(219 days)
No
The device description focuses on the physical components and function of a disposable laser probe for vitreoretinal surgery, with no mention of AI or ML capabilities.
Yes
The device is intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments, which are medical procedures designed to treat or alleviate a disease or condition.
No
The device is described as an ophthalmic instrument used for "endo-ocular laser photocoagulation treatments" and to "guide the laser energy to the intended surgical site to provide photocoagulation treatment." It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components such as optical laser connectors, glass fiber optics, protective sheaths, handles, and metal tubing. It is a physical instrument used in surgery, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endo-ocular laser photocoagulation treatments" and "illumination during ophthalmic surgery." These are surgical procedures performed directly on the patient's eye.
- Device Description: The device is described as an "ophthalmic instrument" used in "posterior segment eye surgery." It is introduced into the eye to deliver laser energy or provide illumination.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) outside of the body to provide diagnostic information. IVDs are designed for testing samples in vitro.
The device is clearly intended for therapeutic and procedural use within the body during surgery, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.
The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.
Product codes (comma separated list FDA assigned to the subject device)
HQB, HQF, MPA
Device Description
The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application.
The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery.
The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip.
To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens.
The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for single-use only.
The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm.
For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application.
The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available.
The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment eye, vitreo-retinal
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)
Performance Testing Summary:
The VitreQ Disposable Laser Probes, Light Fibers and Chandelier have been tested to meet the product requirements and requirements from (safety) standards. Verification covers performance testing and human factors testing.
Differences in performance (related to laser only):
The laser power output value of the VitreQ device and the predicate device are identical. The VitreQ device has more strict tolerances than the predicate device.
Differences in performance (related to illumination only):
VitreQ has tested Light Hazard Protection according to the FDA recognized standard ANSI Z80.36-2016. The predicate device delivers information in the Instructions for Use according the standard ISO 15004-2, which is no longer FDA recognized. Information to the user is provided according to standard ANSI Z80.36-2016.
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.
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
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Vitreq B.V. % Genci Omari, Official Correspondent Beaver-Visitec International, Inc. 500 Totten Pond Rd - 10 CityPoint Waltham, Massachusetts 02451
Re: K182646
Trade/Device Name: Vitreq disposable laser probes, light fibers and Chandelier Regulation Number: 21 CFR 886.4690 Regulation Name: Ophthalmic Photocoagulator Regulatory Class: Class II Product Code: HQB, HQF, MPA Dated: March 18, 2019 Received: March 22, 2019
Dear Denise Kelly:
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.
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
1
801); medical device 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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182646
Device Name
VitreQ Disposable Laser Probes, 90° Directional Laser Probes, 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier.
Indications for Use (Describe)
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.
The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary VitreQ Disposable Laser Probes, Light Fibers and Chandelier
Submitter of 510(k):
| Company name: | VitreQ B.V. |
|---|---|
| Registration number: | 3012037425 |
| Address | Seggelant-Noord 2, 3237 MG Vierpolders, The Netherlands |
| Phone: | +31 181 745090 |
| Fax: | +31 181 478583 |
| Correspondent: | JanKees Wouts |
| Email: | RA@vitreq.com |
Device Name:
| Device Trade Name: | VitreQ Disposable Laser Probes, 90° Directional Laser Probes and
(90°) Directional Illuminated Laser Probes
VitreQ Disposable Light Fibers, Standard Light Fibers, Wide View
Light Fibers, 45 Degree Shielded Light Fibers and Chandelier. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 886.4390 |
| Regulatory Name: | Ophthalmic Photocoagulator |
| Regulatory Class: | II |
| Product Code: | HOF, HQB, MPA |
Predicate Devices
Our device is substantially equivalent to the predicate device cited in the table below:
| 510(k) | Applicant | Device Name | Product Code | Claim |
|---|---|---|---|---|
| K121187 | Katalyst Surgical, LLC | Katalyst Laser Probes & Illuminated Laser Probes | HQF, HQB, MPA | Predicate Device (primary) |
| K151604 | Peregrine Surgical Ltd. | Peregrine 23 ga and 25 ga Adjustable Chandelier Illuminator | MPA | Predicate Device (secondary) |
Description
The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application.
The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery.
The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip.
To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens.
4
The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for singleuse only.
The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm.
For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application.
The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available.
The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.
Indications for Use:
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm. The (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700nm.
Summary of technological characteristics
Comparison of identifications for Use
The indications for use of the VitreQ Disposable Laser Probes, Light Fibers and Chandelier are identical to the indications for use of the predicate devices.
The subject device and primary predicate device are both intended for use in vitreoretinal surgery to perform endo-ocular laser photocoaqulation treatments at operating wavelengths of 500nm to 900nm.
Although the secondary predicate device is only used to support similar technology. Both, the subject device and secondary predicate device, are for illumination during ophthalmic surgery. The subject device is more specification of the wavelengths.
Comparison of device characteristics
The table below shows the substantial equivalence with regards to the characteristics of the subject device and predicate device.
| Characteristics | Subject Device | Predicate Device (primary) | Predicate Device (secondary) | SE Discussion | ||
|---|---|---|---|---|---|---|
| Directional Laser Probes | Illuminated Laser Probes | Light Fibers & Chandelier | ||||
| Laser Probe | Nitinol | Not applicable | Nitinol | Not applicable | Not applicable | |
| Laser Optical Fiber | Glass | Not applicable | Glass | Not applicable | Not applicable | |
| Characteristics | Subject Device | Predicate Device (primary) | Predicate Device (secondary) | SE Discussion | ||
| Directional Laser Probes | Illuminated Laser Probes | Light Fibers & Chandelier | K121187 Laser Probes & Illuminated Laser Probes | K151604 23 ga and 25 ga Adjustable Chandelier Illuminator | ||
| Illumination Fiber | Not applicable | PMMA Fluorinated Polymer Cladding | PMMA Fluorinated Polymer Cladding | PMMA Fluorinated Polymer Cladding | Not applicable | |
| Handpiece | ABS | PMMA Fluorinated Polymer Cladding | 3D-printed Nylon | Acetal | Substantial Equivalent. Vitreq handpiece is made of ABS, it concerns a part which is not in contact with the patient | |
| Laser Jacket | Thermoplastic rubber | Not applicable | Elastomer | Not applicable | Substantial Equivalent. Vitreo jacket is made from thermoplastic rubber, it concerns a part which is not in contact with the patient | |
| Light jacket | Not applicable | LDPE/EVA/ PVC | Unknown | PTFE | Substantial Equivalent. Vitreo jacket is made from EVA/PVC/LDPE, it concerns a part which is not in contact with the patient | |
| Needle | Not applicable | Stainless Steel / MP35N | Not applicable | Stainless Steel | Substantial Equivalent. Vitreq needle is made from Stainless Steel/ MP35N, it is biocompatible. See Tab 15. | |
| Laser connector | Nickel plated brass Stainless Steel | Not applicable | Nickel plated brass Stainless Steel | Not applicable | Not applicable | |
| Light connector | Not applicable | Stainless Steel | Unknown | Acetal with Stainless Steel | Substantial Equivalent. VitreQ connector is from stainless steel only, it concerns a part which is not in contact with the patient | |
| Laser Type | Solid state diode | Not applicable | Solid state diode | Not applicable | Not applicable | |
| Laser Wavelength | 500nm to 900nm | Not applicable | 500nm to 900nm | Not applicable | Not applicable | |
| Max Threshold of Laser Fiber | 3 Watt | Not applicable | 3 Watt | Not applicable | Not applicable | |
| Transmission of Treatment Laser | 99.8% | Not applicable | 99.6% | Not applicable | Substantial Equivalent. The difference between predicate and subject device are negligible. See Tab 18. | |
| Laser Power Efficiency | 0.998 | Not applicable | 0.996 | Not applicable | Substantial Equivalent. The difference between predicate and subject device are negligible. | |
| Laser Output Power | $500 \pm 15%$ mW | Not applicable | $500 \pm 20%$ mW | Not applicable | Substantial Equivalent. The Vitreq device has mor strict tolerances than the predicate device. | |
| Laser Size | NA value between 0.1 and 0.2 | Not applicable | NA value between 0.1 and 0.2 | Not applicable | Not applicable. Bench testing is performed see Tab 18 | |
| Light Type | Not applicable | LED, Xenon or Mercury | Xenon or Mercury | Xenon or Mercury | Substantial Equivalent. Vitreq also tested the LED, | |
| Characteristics | Subject Device | Predicate | ||||
| Device | ||||||
| (primary) | Predicate | |||||
| Device | ||||||
| (secondary) | SE Discussion | |||||
| Directional | ||||||
| Laser Probes | Illuminated | |||||
| Laser Probes | Light Fibers & | |||||
| Chandelier | K121187 | |||||
| Laser Probes & | ||||||
| Illuminated Laser | ||||||
| Probes | K151604 | |||||
| 23 ga and | ||||||
| 25 ga | ||||||
| Adjustable | ||||||
| Chandelier | ||||||
| Illuminator | ||||||
| art technology. The values | ||||||
| Xenon and LED are | ||||||
| substantial equivalent. | ||||||
| Bench testing is performed | ||||||
| see Tab 18. | ||||||
| Wavelength | Not | |||||
| applicable | 425nm to 700nm | 425nm to 700nm | 425nm to 700nm | Not applicable | ||
| Transmission of | ||||||
| Illumination Light | Not | |||||
| applicable | 12.5 % | 39% | Unknown | 39% | Identical, transmission of | |
| illuminated laser probes is | ||||||
| less than light fibers/ | ||||||
| chandeliers |
5
K182646
6
Substantial Equivalence Discussion
The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm. The (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700nm.
The VitreQ Disposable Laser Probes, Light Fibers and Chandelier make use of the same principle of operation, which is transmission of radiation energy through a fiber based on the principle of total reflection within a multimode fiber (consisting of a core and cladding).
The differences in technological characteristics are accompanied by information that demonstrates that the device is as safe and effective as the predicate device.
Design Differences:
The VitreQ Directional Laser probes have a different tip design same surgical result will be achieved.
The VitreQ light fibers have a different tip design, which decrease the hazard of phototoxicity, which is confirmed by test results according to standard ANSI Z80.36.
There are differences in available product sizes between the subject and predicate device, this is not related to safety and efficacy.
The subject and predicate device have a different handle design. Both solutions are considered equivalent to initiate movement of the tip. There are differences in shape and dimensions, which are considered related to the look and feel of the instrument.
The purpose of the jacket of the laser fiber and the optical fiber is identical. There are small differences in dimensions and material.
The lengths of the subject and predicate device are different, but the length of the device is not related to safety and effectiveness.
Reorientation of the subject and predicate device is based on a different principle. Providing a means to direct the device to the surgical site does not influence the safety and effectiveness but can improve performance and allow bimanual surgery to shorten the surgical intervention.
7
Differences in materials
The VitreQ handle, jackets (light and light connector have differences with regards to material, but these items are not a patient contact material.
Differences in performance (related to laser only)
The laser power output value of the VitreQ device and the predicate device are identical. The VitreQ device has more strict tolerances than the predicate device.
Differences in performance (related to illumination only)
VitreQ has tested Light Hazard Protection according to the FDA recognized standard ANSI Z80.36-2016. The predicate device delivers information in the Instructions for Use according the standard ISO 15004-2, which is no longer FDA recognized. Information to the user is provided according to standard ANSI Z80.36-2016.
Substantial Equivalence Conclusion
There are differences with regards to design, handle construction, materials, packaging, shelf life and labeling. These differences do not affect the similarity in principal technology. function and operational characteristics of the devices. As a result, it is determined that the Vitreq Disposable Laser Probes, Light Fibers and Chandelier is substantially equivalent to the predicate device.
Sterilization and shelf life
The Vitrea Disposable Laser Probes, Light Fibers and Chandelier have been successfully adopted to the validated Ethylene Oxide sterilization method. Sterilant residuals and bacterial endotoxins are kept below the allowable limits. A Shelf life study is performed to establish an expiration date of 5 years after sterilization.
Biocompatibilitv
The Vitrea Disposable Laser Probes. Light Fibers and Chandelier have been evaluated and tested for biological safety according to the standard ISO 10993-1 and the related FDA quidance for industry.
Performance Testing Summary
The VitreQ Disposable Laser Probes, Light Fibers and Chandelier have been tested to meet the product requirements and requirements from (safety) standards. Verification covers performance testing and human factors testing.
Conclusion
The VitreQ Disposable Laser Probes, Light Fibers and Chandelier were shown to be substantially equivalent to the predicate devices in intended use and fundamental technology and technological characteristics to the predicate devices.