(70 days)
Not Found
No
The description focuses on the hardware and basic image acquisition process, with no mention of AI/ML terms or functionalities like image analysis, diagnosis support, or automated feature detection that would typically involve such technologies.
No
The device aids in diagnosis and monitoring, but it does not directly treat or cure diseases or disorders.
Yes
The "Intended Use / Indications for Use" states that the device is "to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina."
No
The device description explicitly states it is a "scanning laser ophthalmoscope" that uses lasers, a deflection system, a light detector, and converts light to an electrical signal, indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the Panoramic 200T scanning laser ophthalmoscope 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 Panoramic 200T is an ophthalmoscope that uses lasers to image the retina in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for imaging the retina to aid in diagnosis and monitoring of diseases that manifest in the retina. This is a direct imaging and diagnostic aid, not an in vitro test.
Therefore, the device falls under the category of medical imaging devices used for direct examination of a part of the body, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The P200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.
Product codes
MYC
Device Description
The Optos P200T is a scanning laser ophthalmoscope that uses lasers as a light source that is scanned by a deflection system in two axes across the retina to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanning laser ophthalmoscope
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)
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
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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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Special 510k Summary
| AUG 1 9 2011 | ||
|---|---|---|
| Name of Device | P200T Ophthalmoscope | |
| Common or Usual Name | Scanning laser ophthalmoscope | |
| Classification Name | Scanning laser ophthalmoscope (21 C.F.R. § 866.1570) | |
| Product Code | MYC | |
| Submitter | Optos plc, | |
| Queensferry House, | ||
| Carnegie Business Campus | ||
| Dunfermline, | ||
| Fife, | ||
| KY11 8GR | ||
| United Kingdom | ||
| Phone: | 011 44 1383 843300 | |
| Facsimile: | 011 44 1383 843333 | |
| Contact Person: | Robert Tweedlie, Ph.D. | |
| Date Prepared | July 21, 2011 | |
| Predicate Device | Optos Limited's Panoramic 200CAF (K100644) | |
| Indications for Use |
The P200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.
Principles of Operation and Technological Characteristics
The Optos P200T is a scanning laser ophthalmoscope that uses lasers as a light source that is scanned by a deflection system in two axes across the retina to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.
Summary of Modifications to the Predicate Device
- The scanhead used for image capture is in a different enclosure and is a table top model; .
- There is no head and chin rest, but there are external handgrips to help patient positioning; .
- There is no powered table which attaches onto the scanhead; rather, there is an electronic . enclosure that connects to the scanhead;
- The mirror used for the horizontal scan is directly connected to a motor, whereas the . horizontal scan mirror in the predicate device is motor driven via a drive bell;
- An optional touch screen monitor is used, rather than a monitor, keyboard, and mouse; .
- Combined laser power monitoring and a single exposure shutter are used, rather than . individual laser power monitoring and individual shutters for each wavelength channel;
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- The return path does not have a translation stage to move optical elements in and out of this . path;
- The autofluorescence sensor has been replaced with a new sensor with greater sensitivity; . and
- The Laser Radiation Management (LRM) firmware and capture software have minor changes . consistent with the modifications described above.
Table of Modifications
()
| Sub-category | P200CAF | P200T |
|---|---|---|
| Imaging Modes | Imaging modes are the same | |
| Autofluorescence is effected by | ||
| laser select shutter being closed | ||
| and return path has optical | ||
| elements removed using a | ||
| translation stage for | ||
| autofluorescence. Belt drive for horizontal slow scan | ||
| mirror Translation stage moves optical | ||
| elements out of return path for | ||
| autofluorescence mode | Imaging modes are the same | |
| Autofluorescence is effected by | ||
| switching off red laser and return | ||
| path has fixed optical elements Direct drive for horizontal slow | ||
| scan mirror Detector gain change for | ||
| autofluorescence; no translation | ||
| stage | ||
| User Interface | Scan head rests on a supporting, | |
| powered table Scan head has integrated monitor Remote review/storage PC User interface: |
- Monitor, keyboard and mouse
- Handheld patient capture button
- Handheld table up/down button | Scan head rests on a supporting
table Scanhead has integrated monitor Remote review/storage PC User interface: - Monitor, keyboard and mouse
- Touchscreen optional
- Handheld patient capture button |
| Patient alignment
system (PAS) | Same for both devices | Same for both devices |
| Laser Radiation
Management
(Including safety
software) | Individual laser power monitoring Individual laser shutters and
separate exposure shutter Vertical and horizontal scan status
monitoring All lasers disable on failure Shutter closure on failure System lock-out on failure Exposure timing monitor Exposure rate control Dual redundancy | Combined laser power monitoring Single exposure shutter Vertical and horizontal scan status
monitoring R/G disable on failure Shutter closure on failure System lock-out on failure Exposure timing monitor Exposure rate control Dual redundancy |
| System
configuration | Scanhead attached to a powered
table | Scanhead connected by cable to
an electronic subsystem |
| Patient support | Head rest/Chin support
Face pad | Face pad and handgrips |
Substantial Equivalence
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The Panoramic 200T has the same intended use and indications for use and similar principles of operation and technological characteristics as the predicate device. The minor technological differences between the Panoramic 200T and the predicate device do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200T Ophthalmoscope is substantially equivalent to Optos' legally marketed Scanning Laser Ophthalmoscope (SLO), the P200CAF (K100644).
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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Optos PLC c/o Mr. Howard M. Holstein Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004
AUG 1 9 2011
Re: K111628
Trade Name: Optos Panoramic 2007' Scanning Laser Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulation Class: Class II Product Code: MYC Dated: July 21, 2011 Received: July 21, 2011
Dear Mr. Holstein:
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. Insting 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
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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); 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tesia Alexander
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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Statement for Indication for Use
510(k) Number (if known):
KIII628
Device Name: Optos Panoramic 200T Scanning Laser Ophthalmoscope Indications for Use:
The Panoramic 200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.
Prescription Use V (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deon
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111628