SLM-1ER, SLM-2ER, SLM-3ER

K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd. · HJO · Dec 21, 2017 · Ophthalmic

Device Facts

• Record ID: K171877
• Device Name: SLM-1ER, SLM-2ER, SLM-3ER
• Applicant: Chongqing Kanghua Ruiming S&T Co., Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Dec 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp biomicroscope 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 affects the structural properties of the anterior eye segment.

Device Story

The KH Ophthalmic Slit-lamp Microscope is an AC-powered biomicroscope used for clinical eye examinations. It projects a thin, intense beam of light into the patient's eye via a control diaphragm. The device consists of a microscope unit, illumination unit, base unit, chinrest, and power unit. A physician operates the binocular stereoscopic microscope to zoom and observe the anterior eye segment, including the cornea and posterior capsule, in three dimensions. The device aids in diagnosing diseases or trauma affecting the anterior segment. It is used in clinical settings; the output is a direct visual observation of the eye, which the clinician uses to inform diagnostic and treatment decisions. The device benefits patients by enabling detailed structural assessment of the eye.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), and performance standards (ISO 15004-1, ISO 15004-2, ISO 10939, IEC 62471).

Technological Characteristics

AC-powered slit-lamp biomicroscope. Features binocular stereoscopic microscope (Galilean converging). Illumination: 12V/50W halogen bulb. Includes chinrest, base, and power unit. Complies with IEC 60601-1 (electrical safety), ISO 15004-1/2 (ophthalmic instruments/light hazard), and ISO 10939 (slit-lamp microscopes). Biocompatibility per ISO 10993. No digital camera or image capture modules.

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment 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

• Keeler Slit Lamp H-Series (K131589)

Submission Summary (Full Text)

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December 21, 2017

Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You Production Manager No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing, 400070 CHINA

Re: K171877

Trade/Device Name: SLM-1ER, SLM-2ER, SLM-3ER Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: November 1, 2017 Received: November 1, 2017

Dear Xi You:

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.

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.

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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 of medical devicerelated 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bradley S. Cunningham -S

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

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

51D(k) Number (if known) K171877

Device Name KH Ophthalmic Slit-lamp Microscope Model: SLM-1ER, SLM-2ER

### Indications for Use (Describe)

The KH Oplithalmic Slit-lamp Microscope is an AC-powered slittamp biomicroscope intended for use in eye examination of the anterior eye segment, from the comes epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eve segment.

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)

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

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FORM FDA 3881 (8/14)

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# 510(k) SUMMARY (K 171877)

# KH Ophthalmic Slit-lamp Microscope

#### Submitter's Information 1.

The submitter of this special pre-market notification is:

| Name: | Chongqing Kanghua Ruiming S&T Co., Ltd. |
|------------------------|----------------------------------------------------------------------------------------|
| Address: | No.5, Road1, Tongjiaxi Industrial Park, Beibei,<br>Chongqing, China<br>Zip Code:400070 |
| Company Phone No: | [phone] |
| Company Fax No: | [phone] |
| Contact Person: | Xi You |
| E-mail: | [e-mail] |
| Date summary prepared: | April 15, 2017 |

#### 2. Device Identification

| Device Trade Name: | KH Ophthalmic Slit-lamp Microscope<br>Model: SLM-1ER, SLM-2ER |
|---------------------|---------------------------------------------------------------|
| Classification Name | AC- Powered Slit-Lamp Biomicroscope |
| Regulation Number: | 21 CFR 886.1850 |
| Regulation Name: | AC Powered Slit lamp Bio-microscope |
| Regulation Class: | II |
| Product Code: | HJO |

#### Predicate Devices 3.

- Model: SLM-1ER, SLM-2ER, the predicate cited is the Keeler Slit Lamp H-• Series of the same instrument:

| Device Trade Name: | Keeler Slit Lamp H- Series |
|-----------------------|-------------------------------------|
| 510(k) Number; | K131589 |
| Common Name | AC Powered Slit lamp Bio-microscope |
| Class: | II |
| Classification Panel: | 86 |
| Product Code: | HJO |
| Regulation Number: | 886.1850 |

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#### Device Description 4.

The KH Ophthalmic Slit-lamp Microscope 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. The KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

#### Intended Use / Indications for Use 5.

The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp biomicroscope 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 affects the structural properties of the anterior eye segment.

| Feature | H-Series Slit<br>Lamp [K131589] | KH Ophthalmic Slit-<br>lamp Microscope | Discussion |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend use | As stated | As stated | No changes |
| Bio-microscope | | | |
| Bio-microscope | Galilean<br>converging<br>binoculars with<br>detachable<br>eyepiece head | • SLM-1ER,<br>Converging<br>binoculars with<br>detachable eyepiece<br>head<br>• SLM-2ER, Galilean<br>converging<br>binoculars with<br>detachable eyepiece<br>head | As head can be separated<br>from the body,<br>intervention of module<br>does not change these<br>elements |
| Digital Camera Module | Not fitted | • SLM-1ER, SLM-<br>2ER: Not fitted | Same |
| Image capture button | Not fitted | • SLM-1ER, SLM-2ER: Not fitted | Same |
| Camera Exposure<br>Buttons | Not fitted | Not fitted | Same |
| Slit Lamp illumination<br>Options | 6VDC 20W<br>halogen bulb /<br>LED | 12V/50W halogen<br>bulb | Required for slit lamp<br>illumination with some<br>light used for background<br>lighting |
| Background<br>Illumination<br>adjuster | Not fitted | • Not fitted | Same |
| Background Light<br>Source Options | Not fitted | • Not fitted | Required for higher<br>background light output<br>but still conforms to<br>requirements of 15004-2<br>Photo toxicity with slightly<br>longer exposure time. |
| Background lighting<br>duty cycle - halogen<br>bulb option only | Not applicable | 50% duty cycle at<br>maximum brightness. | Ensures body of light<br>source does not exceed<br>62.3 °C limit demanded by<br>IEC 60601-1 compliance |
| Duration of illumination | Maximum<br>examination times<br>according to ISO<br>15004-2 and ISO<br>10939 | Maximum examination<br>times according to<br>ISO 15004-2 and ISO<br>10939 | As a result of photo-<br>toxicity testing to ISO<br>15004-2 maximum<br>exposure increased from<br>13 to 17 minutes for bulb<br>option (LED maximum<br>exposure is unchanged at<br>12.5 minutes). |
| Input voltage | AC 100-240 V,<br>50/60 Hz | AC 110 V, 50/60 Hz | Same |

#### Comparison to predicate device 6.

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#### Non-Clinical testing 7.

# Safety and EMC:

Safety and EMC test was performed in according to the

- IEC60601-1:2005 + CORR.1(2006)+CORR.2(2007)+AM1(2012) or IEC 60601--1:2012
- -IEC 60601-1-2:2007 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.

# Biocompatibility :

Biocompatibility testing was performed to evaluate the biocompatibility of the contact materials in accordance with ISO 10993-1:2009, the device passed each biocompatibility test indentified below:

- Cytotoxicity testing in according to ISO 10993-5:2009 -
- Skin irritation testing in according to ISO 10993-10:2010
- -Vaginal irritation testing in according to ISO 10993-10:2010
- Sensitization testing in according to ISO 10993-10:2010 -

# Performance Data:

The following bench testing was conducted in order to support substantial equivalence:

- -ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments. The testing found that the product met the requirements of ISO 15004-1:2006.
- -ISO 15004-2:2007 Ophthalmic Instruments - Fundamental requirements and test methods - Part 2: Light hazard protection. The testing found that the device is a Group 2 instrument.
- -ISO 10939:2007 Ophthalmic Instruments - Slit-lamp microscopes found that the KH OPHTHALMIC SLIT-LAMP MICROSCOPE complies with the requirements of the standard.
- -IEC 62471:2006 Photobiological safety of lamps and lamp systems

#### 8. Conclusions:

The KH Ophthalmic Slit-lamp Microscope (Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate device in indications for use and construct, Safety and EMC testing to IEC60601-1 and IEC 60601-1-2, and performance testing to ISO 15004-1, ISO 15004-2 and ISO 10939, Based on the information provided in this submission, the KH Ophthalmic Slit-lamp Microscope(Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate devices(K131589).