(86 days)
No
The summary describes a rigid gas permeable contact lens for correcting refractive errors and irregular corneal conditions. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies.
Yes
The device is indicated for managing irregular corneal conditions and correcting refractive errors, which are medical conditions, thereby providing therapeutic benefit.
No
Explanation: The device is a contact lens used for correction of refractive ametropia and management of irregular corneal conditions, not for diagnosing them. It corrects or manages existing conditions rather than identifying or characterizing diseases.
No
The device description clearly states it is a "rigid gas permeable contact lens," which is a physical hardware device, not 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 Dyna Intra-Limbal Lens is a rigid gas permeable contact lens. Its function is to correct vision by being placed directly on the cornea of the eye. It is a physical device used for optical correction and management of corneal conditions, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for the "correction of refractive ametropia" and "management of irregular corneal conditions." This is a therapeutic and corrective function, not a diagnostic one.
Therefore, the Dyna Intra-Limbal Lens falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts.
The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens.
The lens material attributes and lens parameters are found in the package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Clinical data presented of 20 patients randomly selected for various corneal conditions supports efficacy of the Dyna Intra-Limbal Lens.
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.
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
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
MAR 2 9 2002
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K020006
Applicant information:
March 26, 2002 Date Prepared:
Name: Address Lens Dynamics, Inc. 8600 W 14th Ave. Suite 2 Lakewood, CO 80215
Contact Person: Phone number:
Mr. Al Vaske (800) 228-2691
Reason for 510(k) submission:
New Indication
Device Information:
Device Classification:
Class II
Classification Name:
Classification #:
Trade Name:
Material Covered By:
Rigid gas permeable (hydrophobic) contact lens; Class II for daily Wear.
21 CFR 886.5916, Ophthalmic: 86 HQD
Dyna Intra-Limbal Lens
enflufocon A; approved, 510(k) K943177 hexafocon A; approved, 510(k) K000795
Predicate Device:
The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable lens is substantially equivalent to the Boston ES (enflufocon A) and Boston XO (hexafocon A) RGP contact lens, which were cleared in 510(k) Premarket Notifications K943177 and K000795 respectively.
1
Device Description:
The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts.
The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens.
The lens material attributes and lens parameters are found in the package insert.
Intended Use:
The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.
Description of Safety and Substantial Equivalence:
The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable lens will be manufactured according to specified process controls and standards as identified in ANSI standard Z80.20-1998, and a cGMP quality assurance program currently in place.
The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the Dyna Intra-Limbal Lens manufactured in either (entlufocon A) or (hexafocon A) rigid gas permeable lens material is equivalent to the predicate devices identified previously. Authorization letters from Polymer Technology allowing the FDA to access all of their pre clinical and clinical data for these materials are enclosed. Reference 510(k) K943177 and K000795 respectively.
Shelf Life ~ The Dyna Intra-Limbal Lens is a hydrophobic rigid gas permeable contact lens material with