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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Vortex Surgical's Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers. As a medical device submission, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving novel clinical efficacy or conducting a multi-reader multi-case (MRMC) study. Therefore, the details requested in points 5, 8, and 9 (related to AI-assisted human reader improvement, training set size, and training set ground truth establishment) are not applicable in this context, as the device is not an AI/ML software or diagnostic tool that requires such studies.

Here's an analysis based on the information provided for the other points:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a table format with specific quantitative thresholds. Instead, the performance evaluation focuses on demonstrating that the subject devices are substantially equivalent to their predicates across various non-clinical bench tests and material assessments. The criteria are implicitly met if the test results show equivalence and do not raise new safety or effectiveness concerns.

Category	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Sterilization	Meet sterilant residual limits and demonstrate sterility assurance	EO sterilization EU residual testing, endotoxin testing performed. All products accessed for biocompatibility utilizing ISO 10993-1.
Biocompatibility	No adverse biological reactions upon patient contact	Biocompatibility assessment performed per 2020 FDA guidance and ISO 10993-1. Included evaluation of cytotoxicity (elution method), sensitization (Guinea pig maximization testing), intracutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity. Externally communicating device with limited (≤24 hrs.) tissue contact.
Shelf-Life	Maintain performance and sterility over designated shelf-life	Shelf-life testing performed.
Laser Output	Meet specified laser output parameters (e.g., power, wavelength compatibility)	Non-clinical bench testing for laser probes included laser output (IEC 60601-2-22) and laser spot size. Laser compatibility with specified laser sources (Alcon Constellation/Pure Point Lasers, Iridex GL Laser, Ellex Solitaire Laser, and DORC EVA) demonstrated.
Illumination Performance	Meet specified illumination parameters (e.g., light intensity, safety limits)	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. Illumination compatibility with DORC EVA, B&L Stellaris, Alcon Constellation.
Mechanical Performance	Functional and durable during intended use (e.g., cannula interface, handle actuation)	Ophthalmic cannula interface and handle actuation testing (for MAXReach models) performed.
Material/Design equivalence	Materials and design elements are comparable to predicate such that no new safety/effectiveness concerns are raised.	Detailed comparison table provided (materials, distal end, jacketing, connector, components, model types, single-use, target population, anatomical sites). The device is manufactured from Stainless Steel, Nitinol, PEEK, Silica Glass, Polyimide, PMMA (for illumination fiber).

The document concludes: "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 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."

2. Sample size used for the test set and the data provenance

The document does not specify a "sample size" in terms of number of patients or cases. The tests described are primarily non-clinical bench tests (e.g., laser output, mechanical actuation, biocompatibility assessments) and material characterization. Therefore, the data provenance is from laboratory testing of the devices themselves, not from patient data. There is no indication of country of origin for such non-clinical test data, nor is it classified as retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is not a diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering specifications, recognized standards (e.g., IEC 60601-2-22, ANSI Z80.36-2016, ISO 10993-1, ISO 11135), and the performance characteristics of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This point is not applicable as there is no human interpretation or subjective assessment of data that would require an adjudication method. The testing involves objective, measurable physical and chemical properties and performance characteristics against established standards or predicate device performance.

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

This is not applicable. The device is not an AI-assisted diagnostic tool. It is a surgical instrument (laser probes, illuminators). MRMC studies are typically performed for diagnostic devices, especially those incorporating AI, to evaluate human reader performance with and without AI assistance. This document describes a submission for a substantially equivalent predicate device, not an AI-powered one.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical surgical instrument, not an algorithm. Standalone performance evaluation (without human-in-the-loop) would refer to the performance of a software algorithm on its own, which is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the "ground truth" for this type of device and submission is based on engineering specifications, recognized international standards (e.g., ISO, IEC, ANSI), and the established performance characteristics of the predicate device. For biocompatibility, it's about meeting the safety thresholds defined by ISO 10993-1. For performance, it's about meeting the requirements of electro-optical and mechanical standards and demonstrating equivalence to a legally marketed predicate. There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus on interpretations.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable. The device is not an AI/ML model, so there is no "training set" or ground truth establishment for such a set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K220263

Device Name

Laser Probe, Illuminated Laser Probe, Endoilluminator, and Chandelier

Indications for Use (Describe)

.- CARLES STATE CALIFLE COLOR COLLECT CLASS CLASS CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS - CLASS.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Vortex Surgical, Inc.				K220263
Laser Probe, Illuminated Laser Probe, Endoilluminator, Chandelier
510(k) SUMMARY K220263
Submitted in accordance with the requirements of 21 CFR 807.92
Submitter name:	Vortex Surgical Inc
Address:	680 Crown Industrial Court, Suite FChesterfield, 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 SurgicalEndoilluminators, 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.

Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye.

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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 MAXReachK191846
LaserCompatibility	Alcon Constellation/Pure Point Lasers, Iridex GLLaser, Ellex Solitaire Laser, and DORC EVA	Alcon Constellation/Pure Point Lasers, Iridex GLLaser, and Ellex Solitaire Laser
IlluminationCompatibility	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,Connector 11, Snap Button2, Front Needle3, FiberCable 24, Connector 24	Needle, Handle, Collar, Fiber Cable 1, Connector 1,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(Patientcontacting)	Stainless Steel, Nitinol, PEEK, Silica Glass,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

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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.

Regulation Number and Section

§ 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.