(204 days)
No
The description focuses on the laser technology, integrated slit lamp, and control panel. There is no mention of AI, ML, image processing for analysis, or data sets for training/testing. The "semi-automated pattern generation method" is described in terms of pulse duration and spot size, not intelligent decision-making.
Yes
The device is described as "intended for use in the treatment of ocular pathology in the posterior segment" and lists various medical conditions it treats, indicating a therapeutic purpose.
No
The device is a laser system intended for the treatment of ocular pathology, not for diagnosis. Its purpose is photocoagulation of retinal and choroidal abnormalities.
No
The device description explicitly lists multiple hardware components including a Laser Console, TruScan integrated Slit Lamp, and Ophthalmic Instrument table. While software is mentioned and its verification/validation is discussed, the device is clearly an integrated hardware and software system.
Based on the provided information, the LightMed TruScan 577 Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The LightMed TruScan 577 Laser System is a therapeutic device. It uses a laser to directly treat ocular pathology in the posterior segment of the eye. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is for the treatment of various retinal and choroidal conditions.
- Device Description: The description details a laser system used for photocoagulation, a treatment method.
Therefore, the LightMed TruScan 577 Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- Clinically Significant Macular edema
- Choroidal neovascularization
- Branch and central retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- Lattice degeneration
- Retinal tears and detachments
Product codes
HQF
Device Description
LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table.
The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.
The LightMed TruScan 577 Laser System is comprised of the following functional components:
- LCD touch panel
- Laser Console
- Ophthalmic Instrument table
- TruScan integrated CSO Slitlamp (K992836)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment (of the eye), retina, choroid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologist
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
Bench Testing were completed including the Finished Product final assembly quality Inspection, System Adjustment, Calibration and Testing for Laser console and TruScan laser delivery unit on TruScan 577 Laser System.
Electrical safety and EMC testing were conducted on the TruScan 577 device, consisting of the laser console and TruScan module integrated Slitlamp. The system complies with the IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the TruScan 577 Laser System should perform as intended in the specified use conditions. The clinical evaluation data demonstrate that the TruScan 577 Laser System performs comparably to the predicate device that is currently marketed for the same intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2015
Lightmed Corp. Ms. Angel Hsieh Regulatory Affairs Coordinator No.1-1, Ln1,Pao-An St., Shulin Dist New Taipei City, 23861 Taiwan, R.O.C.
Re: K142172 Trade/Device Name: Lightmed Truscan 577 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: January 27, 2015 Received: January 28, 2015
Dear Ms. Hsieh:
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
1
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,
Kesia Y. Alexander -S
for Malvina B. Eydelman, MD Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142172
Device Name
LightMed TruScan 577 Laser System
The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
-
- Proliferative and Severe and very severe nonproliferative diabetic retinopathy
-
- Clinically Significant Macular edema
-
- Choroidal neovascularization
-
- Branch and central retinal vein occlusion
-
- The treatment of choroidal neovascularization associated with wet age-related macular degeneration
-
- Lattice degeneration
-
- Retinal tears and detachments
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This is 510(K) summery in accordance with 21 CFR 807.92.
I. SUBMITTER
LightMed Corporation No1-1, Ln1, Sec. 3 Pao-An St., Shulin Dist., New Taipei City 23861, Taiwan, R.O.C. TEL: +886 2 2688 1726 FAX: +886 2 2676 4920 Establishment registration number: 3008156177 Contact person in Taiwan: Angel Hsieh, Regulatory Affairs Coordinator Summary Preparation Date: February 25 2015
II. DEVICE
Trade name: LightMed TruScan 577 Laser System The common name of the device: Laser Instrument, surgical, powered & Laser, ophthalmic The classification name: 21 CFR 886.4390, Class II Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11
III. PREDICATE DEVICE
PASCAL Streamline 577 (with Accessories), K111108 This predicate has not been subject to a design-related recall .
IV. DEVICE DESCRIPTION
LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table.
The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.
4
The LightMed TruScan 577 Laser System is intended for use by ophthalmologist for treatment of ocular pathology.
The LightMed TruScan 577 Laser System is comprised of the following functional components:
- LCD touch panel
- Laser Console ●
- Ophthalmic Instrument table
- TruScan integrated CSO Slitlamp (K992836)
V. INDICATIONS FOR USE
The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- Clinically Significant Macular edema
- Choroidal neovascularization
- Branch and central retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- Lattice degeneration
- Retinal tears and detachments
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
TruScan 577 is compared with predicate as STANDARD type of Pascal Streamline 577 only.
| K number | K142172 | K111108 | Comparison of
Same or
Difference |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Company
name | LightMed Corporation | TOPCON Medical Laser
Systems | Similar |
| Device name | LightMed TruScan 577 | PASCAL Streamline 577 | |
| Indications
for Use | Proliferative and severe
and very severe
nonproliferative
diabetic retinopathy | The PASCAL® Streamline
577 (with Accessories) is
intended for use in the
treatment of ocular
pathology in the posterior
segment; Retinal
photocoagulation, panretinal
photocoagulation, focal
photocoagulation and grid
photocoagulation for
vascular and structural
abnormalities of the retina
and choroid including: | |
| | Macular edema | * proliferative and
nonproliferative diabetic
retinopathy | |
| | Clinically Significant
Choroidal
neovascularization | *macular edema | |
| | Branch and central
retinal vein occlusion | *choroidal
neovascularization | |
| | The treatment of
choroidal
neovascularization
associated with wet
age-related macular
degeneration | *branch and central retinal
vein occlusion | |
| | Lattice degenerationRetinal tears and
detachments | *the treatment of choroidal
neovascularization
associated with wet
age-related macular
degeneration
- lattice degeneration
*retinal tears and
detachments | |
| * retinopathy of prematurity
Intended for use in the
treatment of ocular
pathology in the anterior
segment including: - iridotomy
- trabeculoplasty | | | |
| Treatment Laser | | | |
| Wavelength | 577nm | 577nm | Same |
| Laser Type | OPSL-Optically Pumped
Semiconductor Laser | OPSL-Optically Pumped
Semiconductor Laser | Same |
| Power Output | 50-2000mW | 30-2000mW | Difference |
| Pulse Duration | 10ms to 3s, continuous | 5-1000ms | Difference |
| Pulsing System | Continuous | Continuous | Same |
| Integrated Slitlamp
Multi Spot size | 50(single spot
only),100,200,300,400 μm
selectable on Zoom
assembly of Delivery unit | Slitlamp Microscope
(integrated)
60,100,200,300,400 μm
delivered to the focal plane
of the slitlamp in air | Difference |
| Laser Safety Class | Class IV | Class IV | Same |
| Cooling method | Fan cooled and TEC's for
Laser Diode and Crystal | TEC/ Air cooled | Same |
| Aiming Beam | | | |
| Wavelength | 635nm red laser diode | 635nm Direct Diode | Same |
| Power output | Maximum of 1.0mW | Adjustable to