(140 days)
No
The summary does not mention AI, ML, or any related technologies like deep learning or neural networks. The device description focuses on optical and laser delivery functions, and the performance studies are standard for medical devices, not indicative of AI/ML development or validation.
Yes
The device is intended to deliver laser energy for photocoagulation procedures to treat conditions of the eye, which directly impacts the patient's health.
No
The device is described as an optical instrument for viewing the posterior segment of the eye and for delivering laser energy for photocoagulation procedures. While viewing the eye can be part of diagnosis, its primary stated purpose, as an "ophthalmoscope," is for observation and treatment delivery, specifically photocoagulation. The device is not presented as providing a diagnosis or a diagnostic output, but rather as a tool for observation and therapeutic intervention.
No
The device is described as a "battery-powered optical instrument" and a "wireless headset," indicating it is a physical hardware device with optical components and a power source, not solely software. The performance studies also include electrical safety, electromagnetic compatibility, and light hazard testing, which are relevant to hardware devices.
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 Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is an optical instrument used for viewing the eye and delivering laser energy for treatment. It interacts directly with the patient's eye.
- Lack of Sample Analysis: The device does not analyze any samples taken from the patient's body. Its function is entirely focused on direct interaction with the eye for observation and treatment.
Therefore, the Smart LIO falls under the category of a therapeutic and diagnostic (imaging) medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).
The Smart LIO is indicated for use in the following photocoagulation procedures:
- Panretinal photocoagulation;
- Segmental peripheral photocoagulation;
- Retinopexy; and,
- Pediatric retinal repairs (under general anesthesia).
The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:
- Lumenis Novus Spectra Laser System;
- Lumenis Vision One Laser System; and
- Lumenis Smart532TM Laser System.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.
The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
posterior segment of the eye, peripheral retina of the eye, fundus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Performance testing was conducted in order to demonstrate the performance of the Smart LIO and its substantial equivalence, with respect to the safety and effectiveness of the cleared predicate device. The following activities were performed:
- Risk analysis activities in compliance with the requirements of ISO 14971.
- Electrical safety and electromagnetic compatibility testing as required to conform with the following performance standards:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - requirements and tests.
- Light hazard protection compatibility testing as required to conform with the following performance standard:
- ISO 15004-2 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection
- Verification and validation testing:
- The binocular viewing optics and illumination controls of the Binocular Indirect — Ophthalmoscope (by Keeler Instruments, Inc within their cleared device).
- The modification of the laser delivery optics were verified and confirmed the Smart LIO:
- Laser beam emission test for all laser wavelengths,
- Laser spot size test at working distance of 280mm for all wavelengths
- Aiming beam transmission testing through the Smart LIO.
- Eye safety filters transmission test; performed at laser treatment wavelengths of l 532nm, 577nm, 659 nm and aiming beam wavelength of 635nm
- Smart LIO communication to laser systems test; test preformed for all compatible laser systems for all connection modes.
- Environmental testing demonstrating the ability of the subject device to withstand variant operation, storage and transportation conditions.
Test results indicated that the subject Smart LIO performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the Smart LIO was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.
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.
K060822, K151109, K111213, K022327
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Lumenis Ltd. Naama Jacoby Head of Regulatory Affairs Ophthalmic Platform 6 Hakidma Street PO Box 240 Yokneam Industrial Park Yokneam, IL 2069204
Re: K162837
Trade/Device Name: Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart5327™ Laser System 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: January 22, 2017 Received: January 24, 2017
Dear Ms. Jacoby:
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
1
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 (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 (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) K162837
Device Name
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532TM Laser System
Indications for Use (Describe)
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).
The Smart LIO is indicated for use in the following photocoagulation procedures:
- Panretinal photocoagulation;
- Segmental peripheral photocoagulation;
- Retinopexy; and,
- Pediatric retinal repairs (under general anesthesia).
The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:
- Lumenis Novus Spectra Laser System;
- Lumenis Vision One Laser System; and
- Lumenis Smart532TM Laser System.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Lumenis, a company that provides energy to healthcare. The logo consists of a blue circle with a white "L" inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller blue font. The logo is simple and modern, and it conveys the company's focus on providing energy-based solutions for the healthcare industry.
510(K) SUMMARY
Smart Laser Indirect Ophthalmoscope (LIO);
Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
| Date Prepared: | February 26th, 2016 |
|---|---|
| Applicant Name | |
| and Address: | Lumenis Ltd. |
| 6 Hakidma Street PO Box 240 | |
| Yokneam Industrial Park, | |
| Yokneam 2069204. Israel | |
| Tel: +972-4-9599000 | |
| Fax: +972-4-9599046 | |
| Contact Person: | Naama Jacoby - Head of Regulatory Affairs Ophthalmic Platform |
| Lumenis Ltd. | |
| Tel: +972-4-9599085 | |
| Fax: +972-4-9599198 | |
| Mail: Naama.Jacoby@lumenis.com | |
| Trade Name: | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for |
| Lumenis Novus Spectra Laser System, Lumenis Vision One Laser | |
| System, and Lumenis Smart532™ Laser System | |
| Common Name: | Laser Indirect Ophthalmoscope (LIO) |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4810 |
| Panel: | General & Plastic Surgery |
| Predicate Device: | Laser Indirect Ophthalmoscope, Keeler model, cleared under K022181. |
| Reference Devices: | Keeler Vantage Plus Binocular Indirect Ophthalmoscope cleared under |
| K060822, Lumenis Smart532™ Laser System cleared under K151109, | |
| Lumenis Vision One Laser Systems, cleared under K111213 and | |
| Lumenis Novus Spectra Laser System cleared under K022327 |
4
Intended Use/ Indications for Use:
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).
The Smart LIO is indicated for use in the following photocoagulation procedures:
- Panretinal photocoagulation:
- Segmental peripheral photocoagulation;
- Retinopexy; and,
- Pediatric retinal repairs (under general anesthesia).
The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:
- Lumenis Novus Spectra Laser System;
- Lumenis Vision One Laser System; and
- Lumenis Smart532™ Laser System.
Modified Device Description:
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.
The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.
Technological Characteristics and Substantial Equivalence
The intended use and indications for use of the Smart LIO are the same as the selected predicate devices. In addition, the same technological characteristics and principles of operation apply for the Smart LIO and the predicate device. The modifications introduced to the subject Smart LIO as compared to the predicate device are designed and intended mainly for increased user convenience.
5
Comparison table of technological characteristics of the Smart LIO compared to those of the predicate device is provided below:
| Parameter | Lumenis
LIO, Keeler model (K022181)
(Predicate Device) | Lumenis
Smart LIO
(Subject device) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| LIO Headset | Keeler, Fison model | Keeler, Vantage Plus model
(K060822) |
| Lumenis Laser System
Compatibility | • Smart532 (K151109)
• Vision One (K111213)
• Novus Spectra (K022327)
• Novus Varia,
• Novus Verdi,
• Novus Omni,
• Novus 2000,
• Ultima & Ulima SE, | • Smart532 (K151109)
• Vision One (K111213)
• Novus Spectra (K022327) |
| Laser Source &
Wavelengths Compatibility: | | |
| • Laser Source: | Nd:YAG, Argon, Krypton | Nd:YAG, DPSS, Nd:GdVO4 |
| • Treatment beam: | 532, 561, 659 nm | 532, 577, 659 nm |
| • Aiming beam: | 635nm | 635nm |
| Spot Sizes,
at LIO focal plane | $910 \mu m \pm 10%$ | $1100 \mu m \pm 20%$ |
| Working distance: | 366 mm (14.41") | 280mm (11.02") |
| Eye Safety Filter | Fixed, blocking treatment
wavelengths, OD>5 | Fixed, blocking treatment
wavelengths, OD>5 |
| Transmission: | >70% | >70% |
| Optical Fiber Length | 4.6 meters | 5 meters |
| Illumination source | Xenon Bulb | LED |
| Dimensions (HxWxL): | | |
| • Headset | 17.7cm x 20.3cm x 40.6cm | 18.0-22.0cm× 25.0cm × 30.0-38.0cm |
| • Power Supply / Charging
Station | 26.1cm x 23.1cm x 36cm | 12.0cm x 18.4cm x 20.7cm |
| Weight: | | |
| • Headset | 545 grams (1.2lbs) | 800 grams (1.87 lbs) |
| • Power Supply / Charging
Station | 5.44 Kg (12 lbs) | 0.4 Kg |
| Electrical Requirements | Power Supply;
• Voltage: 120/230V AC±10%;
• Frequency:50/60Hz
• Current: 0.8 Amp max | Charging Station;
• Voltage: 100-240V AC,
• Frequency: 50/60Hz,
• Current: 0.7 Amp max |
Lumenis Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser 510(k) Summary - Page 3 System, Lumenis Vision One Laser System, and Lumenis Smart532TM Laser System
6
Performance testing was conducted in order to demonstrate the performance of the Smart LIO and its substantial equivalence, with respect to the safety and effectiveness of the cleared predicate device. The following activities were performed:
- Risk analysis activities in compliance with the requirements of ISO 14971.
- Electrical safety and electromagnetic compatibility testing as required to conform with the following performance standards:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic । safety and essential performance.
- । IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - requirements and tests.
- . Light hazard protection compatibility testing as required to conform with the following performance standard:
- ISO 15004-2 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection
- Verification and validation testing: ●
- The binocular viewing optics and illumination controls of the Binocular Indirect — Ophthalmoscope (by Keeler Instruments, Inc within their cleared device).
- । The modification of the laser delivery optics were verified and confirmed the Smart LIO:
- Laser beam emission test for all laser wavelengths,
- Laser spot size test at working distance of 280mm for all wavelengths
- " Aiming beam transmission testing through the Smart LIO.
- Eye safety filters transmission test; performed at laser treatment wavelengths of l 532nm, 577nm, 659 nm and aiming beam wavelength of 635nm
- -Smart LIO communication to laser systems test; test preformed for all compatible laser systems for all connection modes.
- Environmental testing demonstrating the ability of the subject device to withstand variant ● operation, storage and transportation conditions.
Test results indicated that the subject Smart LIO performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the Smart LIO was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.