(294 days)
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No
The summary describes a standard portable slit lamp microscope and does not mention any AI/ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
This device is a slit lamp microscope, which is used for examination and diagnosis of the eye, not for treating any condition.
Yes
The device is a portable slit lamp microscope, which is a tool used by healthcare professionals to examine the anterior and posterior segments of the eye. This examination is a diagnostic procedure to identify conditions and diseases of the eye.
No
The device description explicitly states it is a "hand held converging stereomicroscope system powered by rechargeable batteries," indicating it is a physical hardware device, not software only. The performance studies also include hardware-specific standards like IEC 60601-1 and ISO 10939.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Portable Slit Lamp Microscope Model KJ5S is used to directly visualize the anterior and posterior segments of the eye. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly states it's for use in the eye, not for analyzing samples from the eye or body.
- Device Description: The description confirms it's a stereomicroscope system for direct observation.
- Performance Studies: The performance studies listed are related to the safety, performance, and biocompatibility of the device itself for direct use on a patient, not for the analytical performance of a diagnostic test.
Therefore, based on the provided information, the Portable Slit Lamp Microscope Model KJ5S is a medical device used for direct examination, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.
Product codes
HJO
Device Description
The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries. The illumination system and fixation targets are activated using a single/double click trigger located on the rear of the grip/handle. A rheostat located below the eyepieces on the front of the grip /handle is used to increase or reduce the light intensity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital
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 performance tests were conducted:
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 15004-1, Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2, Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
ISO 10939, Ophthalmic instruments - Slit-lamp microscopes
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
IEC 62133, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
Suzhou Kangjie Medical Inc. % Di Wu. Ph.D. Regulatory Affairs Consultant DIWU Regulatory 3440 Indian Queen Lane, Rear Philadelphia, PA 19129
Re: K162778
Trade/Device Name: Portable Slit Lamp Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: May 25, 2017 Received: May 30, 2017
Dear Dr. Di Wu:
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.
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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 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,
Kesia Alexander
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Portable Slit Lamp Microscope Model KJ5S
Indications for Use (Describe)
Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.
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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Date prepared July 13, 2017
Submission Sponsor (Manufacturer):
Suzhou Kanqjie Medical Inc. No.129, Weixin Rd., Weiting Town Suzhou, Jiangsu, P.R. China 215000
Submission Correspondent (Agent):
Mrs. Di Wu, PhD 3440 Indian Queen Lane, Rear Philadelphia, PA 19129 USA Phone: (386) 487-8384 Email: diwuregulatory@gmail.com
Trade/Device Name:
Portable Slit Lamp Microscope Model KJ5S
Common or Usual Name: Slit Lamp Microscope Device Class: II Classification Name: AC-Powered Slitlamp Biomicroscope Requlation Number: 21 CFR 886.1850 Product Code: HJO Review Panel: Ophthalmic
Predicate Device:
- K131711, SUZHOU 66 VISION TECH CO., LTD ● YZ3 PORTABLE SLIT LAMP
Device Description:
Portable Slit Lamp Microscope Model KJ5S
The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries.
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The illumination system and fixation targets are activated using a single/double click trigger located on the rear of the grip/handle. A rheostat located below the eyepieces on the front of the grip /handle is used to increase or reduce the light intensity.
Environment of Use: healthcare facility/hospital Duration and type of contact: less than 24 hours, surface device
Intended Use:
Portable Slit Lamp Microscope Model KJ5S is intended for use in the examination of the anterior and posterior seqment of the eye.
Comparison to Predicate Device:
Refer to the Comparison Table on Pages 4 and 5.
Discussion of Non-Clinical Tests Performed:
The performance tests were conducted:
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 15004-1, Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2, Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
ISO 10939, Ophthalmic instruments - Slit-lamp microscopes
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International
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Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
IEC 62133, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
Discussion of Clinical Tests Performed:
None
Conclusion:
The subject device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. Thus, the subject devices are substantially equivalent to its predicate devices.
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KJ5S Slit Lamp Microscope vs. K131711
| Descriptive Information | Proposed Device | Predicate Device |
|---|---|---|
| 510(k) Number | K162778 | K131711 |
| Manufacturer | Suzhou Kangjie Medical Inc. | 66 Vision Tech Co., Ltd. |
| Proprietary or Model Name | KJ5S portable slit lamp microscope | YZ3 Portable Slit Lamp microscope |
| Indications for Use | Same | Same |
| Flammability of materials near the light source | NONE | NONE |
| Maximum temperature of parts of the device held by the operator or accessible to the patient | Maximum temperature of parts of the device held by the operator: |
- Eyepiece: 35°
- Grip: 35 °
- Slit width control ring: 35°
Maximum temperature of parts of the device accessible to the patient:
Forehead rest 35° | Same |
| Brightness controls | Maximal Illumination ≥12000Lx | Maximal Illumination ≥30000Lx |
| Operating temperature | 10° to 35° | Same |
| Slit Width | 0 to 10mm continuously adjustable | 0 to 12mm continuously adjustable |
| Slit Length | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm |
| Illumination field diameter | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm |
| Radial movement of the slit light illumination relative to the microscope axis | Horizontal ± 30° | Same |
| Stereo angle | 13° | Same |
| Light sources | White LED Single Light Source | Same |
| Pupil-distance | 48 to 72mm | 50 to 75mm |
| Eye piece | 10X, 16X | Same |
| Objective | 1X | Same |
| Total magnifications | 10X, 16X(Optional) | Same |
| Filter | Heat-absorption, Cobalt blue, Red-free, Gray | Cobalt blue, Red-free, Color Temperature Compensation |
| Descriptive Information | Proposed Device | Predicate Device |
| 510(k) Number | K162778 | K131711 |
| Illumination rotation angle | Horizental±30° | Same |
| Working distance | 80mm | 60mm |
| Power | 7.4V 680mAh Li Battery, Rechargeable | 7.4V 2200mA Li Battery, Rechargeable |
| Working time | 5-6 hours | 2.5 hours |
| Net Weight | 750g | 900g |
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