Katalyst Cyclophotocoagulation Probe

K163632 · Katalyst Surgical, LLC · LQJ · Jun 15, 2017 · Ophthalmic

Device Facts

• Record ID: K163632
• Device Name: Katalyst Cyclophotocoagulation Probe
• Applicant: Katalyst Surgical, LLC
• Product Code: LQJ · Ophthalmic
• Decision Date: Jun 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.

Device Story

Katalyst Cyclophotocoagulation Probe is a single-use, sterile fiberoptic device designed for ophthalmic surgery. It consists of a handle, a clear tip for eye placement, and a fiberoptic cable with a ball lens at the distal end. The device connects to an external infrared laser machine. During surgery, the physician places the probe tip on the patient's eye to deliver laser energy to the ciliary process. The device facilitates TSCPC, a procedure used to treat ocular conditions by reducing aqueous humor production. It is intended for use by trained ophthalmic surgeons in a clinical setting. The device is functionally identical to the predicate, utilizing the same optical delivery mechanism to achieve therapeutic outcomes.

Clinical Evidence

No clinical data. Substantial equivalence was established through bench testing, biocompatibility testing (ISO 10993-1, 10993-5, 10993-10), and sterilization validation (ISO 11135).

Technological Characteristics

Single-use fiberoptic probe; 7-foot length; ball lens tip. Materials are identical to predicate. Energy source: external infrared laser. Sterilization: Ethylene oxide (ISO 11135). Shelf life validated per ASTM F1980. No software or electronic components.

Indications for Use

Indicated for patients requiring Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process using an infrared laser.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• Iridex G-Probe (K143154)

Submission Summary (Full Text)

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

June 15, 2017

Katalyst Surgical, LLC Meryl Koch Quality Assurance and Regulatory Affairs Manager 754 Goddard Avenue Chesterfield, MO 63005

Re: K163632

Trade/Device Name: Katalyst Cyclophotocoagulation Probe Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: LQJ Dated: May 3, 2017 Received: May 9, 2017

Dear Meryl Koch:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 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 [phone] or [phone] or at its Internet address

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

Sincerely.

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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) K163632

Device Name Katalyst Cyclophotocoagulation Probe

Indications for Use (Describe)

Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.

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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# 510(k) Summary

| Manufacturer: | Katalyst Surgical, LLC<br>754 Goddard Avenue<br>Chesterfield, MO 63005<br>636-399-0109 (phone)<br>636-787-0603 (fax) |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact: | Meryl Koch<br>Katalyst Surgical, LLC<br>636-536-5950 (phone)<br>636-787-0603(fax)<br>[e-mail] |
| Date Prepared: | March 29th, 2017 |
| Device Trade Name: | Katalyst Cyclophotocoagulation Probe |
| Common Name: | Katalyst Cycloprobe |
| Classification: | 21 CFR886.4390; Lens, Surgical, Accessory, Ophthalmic Laser |
| Class: | II |
| Product Code: | LOJ |

# Indications for Use:

Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.

# Device Description:

The Cycloprobe is a single use device sold sterile.

The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber.

On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip.

The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.

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# Predicate Devices:

The Katalyst Cyclophotocoagulation Probe was shown to be substantially equivalent to the previously cleared device, Iridex G-Probe approved within 510k K143154.

# Substantial Equivalence:

Clinical Testing was not required to prove substantial equivalence. Bench testing performed between the candidate device and the predicate device indicates that the Katalyst Cyclophotocoagulation Probes are substantially equivalent to predicate devices.

The product required the following other tests which were completed successfully:

# Biocompatibility:

ISO 10993-1: 2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process

ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irrigation and Skin Sensitization

# Sterilization:

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

# Shelf Life:

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

| Device Name | Katalyst Cycloprobe | Iridex G-Probe |
|------------------------------|---------------------|----------------|
| Indications for Use | Identical | Identical |
| Target Population | Identical | Identical |
| Design | Similar | Similar |
| Optical Output | Identical | Identical |
| Materials | Identical | Identical |
| Performance | Identical | Identical |
| Sterility | Identical | Identical |
| Biocompatibility | Identical | Identical |
| Anatomical Sites | Identical | Identical |
| Human Factors | Identical | Identical |
| Energy Used and/or Delivered | Identical | Identical |

# Conclusion

The Katalyst Cyclophotocoagulation Probes were shown to be substantially equivalent to previously cleared devices with respect to intended use, indications for use, technological characteristics, performance characteristics, and biocompatibility.