(111 days)
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.
Nidek Co., Ltd. has developed the Model NM-1000, which is a stationary-type ophthalmic non-mydriatic fundus camera. Without using 35mm or instant films, this fundus camera incorporates a full digital video capturing system with memory functions, and can transfer captured images to a personal computer. The NM-1000 is designed to deliver its full performance as a fundus camera specializing in digital video capturing as a stand-alone unit or in combination with an image filing system.
In the same manner as other conventional fundus cameras, the Model NM-1000 fundus camera projects the fundus using invisible infrared beams of light during alignment and monitors patient's eye using an infrared video system which does not burden the patient's eye. As a high-sensitivity CCD chip captures an image during use, only a very small amount of flash is used as compared to the flash intensity used with instant film, therefore only giving a mild shock to the patient. The Model NM-1000 fundus camera can capture images with a very low amount of light as compared to a conventional fundus camera that uses an instant film.
The Model NM-1000 fundus camera design incorporates the camera unit and power unit into a single integrated table-top unit. During alignment, the camera displays (on the video monitor) patient ID number, as well as focusing functions such as a working distance detection spot and the focusing indicator.
The captured image is temporarily saved in the camera unit just after being captured, and is displayed as a color still image on the video monitor in real time. This allows the operator to immediately judge if the captured image is satisfactory or not. Furthermore, a large-scale 6.4-inch LCD display is used to enhance ease of operation.
Various terminals are provided to allow the operator to output and use the temporarily saved images for various purposes. The Model NM-1000 fundus camera can interface with other devices through the use of a USB port, RGB analog output and composite video output (NTSC) connections.
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera. The acceptance criteria and the study performed to prove the device meets these criteria are outlined below.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Met all requirements of EN 60601-1 |
| Electromagnetic Compatibility | Met all requirements of EN 60601-1-2 |
| Programmable Electrical Medical Systems | Met all requirements of EN 60601-1-4 |
| Ophthalmic Instrument Standards | Met all requirements of ISO 15004 |
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation. The testing performed focused on electrical safety, electromagnetic compatibility, programmable electrical medical systems, and ophthalmic instrument standards. These types of tests typically do not involve patient data or retrospective/prospective studies.
3. Number of Experts and Qualifications:
Not applicable. The study did not involve expert review or establishment of ground truth by clinical experts, as it focused on engineering and performance standards rather than clinical diagnostic accuracy.
4. Adjudication Method:
Not applicable. There was no clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted. The device is a fundus camera, a tool for capturing images, and the study focused on its adherence to safety and performance standards. It was not designed to assess human reader improvement with AI assistance (as the device itself is a camera, not an AI diagnostic tool).
6. Standalone Performance Study:
A standalone performance study was conducted in the sense that the device was tested on its own against various engineering and performance standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 15004). This was an "algorithm only" or "device only" performance evaluation against established technical benchmarks.
7. Type of Ground Truth Used:
The ground truth for the evaluations were the specific requirements and standards outlined in:
- EN 60601-1 (Electrical Safety)
- EN 60601-1-2 (Electromagnetic Compatibility)
- EN 60601-1-4 (Programmable Electrical Medical Systems)
- ISO 15004 (Test Requirements and Test Methods for Ophthalmic Instruments)
These standards define objective technical and performance criteria for the device.
8. Sample Size for the Training Set:
Not applicable. The document describes the product as a fundus camera and does not mention any machine learning or AI components that would require a "training set" for model development. The focus was on demonstrating compliance with technical standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for machine learning was used. The ground truth for the device's performance was established by international and European standards for medical device safety, electromagnetic compatibility, and ophthalmic instrument performance.
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APR 1 7 2002
KO14274
SECTION 17
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Confidential
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510(k) SUMMARY Nidek Non-Mydriatic Fundus Camera Model NM-1000
SUBMITTER INFORMATION 1.
| A. | Company Name: | Nidek Incorporated |
|---|---|---|
| B. | Company Address: | 47651 Westinghouse Drive.Fremont, CA 94539-7474 |
| C. | Company Phone:Company Fax: | (510) 353-7722(510) 226-5750 |
| D. | Contact Person: | Mr. Hiro MatsuzakiQuality Assurance ManagerNidek Incorporated |
| E. | Date Summary Prepared: | December 21, 2001 |
| DEVICE IDENTIFICATION | ||
| A. | Classification Name: | Ophthalmic Camera (AC-Powered) |
| B. | Trade/Proprietary Name: | Nidek Non-Mydriatic Fundus Camera Model |
- Class II (per 21 CFR 886.1120) C. Device Classification:
- HKI Product Code: D.
SUBSTANTIAL EQUIVALENCE 3.
The Nidek Incorporated NM-1000 device is of comparable type and is substantially equivalent to the following predicate device:
NM-1000
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Canon CR6-45NM Non-Mydriatic Retinal Camera | Canon USA, Inc | K980246 | May 6, 1998 |
、 …
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DEVICE DESCRIPTION 4.
Nidek Co., Ltd. has developed the Model NM-1000, which is a stationary-type ophthalmic non-mydriatic fundus camera. Without using 35mm or instant films, this fundus camera incorporates a full digital video capturing system with memory functions, and can transfer captured images to a personal computer. The NM-1000 is designed to deliver its full performance as a fundus camera specializing in digital video capturing as a stand-alone unit or in combination with an image filing system.
In the same manner as other conventional fundus cameras, the Model NM-1000 fundus camera projects the fundus using invisible infrared beams of light during alignment and monitors patient's eye using an infrared video system which does not burden the patient's eye. As a high-sensitivity CCD chip captures an image during use, only a very small amount of flash is used as compared to the flash intensity used with instant film, therefore only giving a mild shock to the patient. The Model NM-1000 fundus camera can capture images with a very low amount of light as compared to a conventional fundus camera that uses an instant film.
The Model NM-1000 fundus camera design incorporates the camera unit and power unit into a single integrated table-top unit. During alignment, the camera displays (on the video monitor) patient ID number, as well as focusing functions such as a working distance detection spot and the focusing indicator.
The captured image is temporarily saved in the camera unit just after being captured, and is displayed as a color still image on the video monitor in real time. This allows the operator to immediately judge if the captured image is satisfactory or not. Furthermore, a large-scale 6.4-inch LCD display is used to enhance ease of operation.
Various terminals are provided to allow the operator to output and use the temporarily saved images for various purposes. The Model NM-1000 fundus camera can
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interface with other devices through the use of a USB port, RGB analog output and composite video output (NTSC) connections.
INTENDED USE 5.
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.
TECHNOLOGICAL CHARACTERISTICS 6.
A comparison of the technological characteristics of the Nidek Non-Mydriatic Fundus Camera Model NM-1000 and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the Nidek Non-Mydriatic Fundus Camera Model NM-1000 has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device. The differences between the Nidek Non-Mydriatic Fundus Camera Model NM-1000 and the predicate device are insignificant and do not affect the safety or effectiveness of the device.
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| PREDICATE DEVICE COMPARISON CHART | ||
|---|---|---|
| Nidek Non-mydriatic FundusCamera Model NM-100 | Canon CR6-45NMK980246 | |
| Indications For Use | The Nidek NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye. | The CR6-45NM is indicated for use in taking pictures of the retina of the human eye. |
| CAMERA: | ||
| Saved Image Format | Nidek format (extension NFC) or Tiff format (extension TIF) | JPEG, TIF, DICOM |
| Picture angle | 45° | 45° |
| Working distance | 43.3 mm (from camera body to cornea) | 45 mm (from objective to cornea) |
| Working distance detection method | Anterior (Observation)Fundus (Focusing on blight spots) | Anterior (Split Focus)Fundus (Focusing on blight spots) |
| Minimum diameter of pupil | 4 mm | 4 mm |
| CCD Camera for observation | 1/3 inch CCD Camera AnalogInterlace Scan | 1/3 inch CCD Camera AnalogInterlace Scan |
| CCD Camera forPhotographing | ½ inch CCD Camera DigitalProgressive Scan (built-in) | TV Adapter & ½ inch 3 CCD Camera, Analog Non-Interlace Scan (OuterAttachment) |
| Observation Display (B/W) | 6.4 inch LCD Monitor | 5 inch CRT Monitor |
| Photographing Display(Color | 6.4 inch LCD Monitor | Outer Monitor (Option) Use |
| Dioptric compensation | Total -32 D to +40 D | Total -33D to +35D |
| Focusing | Manual (motor driven)Split line focus on the retina (-10 to+14 D) | ManualSplit line focus on the retina (-12 to+15) |
| Observation Light Source | Halogen lamp (Max. 12V 50W) withinfrared filter | Halogen lamp (Max. 12V 75W) withinfrared filter |
| Photographing Light Source | Xenon flash (Max. 25WS) | Xenon flash (Max. 300WS) |
、「。
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T
| PREDICATE DEVICE COMPARISON CHART | ||
|---|---|---|
| Nidek Non-mydriatic FundusCamera Model NM-100 | Canon CR6-45NMK980246 | |
| Internal Fixation Navigation | Manual lever moving | LCD Display |
| Switching light path ofobservation &photographing | Beam Splitter | Mobile Mirror |
| Image File Function | Compact Flash Memory with PC Cardadapter | Connection to external device |
| Data Input | 15 characters, by the use of a numerickeypad | Manual writing data (write on the cardand slide it in) |
| Observation LightAdjustment | Volume adjustment style | Volume adjustment style |
| Photographing LightAdjustment | Step adjustment style (8 steps) | Step adjustment style (5 steps) |
| CAMERA STAND (BASE): | ||
| Type | Table top; power source built-in | Table top; power source built-in |
| Horizontal Movement | 65 mm forward and backward, 106mm left and right | 40 mm forward and backward100 mm left and right |
| Vertical Movement | 30 mm | 40 mm |
| Shutter Release | Joystick upper button | Joystick upper button |
| Signal Outlet | USB, RGB Analog, NTSC CompositeVideo | RGB Analog, NTSC or PALComposite Video (depending on CCDcamera) |
| CHINREST: | ||
| Vertical movement of | 65 mm | 70 mm |
PERFORMANCE DATA 7.
The following testing was performed on the Nidek Non-Mydriatic Fundus Camera Model NM-1000 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:
Electrical Safety Testing & Electromagnetic Compatibility A..
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The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.
Programmable Electrical Medical Systems B.
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.
Test Requirements and Test Methods for Ophthalmic Instruments C.
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with ISO 15004 and was found to meet all requirements of the standard.
CONCLUSIONS 8.
Nidek Incorporated has demonstrated through its evaluation of the Nidek Non-Mydriatic Fundus Camera Model NM-1000 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.
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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are represented by thick, curved lines, giving the logo a modern and minimalist appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nidek Inc. C/O Mr. Carol Patterson President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630
APR 17 2002
Re: K014274
Trade/Device Name: Non-Mydriatic Fundus Camera, Model NM -1000 Regulation Number: 21 CFR 886.1120 Regulation Name: AC-powered ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: April 9, 2002 Received: April 11, 2002
Dear Ms. Patterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo neve 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 for worked of 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 I loas of the 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 or uny 1 watt all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth 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.
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Page 2 - Mr. Carol Patterson
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
(To Be Assigned By FDA) 510(k) Number:
Nidek Non-Mydriatic Fundus Camera Model NM-1000
Indications For Use:
Device Trade Name:
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2-26-02
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K014274 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Per 21 CFR 801.109)(Per 21 CFR 801.109)
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.