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.

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 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Slit Lamp HS-5000" by HUVITZ Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device, the "Slit lamp SL 990" by C.S.O.S.R.L.

However, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would. Instead, it focuses on demonstrating safety and effectiveness for a traditional medical device (a slit lamp) through comparison with a predicate device and adherence to established safety and performance standards.

Therefore, many of the requested sections related to AI/ML device study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission confirms the device's adherence to relevant safety and EMC standards as its "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its successful testing against these standards. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) provided as would be expected for an AI/ML device.

Acceptance Criteria (Standards Met)	Reported Device Performance
Electrical, mechanical, and environmental safety	Performed by UL Korea, Ltd. according to Standard IEC 60601-1.
EMC testing	Performed by EMC Compliance Co., Ltd. according to Standard IEC 60601-1-2(2001).
Overall Conclusion of Safety and Effectiveness	All test results were satisfactory. Device is safe and effective and substantially equivalent to predicate devices.

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

Not Applicable. This is a traditional medical device submission based on engineering and safety standards, not a clinical performance study with 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:

Not Applicable. Ground truth as understood in AI/ML is not relevant here. The "ground truth" for the device's functionality is its adherence to engineering and safety standards.

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

Not Applicable.

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:

No. This is not an AI-powered device, and no MRMC study was conducted.

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

No. This is not an algorithm-only device. It's a physical medical instrument.

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

Not Applicable in the context of clinical "ground truth" for diagnostic performance. For the purpose of this submission, the "ground truth" for the device's safety and functionality is established by its compliance with recognized international safety and electromagnetic compatibility (EMC) standards (IEC 60601-1 and IEC 60601-1-2).

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable.

Summary

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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

1. 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

1. 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

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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
1. Indication for use :

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

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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.

1. 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.
1. HUVITZ Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

689-3 Geumjeong-dang Gunpo-si Gyeonggi-do, 435-862. Republic of Kepublic of Kepublika of Korea

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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.

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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

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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)

Page 1 of _1

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K073196

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0000033

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.