(65 days)
The Multi-Spot Slit Lamp Laser Adapter has two functional modes available to the physician: a single spot mode and a Multi-Spot (4 spot) mode. When the a single spot mode is selected, the preexisting slit lamp laser apparatus is available for all treatment functions for which it was designed as a laser photocoagulator. The multi-spot mode is intended for use with "Green-Only" ine marcr bood me energy for panretinal photocoagulation in the treatment of proliferative retinopathy.
The multi-spot slit lamp laser adapter is a non-powered reusable optical system which, when connected between the laser fiber and the slit lamp 200m optics, generates four spots in a square pattern. Through a rotary mechanism the user can select between single or multiple spot patterns. The multi-spot laser adapter mechanically mimics the fiber cable and will not effect or deactivate any existing salety interlocks. The lens system of the multi-spot adapter provides a one-to-one image of the laser fiber, therefore the spot size indicator on the zoom lens systems is not effected. The selection of single or multiple spot patterns also applies to the aiming beam, this gives the user direct and unambiguous feedback on which mode is selected before treatment begins.
This document describes a 510(k) premarket notification for the Infinitech Multi-Spot™ Slit Lamp Laser Adapter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria. Therefore, most of the requested information regarding detailed study design and acceptance criteria is not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantifiable measures used in clinical studies for diagnostic or treatment devices). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is described qualitatively in the "Efficacy" section and through the comparison chart.
| Device Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Infinitech Multi-Spot Adapter) |
|---|---|---|
| Device Type | Ophthalmic Laser | Ophthalmic Laser |
| Ophthalmic Indications | Proliferative Retinopathy (Argon) | Proliferative Retinopathy (Argon) - "Green-Only" for multi-spot mode |
| Laser Energy Source | Doubled Nd: YAG (similar to predicate) | Doubled Nd: YAG |
| Laser Energy Delivery | Multi-Spot (4 spots) - This is the novel feature compared to predicates | Multi-Spot (4 spots) or Single Spot (pre-existing slit lamp functionality) |
| Spot Placement | Centered on Guide Beam | Centered on Guide Beam |
| Laser Energy Intensity | Selected by Physician | Selected by Physician (with adjustments needed for multi-spot mode as per manual) |
| Tissue Effect | Photocoagulation | Photocoagulation |
| Labeling per 21CFR 801.109 | YES | YES |
| Labeling per 21CFR 1040.10 | YES | YES |
| Reduced Procedure Time | Implicitly, faster than single spot due to 4 burns per exposure | "Greatly speeds up the procedure and should reduce user and patient fatigue." |
| Improved Burn Distribution | Implicitly, more uniform and repeatable than random single spot application | "A 4-spot pattern improves the repeatability of burn distribution." |
| Optical System | No unexpected shifts in focus; 1:1 image, spot size indicator not affected | "No unexpected shifts in focus regardless of zoom range." "spot size indicator on the zoom lens systems is not effected." |
| Safety Interlocks | Not affected or deactivated | "Will not effect or deactivate any existing safety interlocks." |
| Wavelength Use | Multi-spot optimized for 514-532nm (green only for proliferative retinopathy) | Manual reminds user "green only" for multi-spot; operates over 488-650nm in single spot. |
| Calibration | Requires laser console calibration after installation/removal | Manual informs user to have laser calibrated. |
| Output Power | Each spot ~1/4 of displayed energy in multi-spot; user compensation needed | User can compensate by increasing displayed power, exposure time, or decreasing spot size. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a formal clinical performance study or data-driven evaluation. The assessment is based on the design and functionality of the device in comparison to existing predicate devices. Therefore, there is no sample size or data provenance information provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided as there was no study requiring expert-established ground truth in the context of a clinical performance evaluation. The substantial equivalence argument relies on comparing technical and functional characteristics.
4. Adjudication Method for the Test Set
This information is not provided as there was no formal test set or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is an optical accessory for a laser, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a mechanical/optical accessory, not an algorithm. Its performance is intrinsically linked to its use by a human operator with a laser and slit lamp.
7. The Type of Ground Truth Used
This information is not provided as no explicit performance study requiring ground truth was described. The "ground truth" for this 510(k) submission is the functional and safety characteristics demonstrated to be substantially equivalent to predicates.
8. The Sample Size for the Training Set
This information is not provided as there was no AI model or learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided as there was no AI model or learning algorithm requiring a training set and ground truth.
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Premarket Notification Infinitech, Inc. 750 Goddard Avenue Chesterfield, MO 63005 (314) 532-5667; (314) 532 8059 fax
F971950
. . . . . . . . .
777
1
510(k) SUMMARY OF SAFETY AND EFFICACY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Alan T. Beckman, Vice President, RA/QA
Date Prepared: May 15, 1997
Proprietary Names: Infinitech Multi-Spot™ Slit Lamp Laser Adapter.
Common/Usual Name: Ophthalmic slit lamp laser accessory.
Classification Name: Ophthalmic Laser 21CFR §886.4390 (86HQF).
Device Description/Intended Use: The multi-spot slit lamp laser adapter is a non-powered reusable optical system which, when connected between the laser fiber and the slit lamp 200m optics, generates four spots in a square pattern. Through a rotary mechanism the user can select between single or multiple spot patterns. The multi-spot laser adapter mechanically mimics the fiber cable and will not effect or deactivate any existing salety interlocks. The lens system of the multi-spot adapter provides a one-to-one image of the laser fiber, therefore the spot size indicator on the zoom lens systems is not effected. The selection of single or multiple spot patterns also applies to the aiming beam, this gives the user direct and unambiguous feedback on which mode is selected before treatment begins.
Safety: There are three noints which require special safety instructions:
Green Only. The multi-spot laser adapter may operate over 488- 650mm when in the single spot mode. However, the grating which generates the multi-spot pattern is optimized for 514-532nm. The manual reminds the user that the multi-spot pattern should only be used for "green only" treatments. This is not considered a limitation since "green only" is the wavelength of choice for proliferative retinopathy.
Calibration. The Multi-Spot optical systems consists of high efficiency optical elements. However. introduction of this system will require laser console calibration. The manual informs the user to have the laser calibrated after installation or removal of the device.
Output power in multi-spot mode. The multi-spot laser adapter "divides" the single spot energy into four spots, therefore cach spot contains at the most one-fourth the displayed energy value. The user can compensate for this difference by increasing the displayed laser power, increasing the exposure time, or decreasing the spot size. Conversion tables are included in the users manual to show the relative trade-offs of power, exposure and spot size. Cautionary statements to instruct the user to lower the laser power before returning to single spot mode are included. Direct visualization of the aiming beam will provide a reminder as to the mode selected.
Efficacy: The multi-spot laser adapter can be used in a single or multi-spot mode. The multi-spot
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laser adapter uses the laser's own fiber optic cable without modification. The focal plane of the multispot adapter corresponds to the fiber ontic cable and the zoom lens system. Therefore there are no unexpected shifts in focus regardless of zoom range. The multi-spot laser adapter "divides" the single spot energy into four spots of equal energy. The 4 spots are positioned in a square pattern, nominally separated by 1 spot diameter. Efficacy is improved because 4 burns of equal intensity are produced with one exposure from the laser. This greatly speeds up the procedure and should reduce user and patient fatigue. With a single spot exposure, users find laying down a uniform pattern is difficult and the pattern is typically more random than a geometric in distribution. A 4-spot pattern improves the repeatability of burn distribution.
Predicate Device: The Multi-Spot™ Slit Lamp Adapter is substantially equivalent to the Coherent® System 920AD (K844357), the Alcon®/Biophysic™ Ophthalas® (K number unknown), and Alcon Ophthlas® 532 Laser (K Number Unknown). A device comparison chart illustrating substantial equivalence is attached.
Predicate Comparison: A chart comparing the Multi-Spot Adapter to the predicate devices, demonstrating substantial equivalence, is attached.
Submitted by:
Alan T. Beckman
Attachment: Device Comparison Chart
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| DeviceCharacteristic | Infinitech Multi-Spot AdapterMulti-Spot Mode | Alcon/BiophysicOphthalas | Ophthalas532 | Coherent920AD |
|---|---|---|---|---|
| Device Type | Ophthalmic Laser | Ophthalmic Laser | Ophthalmic Laser | Ophthalmic Laser |
| OphthalmicIndications | ProliferativeRetinopathyArgon | Multiple | Multiple | Multiple |
| Laser EnergySource | Doubled Nd: YAG | Doubled Nd: YAG | Argon/Krypton | Argon/Krypton |
| Laser EnergyDelivery | Multi-Spot(4 spots) | Single Spot | Single Spot | Single Spot |
| Spot Placement | Centered onGuide Beam | Centered onGuide Beam | Centered onGuide Beam | Centered onGuide Beam |
| Laser EnergyIntensity | Selected byPhysician | Selected byPhysician | Selected byPhysician | Selected byPhysician |
| Tissue Effect | Photocoagulation | Photocoagulation | Photocoagulation | Photocoagulation |
| Labeling per21CRF 801.109? | YES | YES | YES | YES |
| Labeling per21CFR 1040.10? | YES | YES | YES | YES |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan T. Beckman Vice President, RA/QA INFINITECH™ . . . 750 Goddard Avenue Chesterfield, Missouri 63005
AUG - 1 1997
Re: K971950
Trade Name: Infinitech Multi-Sport Slit Lamp Laser Adapter Regulatory Class: II Product Code: HOF Dated: May 27, 1997 Received: May 28, 1997
Dear Mr. Beckman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMF regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Alan T. Beckman
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
[signature]
M. Witten, Ph.D., M.D. Celiz Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Infinitech Multi-Spot Slit Lamp Laser Adapter
Indications For Use:
The Multi-Spot Slit Lamp Laser Adapter has two functional modes available to the physician:
"
a single spot mode and a Multi-Spot (4 spot) mode. When the a single spot mode is selected, the preexisting slit lamp laser apparatus is available for all treatment functions for which it was designed as a laser photocoagulator .
The multi-spot mode is intended for use with "Green-Only" ine marcr bood me energy for panretinal photocoagulation in the treatment of proliferative retinopathy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
!
§ 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.