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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria for the Dyna Intra-Limbal Lens. Instead, it relies on the concept of "substantial equivalence" to predicate devices (Boston ES and Boston XO RGP lenses) and the demonstration of efficacy through a small clinical study for its new indication.

Therefore, the "acceptance criteria" can be inferred as:

Safety profile equivalent to predicate devices.
Manufacturing adherence to specified standards (ANSI Z80.20-1998) and cGMP.
Clinical data supporting the efficacy of the new indication.

Since specific quantitative acceptance metrics are not provided, I cannot populate a table with "reported device performance" against them in the traditional sense. The document states:

Implicit Acceptance Criterion	Reported Device Performance
Safety Profile	Equivalent to predicate devices (Boston ES/XO RGP lenses) based on pre-clinical toxicology and manufacturing/chemistry data.
Manufacturing Standards	Manufactured according to ANSI Z80.20-1998 and cGMP quality assurance program.
Efficacy for New Indication	Supported by clinical data from 20 randomly selected patients with various corneal conditions.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 20 patients.
Data Provenance: The document does not specify the country of origin. It is a "clinical data presented" which implies a prospective study, though this is not explicitly stated. The nature of the device (contact lens) and the typical regulatory pathway for such devices often involve prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical data. It simply mentions "clinical data," implying a clinical trial where patient outcomes and observations by eye care professionals would serve as the basis for efficacy.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done or reported. The study described is a direct clinical evaluation of the device's performance in patients, not a comparison of human readers with and without AI assistance. The device itself is a contact lens, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a contact lens, not an AI algorithm. No standalone algorithm performance study was mentioned.

7. The Type of Ground Truth Used

The ground truth used for evaluating the efficacy of the Dyna Intra-Limbal Lens in the clinical study was likely patient outcomes and clinical observations by eye care professionals. This would include metrics like visual acuity improvements, comfort, fit, and successful management of irregular corneal conditions, as assessed by the prescribing and follow-up clinicians. The document refers to "efficacy of the Dyna Intra-Limbal Lens" supported by "clinical data."

8. The Sample Size for the Training Set

This question is not applicable. The Dyna Intra-Limbal Lens is a medical device (contact lens), not an AI algorithm that requires a training set. The "training" in this context would refer to the historical data and experience used to design the device, which is not quantified in terms of a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8. No ground truth for a "training set" of an AI algorithm was established. The "ground truth" for the device's design would stem from established ophthalmic knowledge, contact lens science, and the performance of predicate devices.

Summary

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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.

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Device Description:

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:

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 <1% water content. Based on the Premarket Notification Guidance document for Daily Wear Lenses, shelf-life studies are not required for clearance of the Dyna Intra-Limbal Lens.

Solution Compatibility ~ The lens care regimes approved by Polymer Technology will be followed in the Dyna Intra-Limbal labeling.

The sponsor concludes data presented supports substantial equivalence of the Dyna Intra-Limbal Lens to the predicate devices and meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above. The difference between the predicates devices and the Dyna Intra-Limbal Lens is the addition of a new indication for use. Clinical data presented of 20 patients randomly selected for various corneal conditions supports efficacy of the Dyna Intra-Limbal Lens.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2002

Lens Dynamics, Inc. c/o Al Vaske, President 8600 West 14th Ave., Suite 2 Lakewood, CO 80215

Re: K020006

Trade/Device Name: Dyna Intra-Limbal Lens Regulation Number: CFR 886.5916 Regulation Name: Daily Wear RGP Contact Lens Regulatory Class: Class II Product Code: HQD Dated: December 24, 2001 Received: January 2, 2002

Dear Mr. Vaske:

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.

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Page 2 - Al Vaske, President

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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INDICATIONS FOR USE STATEMENT

Device Name:

Dyna Intra-Limbal Lens

INDICATIONS FOR USE:

The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is i he Dyna Intra-Limbal Dells (Clincrool. of refractive ametropia (myopia, hyperopia and indicated for daily wear for the concection of remastry be prescribed in otherwise nonastigmatism) in apliatio and not-aphaxic privations in of irregular comeal conditions such diseased eyes that require a right contact tello for the management of the lens may be disinfected using a chemical disinfection system.

(PLEASE DO OT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norris. C. Brown, Ph.D.

Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

K020006 510(k) Number.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.