Portable Slit Lamp Microscope

K162778 · Suzhou Kangjie Medical, Inc. · HJO · Jul 21, 2017 · Ophthalmic

Device Facts

• Record ID: K162778
• Device Name: Portable Slit Lamp Microscope
• Applicant: Suzhou Kangjie Medical, Inc.
• Product Code: HJO · Ophthalmic
• Decision Date: Jul 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

Portable Slit Lamp Microscope Model KJ5S is intended for use in the examination of the anterior and posterior segment of the eye.

Device Story

Portable Slit Lamp Microscope Model KJ5S is a handheld, battery-powered converging stereomicroscope. Used in healthcare facilities/hospitals by clinicians to examine the anterior and posterior segments of the eye. Device features an illumination system and fixation targets activated by a trigger on the handle; light intensity is adjusted via a rheostat. Clinicians view the eye through the microscope to perform visual examinations; findings inform clinical decision-making regarding ocular health. Benefits include portability and ease of use for point-of-care ophthalmic assessment.

Clinical Evidence

No clinical data. Bench testing only, including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 15004-1/2 (ophthalmic instrument requirements and light hazard protection), ISO 10939 (slit-lamp microscopes), and IEC 62133 (battery safety). Biocompatibility testing conducted per ISO 10993-1, -5, and -10.

Technological Characteristics

Handheld converging stereomicroscope; white LED light source; 7.4V 680mAh rechargeable Li-ion battery. Magnification 10X/16X; working distance 80mm. Materials evaluated for biocompatibility per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1/2, ISO 10939, IEC 62133. No software-based algorithms.

Indications for Use

Indicated for examination of the anterior and posterior segment of the eye in patients requiring ophthalmic evaluation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• YZ3 PORTABLE SLIT LAMP (K131711)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2017

Suzhou Kangjie Medical Inc. % Di Wu. Ph.D. Regulatory Affairs Consultant DIWU Regulatory 3440 Indian Queen Lane, Rear Philadelphia, PA 19129

Re: K162778

Trade/Device Name: Portable Slit Lamp Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: May 25, 2017 Received: May 30, 2017

Dear Dr. Di Wu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

{1}------------------------------------------------

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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K162778

Device Name Portable Slit Lamp Microscope Model KJ5S

Indications for Use (Describe)

Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services [phone] EF

{3}------------------------------------------------

### Date prepared July 13, 2017

### Submission Sponsor (Manufacturer):

Suzhou Kanqjie Medical Inc. No.129, Weixin Rd., Weiting Town Suzhou, Jiangsu, P.R. China 215000

### Submission Correspondent (Agent):

Mrs. Di Wu, PhD 3440 Indian Queen Lane, Rear Philadelphia, PA 19129 USA Phone: [phone] Email: [e-mail]

#### Trade/Device Name:

Portable Slit Lamp Microscope Model KJ5S

Common or Usual Name: Slit Lamp Microscope Device Class: II Classification Name: AC-Powered Slitlamp Biomicroscope Requlation Number: 21 CFR 886.1850 Product Code: HJO Review Panel: Ophthalmic

#### Predicate Device:

- K131711, SUZHOU 66 VISION TECH CO., LTD ● YZ3 PORTABLE SLIT LAMP
#### Device Description:

Portable Slit Lamp Microscope Model KJ5S

The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries.

{4}------------------------------------------------

The illumination system and fixation targets are activated using a single/double click trigger located on the rear of the grip/handle. A rheostat located below the eyepieces on the front of the grip /handle is used to increase or reduce the light intensity.

Environment of Use: healthcare facility/hospital Duration and type of contact: less than 24 hours, surface device

#### Intended Use:

Portable Slit Lamp Microscope Model KJ5S is intended for use in the examination of the anterior and posterior seqment of the eye.

#### Comparison to Predicate Device:

Refer to the Comparison Table on Pages 4 and 5.

#### Discussion of Non-Clinical Tests Performed:

The performance tests were conducted:

IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

ISO 15004-1, Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments

ISO 15004-2, Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection

ISO 10939, Ophthalmic instruments - Slit-lamp microscopes

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International

{5}------------------------------------------------

Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)

ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)

ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)

IEC 62133, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

### Discussion of Clinical Tests Performed:

None

## Conclusion:

The subject device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. Thus, the subject devices are substantially equivalent to its predicate devices.

{6}------------------------------------------------

## KJ5S Slit Lamp Microscope vs. K131711

| Descriptive Information | Proposed Device | Predicate Device |
|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k) Number | K162778 | K131711 |
| Manufacturer | Suzhou Kangjie Medical Inc. | 66 Vision Tech Co., Ltd. |
| Proprietary or Model Name | KJ5S portable slit lamp microscope | YZ3 Portable Slit Lamp microscope |
| Indications for Use | Same | Same |
| Flammability of materials near the light source | NONE | NONE |
| Maximum temperature of parts of the device held by the operator or accessible to the patient | Maximum temperature of parts of the device held by the operator:<br>- Eyepiece: 35°<br>- Grip: 35 °<br>- Slit width control ring: 35°<br>Maximum temperature of parts of the device accessible to the patient:<br>Forehead rest 35° | Same |
| Brightness controls | Maximal Illumination ≥12000Lx | Maximal Illumination ≥30000Lx |
| Operating temperature | 10° to 35° | Same |
| Slit Width | 0 to 10mm continuously adjustable | 0 to 12mm continuously adjustable |
| Slit Length | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm |
| Illumination field diameter | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm |
| Radial movement of the slit light illumination relative to the microscope axis | Horizontal ± 30° | Same |
| Stereo angle | 13° | Same |
| Light sources | White LED Single Light Source | Same |
| Pupil-distance | 48 to 72mm | 50 to 75mm |
| Eye piece | 10X, 16X | Same |
| Objective | 1X | Same |
| Total magnifications | 10X, 16X(Optional) | Same |
| Filter | Heat-absorption, Cobalt blue, Red-free, Gray | Cobalt blue, Red-free, Color Temperature Compensation |
| Descriptive Information | Proposed Device | Predicate Device |
| 510(k) Number | K162778 | K131711 |
| Illumination rotation angle | Horizental±30° | Same |
| Working distance | 80mm | 60mm |
| Power | 7.4V 680mAh Li Battery, Rechargeable | 7.4V 2200mA Li Battery, Rechargeable |
| Working time | 5-6 hours | 2.5 hours |
| Net Weight | 750g | 900g |

{7}------------------------------------------------

# Comparison Table