(9 days)
Not Found
No
The description focuses on the physical components and intended use of a standard slit lamp, with no mention of AI, ML, image processing, or data-driven diagnostic capabilities.
No
The device is used for examination and diagnosis, not for treating or curing a disease.
Yes
The device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment" and is designed "for specific diagnostic procedures (bio-microscopic examination of the eye)."
No
The device description explicitly states that the instrument consists of a microscope, a swiveling illumination system, and a power supply, which are hardware components.
Based on the provided information, 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.
- Device function: The description clearly states that the Slit Lamps HS-5500, HS-7000, HS-7500 are used for eye examination of the anterior eye segment. This is a direct examination of a part of the living body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment through bio-microscopic examination of the eye. This is an in-vivo diagnostic procedure.
Therefore, while it is a diagnostic device, it falls under the category of in-vivo diagnostic devices, not in-vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Slit Lamps HS-5500, HS-7000, HS-7500 are 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
HJO
Device Description
A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, form 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. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific diagnostic procedures (bio-microscopic examination of the eye). The instrument is consist of a microscope, a swiveling 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 / Not Found
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 Inc. EMC testing was conducted by UL Inc. in accordance with Standard IEC 60601-1-2(2001). The devices meet all requirements and passed all lests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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DEC - 3 2009
510(k) Submission HS-5500
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 : October. 12, 2009
-
- Company and Correspondent making the submission:
Name - HUVITZ Co., Ltd.
- Company and Correspondent making the submission:
Address - 689-3, Geumjeong-dong, Gunpo-si, Gyeonggi-do, 435-862, Republic of Korea
Telephone - +82-31-428-9100
Fax - +82-31-477-8618
-
Contact Chang-Soo, Lee / QA Manager
E-mail - cslee@huvitz.com -
- Device:
Trade/ proprietary name : Slit Lamp HS-5500, HS-7000, HS-7500 Common Name : Slit Lamp
- Device:
Classification Name : AC-Powered Slittamp Biomicroscope
3. Predicate Devices:
Manufacturer : Huvitz Co .; Ltd. Device : HS-5000
510(k) Number : K073190 (Decision Date -- Jan. 11. 2008)
4, Classifications Names & Citations:
21 CFR 886.1850, HJO - AC-Powered Slitlamp Biomicroscope, Class 2
5. Description:
5.1 General
A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, form 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.
Huvitz Co., Ltd.
1
These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific diagnostic procedures (bio-microscopic 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 so that the patient's eyes are in line with the notches on the chin-rest.
-
Switch the instruments on, press the switch. You will see the warning light on
-
Adjust the luminous intensity by moving the selector
-
Frame and focus the eye to be examined by moving the lever
5.3 Operation Principles
The instrument is consist of a microscope, a swiveling 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.
6. Indication for use:
The Slit Lamps HS-5500, HS-7000, HS-7500 are intended for use in eye examination of the anterior eye segment, form the cornea epithelium to the posterior capsule. It is used to ald in the diagnosis of diseases or trauma which affect the structural properties of the anterior eve segment.
7. Comparison with predicate device:
HUVITZ Co., Ltd. Belleves that the Slit Lamp, HS-5500, HS-7000 and HS-7500 are substantially equivalent to Slit lamp HS-5000 of Huvitz., Ltd.
8. Safety, EMC and Performance Data:
Electrical, mechanical, and environmental safety testing according to Standard IEC 60601-1 was performed by UL Inc. EMC testing was conducted by UL Inc. in
Huvilz Co., Ltd.
2
accordance with Standard IEC 60601-1-2(2001). The devices meet all requirements and passed all lests.
9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification HUVITZ Co., Ltd. concludes that the Slit Lamp, HS-5500, HS-7000 and HS-7500 are safe, effective and substantially equivalent to predicate devices as described herein.
- HUVITZ Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
Huvitz Co., Ltd.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC - 3 2009
Huvitz Co., LTD c/o Mr. Marc M. Mouser Section Manager & FDA Office Coordinator Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607
Re: K093639
Trade/Device Name: Huvitz Slit Lamp, Models HS-5500, HS-7000 and HS-7500 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit lamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: November 6, 2009 Received: November 24, 2009
Dear Mr. Mouser:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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-5500, HS-7000, HS-7500
Indications for Use:
The Slit Lamps HS-5500, HS-7000, HS-7500 are 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)
AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Azl L. Kaus
(Division Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093639
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