(265 days)
An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.
An AC-powered slit lamp biomicroscope is 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.
An AC-Powered slit lamp 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.
The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.
The patient sits in front of the slit lamp with his chin in the chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. Various maqnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and vertically, and the angle between the illumination unit and the microscope can also be varied horizontally.
The provided document is a 510(k) premarket notification for a Class II medical device, the Z5 and Z2 Slit Lamp Microscopes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in diagnosis or treatment.
Therefore, the document does not contain information related to acceptance criteria or studies that prove the device meets such criteria in the context of diagnostic accuracy, which is typically seen for AI/ML devices.
Instead, the performance data provided relates to the physical and technical specifications of the slit lamps and compliance with recognized safety and performance standards.
Here's the breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
Since this is not a diagnostic AI/ML device, there are no diagnostic accuracy acceptance criteria or performance metrics in that sense. The "performance" described relates to technical specifications and safety standards.
| Characteristic / Standard | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Z5 & Z2 Slit Lamp Microscopes) |
|---|---|---|
| Radiation Hazards | Compliance with ISO 15004-2:2007 and ISO 10939:2007 | In compliance with these FDA recognized standards |
| Electrical Safety | Compliance with IEC 60601-1 | In compliance with this FDA recognized standard |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | In compliance with this FDA recognized standard |
| Specific Features (Example) | Predicate Device Specifications: | Takagi Slit Lamp Specifications: |
| Z5 Max Brightness (Lux) | BQ900: approx. 450,000 Lux | Z5: approx. 240,000 Lux |
| Z2 Max Brightness (Lux) | SL-2G: Unknown | Z2: approx. 150,000 Lux |
| Z5 Illumination Field Diameter (mm) | BQ900: Φ8, Φ5, Φ3, Φ2, Φ1, Φ0.2 | Z5: Φ14, Φ10, Φ5, Φ3, Φ2, Φ1, Φ0.2 |
| Z2 Illumination Field Diameter (mm) | SL-2G: Φ14, Φ10, Φ5, Φ1, Φ0.3 | Z2: Φ14, Φ8, Φ5, Φ3, Φ0.3 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or not provided in this 510(k) submission. No clinical test set of patients or medical images is described for performance evaluation of diagnostic accuracy. The "tests" mentioned are engineering and safety compliance tests on the physical device.
3. 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)
This information is not applicable or not provided. There is no ground truth, as typically understood for diagnostic AI/ML devices, described in this submission. The device is a traditional medical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided.
5. 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
This information is not applicable or not provided. The device is a conventional slit lamp microscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. The device is an optical instrument requiring human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable or not provided.
8. The sample size for the training set
This information is not applicable or not provided.
9. How the ground truth for the training set was established
This information is not applicable or not provided.
Summary of why the requested information is largely absent:
The document describes a traditional medical device (slit lamp microscope) and its premarket notification (510(k)) to the FDA. The purpose of a 510(k) for such a device is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This typically involves comparing technical specifications, materials, safety features, and compliance with recognized industry standards (e.g., electrical safety, EMC, radiation hazards). It does not require clinical studies for diagnostic accuracy, particularly those involving "acceptance criteria" or "ground truth" derived from expert consensus on patient data, which are common requirements for AI/ML-driven diagnostic software. The "performance" referred to in this document relates to the physical and technical functionality of the instrument itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
May 26, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Takagi Seiko Co., Ltd. Nagaike Yoshio Official Correspondent 330-2 Iwafune. Nakano-shi. Nagano-ken, 383-8585 JAPAN
Re: K152535
Trade/Device Name: Z5 Slit Lamp Microscope, Z2 Slit Lamp Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: April 18, 2016 Received: April 26, 2016
Dear Nagaike Yoshio:
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. 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
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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.
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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Section 4: Indications for Use
510(k) Number (if known): None
Device Names : Z5 Slit lamp microscope Z2 Slit lamp microscope
Indications for Use
An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.
Prescription Use X (Part 21 CFR 801 subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/3/Picture/1 description: The image shows the logo for TAKAGI SEIKO CO., LTD. The logo consists of a blue abstract shape on the left, followed by the company name in a bold, sans-serif font. A horizontal line underlines the company name, adding emphasis to the overall design.
-2 IWAFUNE. NAKANO-SHI. NAGANO-KEN. 383-8585. JAPAN 81-269-22-4512 FAX. +81-269-26-6321 http://www.takagi-i.com E-mail: info@takagi-i.com
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Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- Submitter of this pre-market notification: TAKAGI SEIKO CO., LTD. 330-2 Iwafune, Nakano-shi, Nagano-ken, Japan 383-8585
Contact Person: Toru Hagiwara Phone: +80-269-22-4511 Fax : +81-269-26-6321 Email: hagiwara.toru@takagi-j.com
Date prepared: This summary was prepared on June 17, 2015
2.Trade names of the devices: Z5 Slit lamp microscope Z2 Slit lamp microscope
3.Common / Usual name: AC-Powered Slit-lamp Biomicroscope
4.Classification Information:
- Classification name: CFR title: Product code: Device Class: Classification Panel:
Biomicroscope, Slit-Lamp, AC-Powered 21 CFR 886.1850 HJO Class II Ophthalmic Panel
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5. Predicate Devices:
| We claim substantial equivalence to the following devices | |
|---|---|
| Manufacture: | Haag-Streit AG |
| Device name: | BQ900 Slit |
| 510(k) Premarket Notification No: | K100202 |
| Classification name: | Biomicroscope, Slit-Lamp, AC-Powered |
| CFR title: | 21 CFR 886.1850 |
| Product code: | HJO |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic Panel |
| Manufacture: | Topcon Medical Systems, Inc. |
| Device name: | SL-2G Slit lamp Microscope |
| 510(k) Premarket Notification No: | K110489 |
| Classification name: | Biomicroscope, Slit-Lamp, AC-Powered |
| CFR title: | 21 CFR 886.1850 |
| Product code: | HJO |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic Panel |
6. General Device Description:
An AC-powered slit lamp biomicroscope is 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.
An AC-Powered slit lamp 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.
The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.
The patient sits in front of the slit lamp with his chin in the chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. Various maqnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and vertically, and the angle between the illumination unit and the microscope can also be varied horizontally.
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7.Indication for use:
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posteriorcapsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
8. Comparison with predicate devices:
The Z5 Slit lamp is substantially equivalent to the predicate device Slit Lamp BQ 900 because they use similar technology and perform similar functions to provide the physician with the necessary information to make diagnosis.
The Z2 Slit lamp is substantially equivalent to the predicate device Slit Lamp SL-2G because they use similar technology and perform similar functions to provide the physician with the necessary information to make diagnosis.
| Predicate DeviceSlit lamps | TAKAGI Slit lamps | |
|---|---|---|
| BQ 900 Slit lamp microscope | Z5 Slit lamp microscope | |
| SL-2G Slit Lamp microscope | Z2 Slit lamp microscope | |
| BrightnessControls | For BQ900Variable control by potentiometerMaximum brightnessapprox. 450'000 Lux | For Z5Control by Light intensity control knobMaximum brightnessapprox. 240'000 Lux |
| ForSL-2GControl by brightness control knobMaximum brightnessUnknown. | For Z2Control by Light intensity control knobMaximum brightnessapprox. 150'000 Lux | |
| Slit imagewidth | For BQ 9000-8mm continuous | |
| ForSL-2G0-14mm, can be adjusted gradually | ||
| Slit imagelength | For BQ9001-8mm continuous | For all Slit lamps1-14mm continuous |
| ForSL-2G1-14mm, can be adjusted gradually | ||
Major different technological characteristics are as follows:
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| Predicate DeviceSlit lamps | TAKAGI Slit lamp | |
|---|---|---|
| BQ 900 Slit lamp Microscope | Z5 Slit lamp Microscope | |
| SL-2G Slit lamp Microscope | Z2 Slit lamp Microscope | |
| IlluminationfieldDiameter | For BQ900$Φ8,φ5,φ3,φ2,φ1,φ0.2$ mm | For Z5$φ14,φ10,φ5, φ3,φ2,φ1,φ0.2$ mm |
| For SL-2G$φ14,φ10,φ5, φ1,φ0.3$ mm | For Z2$φ14,φ8,φ5, φ3,φ0.3$ mm | |
| Radialmovement ofthe slit lightilluminationrelative to themicroscopeaxis | For BQ900Horizontal ±90°Vertical 0 - 20° | For Z5Horizontal±90°Vertical 0°,5°,10°,15°, 20° |
| For SL-2GVertical to horizontal can be adjustedgradually | For Z2Horizontal±90°Vertical don't apply | |
| Light source | For BQ900 and SL-2GLED | For all Slit lampsLED |
9. Performance, safety and EMC Data:
The slit lamps Z5 and Z2 were tested according to ISO 15004-2:2007 and ISO10939:2007 for radiation hazards, to IEC 60601-1 for electrical safety and IEC-60601-1-2 for electromagnetic compatibility. In all tests the slit lamps were in compliance with these FDA recognized standards.
10.Conclusions:
In accordance to 21 CFR 807.92(d) and based on the technical characteristics and the results of the performance tests we conclude that the slit lamps Z5 and Z2 are safe and effective compared to the predicate device slit lamps BQ 900 and SL 2G.
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Z5 Diagram of Optical Paths
Image /page/7/Figure/2 description: This image is a line drawing of a complex mechanical device, possibly a microscope or similar scientific instrument. The drawing includes numerous labeled parts, indicated by numbers ranging from (1) to (27), which suggests a detailed schematic or technical illustration. The device appears to have both horizontal and vertical components, with intricate connections and adjustments. The overall impression is that of a precise and sophisticated piece of equipment.
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| (1) Examiner's eye | Eye of the user of this device | |
|---|---|---|
| (2) Eyepiece lens | Optical element enlarging the observation image | |
| (3) Eyepiece lens | ||
| (4) Prism | Optical element changing the direction of light | |
| (5) Lens | Light-gathering optical element | |
| (6) Prism | Optical element changing the direction of light | |
| (7) Prism | ||
| (8) Prism | ||
| (9) Lens | Light-gathering optical element | |
| (10) Magnifying lens | Image zooming-in/out optical element | |
| (11) Magnifying lens | ||
| (12) Magnifying lens | ||
| (13) Magnifying lens | ||
| (14) Objective lens | Optical element taking in the light from the object under observation | |
| (15) Mirror | Light-reflecting optical element | |
| (16) LED light | Light source of background illumination | |
| (17) Patient's eye | Eye of the person under observation | |
| (18) Projection lens | Optical element projecting the slit image | |
| (19) Projection lens | ||
| (20) Projection lens | ||
| (21) Filter | Optical element changing the wavelength of light | |
| (22) Slit edge | Edge to make a slit image | |
| (23) Condensing lens | Light-gathering optical element | |
| (24) Condensing lens | ||
| (25) Condensing lens | ||
| (26) Condensing lens | ||
| (27) LED light | Light source of slit illumination |
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Z2 Diagram of Optical Paths
Image /page/9/Figure/2 description: This image is a detailed technical drawing of a complex optical instrument, possibly a microscope or ophthalmic device. The drawing includes callout numbers from (1) to (23), indicating various components and features of the instrument. The diagram shows the internal mechanisms and optical pathways, suggesting a design or engineering schematic for manufacturing or maintenance purposes. The layout includes lenses, prisms, and mechanical parts, illustrating the precision and complexity of the device.
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| (1) Examiner's eye | Eye of the user of this device |
|---|---|
| (2) Eyepiece lens | Optical element enlarging the observation image |
| (3) Eyepiece lens | Optical element enlarging the observation image |
| (4) Prism | Optical element changing the direction of light |
| (5) Lens | Light-gathering optical element |
| (6) Prism | Optical element changing the direction of light |
| (7) Prism | Optical element changing the direction of light |
| (8) Prism | Optical element changing the direction of light |
| (9) Lens | Light-gathering optical element |
| (10) Magnifying lens | Image zooming-in/out optical element |
| (11) Magnifying lens | Image zooming-in/out optical element |
| (12) Objective lens | Optical element taking in the light from the object under observation |
| (13) Prism | Optical element changing the direction of light |
| (14) Patient's eye | Eye of the person under observation |
| (15) Projection lens | Optical element projecting the slit image |
| (16) Projection lens | Optical element projecting the slit image |
| (17) Slit edge | Edge to make a slit image |
| (18) Filter | Optical element changing the wavelength of light |
| (19) Condensing lens | Light-gathering optical element |
| (20) Condensing lens | |
| (21) Condensing lens | |
| (22) Condensing lens | |
| (23) LED light | Light source of slit illumination |
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Image /page/11/Picture/3 description: The image shows two diagrams of a slit lamp, labeled Z5 and Z2. Each diagram labels the slit lamp unit, microscope unit, chinrest unit, and cross-slide base unit. The Z5 diagram shows the slit lamp with a curved light source, while the Z2 diagram shows the slit lamp with a straight light source.
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| Comparing item | Z5 | Z2 |
|---|---|---|
| Slit projection magnification | 0.98x | 1x |
| Working distance | 80mm | 85mm |
| Brightness | φ0.2,φ1,φ2,φ3,φ5,φ10mm | φ0.3,φ1,φ3,φ5,φ8,φ14mm |
| Back ground illumination(Assistance light for takingphotograph) | 240,000lux | 150,000lux |
| Tilting angle | Included in slit lamp unitLight adjustment knob islocated on the cross - slidebase unit. | No back ground illumination isequipped |
| Total magnifications | 6.3x,10x,16x,25x,40x | 10x,16x,25x |
| Real field of view | φ35.9,φ23.3,φ14,φ8.8,φ5.5mm | φ23.3,φ14,φ8.8mm |
| Fixation light(Guides the patient's line ofsight and maintain it) | Standard parts | Optional parts |
| Weight | 12.5kg | 11kg |
Performance
Accessories
| Item name | Explanation | Z5 | Z2 |
|---|---|---|---|
| Image: Short mirror (1 pc.) | Prevent vignetting when used in tilting function | 〇 | ✕ |
| Image: Focusing adjusting rod (1 pc.) | Used in diopter confirmation | 〇 | ✕ |
| Image: Focusing adjusting plate (1 pc.) | Used in diopter confirmation | ✕ | 〇 |
§ 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.