(48 days)
Not Found
No
The description focuses on standard imaging and light projection technology, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as an instrument for the diagnosis of retinal diseases and captures images, but it does not perform any therapy.
Yes
The device description states, "The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases."
No
The device description explicitly 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 a personal computer. While it uses 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 analyze specimens taken from the human body. The MP-1 MICRO PERIMETER directly examines the patient's retina and fundus using light and imaging. It does not analyze blood, urine, tissue samples, or any other specimen removed from the body.
- The intended use and device description clearly indicate direct examination of the eye. The device performs retinography, fixation examination, and microperimetry, all of which are performed in vivo (on the living patient).
The device is an ophthalmic instrument used for in vivo diagnosis of retinal diseases.
N/A
Intended Use / Indications for Use
The MP-1 MICRO PERIMETER is intended for use as:
Color retinography
Fixation exam
Fundus-related microperimetry
The MP-1 MICRO PERIMETER is indicated for use as :
Color retinography ●
Fixation examiner ●
Fundus-related microperimetry ●
Product codes (comma separated list FDA assigned to the subject device)
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 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 15-inch 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, Visible Flash
Anatomical Site
Retina
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)
The performance data indicate that the 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): 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
§ 886.1120 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
DEC 2 3 2002
Image /page/0/Picture/2 description: The image shows the text "K023719" in a large, handwritten font. Below this, the text "ORIGINAL PREMARKET 510(K) NOTIFICATION" and "MP-1 MICRO PERIMETER" are printed in a smaller, sans-serif font. The text appears to be part of a document or label.
SUMMARY OF SAFETY AND EFFECTIVENESS MP-1 MICRO PERIMETER
SUBMITTER INFORMATION
| A. | Company Name: | Nidek Technologies Srl |
|---|---|---|
| B. | Company Address: | Via Regina, 88 |
| Vigonza (Padova), Italy 35010 | ||
| C. | Company Phone: | |
| Company Fax: | 39 49 89 35 191 | |
| 39 49 62 55 84 | ||
| D | Contact Person: | Mr. Aldo Cocchiglia |
| Managing Director | ||
| Nidek Technologies Srl | ||
| E | Date Summary Prepared: | July 03, 2002 |
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 |
1
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 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 15-inch 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:
Color retinography 1)
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 properly for eye fundus movements during the examination;
- generating a sensitivity map of the inspected retinal region. -
2
NIDEK TECHNOLOGIES SRL NOTIFICATION
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 |
|---|---|---|---|
| NON-MYDRIATIC | |||
| FUNDUS CAMERA, | |||
| MODEL NM-1000 | NIDEK, INC | K014274 | 04/17/2002 |
| HUMPHREY FIELD | |||
| ANALYZER | CARL ZEISS, INC. | K954167 | 11/24/1995 |
| CONFOSCAN 2 | |||
| CONFOCAL | |||
| MICROSCOPE | NIDEK | ||
| TECHNOLOGIES | |||
| SRL | K012416 | 10/26/2001 |
In further support of a substantial equivalence determination, Section 10 provides a comparison chart of the MP-1 MICRO PERIMETER and the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the MP-1 MICRO PERIMETER and the predicate devices has been performed. The results of this comparison demonstrate that the MP-1 MICRO PERIMETER device is equivalent to the marketed predicate devices.
PERFORMANCE DATA
The performance data indicate that the MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and service.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
DEC 23 2002
Nidek Technologies, Srl c/o TUV America, Inc. Attention: Mr. Mark Job 1775 Old Highway New Brighton, MN 55112-1891
Re: K023719
Trade Name: MP-1 MICRO PERIMETER Classification Regulation Number: 886.1120; 886.1605 Regulatory Class: II and I Product Code: HKI; HPT Dated: December 9, 2002 Received: December 12, 2002
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job.
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. This letter will allow you to begin marketing your device as clescribed 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 (301) 594-4692. 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
5
ORIGINAL PREMARKET 510(K) NOTIFICATION MP-1 MICRO PERIMETER
INDICATIONS FOR USE
5.10(k) Number:
K02371/9 (To Be Assigned By
FDA).
Device Trade 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 ●
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number. K023719
Prescription Use_ U
OROver-The-Counter Use
(Per 21 CFR 801.109)