(175 days)
Not Found
No
The device description and performance studies focus on the physical components and substantial equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is intended for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process, a medical procedure used to treat a condition, which falls under the definition of a therapeutic device.
No
The device is described as a probe for transscleral cyclophotocoagulation (TSCPC) of the ciliary process, meaning it's used for treatment. There is no mention of it being used to detect, diagnose, monitor, or assess a medical condition.
No
The device description clearly outlines physical components such as a fiberoptic, laser machine connector, handle, clear tip, and protective sheath, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process" using an infrared laser. This is a therapeutic procedure performed directly on the patient's eye.
- Device Description: The description details a probe used to deliver laser energy to the ciliary process. This is a surgical/therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver energy for treatment, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
Product codes (comma separated list FDA assigned to the subject device)
LQJ, LOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ciliary process (eye)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Iridex G-Probe K143154
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.
0
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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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
754 Goddard Avenue
Chesterfield, MO 63005
636-399-0109 (phone)
636-787-0603 (fax) |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact: | Meryl Koch
Katalyst Surgical, LLC
636-536-5950 (phone)
636-787-0603(fax)
m.koch@katalystsurgical.com |
| 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.
4
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.