(179 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses solely on image capture capabilities.
No
The device is described as a camera used to record digital photographs and video of the fundus, which is a diagnostic function rather than a therapeutic one. It captures images for analysis, but does not treat any condition.
No
The device records digital photographs and video of the fundus but does not state that it analyzes or interprets these images for diagnostic purposes. Its use cases, such as telemedicine and electronic filing, suggest it's primarily for image acquisition and storage, not analysis leading to a diagnosis.
No
The device description explicitly states it is a "digital hand-held eye-fundus camera," which is a hardware device.
Based on the provided information, the MiiS Horus Scope DEC 100 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 MiiS Horus Scope DEC 100 is a camera that takes images and video of the fundus of the human eye. This is a direct imaging of a part of the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to "record digital photographs and video of the fundus of the human eye and surrounding area." This is a diagnostic imaging function, not an in vitro diagnostic test.
Therefore, the MiiS Horus Scope DEC 100 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of the fundus of the human eye and surrounding area.
Product codes
HKI
Device Description
MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area. It is more efficient and suitable for many different applications, such as telemedicine and electronic filing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fundus of the human eye and surrounding area
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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Image /page/0/Picture/0 description: The image is a logo with the text "MiiS" in bold, sans-serif font at the bottom. Above the text is a circular graphic that resembles a target or a stylized eye. The target consists of concentric circles with sections cut out, creating a pattern of alternating dark and light areas. The entire logo is contained within a rounded rectangle.
Medimaging Integrated Solution Inc.
SEP 28 2012
510(k) Summary
This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92.
The assigned 510(k) number is K120982.
Date Prepared: February 26, 2012
Submitter and Contact Information:
FDA Establishment Registration Number: 3009197913
| Manufacturer/
Address: | Medimaging Integrated Solution, Inc. (MiiS)
1F, No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan
30076 (R.O.C.) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact | Name: Hsu, Chih-Lu
Title: COO
Telephone: +886-3-5798860 Ext: 110
Fax: +886-3-5798821
Email Address: luu@miis.com.tw |
| Device Name | MiiS Horus Scope DEC 100 |
| Common Name | Digital Eye-Fundus Camera |
| Classification Name | Ophthalmic Camera |
| Classification | Class II |
| Regulation Number | 886.1120 |
| Product Code | HKI |
| Review Panel | Ophthalmic |
| Predicate Device | · K110986
Smartscope M5 EY3
Optomed Oy |
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Image /page/1/Picture/0 description: The image shows a logo with the text "Miis" in bold letters at the bottom. Above the text is a circular graphic that resembles a target or a stylized eye. The logo is contained within a rounded rectangle.
Medimaging Integrated Solution Inc.
Device Description MilS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area. It is more efficient and suitable for many different applications, such as telemedicine and electronic filing. Intended Use MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area. Substantial MiiS Horus Scope DEC 100 is substantially equivalent to the Equivalence predicate device with respect to functionality, design verification, intended use and performance characteristics. Conclusion Based on the 510(k) summaries and the information provided herein, we conclude that the submitted device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.
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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing segments, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2012
Medimaging Integrated Solution, Inc. c/o Mr. Chih-Lu Hsu, Chief Operations Officer 1F, No. 7, R & D Rd. II Hsinchu Science Park Hsinchu, Taiwan 30076 R.O.C.
Re: K120982
Trade/Device Name: Miis Horus Scope DEC 100 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 12, 2012 Received: September 17, 2012
Dear Mr. Hsu:
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 (21
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Page 2 - Mr. Chih-Lu Hsu
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debra Falls
Image /page/3/Picture/6 description: The image shows a signature and some text. The text includes the words "Malv", "Dire", and "Divi". The signature is a stylized symbol with a loop and a line through it. The text is aligned to the right of the signature.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image is a logo with the word "MiiS" in bold, black letters at the bottom. Above the word is a circular target-like design with concentric circles and a central white circle. The logo is contained within a rounded rectangle with a white background. The target design has a black and white color scheme.
Medimaging Integrated Solution Inc.
Indications for Use
510(K) Number (If Known):
Device Name: MiiS Horus Scope DEC 100
Indications for Use: MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of the fundus of the human eye and surrounding area.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Daniel Kaufman, M.A.
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number TC120982
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