(210 days)
Not Found
No
The description focuses on the physical properties and application of a silicone membrane for corneal imaging, with no mention of AI or ML algorithms for image processing or analysis.
No
The device is described as measuring the topographical surface of the cornea for imaging purposes, not for treating or rehabilitating a medical condition.
No
The device is described as assisting in the measurement of the topographical surface of the cornea by providing a membrane for imaging. It is an auxiliary device that facilitates imaging, rather than directly performing a diagnostic function itself by analyzing data or identifying conditions. Its predicate devices are wound dressings and contact lenses, which are not diagnostic devices.
No
The device description explicitly states it consists of a hydrophobic silicone-based membrane fixed within two couplings, which are physical components, not software.
Based on the provided information, the Silon Topomat device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Silon Topomat device is applied directly to the surface of the cornea (an anatomical site on the body) to obtain an image. It does not involve the collection or analysis of a biological specimen like blood, urine, or tissue.
- The intended use is for measuring the topographical surface of the cornea. This is a physical measurement of the eye's shape, not a diagnostic test performed on a biological sample.
- The device description focuses on its physical properties and how it interacts with the cornea and imaging equipment. It doesn't mention any reagents, assays, or procedures for analyzing biological materials.
Therefore, the Silon Topomat device falls under the category of a medical device used for imaging and measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.
Product codes (comma separated list FDA assigned to the subject device)
86 MMQ
Device Description
The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents.
The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
rasterstereographic imaging techniques
Anatomical Site
Cornea
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
§ 886.1350 Keratoscope.
(a)
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files
0
Image /page/0/Picture/0 description: The image shows a logo for Bio Med Sciences, Inc. with the letters "BMS" in a stylized font. The text "Bio Med Sciences, Inc." is printed below the logo. The image also includes the date "DEC 7 1998" and the text "FDA/CDRH/ODE/DMC".
K98 No 65
101 Technology Drive . Bethlehem, PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON (257-4566) http://www.silon.com
Summary 510 (k) Premarket Notification
CONTACT PERSON
Mark E. Dillon, President, Bio Med Sciences, Inc.
PRODUCT NAME
Silon® Topomat™ Corneal Topography Image Enhancement Device
PRODUCT DESCRIPTION
The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents.
The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.
PRODUCT EQUIV ALENCY
Bio Med Sciences claims substantial equivalency for Silon Topomat to the following devices:
1. Silon® Transparent Wound Dressings (K912032 & K923150)
Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, PA 18015 USA
Silon interpenetrating polymer network of polydimethylsiloxane and polytetrafluoroethylene in membrane form used on de-epithelialized dermal tissue.
2. SilSoft® Aphakic Extended-Wear Contact Lens
Bausch & Lomb One Bausch & Lomb Place P.O. Box 450 Rochester, NY 14692
60 Registered Trademark, Bio Med Sciences, Inc.
1
510(k) Premarket Notification Summary Silon® Topomat™ Corneal Topography Image Enhancement Device Bio Med Sciences, Inc., Bethlehem, PA Page 2 of 2
Soft contact lens made from Elastofilcon A™ polydimethylsiloxane from Dow Corning corporation. Used in direct contact with the human eye.
3. Fluorescein Dye
Akorn. Inc. 100 Akorn Drive Abita Springs, LA 70420
Used as an image enhancement dye for corneal topographic mapping.
BIOCOMPATIBILITY SUMMARY
The Silon membrane passes the Tripartite Biocompatibility Guidance for Medical Devices as prepared by the Toxicology Sub-group of the Tripartite Sub-Committee on Medical Devices (September 1986) as related to external devices contacting breached surfaces for short durations. The tests were performed by an FDA registered independent testing company (Toxicon Corporation of Woburn, MA). The data can be summarized as follows:
| Test | Results | Toxicon Reference |
|---|---|---|
| Kligman Maximization | Non-sensitizing (0% sensitization) | 91G-0388 |
| Primary Dermal Irritation | Non-irritant (PDII = 0) | 91G-0387 |
| Hemolysis | Non-hemolytic (2.0 %) | 90G-0670 |
| Agarose Overlay Cytotoxicity | No cytopathic effects (grade 0) | 90G-0669 |
| MEM Cytotoxicity | Non-cytotoxic (grade 0) | 90G-0668 |
Bio Med Sciences has taken the following position relative to the use of the proposed materials:
-
- The Silon membrane material is the corneal contacting surface of the device, and therefore is the material of interest with respect to biocompatibility.
-
- In all biocompatibility tests conducted to date, the Silon membrane has never induced a negative biological response.
-
- The Silon membrane is presently used for woundcare applications wherein it is in direct contact with de-epithelialized tissue for up to 10 days.
-
- The device is only used intermittently for short periods, and therefore is not subject to more rigorous biocompatibility requirements.
-
- Although not in direct contact with the patient, the polyethylene ring and the opacifying agent are known to be generally regarded as safe and are both sterilizable by the EtO method.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 DEC
Mr. Mark E. Dillon President Bio Med Science, Inc. 101 Technology Drive Bethlehem, PA 18015
Re: K981665
Trade Name: Silcon® Topomat ™ Corneal Topography Image Enhancement Device Regulatory Class: I Product Code: 86 MMQ Dated: November 13, 1998 Received: November 18, 1998
Dear Mr. Dillon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Mark E. Dillon, President
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K981665
Device Name:
Silon® Topomat™ Corneal Topography Image Enhancement Device
Indications For Use:
For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.
Evelyn Horton Boone
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
® Registered Trademark, Bio Med Sciences, Inc.