WaveLight FS200 Patient Interface

K190392 · Alcon Laboratories, Inc. · GEX · Mar 26, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190392
• Device Name: WaveLight FS200 Patient Interface
• Applicant: Alcon Laboratories, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 26, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WaveLight FS200 Patient Interface 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Device Story

Sterile, single-use disposable consumable for WaveLight FS200 Laser System; consists of tubing system, integrated suction ring, and applanation cone. Cone bottom acts as applanation plate for patient cornea during laser surgery. Used in clinical ophthalmic settings by trained surgical staff. Device facilitates suction and corneal applanation required for laser operation. Benefits include safe, sterile interface for laser delivery. Differences from predicate include single-blister packaging and DEHP-free materials in tubing and filter housing.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1:2009. Sterilization validated per ISO 11135:2014 (SAL 10^-6). Packaging and shelf life validated per ISO 11607-1:2017 and ASTM F1980-16. Transport stability validated per ISO 11607-1:2017. Functional testing confirmed performance equivalence to predicate after sterilization, transportation, and aging.

Technological Characteristics

Consumable for powered laser surgical instrument. Components: tubing system, suction ring, applanation cone. Materials: DEHP-free plastics. Sterilization: Ethylene Oxide (EtO) per ISO 11135:2014. Packaging: Single-blister sterile barrier system per ISO 11607-1:2017. Shelf life: 3 years per ASTM F1980-16.

Indications for Use

Indicated for use with the WaveLight FS200 Laser System for ophthalmic surgical procedures. Patient population is consistent with the cleared indications for the WaveLight FS200 Laser System.

Regulatory Classification

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.

Predicate Devices

• WaveLight FS200 Patient Interface 1505 (K121031)

Submission Summary (Full Text)

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March 26, 2019

Alcon Laboratories, Inc. Ms. Ophelia Biggs Director, Global Regulatory Affairs Projects, Surgical Instrumentation 20511 Lake Forest Drive Lake Forest, CA 92630

Re: K190392

Trade/Device Name: WaveLight FS200 Patient Interface 1515 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, HNO Dated: February 28, 2019 Received: March 1, 2019

Dear Ms. Biggs:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

| Sincerely yours, | |
|------------------|--------------------------------------------|
| Alexander | 2019.03.26 |
| Beylin -S | 16:54:33 -04'00' |
| | 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) K190392

Device Name WaveLight FS200 Patient Interface 1515

#### Indications for Use (Describe)

The WaveLight FS200 Patient Interface 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K190392 510(k) Summary

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

# Administrative Information

510(k) Submitter:

Alcon Research, Ltd. (on behalf of Alcon Laboratories, Inc.) 20511 Lake Forest Drive Lake Forest, CA 92630 USA

## Contact Person:

Ophelia Biggs Director, Global Regulatory Affairs Projects, Surgical Instrumentation Alcon Research, Ltd. 20511 Lake Forest Drive Lake Forest, CA 92630 Phone: [phone] Email: ophelia.biggs(@alcon.com

## Date Prepared: November 1, 2018

## Subject Device of this Special 510(k):

| Trade/Proprietary Name: | WaveLight® FS200 Patient Interface 1515 |
|-------------------------|--------------------------------------------------------------------------------|
| Submitter: | Alcon Research, Ltd. |
| | 20511 Lake Forest Drive |
| | Lake Forest, CA 92630 USA |
| Common Name: | Sterile Consumable (disposable) |
| Classification Name: | Consumable for use with a powered laser surgical instrument (21 CFR 878.4810) |
| Device Classification: | II |
| FDA Panel: | General and Plastic Surgery / Ophthalmic |
| Product Code: | GEX/HNO |

Predicate Device:

| Trade/Proprietary Name: | WaveLight® FS200 Patient Interface 1505 |
|-------------------------|-----------------------------------------|
| 510(k) Number: | K121031 |

| Trade/Proprietary Name: | WaveLight® FS200 Patient Interface 150 |
|-------------------------|-----------------------------------------------------------------------------|
| 510(k) Number: | K121031 |
| FDA Clearance Date: | June 21, 2012 |
| Submitter: | Alcon Research, Ltd.<br>6201 South Freeway<br>Fort Worth, TX 76134-2099 USA |
| Common Name: | Sterile Consumable (disposable) |

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| Classification Name: | Consumable for use with a powered laser surgical instrument<br>(21 CFR 878.4810) |
|------------------------|----------------------------------------------------------------------------------|
| Device Classification: | II |
| FDA Panel: | General and Plastic Surgery / Ophthalmic |
| Product Code: | GEX/HNO |

## Device Description

The WaveLight® FS200 Patient Interface 1515 is a patient consumable (disposable) consisting of a tubing system with an integrated suction ring and an applanation cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

## Indications for Use

The WaveLight® FS200 Patient Interface 1515 is indicated to be used only with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

# Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate Device

The technological characteristics of the WaveLight® FS200 Patient Interface 1515 are equivalent to those of the predicate device. The WaveLight® FS200 Patient Interface 1515 and its predicate device, the WaveLight® FS200 Patient Interface 1505, 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 operating principles and mechanism of action are the same between subject and predicate devices. The dimensions are also the same. The main differences are in the primary packaging configuration, and in the type of material used for the tubing system and filter housing.

The predicate device is packaged using a double-blister packaging configuration, while the WaveLight® FS200 Patient Interface 1515 uses a single-blister packaging design. Compared to the predicate device, the WaveLight® FS200 Patient Interface 1515 now incorporates DEHP-free materials in its tubing system and filter housing.

# Brief Summary of Non-Clinical Tests and Results

## Biocompatibility

Biocompatibility evaluations of materials coming into contact with the patient or fluid path have been successfully performed against the applicable ISO 10993 standards, taking into account the FDA-recognized consensus standard ISO 10993-1:2009. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (Recognition number 2-220). The materials in the subject device do not introduce chemicals that raise biocompatibility concerns.

## Sterility

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The WaveLight® FS200 Patient Interface 1515 is provided sterile and is intended for single use only. The product is sterilized using ethylene oxide (EtO). The EtO sterilization cycle has been validated according to the FDA-recognized consensus standard ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Recognition number 14-452). The sterilization process for the WaveLight® FS200 Patient Interface 1515 has been validated to achieve a sterility assurance level (SAL) of 10-6.

#### Packaging and Shelf Life

Packaging and shelf life was successfully validated according to the FDA-recogmized consensus standards ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems [Including amendment 1 (2014)] and ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Recognition Number 14-497). The sterile barrier system is maintained during sterilization, distribution, and a shelf life of up to 3 years.

## Transport Stability

Transport stability was successfully validated according to the FDA-recognized consensus standard ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems [Including amendment 1 (2014)]. The sterile barrier system is maintained after subjecting the subject device to extreme transport challenge scenarios.

## Functional Testing

Functional tests were performed after sterilization, transportation, and aging (accelerated and realtime). Tests demonstrated that the performance of the WaveLight® FS200 Patient Interface 1515 is equivalent to that of the predicate device, the WaveLight® FS200 Patient Interface 1505.

## Conclusion

Non-clinical testing successfully demonstrated that the technological characteristics of the WaveLight® FS200 Patient Interface 1515 are substantially equivalent to those of the predicate device.