Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 3, 2022 Vortex Surgical Inc Andrew Ritts Director of Regulatory Affairs 680 Crown Industrial Ct Ste F Chesterfield, MO 63005 Re: K220263 Trade/Device Name: Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers Regulation Number: 21 CFR 886.4690 Regulation Name: Ophthalmic Photocoagulator Regulatory Class: Class II Product Code: HOB. MPA Dated: September 26, 2022 Received: September 26, 2022 Dear Andrew Ritts: 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 {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220263 Device Name Laser Probe, Illuminated Laser Probe, Endoilluminator, and Chandelier Indications for Use (Describe) Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light. | .<br>- CARLES STATE CALIFLE COLOR COLLECT CLASS CLASS CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---| | | | | | | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Vortex Surgical, Inc. | | | | K220263 | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|--|---------| | Laser Probe, Illuminated Laser Probe, Endoilluminator, Chandelier | | | | | | <b>510(k) SUMMARY K220263</b> | | | | | | Submitted in accordance with the requirements of 21 CFR 807.92 | | | | | | Submitter name: | Vortex Surgical Inc | | | | | Address: | 680 Crown Industrial Court, Suite F<br>Chesterfield, MO 63005 | | | | | Telephone number: | 636-778-4350 | | | | | Contact person: | Andrew Ritts | | | | | Date: | 1-20-2022 | | | | | Name of device: | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical<br>Endoilluminators, Vortex Surgical Chandeliers | | | | | Common name: | Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers | | | | | Classification name: | Ophthalmic Photocoagulator | | | | | Regulatory class: | II | | | | | Product Codes: | HQB, MPA | | | | The primary predicate device for the Vortex Surgical Laser Probe, Illuminated Laser Probe, Endoilluminator, and Chandelier is described below: | Predicate Device/Trade Name: | MAXReach Laser Probe | |------------------------------|-------------------------| | Common Name: | Ophthalmic Laser | | Vortex Branded Name: | Direct Flex Laser Probe | | 510(k) Number: | K191846 | | Regulatory class: | II | | Product Codes: | HQB | | Regulation Number: | 21 CFR 886.4690 | | Manufactured by: | Vortex Surgical | # Device Description Vortex Surgical Illuminated Laser Probe is a sterile, single used for delivering laser endophotocoagulation with illumination into the posterior segment of the eye. Vortex Surgical Laser Probe is a sterile, single use medical device used for delivery laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made fiberoptic, one laser connector, one handle for surgeon manipulation, nitinol, PEEK, or stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. The MAXReach model device also contains a slide button allowing the surgeon to bend the nitinol, PEEK, or stainless steel tubing once inside the eye to direct output into the periphery of the eye. On the proximal end the fiberoptic is terminated by a connector that attaches to the distal side, the fiberoptic is terminated by nitinol, PEEK, or stainless steel tubing which penetrates the eye. The probe can be either 23ga, 25ga, or 27ga. The fiber for laser transmission is made from silica glass and is restricted for use with the wavelength of 500nm to 1100mm. In illuminated laser probes, the illumination fiber is made of PMMA. The total length of the device is 90 ± 6 inches. Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye. The endoilluminator is an illuminators made from one fiber optic cable, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and the protective sheath over the fiber. On the proximal side the fiberoptic is terminated by a connector that attaches to the illumination console. The endoilluminator utilizes a needle. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches. {4}------------------------------------------------ The chandelier is an illuminator made from one fiber optic cable and the protective sheath over the fiber. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches. # Intended Use Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100mm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light. Compared to the predicate the indication for use does not have the compatible laser source systems. This information is provided in the instructions for use section in the step for connecting to the laser source. Changing the location of the compatible laser source systems is not critical to the intended surgical use of the device and do not affect the safety and effectiveness when used as labeled. | | Subject Device Vortex Surgical Laser Probe | Predicate Vortex MAXReach<br>K191846 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Laser<br>Compatibility | Alcon Constellation/Pure Point Lasers, Iridex GL<br>Laser, Ellex Solitaire Laser, and DORC EVA | Alcon Constellation/Pure Point Lasers, Iridex GL<br>Laser, and Ellex Solitaire Laser | | Illumination<br>Compatibility | DORC EVA, B&L Stellaris, Alcon Constellation | None | | Classification | II | II | | Product Code | HQB | HQB | | Regulation | 886.4690 | 886.4690 | | Optical Fiber | Silica Glass optical fiber | Silica Glass optical fiber | | Distal End | 23ga, 25ga, or 27ga made from Nitinol, PEEK, or 304 Stainless Steel | 23ga or 25ga made from Nitinol, PEEK, or 304 Stainless Steel | | Jacketing | PVC | PVC | | Connector | 905 SMA | 905 SMA | | Main Components | Needle, Handle, Gauge Indicator, Fiber Cable 11,<br>Connector 11, Snap Button2, Front Needle3, Fiber<br>Cable 24, Connector 24 | Needle, Handle, Collar, Fiber Cable 1, Connector 1,<br>Snap Button, Front Needle | | Model Types | Straight, Curved, Flex-Tip, MAXReach | MAXReach only | | Single Use | Yes | Yes | | Target Population | Age 18-75 | Age 18-75 | | Materials<br>(Patient<br>contacting) | Stainless Steel, Nitinol, PEEK, Silica Glass,<br>Polyimide | Stainless Steel, Nitinol, Silica Glass, Polyimide | | Anatomical Sites | Eye | Eye | | Sterilization | Ethylene Oxide (ISO 11135) | Ethylene Oxide (ISO 11135) | | Packaging | Tray, Tyvek Pouch | Tray, Tyvek Pouch | #### Substantial Equivalence 1 Laser models only ; 2 Only on MAXReach Models ; 3 Only on Flex-Tip and MAXReach models ; 4 Illumination models only ## Risk Management Risk Management has been implemented for the Vortex Surgical Laser Probe Family and complies with ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices. The Vortex Surgical Laser Probe Family, including illumination devices are as safe and effective as the predicate devices they are compared with when used as intended. ## Performance The performance of the Vortex Surgical Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers show that the instruments are substantially equivalent to their predicates. Vortex Surgical had {5}------------------------------------------------ #### Vortex Surgical, Inc. Laser Probe, Illuminated Laser Probe, Endoilluminator, Chandelier # K220263 demonstrated through Ethylene Oxide (EO) sterilization EU residual testing, endotoxin testing, biocompatibility testing, shelf-life testing, and nonclinical bench test results that the Vortex Surgical instruments are safe and effective as their predicate devices and any difference between the two raise of safety or effectiveness. The non-clinical bench testing for laser probes included, laser output (IEC 60601-2-22), laser spot size, laser compatibility, Ophthalmic cannula interface, and handle actuation testing (for MAXReach models). Non-clinical bench testing for illuminated instruments included measurement of time to exceed 10 J/cm² on illumination sources (ANSI Z80.36-2016) in comparison to their predicates. All products were accessed for biocompatibility utilizing ISO 10993-1. Vortex Surgical Illuminated Laser Probe is an externally communicating device with limited (≤24 hrs.) tissue contact. The biocompatibility assessment was performed per 2020 FDA 's Biocompatibility Guidance "Use of International Standard ISO 10993-1, · Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' and included evaluation of cytotoxicity (elution method), sensitization (Guinea pig maximization testing), intracutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity. ## Conclusions The performance of the Vortex Surgical Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers show that the instruments are substantially equivalent to its predicate. Vortex Surgical has demonstrated through Ethylene Oxide (EO) sterilization EO residual testing, endotoxin testing, biocompatibility testing, shelf-life testing, and non-clinical bench that the Vortex Surgical instruments are safe and effective as their predicate devices and any differences between the two raise no new issue of safety or effectiveness.