(260 days)
No
The summary describes standard image processing and analysis techniques for calculating corneal parameters, without mentioning AI or ML.
No.
The device is for examination and measurement, not for treatment or therapy.
Yes
The device is intended for examination of the corneal endothelium and measurement of corneal thickness, which involves analyzing and displaying data such as cell number, cell density, coefficient of variation, and percent hexagonality. These functions directly contribute to the diagnosis of conditions related to the cornea.
No
The device description explicitly details hardware components such as a CCD camera, infrared LEDs, green LED light, and an optical line sensor, which are integral to its function of capturing images and measuring corneal thickness.
Based on the provided information, the Tomey EM-4000 Specular Microscope is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's for "examination of the corneal endothelium and for measurement of the thickness of the cornea." This is a direct examination of a living tissue within the body (in vivo), not the examination of specimens derived from the human body (in vitro).
- Device Description: The description details how the device interacts with the patient's eye using light reflection to capture images and measure thickness. This is a non-contact optical method applied directly to the patient.
- Lack of In Vitro Activities: There is no mention of analyzing blood, tissue samples, or any other biological specimens outside of the body.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue biopsies) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The EM-4000 operates in vivo by directly imaging and measuring the cornea of a living patient.
N/A
Intended Use / Indications for Use
The EM-4000 Specular Microscope 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.
Product codes
NOE
Device Description
The Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory.
Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflected light from the patient's eye with the CCD camera
Anatomical Site
Corneal endothelium, Cornea
Indicated Patient Age Range
young (18-28 years of age) and adult (29-80 years of age)
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)
A prospective clinical study was conducted to assess the agreement, accuracy and precision of the EM-4000 by comparing results across three machines/operators to those obtained with the predicate device, the Konan Cellchek XL. Three populations were studied: young (18-28 years of age) and adult (29-80 years of age) healthy subjects and pathologic adult eyes (29-80 years of age).
There were 70 subjects enrolled in the study: 25 in the non-pathologic young eye population, 23 in the non-pathologic adult eye population, and 22 in the pathologic adult eye population. Of those, 67 were included in the effectiveness population for the agreement portion of the study for the specular microscope variables. For the central corneal thickness (CCT) variable, 68 subjects were included in the effectiveness population.
Of the 70 enrolled subjects, 44 were included in the population for the precision portion of the study: 14 in the non-pathologic young eye population, 15 in the non-pathologic adult eye population, and 15 in the pathologic adult eye population.
The agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with predicate device measurements of Percent Hexagonality 0.40, 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The FDA acronym is in a blue box, and the full name of the agency, "U.S. Food & Drug Administration," is written in blue letters.
January 19, 2018
Tomey Corporation % Ryan Bouchard, Official Correspondent Ora, Inc. 300 Brickstone Square Andover, MA 01810
Re: K171313
Trade/Device Name: EM-4000 Specular Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NOE Dated: December 17, 2017 Received: December 19, 2017
Dear Ryan Bouchard:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
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 medical devices and radiation-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 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
Indications for Use
510(k) Number (if known)
K171313
Device Name EM-4000 Specular Microscopy
Indications for Use (Describe)
The EM-4000 Specular Microscope 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary
This summary of the 510(k) premarket notification for the Tomey EM-4000 Specular Microscope is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.
Date Prepared: January 12, 2018
SPONSER/ 510(k) OWNER/ MANUFACTURER
Tomey Corporation 2-11-33 Noritakeshinmachi Nishi-ku, Nagoya 451-0051 JAPAN
CONTACT PERSON
Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com
NAME OF DEVICE
Trade Name: EM-4000 Specular Microscope Common Name: Specular Microscope
DEVICE CLASSIFICATION/FDA REVIEWING BRANCH
The Ophthalmic Branch has classified AC Powered Slit Lamp Biomicroscopes as Class II devices pursuant to 21 C.F.R. §886.1850.
PRODUCT CODE: CLASSIFICATION / CFR TITLE
NQE, 21 CFR 886.1850
PREDICATE DEVICES Konan Medical, Inc. Cellchek XL (K120264)
INDICATIONS FOR USE
The EM-4000 Specular Microscope 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.
4
PRODUCT DESCRIPTION
The Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory.
Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.
SUBSTANTIAL EQUIVALENCE
The Tomey EM-4000 Specular Microscope is substantially equivalent to the Konan Medical, Inc. Cellchek XL (K120264). The Tomey EM-4000 Specular Microscope has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate device. The Tomey EM-4000 Specular Microscope and the predicate device are both non-contact ophthalmic microscopes, optical pachymeters, and cameras intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
The EM-4000 and the Konan Cellchek XL both utilize the general specular optical principle for imaging endothelial cells and performing pachymetry. The two devices use different light sources for measurement and focusing. However, compliance with ISO 15004-2 is documented. The EM-4000 uses a green LED for measurement and an infrared LED for focusing while the predicate device uses a Xe tube flash lamp for measurement and halogen lamp for focusing.
5
Both devices measure cell number, cell density, coefficient of variation and percent hexagonality. The clinical performance data demonstrates the substantial equivalence of the EM-4000 to the Konan predicate device. Both the EM-4000 and the Konan Cellchek XL include an optical pachymeter with an accuracy of + 10 microns. Bench testing comparing the EM-4000 pachymetry functionality to the predicate device is provided. The non-clinical and clinical performance data demonstrated the substantial equivalence of the pachymetry measurements. For the measurements assessed, the Tomey EM-4000 Specular Microscope and predicate device results were found to be substantially equivalent.
NON-CLINICAL PERFORMANCE SUMMARY
The performance testing conducted using the EM-4000 verified that the device operates as intended. The pachymetry functionality was evaluated and the measurement accuracy of + 10 microns was confirmed.
Additionally, the EM-4000 was subjected to electrical safety testing in accordance with ANSI/AAMI ES60601-1, electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2, and optical radiation safety testing in accordance with ISO 15004-1 and ISO 15004-2.
CLINICAL PERFORMANCE SUMMARY
A prospective clinical study was conducted to assess the agreement, accuracy and precision of the EM-4000 by comparing results across three machines/operators to those obtained with the predicate device, the Konan Cellchek XL. Three populations were studied: young (18-28 years of age) and adult (29-80 vears of age) healthy subjects and pathologic adult eves (29-80 vears of age).
There were 70 subjects enrolled in the study: 25 in the non-pathologic voung eye population, 23 in the non-pathologic adult eye population, and 22 in the pathologic adult eye population. Of those, 67 were included in the effectiveness population for the agreement portion of the study for the specular microscope variables. For the central corneal thickness (CCT) variable, 68 subjects were included in the effectiveness population.
Of the 70 enrolled subjects, 44 were included in the population for the precision portion of the study: 14 in the non-pathologic young eye population, 15 in the non-pathologic adult eye population, and 15 in the pathologic adult eye population.
The agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with predicate device measurements of
6
Percent Hexagonality 0.40, or Cell Density