(97 days)
Not Found
No
The document describes standard image capture and projection technology with dedicated software, but there is no mention of AI or ML algorithms for analysis, interpretation, or decision-making.
No
The device is indicated for diagnosis and examination of retinal diseases, not for treatment or therapy. While "Visual rehabilitation" is listed, the device description and primary indications point to diagnostic functions (capturing images, projecting stimuli for examination), rather than active therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section lists "Color retinography" and "Fundus-related microperimetry," and the "Device Description" explicitly states that it is "an instrument for the diagnosis of retinal diseases."
No
The device description clearly states it is an "instrument" that includes hardware components such as CCD cameras, light sources (Xenon and Halogen), an insulation transformer, an LCD monitor, and an IBM Personal Computer. While it includes software (NAVIS), it is not solely software.
Based on the provided information, the MP-1 MICRO PERIMETER is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MP-1 MICRO PERIMETER directly examines the patient's retina (an anatomical site within the body) using imaging and light projection. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended uses are related to direct examination of the eye. The listed uses (Color retinography, Fixation examiner, Fundus-related microperimetry, Visual rehabilitation) all involve interacting with or observing the patient's eye.
- The device description focuses on capturing images and projecting light onto the retina. This is consistent with an in vivo diagnostic device, not an in vitro one.
Therefore, the MP-1 MICRO PERIMETER is an in vivo diagnostic device used for examining the retina.
N/A
Intended Use / Indications for Use
The MP-1 MICRO PERIMETER is intended for use as:
- Color retinography
- Fixation exam
- Fundus-related microperimetry
- Visual rehabilitation
The MP-1 MICRO PERIMETER is indicated for use as :
- Color retinography .
- Fixation examiner ●
- Fundus-related microperimetry .
- Visual rehabilitation. .
Product codes
HKI , HPT
Device Description
The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retina in those retinal positions chosen by the operator.
The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.
The system includes also a suitable Insulation transformer, a LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared live sequences, color images of the patient retina
Anatomical Site
Retina, fundus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Doctor (for visual rehabilitation)
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 data indicate that the modified MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device.
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
§ 886.1120 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.
0
K 06/768
SUMMARY OF SAFETY AND EFFECTIVENESS MP-1 MICRO PERIMETER
SEP 2 8 2006
SUBMITTER INFORMATION
| A. | Company Name: | Nidek Technologies Srl |
|---|---|---|
| B. | Company Address: | Via Dell'Artigianato, 6/A |
| Albignasego (Padova), Italy 35020 | ||
| C. | Company Phone: | |
| Company Fax: | +39 049 86 29 200 | |
| +39 049 86 26 824 | ||
| D. | Contact Person: | Mr. Aldo Cocchiglia |
| Managing Director | ||
| Nidek Technologies Srl | ||
| E. | Date Summary Prepared: | August 08, 2006 |
DEVICE IDENTIFICATION
:
| A. | Generic Device Name: | Ophthalmic camera, AC-powered
Automated Micro Perimeter, AC-powered |
|----|-------------------------|------------------------------------------------------------------------|
| B. | Trade/Proprietary Name: | MP-1 MICRO PERIMETER |
| C. | Classification: | Class II |
| D. | Product Code: | HKI , HPT |
510(k)
Page 149
1
K06 1768
DEVICE DESCRIPTION
The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retina in those retinal positions chosen by the operator.
The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.
The system includes also a suitable Insulation transformer, a LCD S-VGA Monitor and
an IBM Personal Computer, which incorporates the dedicated NAVIS software (with
Windows 2000 operative system).
INTENDED USE
The MP-1 MICRO PERIMETER is intended for use as:
1) Color retinography
Color image of the fundus obtained in non-mydriatic conditions, using an IR sensible camera as a viewfinder and a visible flash for illuminating the retina at picture taking.
2) Fixation exam
This examination consists in:
- locating, in the patient's fundus, his/her fixation site (anatomical information);
recording the positions, during a certain interval, of the point at which the patient is fixating, as a measure of fixation stability (functional information).
3) Fundus-related microperimetry
Consists in:
. . .
- projecting light stimuli on patient retina at given positions; -
- recording the patient's subjective answer to each stimulus (seen/ not seen); -
- associating precisely the subjective answers (functional information) with the retinal location of the stimuli (anatomical information), compensating wroperly for eye fundus movements during the examination;
- generating a sensitivity map of the inspected retinal region. -
2
4) Visual rehabilitation
The biofeedback tool consists of a software module which implements a new exam mode, called the "feedback exam".
The feedback exam represents a visual rehabilitation tool, which helps the doctor training patients with unstable fixation to develop a new preferred retinal locus (PLR) being led by an audible bio-feedback signal
SUBSTANTIAL EQUIVALENCE
The Nidek Technologies Srl MP-1 MICRO PERIMETER device is of comparable type and is substantially equivalent to the following predicate device:
| Predicate Device | 510(K) Holder | 510(k) No. | Date Cleared |
|---|---|---|---|
| MP-1 MICRO PERIMETER | NIDEK TECHNOLOGIES | ||
| SRL | K023719 | 12 / 23 /2002 | |
| AR-1 PHYSIOLOGICAL | |||
| PRODESSOR | ATAL RESEARCHES LTD. | K810880 | 05 / 27 / 1981 |
In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the modified MP-1 MICRO PERIMETER and the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the modified MP-1 MICRO PERIMETER and the predicate devices has been performed. The results of this comparison demonstrate that the modified MP-1 MICRO PERIMETER device is equivalent to the marketed predicate devices.
PERFORMANCE DATA
:
The performance data indicate that the modified MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized, abstract design with three curved lines that resemble a wave or a flowing shape. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo, with the letters oriented to be read from top to bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2006
Nidek Technologies SRL c/o Mr. Aldo Cocchiglia Via Dell' Artigianato, 6/A Albignasego (Padova), Italy 35020
Re: K061768
Trade/Device Name: MP-1 Micro Perimeter Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: II Product Code: HKI, HPT Dated: August 11, 2006 Received: August 23, 2006
Dear Mr. Cocchiglia:
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.
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 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); 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.
4
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M B Egelman SiWD
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
5
INDICATIONS FOR USE
510(k) Number (if known): K061768
Device Name:
MP-1 MICRO PERIMETER
Indications for Use:
The MP-1 MICRO PERIMETER is indicated for use as :
- Color retinography .
- Fixation examiner ●
- Fundus-related microperimetry .
- Visual rehabilitation. .
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Denis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K061768
MP-1 510(k)
Page 146