(70 days)
The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:
- . Diabetic retinopathy (panretinal photocoagulation)
- . Macular degeneration
- Peripheral neovascularization .
- ◆ Retinal breaks
- Retinal detachments
- . Retinal tears
- Lattice degeneration
- Pneumatic retinopexy reattachment procedures .
- . Segmental peripheral photocoagulation
- . Segmental photocoagulation
- . Cloudy vitreous cavities
- Pediatric retinal repairs (under general anesthesia) .
- . Delivery of laser energy through small pupils or to eyes with focal lens opacities
The OptiMedica Laser Indirect Ophthalmoscope (LIO) is intended for use in the diagnosis and treatment of ocular pathology. The LIO illuminates and magnifies the fundus image. When connected to the Pascal Retinal Photocoagulator, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.
Here's an analysis of the provided text regarding the OptiMedica Laser Indirect Ophthalmoscope (LIO) acceptance criteria and supporting study:
The provided document is a 510(k) summary for the OptiMedica Laser Indirect Ophthalmoscope (LIO). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily aimed at proving this equivalence, particularly in terms of technical characteristics and optical performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the technical specifications of the predicate devices. The reported device performance is compared against these predicate specifications.
| Characteristic | Acceptance Criteria (Predicate Range/Value) | Reported Device Performance (OptiMedica LIO) |
|---|---|---|
| Intended Use | Delivery of laser energy in eyes with retinal pathology (similar to predicate LIOs) | Similar to predicate LIOs |
| Treatment Wavelength | 532nm (Pascal Photocoagulator, predicate systems) | 532nm (used with Pascal Photocoagulator) |
| Aiming Wavelength | 635nm (Pascal Photocoagulator, predicate systems) | 635nm (used with Pascal Photocoagulator) |
| Eye Filter Optical Density | OD > 5 (all predicate devices) | OD > 5 |
| Aerial Spot Size | 973um (Lumenis systems), 1060um (Zeiss LIO) | 960um |
| Working Distance | 270mm (Lumenis systems), 280mm (Zeiss LIO) | 275mm |
| Fiber Length | 5 meters (Zeiss LIO), 4.6 meters (Lumenis/Coherent systems) | 5 meters |
| Electrical Requirements | Same as predicate devices | Same sort of illumination source as predicate devices |
| Cooling Methods | Same as predicate devices | Same sort of illumination source as predicate devices |
| Weight | Roughly same as predicate devices (Heine Omega 500) | Roughly same (uses Heine OMEGA 500) |
| Dimensions | Roughly same as predicate devices (Heine Omega 500) | Roughly same (uses Heine OMEGA 500) |
| Optical Transmissions | Not explicitly quantified, but "optical similarity" to Zeiss LIO | Measured, intended to show optical similarity to Zeiss LIO |
| Delivered Spot Size & Intensity Profiles | Not explicitly quantified, but "optical similarity" to Zeiss LIO | Measured, intended to show optical similarity to Zeiss LIO |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" for this 510(k) submission appears to be a comparison of the OptiMedica LIO's physical and optical characteristics against those of predicate devices.
- Sample Size: The document does not refer to sample sizes in the traditional sense of patient data. Instead, it refers to a comparative analysis of the physical and optical properties of the OptiMedica LIO against a selection of predicate devices (Zeiss LIO, Lumenis Novus 3000, Lumenis Novus VARIA, Coherent Novus Verdi systems). The "sample" here would be the physical devices themselves.
- Data Provenance: The data is generated through performance testing of the OptiMedica LIO in a laboratory setting, specifically characterizing its optical performance. This is prospective data generation for the comparison. The specifications for the predicate devices would come from their own regulatory submissions or product specifications, which are retrospective for the purpose of this comparison. The country of origin for the data (testing lab) is not specified, but the applicant (OptiMedica Corporation) is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the traditional sense. The "ground truth" for this submission is based on the technical specifications and established performance of the predicate devices, which were themselves cleared by regulatory bodies (e.g., FDA) based on their own submissions. These specifications are taken as the benchmark.
- Qualifications of Experts: No external experts were used to establish "ground truth" for the test set of device characteristics. The "expertise" lies within the engineering and scientific teams that designed and tested the OptiMedica LIO, ensuring its compliance with the established technical parameters. The FDA's review process itself involves expert assessment of the submitted data.
4. Adjudication Method for the Test Set
Not applicable. There's no human adjudication process described for comparing the technical specifications. The comparison is objective, based on measured physical and optical parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
This submission is a 510(k), which focuses on substantial equivalence based on technical and performance characteristics, not on a direct comparison of diagnostic or treatment efficacy in a clinical setting with human readers. The document states: "Performance testing has been conducted with the OptiMedica LIO to establish the optical similarity of the OptiMedica LIO with respect to a predicate device, the Zeiss LIO, as a means to assess the relative clinical performance of the devices." This indicates a technical comparison, not a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a laser indirect ophthalmoscope, a piece of hardware used by a human clinician for diagnosis and treatment. It is not an algorithm or an AI-powered system that would have a "standalone" mode in the context of image analysis or diagnostic predictions.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established technical specifications and validated performance characteristics of the predicate devices. The OptiMedica LIO aimed to demonstrate that its technical and optical performance aligns closely with these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument (hardware), not a machine learning algorithm. Therefore, there is no "training set" in the computational or AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned or implied for an AI/ML algorithm, this question is not relevant to the described device.
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SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENE
5.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | OptiMedica Corporation |
|---|---|
| TRADE NAME: | OptiMedica Laser Indirect Ophthalmoscope (LIO) |
| COMMON NAME: | Laser Indirect Ophthalmoscope (LIO) |
| DEVICE | GEX |
| CLASSIFICATION | 21 CFR 878.4810Laser instrument, surgical, powered |
5.1 SUBSTANTIALLY EQUIVALENT TO:
The Laser Indirect Ophthalmoscope (LIO) is substantially equivalent in intended use and the same or similar technological characteristics (including treatment and aiming wavelengths, spot size, working distance and indirect ophthalmoscope used) as the Zeiss LIO (K924588). The OptiMedica LIO is also substantially equivalent to the delivery devices included in 510(k)s K022181 (Novus VARIA and Delivery Devices ) and K052526 (Novus 3000 and Delivery Devices ) by Lumenis and K991258 (Novus Verdi Delivery Systems) by Coherent.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION 5.2
The OptiMedica Laser Indirect Ophthalmoscope (LIO) is intended for use in the diagnosis and treatment of ocular pathology. The LIO illuminates and magnifies the fundus image. When connected to the Pascal Retinal Photocoagulator, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.
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5.3 INDICATION FOR USE
The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:
- . Diabetic retinopathy (panretinal photocoagulation)
- . Macular degeneration
- Peripheral neovascularization .
- ◆ Retinal breaks
- Retinal detachments �
- . Retinal tears
- Lattice degeneration
- Pneumatic retinopexy reattachment procedures .
- . Segmental peripheral photocoagulation
- . Segmental photocoagulation
- . Cloudy vitreous cavities
- Pediatric retinal repairs (under general anesthesia) .
- . Delivery of laser energy through small pupils or to eyes with focal lens opacities
5.4 CONTRAINDICATIONS
Laser surgery with the OptiMedica LIO is contraindicated when an appropriate procedure cannot be performed safely. This occurs when tissue targets cannot be visualized properly. Under such circumstances, an important tissue structure adjacent to a target tissue might be photocoagulated inadvertently. Corneal opacities, cataract formation, and vitreous hemorrhage can all interfere with the laser surgeon's view of appropriate target structures. Treatment should be delayed until the visualization has adequately improved.
TECHNICAL CHARACTERISTICS ર્સ્ડ
Indirect Ophthalmoscope
The OptiMedica LIO uses a Heine OMEGA 500 binocular indirect ophthalmoscope. Each of the predicate devices, including the Zeiss Laser Indirect Ophthalmoscope (K924588), the Lumenis Novus 3000 Delivery Devices (K052526), Lumenis Novus VARIA Delivery Devices (K022181), and Coherent Novus Verdi Delivery Systems (K991258) use a Heine binocular indirect ophthalmoscope as well.
Usable Wavelengths
The OptiMedica LIO is designed to be used with the Pascal Photocoagulator. This system produces 532nm light for treatment, and 635 nm light for aiming, identical to the Lumenis Novus 3000 (K052526), Lumenis Novus VARIA (K022181), Coherent Novus Verdi (K991258), and the Zeiss Visulas system used with the Zeiss Laser Indirect Ophthalmoscope (K924588).
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Eye Filter Optical Density
The OptiMedica LIO eye safety filter optical density at the treatment wavelength is the same as all of the predicate devices, OD>5. The OptiMedica LIO also uses a photopically neutral filter to allow the high transmission of the aiming beam and white balance the image, making visualization easier and more realistic.
Aerial Spot Size
The OptiMedica LIO spot size for delivery through indirect surgical lens is 960um. This is almost identical to that of the Lumenis Novus 3000 (K052526), Lumenis Novus VARIA (K022181), Coherent Novus Verdi (K991258), which are 973um. The Zeiss Laser Indirect Ophthalmoscope (K924588) uses a 1060 um spot.
Working Distance
The OptiMedica LIO working distance of 275mm lies right in the middle of the range specified by the predicate devices. The Lumenis Novus 3000 (K052526), Lumenis Novus VARIA (K022181), Coherent Novus Verdi (K991258) systems specify a 270mm working distance. The Zeiss Laser Indirect Ophthalmoscope (K924588) uses a 280mm working distance.
Fiber Length
The OptiMedica LIO fiber length of 5 meters is equal to that of the Zeiss Laser Indirect Ophthalmoscope (K924588), and slightly longer than that of the Lumenis Novus 3000 (K052526), Lumenis Novus VARIA (K022181), Coherent Novus Verdi (K991258) systems which use 4.6 meter long fibers.
Electrical Requirements
The OptiMedica LIO and all of the predicate devices use the same sort of illumination source, and therefore have the same electrical requirements.
Cooling Methods
The OptiMedica LIO and all of the predicate devices use the same sort of illumination source, and therefore have the same cooling requirements and methods.
Weight
The OptiMedica LIO and all of the predicate devices use the same sort of binocular indirect ophthalmoscope, and therefore have roughly the same weight.
Dimensions
The OptiMedica LIO and all of the predicate devices use the same sort of binocular indirect ophthalmoscope, and therefore have roughly the same dimensions.
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5.6 PERFORMANCE DATA
Performance testing has been conducted with the OptiMedica LIO to establish the optical similarity of the OptiMedica LIO with respect to a predicate device, the Zeiss LIO, as a means to assess the relative clinical performance of the devices. This was accomplished by characterizing the optical performance of both laser delivery systems at their treatment and aiming wavelengths. Optical transmissions, as well as the delivered spot size and intensity profiles were measured.
5.7 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The indications for use for the OptiMedica LIO are similar to the predicate LIOs cited in this application. The safety of the materials used for the manufacture of LIO has previously been demonstrated. Testing demonstrates that the OptiMedica LIO is functionally equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
OptiMedica Corporation % ClinReg Consulting Services, Inc. Judy F. Gordon, D.V.M. 733 Bolsana Drive Laguna Beach. California 92651
Re: K062336
Trade/Device Name: OptiMedica Laser Indirect Ophthalmoscope Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 7, 2006 Received: August 10, 2006
Dear Dr. Gordon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Judy F. Gordon, D.V.M.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
fih xh
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): 1 06233 p
Device Name: OptiMedica Laser Indirect Ophthalmoscope
Indications for Use:
The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:
- Diabetic retinopathy (panretinal photocoagulation) .
- Macular degeneration
- � Peripheral neovascularization
- Retinal breaks ●
- Retinal detachments .
- � Retinal tears
- Lattice degeneration
- Pneumatic retinopexy reattachment procedures .
- Segmental peripheral photocoagulation
- Segmental photocoagulation
- Cloudy vitreous cavities .
- Pediatric retinal repairs (under general anesthesia) ●
- Delivery of laser energy through small pupils or to eyes with focal lens opacities
The CDRH Indications for Use Statement for the OptiMedica LIO can be found on the following page.
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)
in
Division Sig -Off Division of General, Restorative, Jarralogical Devices
Page of
510(K) L061-32
§ 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.