(108 days)
Not Found
No
The description focuses on the optical and illumination components of a traditional slit lamp, with no mention of AI, ML, image processing, or data analysis beyond direct observation.
No
The device is used for examination and aid in diagnosis, not for treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment."
No
The device description clearly outlines hardware components such as a white light source, binocular microscope, blue illumination light, and LEDs. It also mentions changes to battery type and illumination duration, which are hardware-related. While software is mentioned as being validated, the core functionality and description are based on physical components.
Based on the provided information, the KOWA SL-19 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- KOWA SL-19 Function: The KOWA SL-19 is a non-invasive ophthalmic device that directly illuminates and observes the anterior segment of the eye. It does not examine specimens in vitro.
- Intended Use: The intended use is for eye examination and to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment through direct observation.
Therefore, the KOWA SL-19 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
KOWA SL-19 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.
Product codes (comma separated list FDA assigned to the subject device)
HJO
Device Description
The KOWA SL-19 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye.
Illumination light that emitted from a white light source is applied to the eyeball, Refractive media, Eye Anatomy, Ocular Adnexa, Iris, etc. are magnified and observed with a binocular microscope. Fluorescence of the cornea, conjunctiva, etc. can be observed by irradiating background illumination light and irradiating blue illumination light with a built-in light source.
The background White LED function is added to the KOWA SL-19.
The blue filter with white LED for the predicated device is removed, and this function is replaced by blue LED for the KOWA SL-19.
Duration of illumination is lengthened from 140 min to 360 min from predicate device to the KOWA SL-19 due to replace the battery type from AAA battery to AA battery.
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)
Performance testing for Slit-Lamp Microscopes: The KOWA SL-19 conforms to ANSI Z80.37.2017.
Electrical safety and electromagnetic compatibility (EMC): The proposed device complies with the IEC60601-1:2005+A1:2012 and IEC60601-1-2:2014.
Biocompatibility: The forehead rest of the proposed device is a surface device with limited (≤24 hrs.) contact with intact skin. Assessed per FDA Biocompatibility guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' " recommendations.
Software: The software of the proposed device has been validated according to FDA guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Optical radiation safety: KOWA performed estimation of the light hazard and evaluation as to whether the KOWA SL-19 satisfied the requirement of ANSI Z80.36-2016. The KOWA SL-19 is classified in Group 2 of the continuous wave instrument.
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.
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November 21, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square. To the right of the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Kowa Company, Ltd. Nariaki Morita Manager of Quality Assurance Section 3-1, Chofugaoka 3-Chome Chofu-shi, Tokyo 1820021 Japan
Re: K222372
Trade/Device Name: Kowa SL-19 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: October 13, 2022 Received: October 13, 2022
Dear Nariaki Morita:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222372
Device Name KOWA SL-19
Indications for Use (Describe)
KOWA SL-19 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.
| 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/2 description: The image shows the logo for Kowa Company, Ltd. The word "Kowa" is written in red and enclosed in a red oval. To the right of the oval, the words "Kowa Company, Ltd." are written in a black, cursive font. The logo is simple and professional.
Chofu Factory
3-1 Chofugaoka 3-chome, Chofu City
Phone:81-42(440)7612
Tokyo 182-0021, Japan
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… FAX : 81-42(440)7616
510(k) Summary
a. Owner/Company name, address
Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021 Phone: +81-42-440-7612 Fax: +81-42-440-7618
b. Contact
Nariaki Morita
Kowa Company, Ltd. Health and Medical Division 3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021 Phone: +81-42-440-7627 Fax: +81-42-440-7618 Email: n-morita@kowa.co.jp
c. Date prepared
November 15th, 2022
d. Name of device
Trade Name: KOWA SL-19 Regulation description: Slit lamp Regulation number: 21 CFR 886.1850 Product code: HJO
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e. Predicate and Reference Devices
| Predicate Device: | KOWA SL-17 |
|---|---|
| 510(k) number | K133755 |
| Regulation description: | Slit lamp |
| Regulation number: | 21 CFR 886.1850 |
| Product code: | HJO |
f. Description of the device
The KOWA SL-19 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye.
Illumination light that emitted from a white light source is applied to the eyeball, Refractive media, Eye Anatomy, Ocular Adnexa, Iris, etc. are magnified and observed with a binocular microscope. Fluorescence of the cornea, conjunctiva, etc. can be observed by irradiating background illumination light and irradiating blue illumination light with a built-in light source.
The background White LED function is added to the KOWA SL-19.
The blue filter with white LED for the predicated device is removed, and this function is replaced by blue LED for the KOWA SL-19.
Duration of illumination is lengthened from 140 min to 360 min from predicate device to the KOWA SL-19 due to replace the battery type from AAA battery to AA battery.
g. Indications for Use Statement
KOWA SL-19 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.
h. Discussion of substantial equivalence
The proposed device KOWA SL-19 is an instrument of handheld slit-lamp microscope that enables projects slit light onto the human eye and magnify with a binocular microscope and is using for observation and inspection of human eye.
Indications for use of the KOWA SL-19 is identical to that of the predicate device. Technological characteristics
The KOWA SL-19 and predicate device have the following same fundamental technologies:
- Observation of the human eye
- · Function and principle parts
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The difference between the proposal device KOWA SL-19 and the predicate device KOWA SL-17 is as follows.
- The background White light function is added.
- Blue light is replaced from filter with white LED to the blue LED
- Duration of illumination is lengthened from 140 min to 360 min.
Following are discussion regarding differences and substantial equivalence between the proposed and predicated device.
Background White light
This Background White LED is conformed to the light hazard standard ANSI Z80.36.2016 then does not raise any safety concern. Also this function does not affect the efficacy of the slit lamp standards ANSI Z80.37.2017 but simply light to whole eye then does not affect any efficacv concern.
Therefore, this new function does not raise any safety and efficacy concern.
Filter
The blue LED for the proposed device is conformed to ANSI Z80.36.2016 then does not raise any safety concern. Also the both the proposed blue LED and the predicated bule filter with white LED are almost identical excitation wave length that is within 400 to 500 nm conformed to fluorescein excitor filter, then this function does not affect any efficacy concern. Therefore this function does not raise any safety and efficiency concern.
Duration of illumination
This change simply adds convenience for user and conformed the safety standard IEC60601-1:2005+A1:2012 and IEC60601-1-2:2014. Also this duration of illumination does not affect any efficacy of slit lamp. Therefore this function does not raise any safety and efficacy concern.
Following table shows comparison between the KOWA SL-19 and predicate device.
| Proposed device | Predicate device | Note | |
|---|---|---|---|
| Device Name | KOWA SL-19 | KOWA SL-17 | |
| 510(k) number | K222372 | K133755 | |
| Indications for | |||
| use or Scope | KOWA SL-19 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. | KOWA SL-17 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. | Identical |
Table 1 Comparison Table
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| Slit lamp function, Optical path and principal parts | |||
|---|---|---|---|
| Illumination light source | White LED | Identical | |
| Background light | White LED and Blue LED | - | Different |
| Filter | - | Built-in blue filter | Different |
| Slit selection | Turret | ||
| Slit length | 1 mm, 5 mm, 12 mm, and from 1.5 to 12mm continuously | Three selection (1, 5, 12mm) | Similar |
| Slit width | Three selection (0.1, 0.2, 0.8mm) | Identical | |
| Spot | φ1, φ5, φ12mm and shapes of ellipse | Identical | |
| Light intensity | Adjustable continuously by the software | Identical | |
| Slit projection angle | 60 degree for Horizontal | Identical | |
| Duration of illumination | 360 minutes (When used the 3 x AA batteries (Ni-MH) of 1900mAh, and the room temperature is 25 degrees Celsius) | 140 minutes (When used the 4 x AAA batteries (Ni-MH) of 750mAh, and the room temperature is 25 degrees Celsius) | Different |
| Electric rating | DC 3.0 to 4.8V / 3.6VA | DC 4.8 to 6.4V / 3.6 to 4.5VA | Similar |
| Battery type | 3pcs of AA batteries (Alkaline or Ni-MH) | 4pcs of AAA batteries (Alkaline or Ni-MH) | Similar |
| Microscope function and principal parts | |||
| Angle of convergence | 13 degree | Identical | |
| Magnification | 10x / 16x | Identical | |
| Reticles | Built-in both oculars | Identical | |
| Magnification change | 10x and 16x Magnification is changed through movement objectives to two positions. | Identical | |
| Range of interpupillary distance adjustment | 55mm to 72mm | 50mm to 72mm | Similar |
| Range of examiner's dioptric protection adjustment | -8D to +5D | Identical |
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| Dimension | |||
|---|---|---|---|
| Dimension | |||
| (W)x(D)x(H) | |||
| (mm) | 107x197x238 | Microscope: | |
| 95 x 220 x 220 | |||
| Stand: | |||
| 105 x 200 x 50 | |||
| Weight | 620g | ||
| (batteries are not included) | Microscope:745g | ||
| (batteries are not included) | |||
| Stand: | |||
| 655g | |||
| Performance Testing | |||
| IEC60601-1:2005+A1:2012 | IEC60601-1:2005 | Similar | |
| Performance for | |||
| Slit-lamp | IEC60601-1-2:2014 | IEC60601-1-2:2007 | Similar |
| ANSI Z80.36-2016 | ISO15004-2:2007 | Identical | |
| ANSI Z80.37-2017 | ISO10939:2007 | Identical | |
| Biocompatibility | |||
| for forehead rest | Same forehead rest part as used in KOWA SL-17. The | ||
| biocompatibility of the forehead component was assessed | |||
| per FDA Biocompatibility guidance "Use of International | |||
| Standard ISO 10993-1, 'Biological evaluation of medical | |||
| device - Part 1: Evaluation and testing within a risk | |||
| management process" recommendations. | Identical | ||
| Software | Guidance for Industry and FDA Staff-Guidance for the | ||
| Content of Premarket Submissions for Software Contained | |||
| in Medical Devices | Identical | ||
| Optical path | |||
| Optical path | Image: Eye, Prism, Lens, Slit-dial, Spot-dial, Lens, Illumination LED | Image: Eye, Prism, Lens, Slit-dial, Spot-dial, Lens, Illumination LED | Identical |
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i. Performance Testing
Following are listed all standard that is performed.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the KOWA SL-19. The proposed device complies with the IEC60601-1:2005+A1:2012 and IEC60601-1-2:2014.
Biocompatibility
The forehead rest of the proposed device is a surface device with limited (≤24 hrs.) contact with intact skin. The forehead rest of proposed device is same as the forehead rest of the predicate device that has the same nature and duration of the tissue contact. There are 4.200 predicate devices sold in the US and there were no adverse events reported (e.g., allergy) related to the forehead rest of the predicate device.
Furthermore, the biocompatibility of the forehead rest of the proposed device was assessed per FDA Biocompatibility guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' " recommendations.
Software
The software of the proposed device has been validated according to FDA guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The report of software of the proposed device are described in Section 18 Software.
Optical radiation safety
KOWA performed estimation of the light hazard and evaluation as to whether the KOWA SL-19 satisfied the requirement of ANSI Z80.36-2016. As a result. the KOWA SL-19 is classified in Group 2 of the continuous wave instrument. Although the output power of illumination of KOWA SL-19 is higher than that of the predicate device, the risk of radiation is low level.
Performance testing for Slit-Lamp Microscopes
The KOWA SL-19 conform to ANSI Z80.37.2017 as well as the predicate device conform to ISO 10939:2007
Conclusion j.
There are some differences between the proposed and predicate devices. As discussed above, all differences do not raise any safety and efficacy concern.
Based on the information described above, we conclude that KOWA SL-19 is substantially equivalent to the predicate device.