(205 days)
No
The description focuses on the optical and mechanical components of a traditional slit lamp and does not mention any computational or algorithmic features indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The description states the device is used to aid in the diagnosis of diseases or traumas, not to treat them.
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." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines a physical, AC-powered slit lamp biomicroscope with hardware components like a light source, optics, filters, and mechanical controls (joystick, knobs). It is not solely software.
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 description clearly states that this device is a slit-lamp biomicroscope used for the examination of the anterior eye segment. It projects light into the patient's eye and allows the user to observe the structures directly. This is an in vivo examination (performed on a living organism), not an in vitro test.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, this device falls under the category of a medical device used for direct examination and diagnosis, not an in vitro diagnostic device.
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
HJO
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 affect 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 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 magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally 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
The slit lamps M3 and M4 were tested according to ISO 15004-2:2007 and ISO10939:2007 for radiation hazards, to IEC60601-1 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
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Takagi Seiko Co., Ltd. Hagiwara Toru Official Correspondent 330-2 Iwafune, Nakano-Shi, Nagano-Ken Nakano, 383-8585 JP
Re: K162636
Trade/Device Name: Marco Ultra M3, Marco Ultra M4 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 2, 2017 Received: March 7, 2017
Dear Hagiwara Toru:
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
1
(reporting of medical device-related 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,
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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) K162636
Device Name Marco Ultra M3, Marco Ultra M4
Indications for Use (Describe)
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.
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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B-TQMS4101Letterhead Rev. 1
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330-2 IWAFUNE, NAKANO-SHI, NAGANO-KEN, +81-269-22-4512 FAX +81-269-2 http://www.takagi-i.com E-mail: in
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 April 10, 2017
2.Trade names of the devices: MARCO ULTRA M3 MARCO ULTRA M4
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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- Predicate Devices:
We claim substantial equivalence to the following devices Manufacture: Haag-Streit AG Device name: Slit Lamp BM900 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: TAKAGI SEIKO CO., LTD Device name: Z2 Slit lamp microscope 510(k) Premarket Notification No: K152535 Biomicroscope, Slit-Lamp, AC-Powered Classification name: CFR title:
Product code: Device Class: Classification Panel: 21 CFR 886.1850 HJO Class II 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 affect 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 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 magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally 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 MARCO ULTRA M3 is substantially equivalent to the predicate device Slit Lamp BM900 because they use similar technology and perform similar functions to provide the physician with the necessary information to aid in diagnosis.
The MARCO ULTRA M4 is substantially equivalent to the predicate device Z2 Slit lamp microscope because they use similar technology and perform similar functions to provide the physician with the necessary information to aid in diagnosis.
| Predicate Device Slit lamps | TAKAGI Slit lamps | |
|---|---|---|
| Slit Lamp BM900((K100202) | MARCO ULTRA M3(K162636) | |
| Z2 Slit lamp microscope(K152535) | MARCO ULTRA M4(K162636) | |
| Brightness | ||
| Controls | For BM900 (K100202) | For ULTRA M3(K162636) |
| Variable control by potentiometer | Control by Light intensity control knob | |
| Maximum brightness | Maximum brightness | |
| approx. 450'000 Lux | approx. 240'000 Lux | |
| For Z2(K152535) | For ULTRA M4(K162636) | |
| Control by Light intensity control knob | Control by Light intensity control knob | |
| Maximum brightness | ||
| approx. 150'000 Lux | Maximum brightness | |
| approx. 150'000 Lux | ||
| Slit image | ||
| width | For BM 900(K100202) | |
| 0-8mm continuous | For all Slit lamps(K162636) | |
| 0-14mm continuous | ||
| For Z2(K152535) | ||
| 0-14mm | ||
| Slit image | ||
| length | For BM 900 (K100202) | |
| 1-8mm continuous | For all Slit lamps(K162636) | |
| 1-14mm continuous | ||
| For Z2(K152535) | ||
| 1-14mm continuous |
Major different technological characteristics are as follows:
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| Predicate Device Slit lamps | TAKAGI Slit lamp | |
|---|---|---|
| Slit Lamp BM900 (K100202) | MARCO ULTRA M3(K162636) | |
| Z2 Slit lamp microscope(K152535) | MARCO ULTRA M4(K162636) | |
| Illumination | ||
| field | ||
| Diameter | For BM900(K100202) | For M3(K162636) |
| φ8,φ5,φ3,φ2,φ1,φ0.2 mm | φ10,φ5, φ3, φ2, φ1, φ0.2 mm | |
| For Z2(K152535) | For M4(K162636) | |
| φ14,φ8,φ5, φ3,φ0.3 mm | φ14,φ8,φ5, φ3,φ0.3 mm | |
| Radial | ||
| movement of | ||
| the slit light | ||
| illumination | ||
| relative to the | ||
| microscope | ||
| axis | For BM900(K100202) | For M3(K162636) |
| Horizontal ±90° | Horizontal±90° | |
| Vertical 0 - 20° | Vertical 0°,5°,10°,15°,20° | |
| For Z2(K152535) | For M4(K162636) | |
| Horizontal±90° | ||
| Vertical don't apply | Horizontal±90° | |
| Vertical don't apply | ||
| Light source | For BM900(K100202) and Z2(K152535) | For all Slit lamps(K162636) |
| LED | LED | |
| Background | ||
| illumination | For BM900(K100202) | For M3(K162636) |
| Option | None | |
| For Z2(K152535) | For M4(K162636) | |
| None | Mounted in Slit lamp unit |
9. Performance, safety and EMC Data:
The slit lamps M3 and M4 were tested according to ISO 15004-2:2007 and ISO10939:2007 for radiation hazards, to IEC60601-1 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 M3 and M4 are safe and effective compared to the predicate device slit lamps BM 900 and Z2.