" states: "Iridex TruFocus LIO Premiere... is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina." The term "diagnostic" explicitly indicates its function as a diagnostic device.
No
The device description explicitly states it is a "headmounted diagnostic indirect ophthalmoscope" and a "laser delivery device," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device is used to deliver laser energy to the patient's tissues (skin, ear, eye) for treatment purposes (incision, coagulation, vaporization, ablation, photocoagulation, etc.).
- The device is a therapeutic laser system. It is used for surgical and treatment procedures, not for analyzing biological samples to diagnose a condition.
The device is a medical device used for direct treatment of patients, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810mm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
532 nm:
Dermatology:
- · Pigmented Skin Lesions
- · Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- · Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- Primary open angle/Closed angle
577nm
Dermatology:
- · Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation 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, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma
810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
-
Retinal photocoagulation for the treatment of:
-
Diabetic retinopathy, including:
- . Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
-
Retinal Tears, Detachments and Holes
-
Lattice degeneration
-
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
-
Retinopathy of prematurity
-
Sub-retinal (choroidal) neovascularization
-
Central and Branch Retinal Vein Occlusion
-
Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
-
Primary open angle
-
Closed angle
-
Refractory Glaucoma (recalcitrant/uncontrolled)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position.
The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse.
Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and fibrous tissue, including osseous tissue, retina, choroid,
Indicated Patient Age Range
infants
Intended User / Care Setting
Not Found
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)
The ISO 15004-2 testing proves that the proposed device design meets the accepted design standards for this type of device. Additionally, testing to the following standards IEC60601-2, IEC60601-1, IEC60825-1, IEC60601-2-22, IEC60601-1-6 and IEC62366 prove the safety and effectiveness of this device. A comparison of the technological characteristics proves that technological differences do not raise different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
Iridex Corporation Gloria Dy Regulatory Compliance Associate 1212 Terra Bella Avenue Mountain View, CA 94043-1824
Re: K170718
Trade/Device Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 7, 2017 Received: March 9, 2017
Dear Gloria Dy:
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.
1
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 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.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Denise L. Hampton -S
for 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
2
Indications for Use
510(k) Number (if known) K170718
Device Name
Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532m], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
Indications for Use (Describe)
The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810mm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
532 nm:
Dermatology:
- · Pigmented Skin Lesions
- · Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- · Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- Primary open angle/Closed angle
577nm
Dermatology:
- · Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :
- Proliferative and nonproliferative diabetic retinopathy;
3
- Choroidal neovascularization;
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma
810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
- Retinal photocoagulation for the treatment of:
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
-
Retinal Tears, Detachments and Holes
-
Lattice degeneration
-
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
-
Retinopathy of prematurity
-
Sub-retinal (choroidal) neovascularization
-
Central and Branch Retinal Vein Occlusion
-
Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
-
Primary open angle
-
Closed angle
-
Refractory Glaucoma (recalcitrant/uncontrolled)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
Summary prepared on Date: April 27, 2017
510(k) Submitter/Holder:
Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Contact:
Gloria Dy Regulatory Compliance Associate Telephone: 650-605-8807 Fax: 650-962-0486 Email: gdy@iridex.com
Name of Device:
Trade Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IO 577 [577nm], IQ 630-670 [630mm-670mm], hand pieces, delivery devices & accessories
| Common Name: | Laser Indirect Ophthalmoscope |
|---|---|
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |
Predicate Device:
| Trade Name: | Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope |
|---|---|
| Common Name: | Laser Indirect Ophthalmoscope |
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |
| 510(k) Number: | K071687 |
| Manufacturer: | IRIS Medical Instruments, Inc. /Iridex Corporation |
Device Description:
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position.
Premarket Notification Traditional 510(k) Page 1 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
6
The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse.
Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).
Intended Use:
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulseTM or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
532 nm:
Dermatology:
- · Pigmented Skin Lesions
- Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology:
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- Lysis of Adhesions
- Control of Bleeding
- Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
Premarket Notification Traditional 510(k)
Page 2 of 6
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
7
- Proliferative retinopathy
- Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- Primary open angle/Closed angle
577nm
Dermatology:
- · Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation 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, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
Premarket Notification Traditional 510(k) Page 3 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
8
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion:
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma
810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
-
Retinal photocoagulation for the treatment of:
-
Diabetic retinopathy, including:
- . Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
-
Retinal Tears, Detachments and Holes
-
Lattice degeneration
-
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
-
Retinopathy of prematurity
-
Sub-retinal (choroidal) neovascularization
-
Central and Branch Retinal Vein Occlusion
-
Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
-
Primary open angle
-
Closed angle
-
Refractory Glaucoma (recalcitrant/uncontrolled)
Technological Characteristics:
Premarket Notification Traditional 510(k) Page 4 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
9
The technological characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 630-670 [630mm-670mm], and 10 810 [810mm]), hand pieces, delivery devices & accessories are substantially equivalent to those of the predicate device. Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope (K071687). See Table 8-1 below.
Safety and Effectiveness:
The ISO 15004-2 testing proves that the proposed device design meets the accepted design standards for this type of device. Additionally, testing to the following standards IEC60601-2, IEC60601-1, IEC60825-1, IEC60601-2-22, IEC60601-1-6 and IEC62366 prove the safety and effectiveness of this device. A comparison of the technological characteristics proves that technological differences do not raise different questions of safety and effectiveness.
Conclusion:
The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be substantially equivalent to the predicate device - Iridex TruFocus LIO+ (K071687).
The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories shares identical indications for use, similar design features, and functional features with the predicate Iridex TruFocus LIO+ and therefore is substantially equivalent.
The Iridex TruFocus LIO Premiere with the Family of Iridex® IO Laser Systems (10 532 [532m], IO 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be as safe, as effective and performs as well as or better than the predicate Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope.
Table 8-1: Salient characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 577 [577nm], 10 630-670 [630nm-670nm], and 10 810 [810mm]), hand pieces, delivery devices & accessories and the predicate devices.
| | Iridex TruFocus LIO Premiere with
the Family of Iridex® IQ Laser
Systems (IQ 532 [532nm], IQ 577
[577nm], IQ 630-670 [630nm-
670nm], IQ 810 [810nm]), hand
pieces, delivery devices & accessories | Iridex TruFocus LIO+ Laser
Indirect Ophthalmoscope |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) applied and
(predicate devices) | New device for which this Traditional
510(k) is being submitted | 510(k) number: K071687 |
| Classification
Product Code | GEX - Powered Laser Surgical
Instrument | GEX - Powered Laser Surgical
Instrument |
| Intended Use | Retinal photocoagulation. | Retinal photocoagulation. |
| Type/Design | Indirect Ophthalmoscope Binocular
(Headband mounted) | Indirect Ophthalmoscope Binocular
(Headband mounted) |
| Treatment
Wavelength | 532nm, 577nm, 810nm | 532nm, 577nm, 810nm, 630nm, 670nm |
Premarket Notification Traditional 510(k)
Page 5 of 6
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
10
| Eye Filter OD | 6 @ 532 nm & 577nm, 2 @ 810 nm | 6 @ 532 nm & 577nm, 2 @ 810 nm |
|---|---|---|
| Working Distance | 370mm +/- 10mm | 370mm +/- 10mm |
| Fiber Length | 13'8" | 13'8" |
| Aerial Spot Size | Standard LIO spot size: 1.1mm | |
| (0.043in) ±10% | Standard LIO spot size: 1.1mm | |
| (0.043in) ±10% | ||
| Large LIO spot size: 4.0mm (0.157in) | ||
| ±10% | Large LIO spot size: 4.0mm (0.157in) | |
| ±10% | ||
| Illumination Source | LED Illumination light source standard | |
| with optional Halogen bulb | Halogen Lamp | |
| Cooling System | Air Cooled | Air Cooled |
| Electrical | Heine rechargeable battery. Operates | |
| on 100-240VAC, 50/50Hz. Optional | ||
| wall plug in charger. | 6V DC from Iridex Laser console | |
| Weight | ≤ 1000gm (2.2 lbs.) with battery | |
| installed | 1.2 lbs. |
Premarket Notification Traditional 510(k) Page 6 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories