(151 days)
Not Found
No
The device description focuses on the physical components and functionality of laser probes for vitreoretinal surgery, with no mention of AI or ML technologies.
Yes
The device is used to perform laser photocoagulation treatments, which is a therapeutic intervention to treat a medical condition.
No
The device is described as performing "end-ocular laser photocoagulation treatments," which are therapeutic procedures, not diagnostic ones. Its components support laser delivery and illumination for surgery, not for obtaining diagnostic information about a patient's condition.
No
The device description clearly outlines physical components such as fiberoptics, connectors, handles, stainless steel tubing, and protective sheaths, 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 use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments". This describes a surgical procedure performed directly on a patient's eye.
- Device Description: The device is a laser probe designed to deliver laser energy into the eye during surgery. It's a physical tool used for treatment.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens outside the body.
The device is clearly a surgical instrument used for therapeutic purposes within the body, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
Laser Probes and Illuminated Laser Probes: For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.
Product codes
HQF, HQB, MPA
Device Description
The laser probes are cables made out of one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates into the surgical site, and protective sheath over the fiber.
The illuminated laser probes (referred to also as "laser/illumination probes") are cables made out of two fiberoptics (one for laser and one for illumination), one laser connector, one illumination connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle, and protective sheath over both fiberoptics.
On one side, the distal side, the fiberoptic is terminated by a connector that attaches to the machine, be it laser or illumination. On the other side, it is terminated by a stainless steel tubing which penetrates into the eye, and may be 20g, 23g, or 25g in size in case of laser probes, or 20g in case of laser/illumination probes.
The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm. The fiber for illumination is made out of either glass or plastic. The tubing is provided in two shapes, referred to as straight or curved. The configuration is chosen based on the surgeon requirements. The total length of the device is 10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1 foot, while both branches run for 9 feet with each branch having its own protective sheath and each branch ending with its own connector. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endo-ocular
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)
Bench testing performed on this device and compared to the predicate indicates that the Katalyst Illuminated Laser Probes and Laser Probes are substantially equivalent to predicate devices. Bench testing of the Katalyst Illuminated Laser Probes and Laser Probes was performed in accordance with FDA Guidance on the Content and Organization for a Medical Laser. Biocompatibility testing was performed in accordance with ISO 10993. Sterilization development, validation, and control were performed in accordance with ISO 11135-1. Product shelf-life was established in accordance with ASTM Standard #F 1980-09 (2011) and packaging integrity was established in accordance with ASTM F 1929-04 and ASTM F88/F88M-09. Optical radiation safety testing was performed in accordance with ISO 15752 and ISO 15004-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K1211B7
SEP 17 2012
510(k) Summary 5
| Manufacturer: | Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield, MO 63005
636-399-0109 (phone)
636-787-0603 (fax) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michelle McDonough
Associate, Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisers, LLC
202-552-5800 (phone)
202-552-5798 (fax)
mmcdonough@mcra.com |
| Date Prepared: | July 16, 2012 |
| Device Trade Name: | Katalyst Laser Probes & Illuminated Laser Probes |
| Common Name: | Ophthalmic Laser |
| Classification: | 21 CFR 886.4390; Ophthalmic Laser |
| Class: | II |
| Product Code: | HQF, HQB, MPA |
Indications For Use:
Laser Probes and Illuminated Laser Probes:
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.
Device Description:
The laser probes are cables made out of one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates into the surgical site, and protective sheath over the fiber.
The illuminated laser probes (referred to also as "laser/illumination probes") are cables made out of two fiberoptics (one for laser and one for illumination), one laser connector, one illumination connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle, and protective sheath over both fiberoptics.
1
On one side, the distal side, the fiberoptic is terminated by a connector that attaches to the machine, be it laser or illumination. On the other side, it is terminated by a stainless steel tubing which penetrates into the eye, and may be 20g, 23g, or 25g in size in case of laser probes, or 20g in case of laser/illumination probes.
KIZIJBT
The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm. The fiber for illumination is made out of either glass or plastic. The tubing is provided in two shapes, referred to as straight or curved. The configuration is chosen based on the surgeon requirements. The total length of the device is 10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1 foot, while both branches run for 9 feet with each branch having its own protective sheath and each branch ending with its own connector. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
Predicate Devices:
The Katalyst Illuminated Laser Probe was shown to be substantially equivalent to the previously cleared devices (K050807 and K021696).
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Substantial Equivalence:
SUMMARY OF EVALUATION
12/18
Bench testing performed on this device and compared to the predicate indicates that the Katalyst Illuminated Laser Probes and Laser Probes are substantially equivalent to predicate devices. Bench testing of the Katalyst Illuminated Laser Probes and Laser Probes was performed in accordance with FDA Guidance on the Content and Organization for a Medical Laser. Biocompatibility testing was performed in accordance with ISO 10993. Sterilization development, validation, and control were performed in accordance with ISO 11135-1. Product shelf-life was established in accordance with ASTM Standard #F 1980-09 (2011) and packaging integrity was established in accordance with ASTM F 1929-04 and ASTM F88/F88M-09. Optical radiation safety testing was performed in accordance with ISO 15752 and ISO 15004-2.
| FDA File Reference No. | 510(k) No. K021696 for Laser | 510(k) No. K050807 for Illumination |
|---|---|---|
| TECHNOLOGICAL CHARACTERISTICS | Comparison Result | Comparison Result |
| 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 | Similar | Similar |
| Compatibility with Environment and Other Devices | Identical | Identical |
| Where Used | Identical | Identical |
| Standards Met | Identical | Identical |
| Electrical Safety | Identical (not applicable) | Identical (not applicable) |
| Thermal Safety | Identical (not applicable) | Identical (not applicable) |
| Radiation Safety | Identical (not applicable) | Identical (not applicable) |
SUMMARY OF EQUIVALENCE
Design: The tip configuration is straight for the predicate devices and the tip configuration may be straight or curved for the Katalyst Laser and Illuminated Laser Probes ("Probes"). The difference in design between the curved tips of the Probes and the straight tips of the predicate devices does not affect the safety or effectiveness of the Probes when used as indicated.
The only difference between the straight tip predicate device and the curved tip Probe is that the curved tip Probe may aim the distal end of an optical fiber in a curved direction
3
within the inner eye and the straight tip predicate device may aim the distal end of an optical fiber in a straight direction within the inner eye. Compared to the straight tip predicate device, the curved tip Probe: (1) does not allow a surgeon to aim the distal end of an optical fiber at different tissues or types of targets within the inner eye; (2) does not allow a surgeon to perform a different surgical procedure; and (3) does not change the manner that a surgeon may perform a surgical procedure. There is no difference in safety or effectiveness of the straight tip predicate device and the curved tip Probe.
The curved tips of the Probes do not present any inherent safety risk that is not also inherent in a straight tip of the predicate devices. The interface between the device connectors and the illumination or laser machine connectors is identical for Probes with curved tips and predicate devices with straight tips. The optical properties of optical fibers in straight tips of the predicate devices are identical to the optical properties of optical fibers in curved tips of the Probes.
The 510(k) presented the design of the curved tube used for Probes with curved tips and the design of the straight tube used for Probes with straight tips. The straight tubes and the curved tubes are: manufactured from the same material, manufactured with the same inner and outer dimensions, and manufactured at the same overall length. The only between the curved tube and the straight tubes is that the distal end of the curved tubes extends 1.3 inches from the tube proximal end and the distal end of the straight tubes extends 1.4 inches from the tube proximal end. This difference in length is a result of the curved tube being curved, i.e., if a curved tube would be mechanically straightened then the distal end of that straightened tube would extend 1.4 inches from the tube proximal end. This difference does not affect the safety or effectiveness of the Probes.
Energy Used and/or Delivered: The operating range is similar but not identical to the predicate devices. The operating range of the Katalyst Laser and Illuminated Laser Probes ("Probes") is wavelengths of 500 nm to 900 nm. The operating range of the predicate devices is wavelengths of 500 nm to 1100 nm. The difference between the upper limit of operating wavelength of the Probes and the upper limit of operating wavelength of the predicate devices does not affect the safety or effectiveness of the Probes because the upper limit of the wavelength operating range of the Probes falls within the wavelength operating range of the predicate devices.
Conclusion
The Katalyst Illuminated Laser Probes and Laser 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 17 2012
Katalyst Surgical, LLC c/o Ms. Michelle McDonough Associate, Regulatory Affairs 1331 H St NW, 12th Floor Washington, DC 20005
Re: K121187
Trade/Device Name: Katalyst Laser and Illuminated Laser Probes Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HQF, HQB, MPA Dated: August 31, 2012 Received: September 5, 2012
Dear Ms. McDonough:
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
5
Page 2 - Ms. Michelle McDonough
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.
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Sincerely yours,
Kesia Alexander
Malvina B. Evdelman, 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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Katalyst Surgical, LLC Katalyst Laser and Illuminated Laser Probes Traditional 510(k)
Indications for Use 4
510(k) Number (if known): K/21/87
Device Name: Katalyst Laser Probes and Illuminated Laser Probes
Laser Probes and Illuminated Laser Probes:
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.
Prescription Use ﯿﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cl.C.C.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K121187
510(k) Number