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 Description

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BL-5000 Portable Slit Lamp, a medical device. The document primarily focuses on establishing substantial equivalence to a predicate device (PSL Portable Slit Lamp, K061330) based on technological characteristics and non-clinical testing.

However, the document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness. Instead, it relies on demonstrating that the device's technical specifications and safety comply with relevant international standards and are comparable to its predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not available in the provided text, as these are typically associated with performance studies, especially those involving AI or diagnostic accuracy, which is not the focus of this 510(k) submission for a slit lamp.

Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of clinical performance thresholds. Instead, it relies on compliance with international standards and similarity to the predicate device's specifications.

Characteristic / Standard	Acceptance/Conformance Criteria (Implicit)	Reported Device Performance (BL-5000)
Safety and Essential Performance	Compliance with IEC 60601-1:2006+A1:2012	Met requirements
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007	Met requirements
General Ophthalmic Instrument Requirements	Compliance with ISO 15004-1:2006	Met requirements
Light Hazard Protection	Compliance with ISO 15004-2:2007 (classified as non-hazardous)	Classified as Group 2 instrument (non-hazardous)
Slit-lamp Microscope Requirements	Compliance with ISO 10939:2007	Complies with requirements
Total Magnifications	Similar to predicate (10X, 16X)	10X, 16X
Diopter Adjustment	Similar to predicate ($\pm$ 7D)	$\pm$ 5D
Filter	Similar to predicate (Green, cobalt blue, Color temperature conversion)	Green, cobalt blue, Color temperature conversion
Slit Rotation	Similar to predicate ($\pm$ 30°C)	$\pm$ 30°C
Light Source	Similar to predicate (High luminance white LED)	High luminance white LED
Slit Width	Similar to predicate (0~11mm)	0~12.5mm
Slit Length	Similar to predicate (0~11mm)	0~12.5mm

Study to prove device meets acceptance criteria:

The study proving the device meets the "acceptance criteria" (which are primarily regulatory and technical compliance, and comparability to the predicate) consisted of bench testing against the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939). The results of these tests indicated that the product met the requirements of these standards. Additionally, a comparison table was used to demonstrate the technological equivalence of the BL-5000 Portable Slit Lamp to the predicate device (PSL Portable Slit Lamp, K061330).

Detailed breakdown for remaining items:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document describes bench testing of the device itself against technical standards, rather than testing on a dataset of clinical cases. There is no mention of a clinical "test set" in the context of diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. No clinical test set or ground truth determination by experts is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set or adjudication process is described.
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. The device is a "portable slit lamp" for eye examination, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / No. The device is a physical diagnostic instrument and does not involve an algorithm for standalone performance evaluation in the context of this submission. The document explicitly states "All controls are manual. Neither the BL-5000 nor its predicate device has data collection, display systems, motors, or software."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. For the bench testing, the "ground truth" was compliance with the specified international standards. No clinical ground truth (like pathology or expert consensus on patient cases) was used.
The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/machine learning device, there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set exists for this device.

Summary

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Image /page/0/Picture/1 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 an abstract symbol that resembles 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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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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 ParkShanghai, China 201700
Fax:	+86-21-69225166
Email:	sales@sh-bolan.com

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)]

[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)]

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 DevicePSL Portable Slit Lamp(K061330)
Indications For Use	The BL-5000 portable slitlamp is an AC-powered slitlamp biomicroscope that isintended for use inexamining the anterior eyesegment, from the cornealepithelium to the posteriorcapsule. It is used to aid inthe diagnosis of diseases ortrauma, which affect thestructural properties of theanterior segment of the eye	intended for use in eyeexamination of- the anterior segment,from the corneaepithelium to theposteriorcapsule. It is used to aidin the diagnosis ofdiseases or traumawhich affect thestructural properties ofthe anterior eye segment.
Method of Operation	Handheld	Handheld
Data Collection/Display System	None	None
Maximum Temperature	None	None
Total magnifications:	10X, 16X;	10X, 16X;
Diopter adjustment	$\pm$ 5D	$\pm$ 7D
Filter	Green, cobalt blue, Colortemperature conversion	Green, cobalt blue, Colortemperature 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.

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.