(85 days)
Not Found
Not Found
No
The summary describes a modified slit lamp for delivering laser light and does not mention any AI or ML capabilities, image processing, or data analysis beyond the basic function of the device.
No
The device is described as a slit lamp that delivers laser light for examination, not for treating a disease or condition. The text states it is for use in ophthalmology to "deliver a thin, intense beam of light into the eye," and the user should refer to the laser's manual for "clinical use information for the laser," implying the laser, not the slit lamp itself, is the therapeutic component if present.
No
The device description states its purpose is to deliver a thin, intense beam of light into the eye and direct laser light to selected sites. This describes an interventional or treatment delivery function, not a diagnostic one. While slit lamps are often used in diagnosis, the provided text for this specific device focuses on its modification to deliver laser light for treatment.
No
The device description explicitly states that the device is a modified commercially available slit lamp, which is a hardware device. It also mentions the delivery of laser light via fiber optic, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver a thin, intense beam of light into the eye" for use in ophthalmology. This is a therapeutic or diagnostic procedure performed directly on the patient's eye, not an in vitro test performed on a sample taken from the body.
- Device Description: The device is a modified slit lamp that delivers laser light to the eye. This is consistent with an ophthalmic examination and treatment device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information about a patient's health status based on in vitro testing.
Therefore, the SL07 and SL08 laser slit lamps are ophthalmic devices used for examination and potentially treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HJO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmology
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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.
0
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 GmbH |
| Prussingstrasse 41 | |
| D-07739 Jena | |
| GERMANY | |
| Contact Person: | Mr. William T. Kelley |
| General Manager | |
| Aesculap-Meditec, North America | |
| 23832 Via Monte | |
| Coto De Caza, CA 92679-4001 | |
| Telephone: | 714-589-8536 |
| 714-589-6259 (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: HJO | |
| As an accessory to an ophthalmic laser the device could | |
| reference 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 to |
| ophthalmic lasers) |
1
| 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 information |
| This 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. |
2
COMPARISON TABLE/PREDICATE DEVICES
| DEVICE
CHARACTERISTIC | SL08 SLIT LAMP | SL07 SLIT LAMP | INFINITECH MULTI-SPOT
ADAPTER | ACLON FREQUENCY DOUBLE
YAG (Fx-2) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device | Zeiss SL 20 slit lamp modified to
accommodate the adapter | Haag-Streit HS 900 BQ slit lamp
modified to accommodate the
adapter | | 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 | 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 is
capable of creating 4 spots
centered 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 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 |
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.
3
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.
4
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
5
(974467 510(K) Number (if known):
Device Name: SL07 and SL08 Laser Slit Lamps
Indications For Use:
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.
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)
OR
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________