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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a Slit Lamp device (HS-5500, HS-7000, HS-7500). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies to meet specific acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML or novel diagnostic device.

Here's why and what information is available:

Acceptance Criteria & Reported Device Performance: This section is not applicable as the submission leverages substantial equivalence. There are no specific performance metrics like sensitivity, specificity, or accuracy that are typically associated with acceptance criteria for new diagnostic devices.
Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, ground truth type, training set size/ground truth): These details are also not present because the submission for the Slit Lamp is based on demonstrating that its technological characteristics and intended use are similar to a previously cleared device (the predicate device HS-5000). The safety and effectiveness are established through compliance with electrical, mechanical, and environmental safety standards (IEC 60601-1 and IEC 60601-1-2), rather than through performance studies against a clinical ground truth.

What the document does state about "performance":

The "Performance Data" section (Section 8) focuses on safety and electrical compliance, not clinical performance or diagnostic accuracy.

Acceptance Criteria (Implied for Safety & Electrical Performance):
- Compliance with IEC 60601-1 (Electrical, mechanical, and environmental safety).
- Compliance with IEC 60601-1-2(2001) (EMC testing).
Reported Device Performance (for Safety & Electrical Compliance):
- "The devices meet all requirements and passed all tests." (Page 2)

In summary, for the given Slit Lamp device 510(k) submission:

A table of acceptance criteria and the reported device performance: Not applicable in the context of clinical performance. The "acceptance criteria" are compliance with specified electrical and safety standards, which the device reportedly met.
Sample sized used for the test set and the data provenance: Not applicable. Performance was assessed via engineering and safety tests, not clinical data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device, not an algorithm.
The type of ground truth used: For safety testing, the "ground truth" is compliance with engineering standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

This 510(k) submission is indicative of a Class II medical device where the primary pathway to market is through demonstrating substantial equivalence to a predicate, often relying on engineering standards and shared technological characteristics rather than extensive new clinical performance studies.

Summary

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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

1. 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 - +82-31-477-8618

Contact Chang-Soo, Lee / QA Manager
E-mail - cslee@huvitz.com
1. Device:
  Trade/ proprietary name : Slit Lamp HS-5500, HS-7000, HS-7500 Common Name : Slit Lamp

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

Huvitz Co., Ltd.

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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.

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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.

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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 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

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Indications for Use

510(k) Number (if known):

Device Name : Slit Lamp HS-5500, HS-7000, HS-7500

Indications for Use:

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

Page 1 of 1

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.