(215 days)
Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.
The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.
The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.
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 transmission is made out of either glass or plastic.
The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).
The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.
This document is a 510(k) summary for the Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes, and Revolver Illuminated Probes. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data as might be found in a PMA.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria is not explicitly present in the provided text in the typical format of a clinical trial report. The document describes bench testing and biocompatibility testing to support substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" as you've requested for an AI/device performance.
However, I can extract the relevant information and present it in a way that aligns with your request as much as possible, interpreting "acceptance criteria" as the performance specifications and "study" as the testing performed for substantial equivalence.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes
The provided document describes substantial equivalence testing for a medical device rather than a standalone performance study with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The "acceptance criteria" are implicitly met by demonstrating that the new device performs comparably to the predicate device and adheres to relevant standards. The "study" mentioned is primarily a series of bench tests and biocompatibility assessments designed to support this substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets (e.g., minimum sensitivity, maximum false positive rate) are not stated for a diagnostic or AI device, I will use the performance specifications and comparison to the predicate device as the "acceptance criteria" and "reported device performance," respectively.
| Characteristic Category | Implicit Acceptance Criteria (based on predicate equivalence & standards) | Reported Device Performance / Comparison to Predicate |
|---|---|---|
| Optical Fiber Type | Illumination: Plastic/Glass; Laser: Glass | Illumination: Plastic (350W capacity), Glass (314kW capacity); Laser: Glass (314kW capacity) |
| Input Power Capacity (Illumination) | Max Input Power Capacity >= Typical Max Machine Output | Plastic: 350 W (Max Input) vs. 28 mW (Typical Max Machine Output) - MEETS |
| Max Input Power Capacity >= Typical Machine Output Setting | Plastic: 350 W (Max Input) vs. 14 mW (Typical Machine Output Setting) - MEETS | |
| Input Power Capacity (Laser) | Max Input Power Capacity >= Typical Max Machine Output | Glass: 314 kW (Max Input) vs. 2.5 W (Typical Max Machine Output) - MEETS |
| Max Input Power Capacity >= Typical Machine Output Setting | Glass: 314 kW (Max Input) vs. 300 mW (Typical Machine Output Setting) - MEETS | |
| Light Transmission | Performance comparable to predicate device with no extra risk | Katalyst Surgical Probes: 26.3 Lumens (avg); Katalyst Revolver Illuminated Probes: 26.2 Lumens (avg); 0.38% Difference from predicate. - MEETS |
| Biocompatibility | Pass ISO 10993 for patient contact materials | Successfully determined to be biocompatible (by Toxikon, Inc.) - MEETS |
| Sterilization | ISO 11135-1 compliance | Performed in accordance with ISO 11135-1 - MEETS |
| Shelf-Life | Established in accordance with ASTM F1980-09 (2011) | Established in accordance with ASTM F1980-09 (2011) - MEETS |
| Packaging Integrity | Established in accordance with ASTM F1929-04 and ASTM F881F88M-09 | Established in accordance with ASTM F1929-04 and ASTM F881F88M-09 - MEETS |
| Optical Radiation Safety | ISO 15752 and ISO 15004-2 compliance | Performed in accordance with ISO 15752 and ISO 15004-2 - MEETS |
| Technological Characteristics | Identical or similar to predicate without affecting safety/effectiveness | All characteristics (Indications for Use, Materials, Performance, etc.) found Identical or Similar to predicate with no impact on safety/effectiveness. - MEETS |
| Device Design Variation | New tip configurations (straight, curved, flex-curved, steerable) and gauge sizes (20g, 23g, 27g) do not affect safety or effectiveness compared to predicate. | Demonstrated that the variations do not affect safety or effectiveness when used identically to the predicate. - MEETS |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of distinct devices tested for each performance characteristic. The testing appears to have been done on representative samples of the Katalyst Revolver Probes and predicate devices for comparison.
- Data Provenance: The data comes from bench testing performed by the manufacturer (Katalyst Surgical, LLC) and specialized labs (e.g., Toxikon, Inc. for biocompatibility). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission. No information about country of origin of the data beyond the name of the testing labs is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a surgical instrument (laser probe/illuminated probe), not a diagnostic AI device requiring expert-established ground truth. Therefore, this information is not applicable to this 510(k) submission. The performance testing focuses on physical and operational characteristics and comparison to a predicate, not diagnostic accuracy.
4. Adjudication method for the test set
- Not applicable as this is not a diagnostic device requiring expert adjudication of results. Performance is measured against physical specifications and direct comparison.
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
- Not applicable. This device is a surgical tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this type of device is primarily defined by engineering specifications, established industry standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate devices. For biocompatibility, the ground truth is defined by the requirements of ISO 10993.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Katalyst Surgical, LLC Ms. Meryl Koch Ouality Assurance and Regulatory Affairs Manager 754 Goddard Ave. Chesterfield, MO 63005
Re: K140362
Trade/Device Name: Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes
Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, HQB, MPA Dated: August 8, 2014 Received: August 15, 2014
Dear Ms. 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
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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,
Kesia Y. Alexander -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140362
Device Name
Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes
Indications for Use (Describe)
Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.
The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary (K140362)
| Manufacturer: | Katalyst Surgical, LLC754 Goddard AvenueChesterfield, MO 63005636-399-0109 (phone)636-787-0603 (fax) |
|---|---|
| Contact: | Meryl KochQuality Assurance and Regulatory Affairs Manager636-536-5950 (phone)636-787-0603 (fax)m.koch@katalystsurgical.com |
| Date Prepared: | February 9th, 2013 |
| Date Updated: | September 10th, 2014 |
| Device Trade Name: | Revolver Laser Probes, Revolver Illuminated Laser Probes& Revolver Illuminated Probes |
| Common Name: | (1) Ophthalmic photocoagulator, (2) Endoscope andaccessories, and (3) Ophthalmic laser (accessoryfor) |
| Classification: | (1) 21 CFR 886.4690; Ophthalmic photocoagulator, (2) 21CFR 876.1500; Endoscope and accessories, and (3) 21 CFR886.4390; Ophthalmic laser |
| Class: II | |
| Product Code: | HOF. HOB. and MPA |
Indications For Use:
Revolver Laser Probes, Revolver Illuminated Laser Probes, and Revolver Illuminated Probes:
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.
The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900nm. The Revolver assemblies containing illumination should be used with the light wavelength range of 425nm to 700nm.
Device Description:
The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.
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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 transmission is made out of either glass or plastic.
The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).
The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.
Predicate Devices:
The Katalyst Revolver Laser Probe, Revolver Illuminated Laser Probe and Illuminated Probe were shown to be substantially equivalent to the previously cleared devices K121187-Katalyst Laser Probe and Illuminated Laser Probe.
Performance Testing Summary:
The testing for The Revolver Probes was conducted in accordance to All testing was performed in accordance with Attachment C of FDA Guidance on the Content and Organization for a Medical Laser, specifically, the "Specifications to be used in Establishing the Substantial Equivalence" for accessories and other information, is summarized below:
The data presented in Table 6-1 is the output power ratings of illumination and laser surgical machines and the input power capacity of the optical fibers used in the Laser and Illuminated Laser Probes.
| Table 6-1: Power Specifications for Katalyst Laser and Illuminated Laser Probes | ||||||||
|---|---|---|---|---|---|---|---|---|
| Optical FiberType | TypicalMaximumMachineOutput | TypicalMachineOutputSetting | Optical FiberMaximum InputPower Capacity |
|---|---|---|---|
| Illumination | 28 mW | 14 mW | 350 W* |
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| Laser | 2.5 W | 300 mW | 314 kW |
|---|---|---|---|
| *Plastic optical fiber. |
Table 6-1A: Power Specifications for Glass Fiber
| Optical FiberType | TypicalMaximumMachineOutput | TypicalMachineOutputSetting | Optical FiberMaximum InputPower Capacity |
|---|---|---|---|
| Glass | 2.5 W | 300 mW | 314 kW |
Table 6-1B: Power Specifications for Plastic Fiber
| Optical FiberType | TypicalMaximumMachineOutput | TypicalMachineOutputSetting | Optical FiberMaximum InputPower Capacity |
|---|---|---|---|
| Plastic | 28 mW | 14 mW | 350 W |
Additionally, light transmission data was collected for the Katalyst Revolver Illuminated Laser Probes, Revolver Illuminated Probes and the predicate Illuminated Laser Probes.
The results show that the Katalyst Illuminated Probes will perform in the same manner and
| Light Output in Lumens(average) | % Difference | |
|---|---|---|
| Katalyst Surgical Probes | 26.3 | 0.38% |
| Katalyst RevolverIlluminated Probes | 26.2 |
efficacy as the predicate, thus causing no extra risk to the patient and/or the user.
Biocompatibility testing:
Biocompatibility testing was performed on the probes per ISO 10993. Testing was performed by Toxikon, Inc. The testing was conducted on the materials that are in contact with the patient, being the fibers (glass and plastic), and metal tubing, simulating the actual device. The testing successfully determined the Katalyst Revolver Probes to be biocompatible.
Substantial Equivalence:
Bench testing performed on this device and compared to the predicate indicates that the Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes and Revolver Illuminated Probes are substantially equivalent to predicate devices. Bench testing of the Katalyst Revolver Probes was performed in accordance with FDA Guidance on the Content and Organization for a Medical Laser. Biocompatibility testing was performed per 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
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1980-09 (2011) and packaging integrity was established in accordance with ASTM F 1929-04 and ASTM F881F88M-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
The technological characteristics are identical to the predicate device, in terms of the indication for use, target population, optical output, materials, performance, sterility, biocompatibility, anatomical sites, human factors, compatibility with environment and other devices. The electrical, thermal and radiation safety is identical, because it's not applicable to any of the devices.
The Revolver Probes design is similar to the predicate devices. The Revolver Probes comes four different gauges (20g, 23g, 25g, 27g) and four different tip configuration (i.e., straight, curved, flex-curved, and steerable). The tip configuration is straight or curved for the predicate devices. The difference in tip variations of the Katalyst Revolver Probes and the straight or curved tips of the predicate devices does not affect the safety or effectiveness of the Katalyst Revolver Probes when used as indicated. A surgeon may use any variation of the tip, straight. curved, flex-curved and steerable: in an identical manner; (2) to perform an identical surgical procedure; and (3) to achieve the same surgical result.
The predicate devices come in 20g, 23g, and 25ga in laser probes, and 20ga in Illuminated laser probes. Katalyst Revolver Probes come in 20ga, 23ga, and 27ga, for laser, illumination and laser illumination probes. The addition of the various gauge sizes does not affect the safety and effectiveness of the device. All the micron sizes are within the range of the pervious cleared predicate device.
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| Type | Material | Size(microns) |
|---|---|---|
| Laser | GlassSILICA/SILICA | 150-300 |
| Laser/Illumination(plastic illumination fibers) | GlassSILICA/SILICA | 150-300 |
| PlasticAcrylic | 100-500 | |
| Laser/Illumination(glass illumination fibers) | GlassSILICA/SILICA | 100-300 |
| GlassSILICA/SILICA | 100-500 |
Table 3-1: Materials and Sizing of Optical Fibers
| Gauge | Laser Fiber | Illumination Fiber | Laser illumination fiber | |||
|---|---|---|---|---|---|---|
| Core/ | Attenuation/ | Core/ | Attenuation/ | Core/ | Attenuation/ | |
| Cladding | transmission | Cladding | transmission | Cladding | transmission | |
| Diameter | Diameter | Diameter | ||||
| 20 ga | 200 µm ± 4 µm | See Below | 486 µm ± 6% | See Below | 390 µm ± 6% | See Below |
| 220 µm ± 4 µm | 14 µm ± 6% | 10 µm ± 6% | ||||
| 23 ga | 200 µm ± 4 µm | See Below | 240 µm ± 9% | See Below | 240 µm ± 9% | See Below |
| 220 µm ± 4 µm | 10 µm ± 9% | 10 µm ± 9% | ||||
| 25 ga | 150 µm ± 3 µm | See Below | 240 µm ± 9% | See Below | 190 µm ± 9% | See Below |
| 165 µm ± 3 µm | 10 µm ± 9% | 10 µm ± 9% | ||||
| 27 ga | 150 µm ± 3 µm | See Below | 240 µm ± 9% | See Below | 140 µm ± 9% | See Below |
| 165 µm ± 3 µm | 10 µm ± 9% | 10 µm ± 9% |
Image /page/7/Figure/4 description: The image is a graph titled "Typical Attenuation for Glass Fiber". The x-axis is labeled "Wavelength, nm" and ranges from 150 to 1250. The left y-axis is labeled "UV Attenuation, dB/m" and ranges from 0.0 to 2.5, while the right y-axis is labeled "VIS-IR Attenuation, dB/km" and ranges from 0 to 250. There are two curves on the graph, one blue and one red, representing the attenuation of UV and VIS-IR light, respectively.
Attenuation for Plastic Fiber (Katalyst Fiber is Optical Grade)
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Image /page/8/Figure/1 description: The image is a graph that shows the transmission loss in dB/m as a function of wavelength in nm. The x-axis represents the wavelength, ranging from 400 to 1100 nm, and is divided into three regions: Ultra Violet, Visible Band, and Infra-red. The y-axis represents the transmission loss, ranging from 0.1 to 30.0 dB/m. There are two curves on the graph, labeled "INDUSTRIAL" and "OPTICAL", which show the transmission loss for different materials.
Furthermore, the predicate devices are single-use devices. The revolver probes are assembled with single-use, and reusable components. Revolver probes comprise three components, handle, fiber and an adapter. The handle and adapter are reusable and are provided nonsterile. The replaceable fiber is a single-use component, and is provided sterile. This change from the predicate device does not have any impact on the safety and effectiveness of the device. The predicate devices and The Revolver Probes are intended as accessories to devices used to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam and to provide illumination during vitroretinal surgery. The Revolver Probes are substantially equivalent to the previously cleared devices.
Conclusion
The Katalyst Revolver 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.
§ 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.