Portable Slit Lamp

K153545 · Shanghai Bolan Optical-Electric Co., Ltd. · HJO · Jun 22, 2016 · Ophthalmic

Device Facts

• Record ID: K153545
• Device Name: Portable Slit Lamp
• Applicant: Shanghai Bolan Optical-Electric Co., Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Jun 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye

Device Story

The BL-5000 is a handheld, AC-powered slit lamp biomicroscope used by clinicians for eye examinations. It functions by projecting 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, and power unit. The clinician uses the binocular stereoscopic microscope to zoom and observe the anterior segment of the eye. The device utilizes a warm white LED light source (380nm-780nm). It is a purely optical/mechanical instrument; it contains no software, data collection, display systems, or motors. All controls are manual. By providing magnified visualization of the anterior eye, it assists the physician in diagnosing ocular diseases or trauma.

Clinical Evidence

Bench testing only. Compliance demonstrated with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 15004-1 (general requirements), ISO 15004-2 (light hazard protection, classified as Group 2 non-hazardous), and ISO 10939 (slit-lamp microscopes).

Technological Characteristics

AC-powered handheld slit lamp biomicroscope. Light source: warm white LED (380-780nm, 16.77mW max output). Optical components: binocular stereoscopic microscope with 10X/16X magnification. Manual controls for slit width (0-12.5mm), length (0-12.5mm), and rotation (±30°). Diopter adjustment ±5D. Filters: green, cobalt blue, color temperature conversion. No software, motors, or data systems. Standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939.

Indications for Use

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

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

• PSL Portable Slit Lamp (K061330)

Submission Summary (Full Text)

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

June 22, 2016

Shanghai Bolan Optical-Electric Co., Ltd. Mr. Johnny Hu Manager No.29, Jiuyuan Road Oingpu Industrial Park Shanghai, China 201700

Re: K153545

Trade/Device Name: BL-5000 Portable Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: May 15, 2016 Received: May 17, 2016

Dear Mr. Hu:

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.

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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 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.

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

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## Indications for Use

510(k) Number (if known)

Device Name BL-5000 portable slit lamp

Indications for Use (Describe)

The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;width:20px;height:20px;">☑</div> |
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| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;width:20px;height:20px;">☐</div> |

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Image /page/3/Picture/1 description: The image contains the logo for BOLAN. On the left side of the image is a blue symbol that looks like a lens with lines going through it. To the right of the symbol is the word "BOLAN" in a bold, black font.

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

- 1. Date Prepared [21 CFR 807.92(a)(1)] December 1st 2015
### 2. Submitter;s Information [21 CFR 807.92(a)(1)]

| Company Name: | Shanghai Bolan Optical-Electric Co., Ltd. |
|------------------|------------------------------------------------------------------------|
| Company Address: | No. 29, Jiuyuan Road, Qingpu Industrial Park<br>Shanghai, China 201700 |
| Fax: | [phone] |
| Email: | [e-mail] |

### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | BL-5000 Portable Slit Lamp |
|-----------------------------------------------------------------|----------------------------|
| Common Name: | Portable Slit Lamp |
| Product Code: | HJO |
| Regulation Number: | 21 CFR 886.1850 |
| Device Class: | Class II |
| 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)] | |

The identification of predicates within this submission is as follow:

| Predicate I | |
|----------------------|----------------------------------|
| Manufacturer: | REICHERT, INC. |
| Trade Name: | PSL Portable Slit Lamp |
| Product Code: | HJO |
| Classification Name: | AC-Powered Slitlamp Biomicroscop |
| Regulation Number : | 886.1850 |
| FDA 510 (k) #: | K061330 |

### 5. Description of the Device [21 CFR 807.92(a)(4)]

The BL-5000 portable slit lamp 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 BL-5000 portable slit lamp is composed of the following components: microscope unit, illumination unit, base unit and power

# [510(k)] Application

Page 1 of 4

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Image /page/4/Picture/1 description: The image shows the BOLAN logo. The logo consists of a blue abstract symbol on the left and the word "BOLAN" in black bold letters on the right. The abstract symbol appears to be a stylized representation of lenses or optical elements.

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.

### 6. Indications For Use [21 CFR 807.92(a)(5)]

The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye

## 7. Technological Characteristic [21 CFR 807.92(a)(6)]

The BL-5000 Portable Slit Lamp has similar technological characteristics to the predicate devices. The BL-5000 Portable Slit Lamp and the predicate devices are all AC powered slit lamp biomicroscopes that project a beam of light into the patient's eye through a control diaphragm. Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are the same or similar to the specifications of the previously cleared predicate devices. All controls are manual. Neither the BL-5000 nor its predicate device has data collection, display systems, motors, or software.

The BL-5000 Portable Slit Lamp uses the warm white LED as the light source, the exposure condition is continuous wave.

Light source operation characteristics:

Wavelength: 380nm-780nm Maximum output: 16.77mW

## 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Non-clinical consideration:

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

IEC 60601-1:2006+A1:2012 medical electrical equipment -- part 1: general requirements for basic safety and essential performance

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.

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

# [510(k)] Application

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Image /page/5/Picture/1 description: The image shows the logo for Bolan. The logo consists of a blue abstract symbol on the left and the word "BOLAN" in black bold letters on the right. The abstract symbol appears to be a stylized representation of a lens or optical element.

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 which is non-hazardous. ISO 10939:2007 Ophthalmic Instruments – Slit-lamp microscopes found that

the BL-5000 complies with the requirements of the standard.

Also the comparison table below demonstrates that the proposed device BL-5000 is substantial equivalence to the predicated device.

| Comparison Item | Proposed Device | Predicate Device<br>PSL Portable Slit Lamp<br>(K061330) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The BL-5000 portable slit<br>lamp is an AC-powered slit<br>lamp biomicroscope that is<br>intended for use in<br>examining the anterior eye<br>segment, from the corneal<br>epithelium to the posterior<br>capsule. It is used to aid in<br>the diagnosis of diseases or<br>trauma, which affect the<br>structural properties of the<br>anterior segment of the eye | intended for use in eye<br>examination of<br>- the anterior segment,<br>from the cornea<br>epithelium to the<br>posterior<br>capsule. It is used to aid<br>in the diagnosis of<br>diseases or trauma<br>which affect the<br>structural properties of<br>the anterior eye segment. |
| Method of Operation | Handheld | Handheld |
| Data Collection/<br>Display System | None | None |
| Maximum Temperature | None | None |
| Total magnifications: | 10X, 16X; | 10X, 16X; |
| Diopter adjustment | $\pm$ 5D | $\pm$ 7D |
| Filter | Green, cobalt blue, Color<br>temperature conversion | Green, cobalt blue, Color<br>temperature conversion |
| Slit rotation | $\pm$ 30°C | $\pm$ 30°C |
| Light source | High luminance white LED | High luminance white LED |

[510(k)] Application

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# Shanghai Bolan Optical-Electric Co., Ltd.

Image /page/6/Picture/1 description: The image shows the logo for BOLAN. The logo consists of a blue graphic on the left and the word "BOLAN" in black on the right. The graphic is a stylized representation of an eye or lens. The word "BOLAN" is in a bold, sans-serif font.

| Slit width | 0~12.5mm | 0~11mm |
|--------------|-----------|-----------|
| Slit length | 0~12.5mm | 0~11mm |
| Light source | White LED | White LED |

The BL-5000 Portable Slit Lamp has the same intended use and principles of operation, most technological characteristics are same or similar as the previously cleared predicates.

### 9. Conclusion [21 CFR 807.92(b)(3)]

BL-5000 Portable Slit Lamp is substantially equivalent to the currently legally marketed devices. It does not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.