(113 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional optical and imaging principles.
No
The device is described as a "diagnostic system" intended for "observation, analysis and photography" of the eye, which indicates its purpose is to identify or characterize conditions rather than to treat them.
Yes
The "Device Description" explicitly states, "This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area." The "Intended Use / Indications for Use" section further details its use for "observation, analysis and photography of the anterior segments of the eye" to "evaluate and analyze conditions."
No
The device description explicitly states it is a "non-invasive, table mounted, AC powered diagnostic system" containing hardware components such as an illumination device, viewing optics, a computer (CPU), image capturing devices, a Xenon flash lamp, and an Infrared LED. This indicates it is a hardware system with integrated software, not a software-only device.
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 EAS-1000 is described as a system that takes photographs of the eye and surrounding area for non-invasive observation, analysis, and photography of the anterior segments of the eye. It uses light and imaging techniques to evaluate the eye's structure and conditions.
- No Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device directly interacts with the eye using light and imaging.
Therefore, the EAS-1000 falls under the category of an ophthalmic diagnostic device that performs in-vivo (within the living body) imaging and analysis, rather than in-vitro (outside the living body) diagnostic testing.
N/A
Intended Use / Indications for Use
The EAS-1000 is intended to take photographs of the eye and surrounding area, which includes the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate:
- corneal shape,
- and analyze conditions of lens (opaque crystalline lens),
- the state of lens (pre and post Intraocular Lens Transplant), .
- and analyze anterior chamber angles, .
- and analyze anterior or posterior cortical opacity, .
- the degree and location of cataracts (nuclear, subcapsular and or cortical) . using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
Product codes (comma separated list FDA assigned to the subject device)
86 MXK
Device Description
This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area. The system contains a illumination device, viewing optics, a computer (CPU), image capturing devices, and is based on the Scheimpflug Principle for Slit Image photography. The system uses a Xenon flash lamp for Flash Photography, and an Infrared LED for Retro-Illumination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flash Photography, Retro-Illumination
Anatomical Site
eye and surrounding area, which includes the cornea, aqueous, lens, vitreous and retina of the eye.
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)
Published Journal Articles were supplied to support the claims for use, accuracy, safety and effectiveness of the EAS-1000 for the prescribed intended uses defined in this submission.
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.
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510(k) SUMMARY [As required by 21 CFR 807.93]
GENERAL INFORMATION I
Applicant's Name & Address: Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474 Mr. Jerry Tsutsumi Contact: Regulatory/Quality Manager Date Summary Prepared: 12 April 1999
DEVICE NAME II
Trade or Proprietary Name: Model Number: Common/Classification Name: Class: Classification Panel: Product Code: Regulation Number:
Anterior Eye-Segment Analysis System EAS-1000 Ophthalmic Camera Class II 86 MXK 886.1850
III PREDICATE DEVICES
The Nidek EAS-1000 Anterior Eye-Segment Analysis System is claimed to be substantially equivalent to the following currently Marketed Devices:
- Nidek, 3-DXF Stereo Fundus Camera K973533 received 11/4/ 97 .
- KOWA Optimed Inc., SC-1200 Slit Lamp -- K955442 received 1/3/96 .
IV PRODUCT DESCRIPTION
This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area. The system contains a illumination device, viewing optics, a computer (CPU), image capturing devices, and is based on the Scheimpflug Principle for Slit Image photography. The system uses a Xenon flash lamp for Flash Photography, and an Infrared LED for Retro-Illumination.
1
| EW DEVICE. | PREDICATE DEVICE | PREDICATION WORLDE | |
|---|---|---|---|
| Nidek Inc. | Nidek Inc. | Kowa Optimed | |
| EAS-1000 | 3DXF Stereo Fundus Camera | KOWA SC-1200 | |
| Single Aperature | Stereo Aperature | Single or Stereo | |
| Aperature | |||
| 5.5" Black & White CRT | Eyepiece, Stereo Viewing | Eyepiece, Stereo/Mono | |
| Optics | Viewing Optics | ||
| Infrared LED for Retro- | Halogen Lamp | Halogen Lamp | |
| Illumination 800 nm | 50W | 30W | |
| Xenon Lamp | Xenon Lamp | Xenon Lamp | |
| 200Wsec | 200Wsec | 300W | |
| 4 Step - Selectable | 5 Step – Manual | 5 Step - Manual | |
| (50, 100, 150, 200 WS) | (25, 50, 100, 200, 400 WS) | (25, 50, 100, 200, 300 WS) | |
| CCD Camera | 35 mm Film Plane | 35 mm Film Plane | |
| or Polaroid Media | or Polaroid Media | ||
| Data digital and can be | Image is a film hard copy | Image is a film hard copy | |
| displayed on a CPU | only | only | |
| 640 x 400 pixels | N/A | N/A | |
| GAMAN | 8 mm X 6.6 mm | 20 mm X 16 mm (stereo) | 24 mm X 17 mm (stereo) |
| 24 mm X 24 mm (mono) | |||
| 24 mm X 36 mm (right) | |||
| otograph | Offers Photographic angles | Offers a swing angle of 15° | Offers a Slit Projection |
| from 0 to 180° | right or left | angle of 90° from vertical | |
| 0.5 X | 2.6X | 0.7, 1.1, 1.7, 2.8, 4.3X | |
| Stereo | |||
| 2 ~ 14 mm, adjustable | N/A | 0 ~ 11 mm, adjustable | |
| 150 V A | 600 VA | 1300 VA | |
| 100 Vac | AC 100, 120, 220, 240V | AC 100, 117 , 220, 240V | |
| 50/60 Hz | 50/60 Hz | 50/60 Hz | |
| 25 Kg | 30 kg | N/A |
INDICATIONS FOR USE V
Intended Use: The EAS-1000 is intended to take photographs of the eye and surrounding area, which includes the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate:
- corneal shape,
- and analyze conditions of lens (opaque crystalline lens), ●
- the state of lens (pre and post Intraocular Lens Transplant), .
- and analyze anterior chamber angles, .
- and analyze anterior or posterior cortical opacity, .
- the degree and location of cataracts (nuclear, subcapsular and or cortical) . using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
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VI CLINICAL PERFORMANCE DATA
Published Journal Articles were supplied to support the claims for use, accuracy, safety and effectiveness of the EAS-1000 for the prescribed intended uses defined in this submission.
VII NON-CLINICAL PERFORMANCE DATA
None provided at this time.
VIII RATIONAL FOR SUBSTANTIAL EQUIVALENCE
The GENERAL INTENDED USES of all three of these devices is "to take photographs of the eye and surrounding area".
Our claim of Substantial Equivalence, and is also based on the following;
- The devices compared, utilize the same or similar OPERATING PRINCIPLES, in . that they all contain an optical system, a source of illumination for observation, a source of illumination for photography, and photographic mediums.
- All three devices utilize the same DEVICE FEATURES, a Head Stabilizing device, . an External Fixation Target, a Joy Stick or Control Mechanism, and a Exposure Control.
- All three devices utilize a ILLUMINATION SOURCE, and a FLASH OUTPUT ● SOURCE, and safety concerns regarding "Photo Toxicity" is not an issue with these devices.
- All three devices are considered "Non Invasive" devices as defined in 21 CFR . §812.3(k) and are considered NOT to be a "Significant Risk Device" as defined in 21 CFR §812.3(m).
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IX SAFETY AND EFFECTIVENESS
The EAS-1000 is a non-invasive diagnostic system and only contacts the patient on his/her chin and forehead, and DOES NOT present or pose any new or additional significant effects or risks on the safety, performance, use or effectiveness for its prescribed intended uses. Light safety concerns or "Photo Toxicity" is not an issue with this device as light output is of an eyesafe intensity and wavelength. Electrical Safety requirements for medical device are met. The device is proven effective for its intended uses through internal company and independent international clinical studies. The information provided in this submission reasonably assures this product to be Safe and Effective for it intended uses.
CONCLUSION ×
We believe that the data submitted in this document, demonstrates that the EAS-1000 is substantially equivalent with respect to the indications for use, operating principles, and the device features to other legally market predicate devices. The safety and effectiveness of this product can be reasonably assured, as the EAS-1000 DOES NOT pose any new or additional significant effects on the safety, performance, use or effectiveness of this device for its prescribed intended uses. We believe that this device clearly meets the requirement for substantial equivalence according to the 510(k) guidelines. Therefore, justifying 510(k) PreMarket Notification Clearance for commercial sale and distribution of this product within the United States.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Mr. Jerry Tsutsumi Regulatory/Quality Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474
Re: K991284 Trade Name: Anterior Eye-Segment Analysis System Regulatory Class: II Product Code: 86 MXK Dated: July 13, 1999 Received: July 14, 1999
Dear Mr. Tsutsumi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Jerry Tsutsumi
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Concurrence of CDRH ODE Form
510(k) Number (if known): K991284
Device Name: Nidek Inc. EAS-1000 Anterior Eye Segment Analysis System
INDICATIONS FOR USE:
The EAS-1000 "Anterior Eye-Segment Analysis System" is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Everett Beam
(Division Sign-Off)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use