(194 days)
Not Found
No
The description focuses on the optical and mechanical components of a standard slit lamp and does not mention any computational or analytical features that would suggest AI/ML.
No
The device is used to examine the anterior eye segment to aid in the diagnosis of diseases or trauma; it does not treat or cure any conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma."
No
The device description explicitly states it is an AC-powered device composed of physical components like a microscope unit, illumination unit, base unit, and power unit, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BL-5000 portable slit lamp is a medical device used for direct visual examination of the anterior segment of the eye. It uses light and magnification to allow a healthcare professional to observe the structures of the eye.
- No Sample Analysis: The device does not analyze samples taken from the patient's body. It is used for direct observation of the living tissue.
Therefore, the BL-5000 portable slit lamp falls under the category of an ophthalmic instrument used for examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
HJO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the corneal epithelium to the posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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 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
2
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
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)
-
- 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 |
| Shanghai, 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)]
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
4
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
5
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
PSL Portable Slit Lamp
(K061330) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For 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 | intended for use in eye
examination of
- the anterior 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. |
| 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, Color
temperature conversion | Green, cobalt blue, Color
temperature conversion |
| Slit rotation | $\pm$ 30°C | $\pm$ 30°C |
| Light source | High luminance white LED | High luminance white LED |
[510(k)] Application
6
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.