The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

Device Description

The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.

AI/ML Overview

This document describes the SL07 and SL08 Laser Slit Lamps, which are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. They also include an adapter for delivering green laser light (532 nm) via fiber optic.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for substantial equivalence. Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity). Instead, the device's performance is accepted based on its similarity to legally marketed predicate devices.

The "Performance Data" section explicitly states:

"The specifications and intended uses of the SL07 and SL08 laser slit lamps are the same or very similar to those of the claimed predicate devices and other legally marketed slit lamps (as devices or as accessories to ophthalmic lasers). There are no significant differences between the SL07 and SL08 devices and claimed predicates under conditions of intended use. Because of this, performance data were not required."

The comparison table highlights key characteristics of the SL07 and SL08 in comparison to predicate devices, demonstrating their equivalence in design and function rather than quantitative performance.

Device Characteristic	SL08 Slit Lamp	SL07 Slit Lamp	Infinitech Multi-Spot Adapter (Predicate)	Acion Frequency Double YAG (FX-2) (Predicate)
Device Base	Zeiss SL 20 slit lamp modified to accommodate adapter	Haag-Streit HS 900 BQ slit lamp modified to accommodate adapter	Relies on slit lamp	Cites Zeiss, Haag-Streit and similar slit lamps
Indications (biomicroscope, slit lamp)	See 21 CFR 886.1850 and medical practice	See 21 CFR 886.1850 and medical practice	No information (implied for ophthalmic use)	Labeled for ophthalmic use; refers to several slit lamps
Spot Size	Range: 50 um - 1000 um; Imaging: 50 um - 400 um focusing; >400 um - 1000 um defocusing	Range: 50 um - 1000 um; Imaging: 50 um - 400 um focusing; >400 um - 1000 um defocusing	Relies on slit lamp, multi-spot capable of creating 4 spots	Relies on slit lamps
Laser Connection	50 um fiber with SMA connector	50 um fiber with SMA connector	- (Implied)	Has connector
Wavelength	Frequency doubled Nd:YAG	Frequency doubled Nd:YAG	Argon/Krypton and frequency doubled Nd:YAG	Frequency doubled Nd:YAG
Eye Protection	For wavelength; protection type L5 (DIN EN 207) at 532 um	For wavelength; protection type L5 (DIN EN 207) at 532 um	Not specified; presumably for wavelength	Not specified; presumably for wavelength
Tissue Effect of Laser	Photocoagulation	Photocoagulation	Photocoagulation	Photocoagulation
Laser Intensity	Selected by physician	Selected by physician	Selected by physician	Selected by physician

2. Sample size used for the test set and the data provenance:

Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical performance study requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No new ground truth for a test set was established. The basis for safety and effectiveness is the established usage and regulatory approval of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set was used.

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:

Not applicable. No MRMC study was conducted. This device is a modified slit lamp, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical instrument (slit lamp) with an adapter for laser delivery, which is inherently used with a human ophthalmologist. It does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices (Zeiss and Haag Streit Slit Lamps, Infinitech Multi-Spot Slit Lamp laser Adapter, Oculight SLx), as well as the general understanding of ophthalmic slit lamps as described in 21 CFR 886.1850 and ophthalmic lasers in 21 CFR 886.4390. The modifications made to the slit lamps (to accommodate the laser adapter) were deemed not to raise new questions of safety or effectiveness.

8. The sample size for the training set:

Not applicable. No training set was used, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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72744601

APPENDIX E

510(k) SUMMARY

FEB 1 9 1998

SL07 and SL08 LASER SLIT LAMPS

This 510(k) summary of safety and effectiveness for the SL07 and SL08 laser slit lamps is I his 5 r (x) bananary of vith the requirements of SMDA 1990 and follows guidance from the Office of Device Evaluation concerning the organization and content of a 510(k) summary.

Applicant:	Aesculap-Meditec, North America
Address (Manufacturer):	Aesculap-Meditec GmbHPrussingstrasse 41D-07739 JenaGERMANY
Contact Person:	Mr. William T. KelleyGeneral ManagerAesculap-Meditec, North America23832 Via MonteCoto De Caza, CA 92679-4001
Telephone:	714-589-8536714-589-6259 (Fax)
Preparation Date:	November 1997
Device Trade Name:	SL07 and SL08 Laser Slit Lamps
Common Name:	Slit Lamp
Classification Name:	Biomicroscope, Slit Lamp, AC powered(see: 21 CFR 886.1850)Product Code: HJOAs an accessory to an ophthalmic laser the device couldreference the classification regulation for ophthalmic lasers (21 CFR 886.4390) and the ophthalmic laser product code (HQF
Class:	Class II medical device (as slit lamps or as accessories toophthalmic lasers)

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Legally marketed predicate devices:	Zeiss and Haag Streit Slit Lamps; Infinitech Multi-Spot Slit Lamp laser Adapter for Haag Streit Slit Lamp; Oculight SLx
Description of Devices:	The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.
Intended Use:	The SL07 and SL08 slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional informationThis intended use is the same or similar to that for the claimed predicate devices (see below) and for slit lamps as described in 21 CFR 886.1850, i.e., to direct a thin, intense light into the eye.
Performance Data:	The specifications and intended uses of the SL07 and SL08 laser slit lamps are the same or very similar to those of the claimed predicate devices and other legally marketed slit lamps (as devices or as accessories to ophthalmic lasers). There are no significant differences between the SL07 and SL08 devices and claimed predicates under conditions of intended use.Because of this, performance data were not required.
CONCLUSION:	Based on the foregoing, Aesculap-Meditec believes that the SL07 and SL08 laser slit lamps are substantially equivalent to legally marketed predicate devices.

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COMPARISON TABLE/PREDICATE DEVICES

DEVICECHARACTERISTIC	SL08 SLIT LAMP	SL07 SLIT LAMP	INFINITECH MULTI-SPOTADAPTER	ACLON FREQUENCY DOUBLEYAG (Fx-2)
Device	Zeiss SL 20 slit lamp modified toaccommodate the adapter	Haag-Streit HS 900 BQ slit lampmodified to accommodate theadapter		Cites Zeiss, Haag-Streit andsimilar slit lamps
Indications (biomicroscope, slitlamp)	See 21 CFR 886.1850 and medicalpractice	See 21 CFR 886.1850 and medicalpractice	No information	Labeled for ophthalmic use; refersto several slit lamps
Spot Size	Range: 50 um - 1000 umImaging: 50 um - 400 umfocusing>400 um - 1000 umdefocusing	Range: 50 um - 1000 umImaging: 50 um - 400 umfocusing>400 um - 1000 umdefocusing	relies on slit lamp, multi-spot iscapable of creating 4 spotscentered on guide beam	relies on slit lamps
Laser Connection	50 um fiber with SMA connector	50 um fiber with SMA connector	-	Has connector
Wavelength	Frequency doubled Nd:YAG	Frequency doubled Nd:YAG	Argon/Krpton and frequencydoubled Nd:YAG	Frequency doubled Nd:YAG
Eye Protection	For wavelength; protection type L5(DIN EN 207) at 532 um	For wavelength; protection type L5(DIN EN 207) at 532 um	not specified; presumably forwavelength	not specified; presumably forwavelength
Tissue Effect of Laser	Photocoagulation	Photocoagulation	Photocoagulation	Photocoagulation
Laser Intensity	selected by physician	selected by physician	selected by physician	selected by physician

Note: The IRLS Oculite Slx brochure (referenced above but not included in the tabular comparisons) cites adapters for the Zeiss 20 SL and Haag-Streit 900 BQ slit lamp.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB | 9 1998

Mr. William T. Kelley General Manager Aesculap- Meditec North America 23832 Via Monte Coto De Caza, CA 92679-4001

Re: K974467

Trade Name: AESCULAP- MEDITEC SLIT LAMPS SL07 AND SL08 Regulatory Class: II Product Code: 86 HJO Dated: November 21, 1997 Received: November 26, 1997

Dear Mr. Kelley:

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 GMP 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 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.

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Page 2 - Mr. William T. Kelley

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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) 594-4613. Additionally, for questions on the promotion and advertising of your devices, 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,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(974467 510(K) Number (if known):

Device Name: SL07 and SL08 Laser Slit Lamps

Indications For Use:

Daryl L. Coulsen

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_ K 9 > 4 46 7

(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)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.