The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Device Description

The WaveLight® FS200 Patient Interface 1505 is a patient contact consumable (disposable) consisting of a Tubing System with integrated Suction Ring and an Applanation Cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

AI/ML Overview

The provided 510(k) summary for the WaveLight® FS200 Patient Interface 1505 describes a device that is essentially a consumable component (patient interface) for an existing laser surgical system (WaveLight® FS200 Laser System). The focus of the submission is to demonstrate substantial equivalence to a predicate device (WaveLight® FS200 Patient Interface 1504), rather than proving the performance of a novel diagnostic or therapeutic algorithm.

Therefore, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this submission. This device does not involve an AI algorithm, a diagnostic output, or a performance metric like accuracy that would require human expert adjudication of ground truth or a comparative effectiveness study with human readers.

Instead, the acceptance criteria and supporting studies for this device relate to its safety and functional equivalence as a consumable physical component.

Here's a breakdown based on the provided text, addressing the points where applicable and explaining why others are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance/Conclusion
Biocompatibility	Compliance with ISO 10993 standards.	Passed: "Biocompatibility evaluations... have been performed against the applicable ISO 10993 standards." Laser exposure test (ISO 11979-5:2006) also performed.
Sterility	Achievement of 10⁻⁶ SAL (sterility assurance level).	Passed: "The EtO sterilization cycle has been validated per the FDA Recognized Consensus Standard - 'AAMJISO 11135: 2007'... validated to achieve a 10⁻⁶ SAL." (Provided sterile; single use only).
Packaging & Shelf-life	Compliance with ISO 11607-1:2006.	Passed: "Packaging and shelf-life have been validated according to the FDA Recognized Consensus Standard 'ISO 11607-1: 2006'."
Function & Performance	Equivalence to predicate device in flap cutting results.	Passed: "Flap cutting tests demonstrate that the performance of the WaveLight® FS200 Patient Interface 1505 is equivalent to the one of the predicate device." (Performed after sterilization, transportation, and aging). Compliance with FDA Guidance for Keratomes.
System Validation	Compliance with 21 CFR 820 and ISO 14971:2007 (risk management).	Passed: "The use of the WaveLight® FS200 Patient Interface 1505 with the WaveLight® FS200 Laser system has been validated at the system level." Developed/manufactured per 21 CFR 820 and ISO 14971:2007.
Technological Equivalence	Identical tubing system, one-piece molded plastic applanation cone (vs. aluminum/glass of predicate).	Concluded: "The technological characteristics... are equivalent to those of the predicate device." (Main difference is the applanation cone material, which was supported by the functional and performance tests).

2. Sample size used for the test set and the data provenance

Biocompatibility: No specific sample size provided, but tests were "evaluations of materials coming into contact with the patient or fluid path."
Sterility: Validated for the "product." No specific sample size mentioned, but validation typically involves multiple batches/units for statistical confidence.
Packaging & Shelf-life: Validated for the "product." No specific sample size mentioned.
Function and Performance (Flap cutting tests): No specific sample size (number of cuts or units tested) is provided in the summary. Data provenance is implied to be laboratory testing conducted by the manufacturer, not patient data from a specific country or retrospective/prospective collection.

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

Not Applicable. This device is a physical consumable component for a surgical laser, not a diagnostic or AI-powered device requiring expert-established ground truth. The "ground truth" here is objective physical and chemical properties and functional equivalence to the predicate device.

4. Adjudication method for the test set

Not Applicable. As this is not a diagnostic device requiring interpretation, no adjudication method (e.g., 2+1, 3+1) was used. Testing relies on objective measurements and established standards.

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

No. An MRMC study is not relevant as this device is a physical consumable for a surgical laser, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting output.

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

Not Applicable. This device does not contain an algorithm or AI component; it is a passive, sterile, disposable physical interface.

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

Objective Measurements and Predicate Equivalence: The "ground truth" for this device's performance relies on:
- Compliance with recognized international standards (ISO 10993 for biocompatibility, AAMJ/ISO 11135 for sterility, ISO 11607-1 for packaging) which define acceptable limits for parameters.
- Functional comparison to the legally marketed predicate device (WaveLight® FS200 Patient Interface 1504) for "flap cutting results," demonstrating equivalence rather than an absolute ideal "ground truth."
- System validation against internal development and risk management procedures (21 CFR 820, ISO 14971).

8. The sample size for the training set

Not Applicable. This product does not involve an AI/ML algorithm that requires a training set.

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

Not Applicable. This product does not involve an AI/ML algorithm that requires a training set or its associated ground truth establishment.

In summary, this 510(k) submission successfully demonstrated substantial equivalence of a consumable device based on rigorous non-clinical testing (biocompatibility, sterility, packaging, functional performance, and system validation) against established standards and direct comparison to a predicate device, rather than patient-level clinical performance data or AI algorithm validation.

Summary

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K121031

క్. 510(k) Summary

This summary document is being prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76132 Phone: (817) 551-8975 Fax: (817) 551-4630

Device Subject to this 510(k):

Trade Name:	WaveLight® FS200 Patient Interface 1505
Common Name:	Sterile Consumable (disposable)
Classification Name:	Consumable for use with a Powered Laser Surgical Instrument (per 21 CFR 878.4810)

5.1 Predicate Device

The legally marketed device to which we are claiming equivalence to is:

510(k) Number Device

K101006

WaveLight®FS200 Patient Interface 1504 (Consumable cleared with the WaveLight® FS200 Laser System )

5.2 Device Description

5.3 Indications for Use

The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

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Statement of how the Technological Characteristics of the Device compare to 5.4 those of the Predicate or legally marketed Device

The technological characteristics of the WaveLight® FS200 Patient Interface 1505 are equivalent to those of the predicate device. The WaveLight® FS200 Patient Interface 1505 and the predicate device WaveLight® FS200 Patient Interface 1504 are alternative consumables for use with the WaveLight® FS200 Laser System. They both consist of a Tubing System with integrated Suction Ring and an Applanation Cone.

The Tubing System with integrated Suction Ring used in the WaveLight® FS200 Patient Interface 1505 is identical to the one used in the predicate device. The main difference between the WaveLight® FS200 Patient Interface 1505 and the predicate device is the Applanation Cone.

The Applanation Cone of the predicate device consists of an aluminum cone with a bonded glass plate. The Applanation Cone of the WaveLight® FS200 Patient Interface 1505 is a one piece molded plastic cone.

ર. ર Brief Summary of Nonclinical test and Results

5.5.1 Biocompatibility

Biocompatibility evaluations of materials coming into contact with the patient or fluid path have been performed against the applicable ISO 10993 standards, taking into account the FDA Guidance "Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. In addition, a laser exposure test designed in analogy to the laser treatment of intraocular lenses has been performed per the FDA Recognized Consensus Standard - "ISO 11979-5:2006: Ophthalmic Implants - Intraocular lenses - Part 5: Biocompatibility".

5.5.2 Sterility

The WaveLight® FS200 Patient Interface 1505 is provided sterile and intended for single use only. The product is EtO sterilized. The EtO sterilization cycle has been validated per the FDA Recognized Consensus Standard - "AAMJISO 11135: 2007: Medical devices -Validation and Routine Control of Ethylene Oxide Sterilization". The sterilization process for the WaveLight® FS200 Patient Interface 1505 has been validated to achieve a 10° SAL (sterility assurance level).

5.5.3 Packaging and shelf-life

Packaging and shelf-life have been validated according to the FDA Recognized Consensus Standard " ISO 11607-1: 2006: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems."

5.5.4 Function and Performance

Functional tests test were performed after sterilization, transportation and aging (realtime and accelerated).

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Performance tests according to the FDA Guidance for Industry and FDA staff "Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions", were conducted for direct comparison of the cutting results with the predicate device. These Flap cutting tests demonstrate that the performance of the WaveLight® FS200 Patient Interface 1505 is equivalent to the one of the predicate device.

5.5.5 System validation

The WaveLight® FS200 Patient Interface 1505 has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971: 2007: "Medical devices - Application of risk management to medical devices". Accordingly, the use of the WaveLight® FS200 Patient Interface 1505 with the WaveLight® FS200 Laser system has been validated at the system level.

5.6 Conclusion

Non-clinical testing noted above has demonstrated that the technological characteristics affecting clinical performance of the WaveLight® FS200 Patient Interface 1505 are equivalent to those of the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES .

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another person, represented by three curved lines.

Public Health Service

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

JUN 2 1 2012

Alcon Research, Ltd. c/o Mr. Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134

Re: K121031

Trade/Device Name: WaveLight® FS200 Patient Interface 1505 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, HNO Dated: May 11, 2012 Received: May 14, 2012

Dear Mr. Buenger:

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

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Page 2 - Mr. Michael Buenger

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4.

510(k) Number (unknown): バノ2/03 /

Device Name: WaveLight® FS200 Patient Interface 1505

Indications for Use:

The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluationy(ODE)

CLCC
(Division Sign-Off)

(Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121031

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.