(181 days)
Not Found
No
The description focuses on the optical and mechanical components of a standard slit-lamp microscope and does not mention any AI/ML capabilities or image processing features.
No.
The device is used to aid in the diagnosis of diseases or trauma, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment." This directly indicates its role in the diagnostic process.
No
The device description explicitly lists multiple hardware components (microscope unit, illumination unit, base unit, chinrest, table, and power unit) and describes it as an AC-powered device, indicating it is a physical hardware device, not software-only.
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 the KH Ophthalmic Slit-lamp Microscope is used for eye examination of the anterior eye segment. It projects light into the eye and uses a microscope for direct observation of the eye's structures.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The examination is performed directly on the living eye.
Therefore, the KH Ophthalmic Slit-lamp Microscope is a medical device used for direct visualization and examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KH Ophthalmic Slit-lamp Microscope is an AC-powered slittamp biomicroscope intended for use in eye examination of the anterior eye segment, from the comes 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 eve segment.
Product codes (comma separated list FDA assigned to the subject device)
HJO
Device Description
The KH Ophthalmic Slit-lamp Microscope 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 KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.
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)
Non-Clinical testing was performed including Safety and EMC testing (IEC60601-1:2005 + CORR.1(2006)+CORR.2(2007)+AM1(2012) or IEC 60601--1:2012 and IEC 60601-1-2:2007) and Biocompatibility testing (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010). The device passed each biocompatibility test. Performance data was collected through bench testing according to ISO 15004-1:2006, ISO 15004-2:2007, and ISO 10939:2007, and IEC 62471:2006. The testing found that the product met the requirements of ISO 15004-1:2006. The testing found that the device is a Group 2 instrument per ISO 15004-2:2007. The KH OPHTHALMIC SLIT-LAMP MICROSCOPE complies with the requirements of ISO 10939:2007.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2017
Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You Production Manager No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing, 400070 CHINA
Re: K171877
Trade/Device Name: SLM-1ER, SLM-2ER, SLM-3ER Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: November 1, 2017 Received: November 1, 2017
Dear Xi You:
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.
1
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 devicerelated 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley S. Cunningham -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,
51D(k) Number (if known) K171877
Device Name KH Ophthalmic Slit-lamp Microscope Model: SLM-1ER, SLM-2ER
Indications for Use (Describe)
The KH Oplithalmic Slit-lamp Microscope is an AC-powered slittamp biomicroscope intended for use in eye examination of the anterior eye segment, from the comes 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 eve 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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (8/14)
3
510(k) SUMMARY (K 171877)
KH Ophthalmic Slit-lamp Microscope
Submitter's Information 1.
The submitter of this special pre-market notification is:
| Name: | Chongqing Kanghua Ruiming S&T Co., Ltd. |
|---|---|
| Address: | No.5, Road1, Tongjiaxi Industrial Park, Beibei, |
| Chongqing, China | |
| Zip Code:400070 | |
| Company Phone No: | +86-23-63227332 |
| Company Fax No: | +86-23-63227336 |
| Contact Person: | Xi You |
| E-mail: | doumeki2007@163.com |
| Date summary prepared: | April 15, 2017 |
2. Device Identification
| Device Trade Name: | KH Ophthalmic Slit-lamp Microscope
Model: SLM-1ER, SLM-2ER |
|---------------------|---------------------------------------------------------------|
| Classification Name | AC- Powered Slit-Lamp Biomicroscope |
| Regulation Number: | 21 CFR 886.1850 |
| Regulation Name: | AC Powered Slit lamp Bio-microscope |
| Regulation Class: | II |
| Product Code: | HJO |
Predicate Devices 3.
- Model: SLM-1ER, SLM-2ER, the predicate cited is the Keeler Slit Lamp H-• Series of the same instrument:
| Device Trade Name: | Keeler Slit Lamp H- Series |
|---|---|
| 510(k) Number; | K131589 |
| Common Name | AC Powered Slit lamp Bio-microscope |
| Class: | II |
| Classification Panel: | 86 |
| Product Code: | HJO |
| Regulation Number: | 886.1850 |
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Device Description 4.
The KH Ophthalmic Slit-lamp Microscope 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 KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.
Intended Use / Indications for Use 5.
The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp biomicroscope 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.
| Feature | H-Series Slit
Lamp [K131589] | KH Ophthalmic Slit-
lamp Microscope | Discussion |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend use | As stated | As stated | No changes |
| Bio-microscope | | | |
| Bio-microscope | Galilean
converging
binoculars with
detachable
eyepiece head | • SLM-1ER,
Converging
binoculars with
detachable eyepiece
head
• SLM-2ER, Galilean
converging
binoculars with
detachable eyepiece
head | As head can be separated
from the body,
intervention of module
does not change these
elements |
| Digital Camera Module | Not fitted | • SLM-1ER, SLM-
2ER: Not fitted | Same |
| Image capture button | Not fitted | • SLM-1ER, SLM-2ER: Not fitted | Same |
| Camera Exposure
Buttons | Not fitted | Not fitted | Same |
| Slit Lamp illumination
Options | 6VDC 20W
halogen bulb /
LED | 12V/50W halogen
bulb | Required for slit lamp
illumination with some
light used for background
lighting |
| Background
Illumination
adjuster | Not fitted | • Not fitted | Same |
| Background Light
Source Options | Not fitted | • Not fitted | Required for higher
background light output
but still conforms to
requirements of 15004-2
Photo toxicity with slightly
longer exposure time. |
| Background lighting
duty cycle - halogen
bulb option only | Not applicable | 50% duty cycle at
maximum brightness. | Ensures body of light
source does not exceed
62.3 °C limit demanded by
IEC 60601-1 compliance |
| Duration of illumination | Maximum
examination times
according to ISO
15004-2 and ISO
10939 | Maximum examination
times according to
ISO 15004-2 and ISO
10939 | As a result of photo-
toxicity testing to ISO
15004-2 maximum
exposure increased from
13 to 17 minutes for bulb
option (LED maximum
exposure is unchanged at
12.5 minutes). |
| Input voltage | AC 100-240 V,
50/60 Hz | AC 110 V, 50/60 Hz | Same |
Comparison to predicate device 6.
5
6
Non-Clinical testing 7.
Safety and EMC:
Safety and EMC test was performed in according to the
- IEC60601-1:2005 + CORR.1(2006)+CORR.2(2007)+AM1(2012) or IEC 60601--1:2012
- -IEC 60601-1-2:2007 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
Biocompatibility :
Biocompatibility testing was performed to evaluate the biocompatibility of the contact materials in accordance with ISO 10993-1:2009, the device passed each biocompatibility test indentified below:
- Cytotoxicity testing in according to ISO 10993-5:2009 -
- Skin irritation testing in according to ISO 10993-10:2010
- -Vaginal irritation testing in according to ISO 10993-10:2010
- Sensitization testing in according to ISO 10993-10:2010 -
Performance Data:
The following bench testing was conducted in order to support substantial equivalence:
- -ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments. The testing found that the product met the requirements of ISO 15004-1:2006.
- -ISO 15004-2:2007 Ophthalmic Instruments - Fundamental requirements and test methods - Part 2: Light hazard protection. The testing found that the device is a Group 2 instrument.
- -ISO 10939:2007 Ophthalmic Instruments - Slit-lamp microscopes found that the KH OPHTHALMIC SLIT-LAMP MICROSCOPE complies with the requirements of the standard.
- -IEC 62471:2006 Photobiological safety of lamps and lamp systems
8. Conclusions:
The KH Ophthalmic Slit-lamp Microscope (Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate device in indications for use and construct, Safety and EMC testing to IEC60601-1 and IEC 60601-1-2, and performance testing to ISO 15004-1, ISO 15004-2 and ISO 10939, Based on the information provided in this submission, the KH Ophthalmic Slit-lamp Microscope(Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate devices(K131589).