The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

Device Description

The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.

The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.

The lenses are provided sterile for single use.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is for the Volk Disposable Contact Laser and Diagnostic Lens, a Class II medical device. It's a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to legally marketed predicate devices, rather than submitting a full-blown PMA (Premarket Approval) which would typically require extensive clinical trials.

The provided text focuses on demonstrating substantial equivalence, not on establishing specific performance criteria against a predefined standard for a novel device. As such, there is no detailed "acceptance criteria" table in the traditional sense of performance metrics because the device is a contact lens and its primary function is direct visualization, similar to existing devices.

However, based on the "Performance Data" section, we can infer the critical acceptance criteria and studies that were performed to support the device's safety and effectiveness for its intended use, leveraging its similarity to predicates.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Basis of Acceptance
Sterilization	Device must meet specified sterilization requirements to ensure safety for single-use, sterile application.	"Sterilization validation testing was performed, which demonstrated that the Volk Disposable Contact Laser and Diagnostic Lenses met the sterilization requirements specified in the validation protocol."	Validation against industry standards/pre-defined protocol for EO sterilization.
Shelf Life	Device must maintain intended performance and integrity over a specified storage period.	"Shelf life testing was performed, which confirmed a five (5) year shelf life."	Testing conducted to demonstrate stability and sterility over the 5-year period.
Biocompatibility	(Implicit, as it's a contact device) Material must be biocompatible for ophthalmic use.	Not explicitly detailed in "Performance Data" but inferred from extensive use of PMMA in predicate devices and general medical device requirements.	Use of PMMA, a widely accepted material for contact lenses, and substantial equivalence to predicates.
Optical Performance	(Implicit) Provide "excellent visualization of the ocular anatomical areas for the particular intended use."	"Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use."	Substantial equivalence to predicate visually-focused lenses, implying similar optical quality.
Design & Material	Designs for specific procedures (iridotomy, capsulotomy); material (PMMA)	Designs include Iridotomy Lens and Capsulotomy Lens; Contact Material is PMMA.	Comparison to predicate devices (K943125, K023221, K050623) confirms similar design principles and use of PMMA.
Indications for Use	For diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.	"The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities."	Identical to the indications for use of the predicate devices.

Regarding the study that proves the device meets the acceptance criteria, and further details as requested:

This submission is a 510(k) for a device claiming substantial equivalence, not a de novo or PMA where extensive clinical studies proving novel performance are typically required. Therefore, the "studies" mentioned are primarily validation testing to confirm specific aspects of the device's manufacturing and stability, rather than clinical trials assessing diagnostic accuracy or treatment efficacy compared to a gold standard.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the sterilization validation testing or the shelf-life testing. These would typically be determined by established standards for such validation (e.g., ISO standards for sterilization, statistical sampling for shelf-life).
The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing (Volk Optical Inc. in Mentor, Ohio, USA). These would be prospective validation studies designed to test the sterility and shelf life of the newly manufactured disposable lenses.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not mentioned. For sterilization and shelf-life testing, "ground truth" is established by laboratory measurements against defined specifications (e.g., microbial load reduction, chemical stability) rather than expert consensus on a diagnostic outcome.
For the optical performance, the "ground truth" and expertise would logically stem from the design and manufacturing capabilities of Volk, which has a long history in ophthalmic optics, and the clinical experience with their predicate devices. The statement "Each model lens is similar in design, but provide different optical elements to provide excellent visualization" suggests reliance on established optical design principles and potentially in-house optical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient outcomes requires reconciliation among multiple experts. The studies cited are laboratory-based validation tests (sterilization, shelf life) which rely on analytical measurements and adherence to protocols, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive optical lens, not an AI-powered diagnostic system. No MRMC study was performed or is relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical optical lens, not an algorithm or AI system. Its function inherently requires a human operator (the clinician) to use it for diagnosis or therapy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For sterilization validation: The ground truth is the absence of viable microorganisms to a specified sterility assurance level (SAL), measured by biological indicators and microbiological testing methods.
For shelf-life testing: The ground truth is the stability of the device's material properties, packaging integrity, and sterility over time, measured by physical, chemical, and microbiological tests at various time points.
For optical performance: The ground truth is (implicitly) the ability to provide "excellent visualization," which is assessed by design specifications and comparison to the known performance of predicate lenses.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI model.

Summary of the 510(k) Approach:

The core of this 510(k) submission relies on substantial equivalence to predicate devices that have been legally marketed. The performance data provided mainly addresses the differences between the proposed device and its predicates – specifically, the fact that the new lenses are disposable and sterile. Therefore, the critical acceptance criteria and studies focus on proving the safety and efficacy of these new features (sterility and stability over a shelf life) for a device that otherwise shares fundamental design and intended use with its predicates. No complex clinical trials or AI performance evaluations are presented because they are not required for this type of device and submission pathway.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2015

Volk Optical Inc. Ms. Meghan M. Leonard Quality and Regulatory Manager for Volk Optical Inc. 7893 Enterprise Drive Mentor, Ohio 44060

Re: K151961

Trade/Device Name: Volk Disposable Contact Laser and Diagnostic Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Lens, Contact, Polymethylmethacrylate (PMMA), Diagnostic Regulatory Class: Class II Product Code: HJK Dated: July 17, 2015 Received: July 20, 2015

Dear Ms. Leonard:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, M.D. 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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Indications for Use

510(k) Number (if known)

Device Name

Volk Disposable Contact Laser and Diagnostic Lens

Indications for Use (Describe)

The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Volk, a company that specializes in aspheric optics. The logo features the company name in a stylized font, with the tagline "the leader in aspheric optics" underneath. Below the logo is the text "A HALMA COMPANY", indicating that Volk is a subsidiary of Halma plc.

ATTACHMENT 6 510(K) SUMMARY

510(k) Owner

Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 Phone: (440) 942-6161 Contact: Meghan M. Leonard

Submission Correspondent

Meghan M. Leonard Ouality Assurance and Regulatory Affairs Manager Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 Phone: (440) 510-0745 Fax: (440) 510-0845 Email: meghan.leonard@volk.com

Date Prepared: July 15, 2015 (revised July 29, 2015)

Trade Name of Device

Volk Disposable Contact Laser and Diagnostic Lens

Common or Usual Name

Polymethylmethacrylate (PMMA) diagnostic contact lens

Classification Name and Regulation

Lens, Contact, Polymethylmethacrylate, Diagnostic 21 CFR 886.1385, HJK Ophthalmic Review Panel

Predicate Device

Quadraspheric Diagnostic Fundus Lens (K943125, Cleared on September 2, 1994)

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Image /page/4/Picture/0 description: The image shows the logo for Volk, a company that specializes in aspheric optics. The logo features the word "VOLK" in large, stylized blue letters, with the tagline "the leader in aspheric optics" underneath. Below the main logo is the text "A HALMA COMPANY", indicating that Volk is part of the Halma group of companies.

Device Description

The lenses are provided sterile for single use.

Intended Use / Indications for Use

The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

Substantial Equivalence

The family of Volk Disposable Contact Laser and Diagnostic Lenses are equivalent to other diagnostic contact lenses as described in 21 CFR Part 886.1385. The principal difference is the packaging and sterilization of the lenses within a sterile pouch. The device modification is being made as a result of a device improvement or enhancement.

The family of Volk Disposable Contact Laser and Diagnostic Lenses are substantially equivalent in design, material, classification, and intended use to the Volk Quadraspheric Fundus Lens (K943125) cleared on 9/2/1994, the Volk Contact Laser & Diagnostic Lenses (K023221) cleared on 10/11/2002, and the Volk Disposable Vitrectomy Lens (K050623) cleared on 5/28/2005, as seen in the chart below.

Comparison	Volk DisposableContact Laser andDiagnostic Lenses(currentapplication)	VolkQuadrasphericFundus Lens(K943125)	Contact Laser &Diagnostic Lenses(K023221)	Volk DisposableVitrectomy Lenses(K050623)
IndicatedUse	The Volk Single-Use Contact Laserand DiagnosticLenses (DirectContact) areindicated for use asdiagnostic lensesfor eye fundusexaminations anduse in the therapy ofintraocularabnormalities.	The device isindicated for use asa diagnostic contactlens for eye fundusexaminations anduse in the therapy ofintraocularabnormalities.	The device isindicated for use as adiagnostic contactlens for eye fundusexaminations anduse in the therapy ofintraocularabnormalities.	The devices areindicated for use asdiagnostic contactlenses for eyefundusexaminations anduse in the therapy ofintraocularabnormalities. Thedevices are sterile,single use,disposable lenssystems.

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Comparison	Volk DisposableContact Laser andDiagnostic Lenses(currentapplication)	VolkQuadrasphericFundus Lens(K943125)	Contact Laser &Diagnostic Lenses(K023221)	Volk DisposableVitrectomy Lenses(K050623)
Design	Various, includingdesigns foriridotomy andcapsulotomy.	Various, includingthe quadrasphericand other designsrepresenting a rangeof magnification andfield of view.	Various, includingdesigns foriridotomy,capsulotomy, andfundus.	Various designsinclude the flat, midfield, wide field,and 15°, 30°, and45° prisms.
ContactMaterial	PMMA	PMMA and glass	Thermosetpolyesterurethaneand glass	PMMA
Packaging	Single lenspackaged sterile insterilization pouch	Single lenspackaged in a non-sterilizable case	Single lens packagedin a non-sterilizablecase	Single lenspackaged sterile insterilization pouch
Sterility	EO Sterilized	Non-sterile	Non-sterile	EO Sterilized

Performance Data

Performance standards for diagnostic contact lenses have not been issued. However, sterilization validation testing was performed, which demonstrated that the Volk Disposable Contact Laser and Diagnostic Lenses met the sterilization requirements specified in the validation protocol. Additionally, shelf life testing was performed, which confirmed a five (5) year shelf life.

Regulation Number and Section

§ 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.