(12 days)
No
The summary describes a set of disposable lenses for visualization during surgery and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is strictly for visualization during surgery and does not provide therapy or treatment.
No
Explanation: The device is described as an optical lens system designed for visualization during surgery, not for diagnosing conditions. Its intended use is to "Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery," which is an assistive tool for a surgical procedure, not a diagnostic one.
No
The device description explicitly states it consists of "multiple sterile, disposable, thermoplastic lenses," which are physical hardware components.
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 the device is a lens set used for visualization of internal ocular structures during surgery. It is a tool used by a surgeon to see better, not a test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic interpretation of test results, which are hallmarks of IVDs.
Therefore, the Super View Disposable BIOM Lens Set is a surgical accessory used for visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
Product codes
HJK
Device Description
The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular fundus, vitreous, and retinal structures
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.
0
JUN 2 9 2005
Insight Instruments, Inc.
Image /page/0/Picture/3 description: The image shows a diagram with overlapping concepts. On the left side of the diagram, the words "insight" and "instruments" are written. On the right side of the diagram, the words "instruments" and "insight" are written, but they are oriented vertically. The diagram is composed of lines and circles.
3. 510(k) Summary
| 3.1 Date Prepared: | April 19, 2005 |
|---|---|
| 3.2 Applicant: | Insight Instruments, Inc. |
| 5400 S. Bryant Avenue | |
| Sanford, FL 32773, USA | |
| Phone: (407) 324 0388 | |
| Fax: (407) 324 0522 | |
| Contact: Michael Annen, VP Engineering & Mfg. | |
| 3.3 Device Name | Proprietary Name: Super View Disposable BIOM Lens Set |
| Common Name: Diagnostic Lens | |
| Classification Name: Lens, Contact, Polymethylmethacrylate, Diagnostic | |
| 3.4 Device Classification | HJK, Class II, 21 CFR 886.1385 |
| 3.5 Device Description | The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, |
| disposable, thermoplastic lenses for both contact and non-contact use in | |
| conjunction with an operating microscope equipped with a BIOM wide- | |
| angle viewing system. | |
| 3.6 Intended Use | The Diagnostic Lenses are intended to be used in conjunction with an |
| operating microscope as a surgical optic to improve visualization of the | |
| ocular fundus, vitreous and retinal structures. Diagnostic lenses are | |
| indicated for use during vitreoretinal surgical procedures. |
3.7 Summary and comparison of technological characteristics:
| Insight Instruments, Inc.
Diagnostic Lenses | Ocular Instrument, Inc. Vitrectomy
Lenses | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | PMMA, Polystyrene, other thermoplastics | PMMA, Silicone, Glass, Quartz |
| Design | Contact lens has concave surface with corneal
radius on one side, flat surface on other side.
Non-contact lenses have spheric and aspheric
surfaces and thermoplastic housings. | Contact lens has concave surface with
corneal radius on one side, flat surface
on other side.
Other designs include biconcave, 20°
and 30° prism lenses. Some designs may
be used with a handle or scleral ring. |
| Sterility | Sterile disposable | Sterile disposable and Non-sterile
reusable |
1
The Insight Instruments, Inc. Diagnostic Lenses are equivalent in design, 3.6 Substantial Equivalence The might interamions, and intended use and indications to vitrectorny materials, chasilibation on the ments, Inc. cleared via 510(k) number K012096, 8/24/01.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Insight Instruments, Inc. c/o Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Rd. Boxborough, MA 01719
Re: K051630
Trade/Device Name: Super View Disposable BIOM Lens Set Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: June 16, 2005 Received: June 17, 2005
Dear Lehtonen:
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.
3
Page 2 - Daniel W. Lehtonen
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/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Statement of Indications for Use
510(k) Number (if known): _ KO SKO SKO SKO
Device Name: Diagnostic Lenses
Indications for Use:
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Soveria
tvision Sign-Off ision of Ophthalmic Ear. Nose and Throat Devise
510(k) Number K051630