(525 days)
Konan Noncon Robo Pachy, K980357
Unknown
The description mentions "computer-assisted cell counting and cell analysis capabilities," which could potentially involve AI/ML, but the summary does not provide enough detail to confirm this. The performance study focuses on agreement and variability of analysis methods, not on the performance of an AI/ML model.
No.
The device is for examination and measurement of the cornea, which are diagnostic functions, not therapeutic.
Yes
The device is intended for the "examination of corneal endothelium and for measurement of the thickness of the cornea," which are diagnostic activities. It helps in assessing the condition and health of the cornea through visual inspection, photography, and measurement.
No
The device description clearly states it is a "non-contact ophthalmic microscope, optical pachymeter, and camera," which are hardware components. While it includes computer-assisted analysis, 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 Noncon Robo Pachy F&A is a non-contact ophthalmic device that examines the corneal endothelium and measures corneal thickness directly on the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "examination of corneal endothelium and for measurement of the thickness of the cornea," which are in-vivo procedures.
Therefore, while it is a medical device used for diagnosis and monitoring, it falls under the category of ophthalmic devices used for direct examination of the eye, not in-vitro testing of biological samples.
N/A
Intended Use / Indications for Use
The Konan Noncon Robo Pachy F&A is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a non-contact ophthalmic microscope and camera intended for examination of the corneal endonelium, with the additional capability of measuring the corneal thickness by optical means. Cell counting endomalysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
Product codes
NQE
Device Description
The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357.
The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
The Konan Noncon Robo Pachy is technically the same as the predicate device, the Konan Noncon Robo F&A, with the addition of an improved cell counting algorithm and a new computer. The computer program that controls the system has been modified to be used with the new computer and to include the new algorithm.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Photography of the corneal endothelium, optical pachymetry.
Anatomical Site
Corneal endothelium, cornea
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
A clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes. Each classifier analyzed each image three. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The non-clinical tests done for the original Noncon Robo Pachy to the Noncon Robo Pachy F&A, since the device is essentially the same. A new software validation test has been done, to validate the new software. ISO 60601-1 and IS) 60601-1-2 have been repeated because of the new electronics, and a test has been done on the new algorithm.
Clinical tests: A clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes. Each classifier analyzed each image three. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation. Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density
§ 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
Konan F&A
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Konan Medical Inc. Konan NonCon Robo Pachy F&A 510(k) Submission
510(k) Summary
( 1 ) Submitter Information
Name: Konan Inc.
Address: 10-29 Miyanishi-Cho Nishimomiya 662 Japan
Telephone Number: 011-81-798363456
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: October 31, 2007
(2) Name of Device:
876
Trade Name: Konan NonCon Robo Pachy F&A Common Name: Specular Endothelial Microscope and Camera and optical pachymeter Classification Name: Camera, Ophthalmic, AC-powered
(3) Equivalent legally-marketed devices:
Konan Noncon Robo Pachy, K980357
(4) Description
The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357.
The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
1
Konan F&A
Page 1-2
(5) Intended Use
The Konan Noncon Robo Pachy F&A is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a non-contact ophthalmic microscope and camera intended for examination of the corneal endonelium, with the additional capability of measuring the corneal thickness by optical means. Cell counting endomalysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
(6) Technological characteristics
The Konan Noncon Robo Pachy is technically the same as the predicate device, the Konan Noncon Robo F&A, with the addition of an improved cell counting algorithm and a new computer. The computer program that controls the system has been modified to be used with the new computer and to include the new algorithm.
(b) Performance data
(1) Non-clinical tests
The non-clinical tests done for the original Noncon Robo Pachy to the Noncon Robo Pachy F&A, since the device is essentially the same. A new software validation test has been done, to validate the new software. ISO 60601-1 and IS) 60601-1-2 have been repeated because of the new electronics, and a test has been done on the new algorithm.
(2) Clinical tests
A clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes. Each classifier analyzed each image three. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density