(90 days)
Not Found
No
The summary describes a laser delivery system for ophthalmic treatment and does not mention any AI or ML components, image processing, or performance studies typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye," which directly describes a therapeutic application.
No
The device is described as an ophthalmoscope intended for "photocoagulating ocular tissue in the treatment of diseases." Its main purpose is the "delivery of the laser light." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the LIO-500's main purpose is the "delivery of the laser light," indicating it is a hardware component that physically interacts with the patient's eye. It also mentions being used with an indirect ophthalmoscope, which is a hardware device for observation.
Based on the provided information, the Laser Indirect Ophthalmoscope 500 (LIO-500) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "photocoagulating ocular tissue in the treatment of diseases of the eye." This is a therapeutic procedure performed directly on a patient's body (in vivo).
- Device Description: The device is described as a delivery system for laser light generated by an ophthalmic treatment laser unit. It's a tool used in a medical procedure, not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic function. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the LIO-500 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Product codes
GEX
Device Description
The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm.
The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular tissue / eye
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
LIO-500 510(k) Summary
Submitter:
113390
Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Contact: Mr. Kevin Walls, RAC Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
for
MERIDIAN AG Bierigutstrasse 7 CH-3608 Thun Switzerland Phone: +41 33 334 11 11 Fax: + 41 33 334 11 19 Homepage: www.meridian.ch Email address: info@meridian.ch
Device Name:
Trade Name: Laser Indirect Ophthalmoscope 500 (LIO-500) Common Name: Ophthalmic Surgical Laser Classification Name: Powered Laser Surgical Instrument
Predicate Device:
VISULAS 532S manufactured by CARL ZEISS, INC. and cleared under 510(k) # K013402
Device Description:
The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm.
The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.
Intended Uses:
The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary delivery or intraccular endoprobe delivery.
1
Comparison to Predicate Device:
The LIO-500 has the same technical characteristics as the VISULAS 532S. There are no clinical or non-clinical tests required to show substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 4 2012
Meridian AG % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 South Cottonwood Court Greenwood Village, Colorado 80121
Re: K113390 ·
Trade/Device Name: Lase Indirect Ophthalmoscope 500 (LIO-500) 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: November 15, 2011 Received: November 16, 2011
Dear Mr. Walls:
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.
3
Page 2 - Mr. Kevin Walls, RAC
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 A. Mellman
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
510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: Laser Indirect Ophthalmoscope 500 (LIO-500)
Indications for Use:
The Laser Indirect Ophthalmoscope 500 (LiO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113390