(92 days)
No
The document describes a standard ophthalmic device with optical systems for illumination, magnification, and observation, with no mention of AI, ML, image processing, or any related concepts.
No
The device is used for examination and diagnosis, not for treating diseases or trauma.
Yes
The "Intended Use / Indications for Use" section 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 explicitly states it is a "hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand," indicating it is a hardware device with optical and illumination components, not software only.
Based on the provided information, the KOWA SL-17 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.
- KOWA SL-17 Function: The KOWA SL-17 is a non-invasive ophthalmic device used for direct visual examination of the anterior eye segment. It uses light and magnification to observe the eye's structure.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. It is used for direct observation of the living eye.
Therefore, the KOWA SL-17 falls under the category of a medical device used for examination and diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HJO
Device Description
The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.
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)
To guarantee Performance, ISO10939 test was performed. The KOWA SL-17 met all 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
K133755 MAR 1 1 2014 Kowa, Kowa Company. Ltd.
LIFE SCIENCE DIVISION 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)42-444-5079 FAX: +81-(0)42-440-7618
510(k) Summary
| Submitter information: | |
|---|---|
| Applicant: | Kowa Company, Ltd. |
| 4-14, Nihonbashi-honcho 3-Chome | |
| Chuo-ku, Tokyo, 103-8433 Japan | |
| Phone: +81-42-444-5079 | |
| Fax: +81-42-440-7618 | |
| Contact: | Hiroyuki Koide |
| Date summary prepared: | December 6, 2013 |
| Device identification: | |
| Device trade name: | KOWA SL-17 |
| Classification name: | Biomicroscope, Slit-Lamp, Ac-Powered |
| Product code: | HJO |
Identification of predicate device:
Kowa Company believes that this device is substantially equivalent to: KOWA SL-15 manufactured by Kowa, 510(k) # K063640
Device description:
The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.
Intended use:
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.
1
510tk) Notification
Technical characteristics:
Performance
To guarantee Performance, ISO10939 test was performed. The KOWA SL-17 met all requirements of the standard.
Electrical safety
To guarantee Electrical safety, IEC60601-1 test was performed. The KOWA SL-17 met all requirements of the standard.
Electromagnetic compatibility
To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The KOWA SL-17 met all requirements of the standard.
Optical safety
To guarantee Optical safety, ISO15004-2 evaluation was performed. The KOWA SL-17 met all requirements of Group 2 instrument in the standard.
Software evaluation
The Software of KOWA SL-17 was evaluated by FDA guidance, "Guidance for the content of premarket submissions for software contained in medical devices, 2005" and
"General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002". It was confirmed that the software was appropriate.
Biocompatibility
To guarantee biocompatibility, biocompatibility assessment was performed. The materials were used the same of the other legally marked devices in US. (#K063640)
Risk Management
The KOWA SL-17 was evaluated in accordance with ISO14971. The risk management of the device was deemed satisfactory. There was no remnant risk.
Substantial Equivalence
According to Guidance on the CDRH Premarket Notification Review Program 6/30/86, we determined the predicate device. From the above assessment, KOWA SL-17 and the predicate device is substantially equivalent.
Conclusion
The KOWA SL-17 is equipped with the fundamental technology features equivalent to the predicate device, and also delivers the equivalent level of safety. Therefore, it is concluded that there is no significant difference in the basic functions, safety and effectiveness between KOWA SL-17 and the predicate device.
2
510(k) Notification
.
| Proposed device | Predicate device | |
|---|---|---|
| Device Name | KOWA SL-17 | KOWA SL-15 |
| 510(k) number | - | K063640 |
| Indications for use or | ||
| Scope | 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. | KOWA SL-15 is an ophthalmic | |
| device indicated for non-invasive | ||
| illumination, magnification andobservation of the human eye. It | ||
| consists of a hand-held, battery | ||
| powered slit-lamp biomicroscope | ||
| with viewing and illumination | ||
| optical systems and an | ||
| AC-powered stand. | ||
| Slit lamp function and principal parts | ||
| Illumination light source | White LED | Halogen lamp |
| Aperture diameter | Three selection | |
| (φ1, φ5, φ12mm) | φ12mm Fixed | |
| Slit length | 12mm | |
| Slit width | Three selection | |
| (0.1, 0.2, 0.8mm) | ||
| Spot | φ1, φ5, φ12mm | |
| and shapes of ellipse | ||
| Light intensity | Adjustable continuously | Three selection |
| (1/16, 1/4, Full) | ||
| Power supply | 4pcs of AAA batteries (Alkaline or | |
| Ni-MH) | Lithium-ion rechargeable battery |
Table 5-1: Comparison with Predicate Device
. .
.
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
March 11, 2014
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Kowa Company, Ltd. % Mr. Hiroyuki Koide 4-14, Nihonbashi-honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan
Re: K133755
Trade/Device Name: KOWA SL-17 slit lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: January 14, 2014 Received: January 16, 2014
D
Dear Mr. Koide:
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 cither 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.
4
Page 2 - Mr. Ryan O'Leary
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53)-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/deTault.hun 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 Small Manufacturers, International and Consumer Assistance 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.htm1.
Sincerely yours,
Kesia Y. Alexander -S
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
5
3 (41) Socilianion:
4.0 Indications for Use Statement
_ K133755 510(k) Number (if know):
Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
Clu
(Division Sign-Off)
Division of Ophthalmic and Ear, Nose
and Throat Devices
510(k) Number K133755
Andrew Yang -S
2014.02.24
17:01:35 -05'00'
Kowa Company, Tra KOREA SI F