(73 days)
K98399, K97167, K88251, K87126
K98399, K97167, K88251, K87126
No
The description focuses on the hardware and basic image acquisition process, with no mention of AI/ML terms, image processing beyond basic digitization, or performance studies related to algorithmic analysis.
No.
The device is used for diagnosis and monitoring of diseases, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina." This directly indicates its role in diagnosis.
No
The device description explicitly states it uses lasers, a deflection system, a light detector, and a personal computer to build and display images, indicating it is a hardware device with integrated 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an ophthalmoscope that images the retina of the eye using a laser. It works by scanning light directly into the eye and detecting the returned light. This is an in vivo (within the living body) imaging technique, not an in vitro test on a sample.
- Intended Use: The intended use is to aid in the diagnosis and monitoring of diseases that manifest in the retina by providing images. This is consistent with an imaging device used for clinical examination.
Therefore, the Optos Panoramic 200A is an ophthalmic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Optos plc's ("Optos") Panoramic 200A, Panoramic 200, Heidelberg Retina Angiography 2 and G.Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the Rodenstock SLOs") is intended to examine the retina. The Panoramic 200A, Panoramic 200 and the Rodenstock SLOs are indicated for diagnosing and monitoring disease and disorders that manifest themselves in the retina of the eye. Additionally, the Panoramic 200A, Heidelberg Retina 2 and Rodenstock SLOs are indicated for imaging the fluoresced ocular vasculature. Thus, the Panoramic 200A Ophthalmoscope has the same intended use and same indications as these predicate devices.
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
HLI
Device Description
The Optos Panoramic 200A and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. They use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina of the eye 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 personal 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 Ophthalmoscopy (SLO)
Anatomical Site
Retina (of the eye)
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)
K98399, K97167, K88251, K87126
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.
0
KO42001 Attachment 2: 510k Summary-Optos Panoramic 200A
| Name of Device | Panoramic 200A Angiograph Ophthalmoscope |
|---|---|
| Common or Usual Name | Scanning laser ophthalmoscope |
| Classification Name | Ophthalmoscope, AC powered |
| (per 21 C.F.R. 866.1570) | |
| Product Code | HLI |
| 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 | 15th July,2004 |
Predicate Devices
| Trade Name | Manufacturer | 510(k) |
|---|---|---|
| Panoramic 200 | Optos | K98399 |
| Heidelberg Retina Angiography 2 | Heidelberg Engineering | K97167 |
| Scanning Laser Ophthalmoscope(SLO) | Rodenstock | K88251 |
| Scanning Laser Ophthalmoscope(SLO) | Rodenstock | K87126 |
Intended Uses
Optos plc's ("Optos") Panoramic 200A, Panoramic 200, Heidelberg Retina Angiography 2 and G.Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the Rodenstock SLOs") is intended to examine the retina. The Panoramic 200A, Panoramic 200 and the Rodenstock SLOs are indicated for diagnosing and monitoring disease and disorders that manifest themselves in the retina of the eye. Additionally, the Panoramic 200A, Heidelberg Retina 2 and Rodenstock SLOs are indicated for imaging the fluoresced ocular vasculature. Thus, the Panoramic 200A Ophthalmoscope has the same intended use and same indications as these predicate devices.
1
The Optos Panoramic 200A and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. They use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina of the eye 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 personal computer and displayed either on a cathode ray tube or a liquid crystal display.
The technological differences between the Panoramic 200A Ophthalmoscope and its predicate devices in an angiographic mode are the lack of an infrared laser, different display format, wider imaging angle and associated resolution. However, these differences do not raise any new questions of safety or effectiveness.
Performance Standards
The Optos Panoramic 200A Ophthalmoscope is a Class 1 laser device. This device complies with 21 C.F.R., Parts 1010 and 1040.
The Optos Panoramic 200A 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; |
2
| 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; |
Conclusion
The Panoramic 200A has the same intended use, the same indications and very similar principles of operation and technological characteristics as the predicate devices. The minor differences between the Panoramic 200A and the predicate devices do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200A Ophthalmoscope is substantially equivalent to legally marketed Scanning Laser Ophthalmoscopes (SLO).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OC1 7 - 2004
Optos PLC c/o Hogan and Hartson, LLP Attn: Mr. Howard M. Holstein 555 Thirteenth Street, N.W. Columbia Square Washington, D.C. 20004
Re: K042001 RC: K042001
Trade/Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation: Ophthalmoscope, AC powered Regulatory Class: II Product Code: HLI Dated: July 26, 2004 Received: July 26, 2004
Dear Mr. Holstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to conniner of provises that have been reclance with the provisions of the Federal Food, Drug, de nees may been robat 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 I ou may, ateres, and server 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
Page 2- Mr. Howard M. Holstein
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) 594-4613. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
A halyi 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
Enclosure
5
Statement for Indication for Use
510(k) Number (if known): K042001
Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope
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)
Ada C. Callaway
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K072001
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