(265 days)
Not Found
No
The description details a standard optical slit lamp with manual controls and no mention of automated analysis, image processing, or AI/ML terms.
No
The device is used for diagnosis and examination, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment."
No
The device description clearly outlines a physical, AC-powered slit lamp biomicroscope with various hardware components (light source, optics, chin rest, joystick, etc.) used for direct examination of the eye. It is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device is used for the "examination of the anterior eye segment" in vivo (on a living patient). It does not process or analyze samples taken from the body.
- The device is a diagnostic aid based on direct observation of the patient's anatomy. It uses light and a microscope to visualize the eye's structure, which is a form of in vivo diagnostic imaging, not in vitro testing.
- The intended use and device description focus on structural examination. The purpose is to aid in the diagnosis of diseases or traumas affecting the structural properties of the anterior eye segment, which is achieved through visual inspection.
Therefore, this device falls under the category of an ophthalmic diagnostic device used for direct examination of the patient, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HJO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the cornea 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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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Image /page/2/Picture/1 description: The image shows the logo for TAKAGI SEIKO CO.,LTD. The logo consists of a blue abstract symbol on the left, followed by the company name in a bold, sans-serif font. A dark brown line is located underneath the company name.
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
4
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.
5
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 Device
Slit lamps | TAKAGI Slit lamps |
|------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | BQ 900 Slit lamp microscope | Z5 Slit lamp microscope |
| | SL-2G Slit Lamp microscope | Z2 Slit lamp microscope |
| Brightness
Controls | For BQ900
Variable control by potentiometer
Maximum brightness
approx. 450'000 Lux | For Z5
Control by Light intensity control knob
Maximum brightness
approx. 240'000 Lux |
| | ForSL-2G
Control by brightness control knob
Maximum brightness
Unknown. | For Z2
Control by Light intensity control knob
Maximum brightness
approx. 150'000 Lux |
| | Slit image
width | For BQ 900
0-8mm continuous |
| | | ForSL-2G
0-14mm, can be adjusted gradually |
| | | |
| Slit image
length | For BQ900
1-8mm continuous | For all Slit lamps
1-14mm continuous |
| | ForSL-2G
1-14mm, can be adjusted gradually | |
| | | |
Major different technological characteristics are as follows:
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| | Predicate Device
Slit lamps | TAKAGI Slit lamp |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------|
| | BQ 900 Slit lamp Microscope | Z5 Slit lamp Microscope |
| | SL-2G Slit lamp Microscope | Z2 Slit lamp Microscope |
| Illumination
field
Diameter | 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 |
| Radial
movement of
the slit light
illumination
relative to the
microscope
axis | For BQ900
Horizontal ±90°
Vertical 0 - 20° | For Z5
Horizontal±90°
Vertical 0°,5°,10°,15°, 20° |
| | For SL-2G
Vertical to horizontal can be adjusted
gradually | For Z2
Horizontal±90°
Vertical don't apply |
| Light source | For BQ900 and SL-2G
LED | For all Slit lamps
LED |
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 taking | ||
| photograph) | 240,000lux | 150,000lux |
| Tilting angle | Included in slit lamp unit | |
| Light adjustment knob is | ||
| located on the cross - slide | ||
| base unit. | No back ground illumination is | |
| equipped | ||
| 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 of | ||
| sight 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 |