(336 days)
Ophthalmology:
532nm Laser
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include:
- Slitlamp Integrated into CSO model SL980.
- Slitlamp Attachment for CSO model SL990 and other Haag Streit clones.
- Slitlamp Attachment for Zeiss model SL30 Slitlamp.
- Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
- Endophotocoagulation handpieces (Endoprobes).
This submission describes a medical laser system and focuses on its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
Key Takeaway: The submission for the LightLas Multi-Wavelength Medical Laser System (LightLas 532/670) focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through a novel study. This means the device's performance is inferred to be similar to legally marketed devices based on shared technological characteristics and intended use, not through a separate quantitative performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate devices | "The intended use has not changed from the predicate devices." (Explicitly stated) |
| Technological Characteristics | Same general design, fundamental scientific technology, functional elements (treatment wavelengths, treatment power, spot size, cooling system), control systems (door interlock, safety systems, displays) as predicate devices. No new hazards introduced. | "The LightMed Multi-wavelength Medical Laser system... has the same intended use, general design and fundamental scientific technology as the predicate devices... Also the operating controls and functions are equivalent to these products. They have the same functional elements such as treatment wavelengths, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored... There are no new hazards introduced..." (Explicitly stated) |
| Clinical Effectiveness | Equivalent to previously marketed products based on specifications affecting treatment modality. | "Therefore the Clinical effectiveness of the LightLas 532/670 is equivalent to the previously marketed products as these specifications are the key factors that will affect the treatment modality." (Explicitly stated) |
| Safety Testing | Met appropriate safety standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Performance Testing | Met appropriate performance standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Functional Testing | Met appropriate functional standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission is for a physical medical laser device, not a software or AI device that would typically use a test set of data. The "testing" mentioned refers to engineering and safety performance of the hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As above, this is not a data-driven AI/software device. The "ground truth" here is the established safety and effectiveness of the predicate devices in clinical practice, as recognized by the FDA through their previous clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No specific test set with human adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic or therapeutic device that involves "human readers" in the sense of interpreting medical images or data. It is a direct medical laser system for ophthalmic procedures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Indirect Ground Truth: Clinical Efficacy and Safety of Predicate Devices. The "ground truth" for this substantial equivalence claim is the well-established safety and efficacy of the predicate devices. The new device is deemed equivalent because its technological characteristics and intended use are the same, implying it will perform in a clinically similar and safe manner.
8. The sample size for the training set:
- Not applicable / Not provided. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
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Section 3 510(k) Summary or Statement
510(K) Summary
This is 510(K) summary in accordance with CFR807.82(c).
. . . . .
Submitter Information: A.
| Submitter: | LightMed Corporation |
|---|---|
| Address: | NO.1-1,Lane1, Pao-An St. Sec. 3, Shulin Dist., New Taipei City 23861, Taiwan |
| Owner/ Operation Number: | Mr. Gary Lee, President / 9040850 |
| Contact person: | Jocelyn Liu, Regulatory Affair |
TEL: +886-2-2688-1726
FAX: +886-2-2676-4920
B. Device Name
Product Name: LightLas Multi-Wavelength Medical Laser System Trade Name: LightLas 532/670
Common Name: Ophthalmic Laser, Surgical Laser
Classification Name:
86 HQF, Laser, Ophthalmic
79 GEX, Laser Power Surgical Instrument
Regulation Name:
21 CFR 886.4390, Ophthalmic Laser
21 CFR 878-4810, Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Performance standards: 21 CFR 1040.10 & 1040.11
Predicate Device Names: C.
(1) Ellex Integre Duo (K052777)
(2) Lumenis Nevus@ Varia'M Ophthalmic Laser and Delivery Devices (K022181)
(3) Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)
(4) LightMed Lightlas532 (K091534)
D. Device Description
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and
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various Laser Delivery Units (LDU's). The LDU's include:
- Slitlamp Integrated into CSO model SL980. .
- Slitlamp Attachment for CSO model SL990 and other Haag Streit clones. .
- Slitlamp Attachment for Zeiss model SL30 Slitlamp .
- . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
- Endophotocoagulation handpieces (Endoprobes) .
E. Intended Use
The LightLas 532 is an Ophthalmic Laser intended to coagulate or burn structures within the patient's eye and is suitable for performing the following clinical procedures: 532nm Laser:
- · Retinal Photocoagulation
- · Pan Retinal Photocoagulation
- · Endophotocoagulation
- · Macular photocoagulation to treat leaking vessels
- Laser Trabeculoplasty
670nm Laser:
-
· Retinal/Pan Retinal Photocoagulation
The intended use has not changed from the predicate devices. -
F. Technological Characteristics summary & Substantial Equivalence
The LightMed Multi-wavelength Medical Laser system of ophthalmic lasers, LightLas 532/670, has the same intended use, general design and fundamental scientific technology as the predicate devices (K052777, K022181, K042785, and K091534). Also the operating controls and functions are equivalent to these products. They have the same functional elements such as treatment wavelengths, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored in these systems for user intervention during a procedure or maintenance. There are no new hazards introduced by the Laser System as compared with the predicate devices. Therefore the Clinical effectiveness of the LightLas 532/670 is equivalent to the previously marketed products as these specifications are the key factors that will affect the treatment modality.
G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670 Multi-Wavelength Medical Laser system.
.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 3 2011
LightMed Corporation % Ms. Jocelyn Liu Regulatory Affair No. 1-1, Lane 1, Pao-An St. Sec. 3, Shulin Dist., New Taipei City 23861 Taiwan
Re: K103547
Trade/Device Name: LightLas Multi-Wavelength Medical Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: September 28, 2011 Received: October 05, 2011
Dear Ms. Liu:
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.
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Page 2 - Ms. Jocelyn Liu
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement as Requested by FDA
510(K) Number (if Known): ____________________________________________________________________________________________________________________________________________________ 103547
Product Name: LightLas Multi-Wavelength Medical Laser System Trade Name: LightLas 532/670
Indications for Use:
Ophthalmology:
532nm Laser ··
- · Retinal Photocoagulation
- Pan Retinal Photocoagulation
- · Endophotocoagulation
- · Macular photocoagulation to treat leaking vessels
- Laser Trabeculoplasty
670nm Laser
- Retinal/Pan Retinal Photocoagulation
The intended use has not changed from the predicate devices (K052777, K022181, K042785, and K091534)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR, Office of Device Evaluation (ODE)
Prescription Use:
Over-The-Counter Use: OR
(Per 21 CFR 801.109)
Nil R. Patil for mxm
ivision of Surgical, Orthopedic, nd Restorative Devices
510(k) Number_
§ 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.