(28 days)
Not Found
No
The description focuses on the hardware and basic image acquisition process, with no mention of AI/ML for image analysis, diagnosis, or other functions.
No
The device is indicated for diagnosis and monitoring, and its description focuses on image generation, not direct treatment.
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 themselves in the retina." This explicitly indicates a diagnostic function.
No
The device description explicitly details hardware components like lasers, deflection systems, light detectors, and a computer for image display, indicating it is a hardware device with associated software.
Based on the provided information, this device 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device 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 is to aid in the diagnosis and monitoring of diseases that manifest in the retina by providing imaging, not by analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Optos plc's ("Optos") Panoramic 200MA has the same intended use and same indications as the Optos predicate device, the Panoramic 200A. Both devices are intended to examine the retina and are indicated to aid in the diagnosing and monitoring disease and disorders that manifest in the retina. Additionally, the Panoramic 200MA and Panoramic 200A are indicated for imaging the fluoresced ocular vasculature.
This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.
Product codes (comma separated list FDA assigned to the subject device)
MYC
Device Description
The Optos Panoramic 200MA and the predicate device are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. Both devices use a laser or 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 digitised 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 Ophthalmoscopes (SLO)
Anatomical Site
retina, ocular vasculature
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): 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
§ 886.1570 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.
0
MAR 1 7 2006
Image /page/0/Picture/1 description: The image contains a sequence of numbers and letters. The sequence is 'K060424'. The characters are written in a bold, sans-serif font.
Attachment 2: Special 510k Summary-Optos Panoramic 200MA
| Name of Device | Panoramic 200MA Angiograph Ophthalmoscope | |
|---|---|---|
| Common or Usual Name | Scanning laser ophthalmoscope | |
| Classification Name | Ophthalmoscope, AC powered | |
| (per 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 | 8th February, 2006 | |
| Predicate Device | ||
| Trade Name | Manufacturer | 510(k) |
| Panoramic 200A | Optos | K042001 |
Intended Uses
Optos plc's ("Optos") Panoramic 200MA has the same intended use and same indications as the Optos predicate device, the Panoramic 200A. Both devices are intended to examine the retina and are indicated to aid in the diagnosing and monitoring disease and disorders that manifest in the retina. Additionally, the Panoramic 200MA and Panoramic 200A are indicated for imaging the fluoresced ocular vasculature. Thus, the Panoramic 200MA Ophthalmoscope has the same intended use and same indications as the predicate device.
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1
Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K060424'. The characters are written in a handwritten style.
Principles of Operation and Technological Characteristics
The Optos Panoramic 200MA and the predicate device are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. Both devices use a laser or 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 digitised and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.
The above principle of operations holds for imaging the retina or a fluoresced retina. The detailed technological differences do not raise any new questions of safety or effectiveness.
Performance Standards
The Optos Panoramic 200MA Ophthalmoscope is a Class 1 laser device. This device complies with 21 C.F.R., Parts 1010 and 1040 (and also EN 60825:2001). The Optos Panoramic 200MA Ophthalmoscope complies with the following standards:
| IEC 60601-1 Second Edition 1988/A1: 1991
& A2:1995 | Medical electrical equipment. General
Requirements for safety. |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN 60601-1:1990/A1:1993, A11:1993, A12:1993
& A2:1995, A13:1996 | Medical electrical equipment. General
requirements for safety. |
| EN 60601-1-1:2001 | Medical electrical equipment. General
Requirements for safety. Collateral
Standard. Safety requirements for
Medical electrical systems. |
| EN 60601-1-2:2001 | Medical electrical equipment. General
Requirements for safety. Collateral
Standard. Electromagnetic compatibility
Requirements and tests; |
| EN 60601-1-4:1996 | Medical electrical equipment. General
Requirements for safety. Collateral
Standard. General requirements for
Programmable electrical medical
Systems; |
| UL60601-1 First Edition:2003 | Medical electrical equipment.
General requirements for safety; |
| CAN/CSA-C22.2 No.601.1-M90 including S1-94 | Medical electrical equipment. General
requirements for safety. |
95000 66198/0001 2263650 |
2
Image /page/2/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K060424'. The characters are handwritten in a clear, legible style. The numbers are easily distinguishable, and the letter 'K' is written in uppercase.
Conclusion
The Panoramic 200MA has the same intended use, the same indications and very similar principles of operation and technological characteristics as the predicate device. The minor technological differences between the Panoramic 200MA and the predicate devices do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200MA Ophthalmoscope is substantially equivalent to Optos` legally marketed Scanning Laser Ophthalmoscopes (SLO), the P200A (K042001)
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2006
Optos PLC % Hogan & Hartson, LLP 555 Thirteenth St. N.W. Columbia Square Washington, DC 20004 Attn: Howard M. Holstein
Re: K060424
Trade/Device Name: Panoramic, Model 200MA Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: February 17, 2006 Received: February 17, 2006
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, 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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
MB. Eychhaus - MD
Malvina B. Eydelman, M.D Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement for Indication for Use
510(k) Number (if known): KOGOYZY
Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope 200 HA
Indications for Use:
This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.
Prescription Use ✓ (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)
Clay P. Buttner
(Division Sign-Off)
Division of thalmic Ear,
Nose and Thuat Devises
510(k) Number.
WDC - 66148880001 - 22636511 1
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