(59 days)
Not Found
No
The device description and summary of performance studies describe a standard optical slit lamp with no mention of AI or ML capabilities.
No
The device is used to aid in the diagnosis of diseases or trauma, not to treat them. It is a diagnostic tool for eye examination.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment." This clearly indicates its role as a diagnostic aid.
No
The device description explicitly states it consists of a microscope, a swivelling illumination system, and a power supply, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the living body ("in vitro").
- This Device's Function: The SLIT LAMP, HS-5000 is used for direct visual examination of the anterior segment of the eye on a living patient. It uses light and a microscope to observe the structures of the eye. This is an in vivo examination, not an in vitro test.
The description clearly states its use in "eye examination of the anterior eye segment" and observing the eye "through the microscope," which are all procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The SLIT LAMP, HS-5000 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Product codes (comma separated list FDA assigned to the subject device)
HJO
Device Description
A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the dragnosis of diseases or trauma which affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific procedures (biomicroscopic examination of the eye).
The instrument is consist of a microscope, a swivelling illumination system providing a slit image and a power supply.
- AC Power is converted to DC Power through the SMPS.
- DC Power is supplied to the Lamp providing the light
- Light is converted to the slit image through the aperture, filter etc.
- The slit image is illuminate the eye
- Observe the eye through the microscope
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the cornea epithelium to the posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists and optometrists (within the realms of their respective professions)
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)
Electrical, mechanical, and environmental safety testing according to Standard IEC 60601-1 was performed by UL Korea, Ltd. EMC testing was conducted by EMC Compliance Co., Ltd. in accordance with Standard IEC 60601-1-2(2001). All test results were satisfactory.
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.
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
Ko 73190
HUVITZ Co., Ltd.
| JAN II 1 2008
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: Oct. 01, 2006
- Company and Correspondent making the submission: Name -- HUVITZ Co , Ltd.
Address - 689-3, Geumjeong-dong, Gunpo-si, Gyeonggi-do. 435-862, Republic of Korea Telephone -- +82-31-428-9100
Fax - +82-31-477-8617
Contact - Chang-Soo, Lee / OA Assistant Manager
E-mail – cslee@huvitz.com
2. Device :
| Trade/proprietary name | : Slit Lamp HS-5000 |
|---|---|
| Common Name | : Slit Lamp |
| Classification Name | : AC-Powered Slitlamp Biomicroscope |
-
- Predicate Devices :
| Manufacturer | : C.S.O.S.R.L. |
|---|---|
| Device | : SL 990 |
| 510(k) Number | : K992836(Decision Date - Nov. 9. 1999) |
4 . Classifications Names & Citations
21CFR 886.1850. HJO - AC-Powered Slitlamp Biomicroscope, Class 2
-
- Description :
- 5.1 General
A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the dragnosis of diseases or trauma which affect the structural properties of the anterior eye
689 3 Geurnjeong dong Gungo-si Gyeonggi-do 435-862 Republic of Korea 00000029
1
HUVITZ Co., Ltd.
segment.
These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific procedures (biomicroscopic examination of the eye)
5 2 Operation method
- Let the patient sit down comfortable with his chin on the chin-rest and his forehead against the forehead-rest
- Lift or lower the chin-rest by moving the handle (25) so that the patient s eyes are in line with the notches on the chin rest (29)
- Switch the instruments on, press the switch (13). You will see the warning light on (12).
- Adjust the luminous intensity by moving the selector (14)
- Frame and focus the eye to be examined by moving the lever (9)
5 3 Operation Principles
The instrument is consist of a microscope, a swivelling illumination system providing a slit image and a power supply
- AC Power is converted to DC Power through the SMPS.
- DC Power is supplied to the Lamp providing the light
- Light is converted to the slit image through the aperture, filter etc.
- The slit image is illuminate the eye
- Observe the eye through the microscope
-
- Indication for use :
The SLIT LAMP, HS-5000 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment
7. Comparison with predicate device :
HUVITZ Co., Ltd. believes that the Silt Lamp, HS-5000 is substantially equivalent to Slit lamp SL 990 of C.S.O.S.R.L.
8. Safety, EMC and Performance Data
Electrical, mechanical, and environmental safety testing according to Standard IEC
GB-3 Geumicong-dong. Gungg-si. Gyeongg-do, 435-862. Republic of Korca
GB-3 Geumicong-dong. Gunpo-si. Gyeonggi-do, 435-862. Republic of Korea
2
HUVITZ Co., Ltd.
60601-1 was performed by UL Korea, Ltd. EMC testing was conducted by EMC Compliance Co., Ltd. in accordance with Standard IEC 60601-1-2(2001). All test results were salisfactory.
-
- Conclusions :
In accordance with the Federal Food, Drug and Cosmelic Act, 21 CFR Part 807 and based on the information provided in this premarket notification HUVITZ Co., Ltd. concludes that the Slit Lamp, HS-5000 is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
- HUVITZ Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- HUVITZ Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
689-3 Geumjeong-dang Gunpo-si Gyeonggi-do, 435-862. Republic of Kepublic of Kepublika of Korea
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, torso, and legs.
JAN 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Huvitz Co., Ltd. c/o Charles F. Mack International Regulatory Consultants 340 Shady Grove Road Flintville, TN 37335
Re: K073190
Trade/Device Name: Slit Lamp HS-5000 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp microscope Regulatory Class: Class II Product Code: HJO Dated: December 26, 2007 Received: December 28, 2007
Dear Mr. Mack:
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.
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,
M. B. Egerlton, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number(if known):
Device Name: Slit Lamp HS-5000
Indications for Use
The SI.IT LAMP, HS-5000 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 21 CFR 807 Subparl C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Bruce Drum
Concurrence of CDRH, Office of Device Evaluation(ODE)
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| Division of Ophthalmic Ear, | |
| Nose and Throat Devises |
510(k) Number K073196
ﻤﺴ
0000033