The VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements.

The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.

Device Description

The VERITAS™ Vision System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) ophthalmic surgery. The device uses ultrasonic energy via finely modulated pulses of energy, interrupted by brief cooling periods, to emulsify and extractous lens. This allows the system to achieve full ultrasound cutting efficiency while introducing less energy to the eye, which reduces risk of thermal damage. The VERITAS™ System performs phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy functions, and is a peristaltic system with a graphic user interface that has updated technology and hardware to meet current electrical and material safety standards.

The VERITAS™ Vision System consists of components that are used to perform cataract surgery, which include the 1) System Console, 2) Wireless Remote Control, 3) Advanced Foot Pedal and 4) Single-Use Fluidics Pack or Single-Use Infusion Pack 5) Swivel Handpiece 6) Hardware 7) Software.

The VERITAS™ Advanced Infusion Pack or VERITAS™ Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS™ Vision System. The VERITAS™ Pack is sterilized using ethylene oxide and is designed for single use only.

AI/ML Overview

This report describes the acceptance criteria and the study that proves the device meets those criteria for the VERITAS™ Vision System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not present a formal table detailing specific, quantifiable acceptance criteria and directly corresponding reported device performance metrics in a side-by-side format. Instead, it states that the device "passed the acceptance criteria" and "all tests passed and all acceptance criteria were met" for various functional aspects.

The performance testing primarily focuses on demonstrating substantial equivalence to predicate devices (WHITESTAR SIGNATURE® PRO Phacoemulsification System and OPO73 Dual Pump Fluidics Pack) rather than meeting predefined numerical acceptance thresholds for novel performance claims.

Based on the text, the acceptance criteria are implicitly tied to the performance and safety profiles of the predicate devices and compliance with relevant standards.

Implicit Acceptance Criteria and Reported Performance (derived from text):

Acceptance Criteria Category	Implicit Criteria	Reported Device Performance
Overall System Functionality	Perform safely and effectively in all modes of anterior segment ophthalmic surgery: phacoemulsification, irrigation, diathermy, and vitrectomy.	"The subject device passed the acceptance criteria and was found to perform as safely and effectively as the primary predicate device during the following modes of anterior segment ophthalmic surgery: phacoemulsification, irrigation, diathermy, and vitrectomy."
Electromechanical Safety	Comply with IEC 60601 testing standards.	"The VERITAS™ Vision System has undergone preliminary design verification and validation testing to address regulatory requirements, including electromechanical safety testing (IEC 60601 testing)... and is in compliance with the applicable requirements."
Electromagnetic Compatibility (EMC)	Comply with relevant EMC testing standards.	"The VERITAS™ Vision System has undergone preliminary design verification and validation testing to address regulatory requirements, including... electromagnetic compatibility testing... and is in compliance with the applicable requirements."
Software Validation	Software functionality meets specified requirements.	"The VERITAS™ Vision System has undergone preliminary design verification and validation testing to address regulatory requirements, including... software validation... and is in compliance with the applicable requirements."
Fluidics Pack Functionality	Perform safely and effectively in anterior segment ophthalmic surgery modes requiring fluidics functionality, including irrigation/aspiration and gas-forced infusion.	"During performance testing, all anterior segment ophthalmic surgery modes that require the Advanced Fluidics Pack and Advanced Infusion Pack functionality, including irrigation/aspiration and gas-forced infusion were conducted; all tests passed and all acceptance criteria were met."
Sterilization	Sterilization process meets ISO 11135:2014 and ISO 11137:2014 standards; sterilization equivalency to predicate packs.	"Verification and validation testing, including sterilization (using ISO 11135:2014 and ISO 11137:2014, Sterilization of Health-Care Products - Ethylene Oxide)... was completed and all acceptance criteria were met, demonstrating that the VERITAS™ Advanced Fluidics Pack and VERITAS™ Advanced Infusion Pack have a similar safety, effectiveness and performance profile as the secondary predicate device."
Biocompatibility	Biocompatibility meets ISO 10993:2018 standards.	"Verification and validation testing, including... biocompatibility testing (using ISO 10993:2018, Biological Evaluation of Medical Devices), was completed and all acceptance criteria were met..."
Risk Assessment	Residual risks are acceptable and no new risks are identified by human factors studies.	"Risk assessment has been performed in accordance with ISO 14971:2017. Formative and summative human factor studies identified no new risks associated with the VERITAS™ Vision System."

The overall reported performance is that all required acceptance criteria were met, and the device is substantially equivalent to the predicate devices.

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

The document indicates that "bench testing" was performed for design verification and validation. However, it does not specify the sample size (e.g., number of devices, number of tests, volume of data) used in these tests. The provenance of this test data is implied to be internal testing conducted by Johnson & Johnson Surgical Vision, Inc. The document does not specify a country of origin for the data or whether the tests were retrospective or prospective, though design verification and validation testing are typically prospective.

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

The document makes no mention of experts being used to establish ground truth for a test set. The validation relies on meeting technical specifications, safety standards, and functional equivalence to predicate devices, rather than expert interpretation of medical images or diagnostic outputs. Human factors studies were conducted, but these are for usability and risk, not for establishing diagnostic ground truth.

4. Adjudication method for the test set

No adjudication method is described, as the testing performed does not involve subjective assessments requiring adjudication. The device validation relies on objective physical measurements, functional tests, and compliance with standards.

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

No MRMC comparative effectiveness study was done. This device is a phacoemulsification system and not an AI-assisted diagnostic or imaging device, so such a study would not be applicable. The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the primary and secondary predicate devices."

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

The device is a medical system for surgical procedures, not an algorithm, so a "standalone" algorithm-only performance assessment as typical for AI/ML devices is not applicable. Its performance is assessed through its mechanical and electrical functionality, and its interaction with a surgeon (human-in-the-loop) is the inherent design.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

Compliance with recognized international standards (e.g., IEC 60601 for electrical safety, ISO 11135 and 11137 for sterilization, ISO 10993 for biocompatibility, ISO 14971 for risk management).
Demonstrating functional equivalence to legally marketed predicate devices through bench testing.
Meeting design specifications and requirements for each component and the system as a whole.

This is a form of technical and regulatory compliance ground truth, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set. This device is a hardware/software medical system, not a machine learning or AI model that typically requires a training set.

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

Not applicable, as no training set is mentioned or relevant for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 12, 2021

Johnson & Johnson Surgical Vision, Inc. Amanda Houston Senior Regulatory Affairs Specialist 1700 East St. Andrew Place Santa Ana, CA 92705

Re: K203060

Trade/Device Name: VERITAS™ Phacoemulsification Console, VERITAS™ Advanced Fluidics Pack and Advanced Infusion Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC

Dated: January 21, 2021 Received: January 22, 2021

Dear Amanda Houston:

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

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(21 CFR Part 801); medical device reporting (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-safetyreporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

for LT Charles Chiang 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) K203060

Device Name VERITAS(TM) Vision System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Indications for Use

510(k) Number (if known) K203060

Device Name

VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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."

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The following 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92:

510(k) Summary: K203060

Sponsor/ Submitter:	Johnson & Johnson Surgical Vision, Inc.1700 East Saint Andrew PlaceSanta Ana, CA 92705 USAPhone: 408-723-5166Fax: 408-273-5966
Contact Person:	Amanda HoustonSr. Regulatory Affairs Specialistahousto1@its.jnj.com512-789-8317
Date Prepared:	March 12, 2021
Device Trade Names:	VERITAS™ Vision System
	VERITAS™ Advanced Infusion Pack and Advanced Fluidics Pack
Common Name:	Phacoemulsification System
Device Classification:	Class II
Regulation Number:	21 CFR 886.4670
Classification Name:	Phacofragmentation System
Product Code:	HQC
Primary PredicateDevice:VERITAS™ VisionSystem	WhiteStar Signature Pro Phacoemulsification System, (K151636)
Secondary PredicateDevice: VERITAS™Packs	OPO73 Dual Pump Fluidics Pack (K160236)
Reference PredicateDevices:VERITAS™ VisionSystem	WhiteStar Signature Phacoemulsification System, (K111697, WhiteStarHandpiece)
	Sovereign Cataract Extraction System, (K981116, Ellips Handpiece)
	Bausch and Lomb Stellaris Elite Phacoemulsification System, (K162342)

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Device Description

The intended use of the subject device is anterior segment ophthalmic surgery (i.e., cataract), which is the same as the primary and secondary predicate devices. The materials, energy source, operating mechanism, fundamental scientific technology, physical properties, duration, and type of contact, and intended use of the subject device are identical to those of the WHITESTAR SIGNATURE® Pro Phacoemulsification System and the OPO73 Dual Pump Fluidics Pack. The VERITAS™ Vision System is intended for use by trained ophthalmic surgeons and their support staff under the direction of the surgeon in adult patients with cataracts or adult patients undergoing anterior segment ophthalmic surgery (e.g., removal of the crystalline lens).

The functionality of the subject and primary predicate devices is the same, with the exception of the addition of Gas Forced Infusion (GFI) functionality to the subject device, which adds supplemental pressure to the existing gravitational forces within the irrigation line. The wireless remote control, foot pedal, and phacoemulsification handpiece are also updated versions of the accessories that are used with the primary predicate device.

Other modifications made for the subject device are:

Redesigned exterior skin
. Slightly larger 19-inch touchscreen display
Updated venting algorithm which can be configured by the user
. Continuous irrigation auto-off feature - irrigation will stop when the handpiece is removed from the eye
Updated Mayo tray design for improved cleaning robustness
. Updated foot pedal
. Updated, smaller remote for easier use

Indications for Use

The VERITAS™ Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements. The indications for use are identical to the primary predicate WHITESTAR SIGNATURE® PRO.

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Difference in Indications for Use from Secondary Predicate

The VERITAS™ Advanced Infusion Pack and VERITAS™ Advanced Fluidics Pack Indications for Use statement is essentially identical to the secondary predicate device, OPO73 Dual Pump Fluidics Packs. A minor revision has been made to include reference to both models of the VERITAS packs (Advanced Infusion Pack and Advanced Fluidics Pack) whereas the secondary predicate device had a single product reference included. In addition, product nomenclature was also revised.

Technological Characteristics of the Device

The main technological characteristics of the VERITAS™ Vision System include phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. These technological characteristics are the same as those in the legally marketed device, the WHITESTAR SIGNATURE® PRO Phacoemulsification System (K151636).

. The Phacoemulsification mode is used to break up (emulsify) the nucleus of a lens, allowing it to be aspirated from the eye through a small incision.
. The Diathermy (bipolar) mode is used to coagulate blood vessels during a surgical procedure and, in some cases, to coagulate the conjunctiva following a procedure.
The Irrigation/Aspiration mode allows for controlled aspiration of cortical material from the eve. while maintaining intraocular stability by replacing aspirated material with a balanced salt solution. A peristaltic pump provides a predictable and stable aspiration rate. Irrigation is gravity-fed, and intraocular pressure can be regulated by adjusting the height of the balanced salt solution bottle.
. The Vitrectomy mode is used to cut and remove vitreous from the anterior segment of the eye during secondary intraocular lens implantation, following vitreous loss associated with trauma, or during primary cataract surgery.

These surgery modes are equivalent to the surgery modes of the primary predicate device, the WHITESTAR SIGNATURE Pro Phacoemulsification System.

Substantial Equivalence

The subject VERITAS " Vision System is substantially equivalent to the primary WHITESTAR SIGNATURE® PRO Phacoemulsification System which was cleared under premarket notification K151636 (cleared October 29, 2015), in terms of:

· Indications for use
Intended use
Fundamental technological characteristics

In addition, the VERITAS™ Advanced Fluidics Pack and VERITAS" Advanced Infusion Pack are substantially equivalent to the secondary predicate device, the OPO73 Dual Pump Fluidics Pack

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cleared under K160236 (cleared April 27, 2016). The VERITAS™ Advanced Fluidics Pack is identical in functionality to the secondary predicate device; however, the Advanced Infusion Pack adds an infusion line that adds supplemental pressure to the irrigation system. This enhancement does not alter the overall functionality of the Advanced Infusion Pack.

The following reference devices listed in Table 1 provide additional support for the substantial equivalence of the VERITAS™ Vision System:

Reference Devices	Reason for Reference	VERITAS™ VisionSystem
WhiteStar SignaturePhacoemulsification System,(K111697, WhiteStar Handpiece)	The WhiteStar SignaturePhacoemulsification System, whichincludes the WhiteStar Handpiece,was the primary predicate device forthe WhiteStar Signature ProPhacoemulsification System	The WhiteStar Handpiece iscompatible with the VERITAS™Vision System.
Sovereign Cataract ExtractionSystem (K981116, EllipsHandpiece)	The Ellips handpiece was firstcleared for use as part of theSovereign Cataract ExtractionSystem.	The Ellips handpiece was acomponent of the WhiteStarSignature Pro PhacoemulsificationSystem, which is the primarypredicate device for theVERITAS™ Vision System
Bausch and Lomb Stellaris ElitePhacoemulsification System,(K162342)	Gas Forced Infusion functionality	The VERITAS™ Vision Systemincludes Gas Forced Infusionfunctionality to add supplementalpressure to the irrigation line

Table 1: List of Reference Devices

Table 2 provides a comparison of the VERITAS™ Vision System and the primary predicate device:

Table 2: Comparison of VERITAS™ Vision System with WHITESTAR SIGNATURE PRO
Phacoemulsification System
Attributes	Predicate DeviceWHITESTARSIGNATURE® PROPhacoemulsification System	Subject DeviceVERITAS™ Vision System
510(k)	K151636	K203060
Intended Use	Anterior Segment OphthalmicSurgery	Same
Indications for Use	Modular ophthalmic microsurgicalsystem that facilitates anteriorsegment (cataract) surgery. Themodular design allows the users toconfigure the system to meet theirsurgical requirements.	Same
	Predicate Device	Subject Device
Attributes	WHITESTARSIGNATURE® PROPhacoemulsification System	VERITAS™ Vision System
Target Population	Adult patients with cataracts or adultpatients undergoing anteriorsegment ophthalmic surgery (e.g.,removal of the crystalline lens).	Same
Intended User	Ophthalmologist and support staffoperating under the direction of thesurgeon.	Same
Energy Used	Ultrasonic energy	Same
Multifunction Wired/WirelessFoot Pedal	Yes	Same
Wireless remote control	Yes	Same
Surgical media center (optional)	Yes	Same
iPad Viewing Capability(optional)	Yes	Same
GFI Functionality	No	Yes
User interface:Touchscreen graphical userinterface (GUI)	Yes	Same
Wireless remote control	Yes	Same
Multifunction Wired/WirelessFoot Pedal	Yes	Same
Accessories:Tubing packs	Yes	Same
Phaco handpieces, tips, andsleeves	Yes	Same
Pneumatic vitrectomy handpiece	Yes	Same
Irrigation/aspiration (I/A)handpiece	Yes	Same
Diathermy forceps, pencil, andcord	Yes	Same
Instrument sterilization tray	Yes	Same
Power cord	Yes	Same
Operator's Manual	Yes	Same
Software operating environment-GUI host-Instrument host	-Windows 7(embedded)-QNX 6.5 with SP1	Same
Programming Language	C++	Same
	Predicate Device	Subject Device
Attributes	WHITESTAR® PROPhacoemulsification System	VERITAS™ Vision System
Operating Temperature Range	+10 to +40°C	Same
Maximum Humidity (RH orrelative humidity)	95% RH non-condensing	Same
Microprocessor-based	Yes	Same
Programmable for MultipleSurgeons	Yes	Same
Electrical Power Specification	100-240VAC, 50/60 Hz	Same
Self-Diagnostic	Yes	Same
Real-Time Display	Yes	Same
U/S Pulse Mode	Yes	Same
Diathermy/Cautery	Yes	Same
Irrigation	Yes	Same
Aspiration Pump Type	Peristaltic and Venturi pumpcapabilities	Same
Vacuum Range (in mmmercury)	0-650 (peristaltic) 0-600(Venturi)	Same
Anterior Vitrectomy	Yes	Same
Voice Confirmation	Yes	Same
Prime Mode	Yes	Same
Machine Width, Depth, HeightHie	24" W x 24" D x 54"H	24" W x 24" D x 62" H
Hardware (Modular Design): -System console, with activematrix color LCD displayscreen, Mayo stand/tray andprogrammable IV pole	Yes	Hardware (Modular Design):Same with 19" diagonal, activematrix TFT LCD display screen.
Foot Pedal
Description	Programmable Foot Switch	Same
Purpose	Control and operation of programsand handpieces	Same
Actuation	Single Linear; Dual Linear	Same
User Programmable Buttons	Four	Same
Wired/Wireless	Yes	Same
Attributes	Predicate DeviceWHITESTARSIGNATURE® PROPhacoemulsification System	Subject DeviceVERITAS™ Vision System
Battery Charging	Rechargeable	Same
	Remote Control
Purpose	System control and programselection	Same
Wired/Wireless	Wireless	Same
Number of Buttons	12	11
Battery Charging	Conductive Charge	None (User-replaceable AAbatteries)
	Handpiece
Purpose	Emulsification and removal of lens	Same
Energy Source	Piezoelectric crystals	Same
Crystal Vibration Frequency	37.5-39.5kHz	38-40kHz
Re-sterilization Method	Compatible with conventionalautoclave sterilization methods	Same
Swivel Proximal Handle	No	Yes
Description	WHITESTAR Phaco Handpiece,Ellips FX Phaco Handpiece	VERITAS™ Swivel Handpiece,Ellips FX Phaco Handpiece,WHITESTAR Phaco Handpiece
Luer Lock Attachment	No(Friction Fit)	Yes (for irrigation luer inAdvanced Infusion and AdvancedFluidics Pack with Veritas SwivelHandpiece)
Smart Technology	No	Yes, EPROM to track number ofprimes for assessing device usage

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Table 3 provides a comparison between the VERITAS™ Advanced Fluidics Pack, the VERITAS™ Advanced Infusion Pack, and the secondary predicate device.

Table 3: Substantial Equivalence Table: Comparison of Fluidics Packs Used for the VERITAS
Vision System

Attributes	Predicate Device	Subject Device	Subject Device
	DUAL PUMP PACKMODEL OPO73	VERITAS™ ADVANCEDFLUIDICS PACKMODEL VRT-AF	VERITAS™ ADVANCEDINFUSION PACKMODEL VRT-AI
510(k)	K160236	K203060	K203060
Intended Use	Cataract Surgery (Anteriorsegment)	Same	Same

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	Predicate Device	Subject Device	Subject Device
Attributes	DUAL PUMP PACKMODEL OPO73	VERITAS™ ADVANCEDFLUIDICS PACKMODEL VRT-AF	VERITAS™ ADVANCEDINFUSION PACKMODEL VRT-AI
Indications for use	Perform irrigation andaspiration during anteriorsegment cataract surgery	Same	Same
Size	5.0" L x 4.375" W x 2.2" H	Same	Same
Peristaltic AspirationSupport	Yes	Same	Same
Venturi AspirationSupport	Yes	Same	Same
Pack Loading	Single-Step	Same	Same
Usage	Single-Use	Same	Same
Packaging	Thermoform tray withTyvek Lid	Same	Same
Tray Components	Housing Manifold with I/ATubingTouchscreen coverMayo tray stand coverPouched test chamber	Same	Same
Function	Irrigation/Aspiration	Same	Same with SupplementalPressure
Shelf Life	Three (3) years	Two (2) years	Two (2) years
Compatible SurgicalSystem	VERITAS™ Vision SystemWhiteStar Signature ProSystem	VERITAS™ VisionSystem	VERITAS™ VisionSystem

Summary of Performance Testing

VERITAS™ Console, VERITAS™ Foot Pedal, VERITAS Wireless Remote Control, and VERITAS Swivel Handpiece

The VERITAS™ Vision System has undergone preliminary design verification and validation testing to address regulatory requirements, including electromechanical safety testing (IEC 60601 testing), electromagnetic compatibility testing, and software validation, and is in compliance with the applicable requirements. The subject device passed the acceptance criteria and was found to perform as safely and effectively as the primary predicate device during the following modes of anterior segment ophthalmic surgery: phacoemulsification, irrigation, diathermy, and vitrectomy. Therefore, the subject device, including the VERITAS™ console, VERITAS™ Foot Pedal VERITAS™ Wireless Remote Control and VERITAS" Swivel Handpiece, has similar safety, effectiveness, and performance profiles as the primary predicate device.

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VERITAS™ Advanced Fluidics Pack and VERITAS™ Advanced Infusion Pack

The VERITAS" Advanced Fluidics Pack and VERITAS™ Advanced Infusion Pack have undergone design verification and validation testing. The test results demonstrate that the Advanced Fluidics Pack and Advanced Infusion Pack perform as safely and as effectively as the secondary predicate device, the OPO73 Dual Pump Fluidics Pack. During performance testing, all anterior segment ophthalmic surgery modes that require the Advanced Fluidics Pack and Advanced Infusion Pack functionality, including irrigation/aspiration and gas-forced infusion were conducted; all tests passed and all acceptance criteria were met.

Components of the VERITAS™ Advanced Fluidics Pack and VERITAS™ Advanced Infusion Pack have indirect contact with the patient by providing a fluid path for sterile Balanced Salt Solution (BSS) to enter the eye during surgery. A sterilization equivalency assessment was conducted for the adoption of the Veritas packs to the current process employed for the OPO73 Dual Pump Packs and determined that the Veritas packs may be considered similar or equivalent to the OPO73 packs for validation purposes. Verification and validation testing, including sterilization (using ISO 11135:2014 and ISO 11137:2014, Sterilization of Health-Care Products - Ethylene Oxide) and biocompatibility testing (using ISO 10993:2018, Biological Evaluation of Medical Devices), was completed and all acceptance criteria were met, demonstrating that the VERITAS" Advanced Fluidics Pack and VERITAS" Advanced Infusion Pack have a similar safety, effectiveness and performance profile as the secondary predicate device.

Risk assessment has been performed in accordance with ISO 14971:2017. Formative and summative human factor studies identified no new risks associated with the VERITAS™ Vision System. No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the primary and secondary predicate devices.

Conclusion:

The results of the bench testing, EMC testing, and software validation demonstrates that the VERITAS™ Vision System and VERITAS" Advanced Infusion Pack and Advanced Fluidics Pack have met all required acceptance criteria. The VERITAS™ Vision System is substantially equivalent to the currently cleared WhiteStar Signature Pro Phacoemulsification System (K151636) based on completion of nonclinical bench testing, software validation, as well as similar principles of design, operation, and indications for use. The VERITAS™ Advanced Fluidics Pack Model VRT-AF and VERITAS™ Advanced Infusion Pack Model VRT-AI are substantially equivalent to the currently cleared Dual Pump Pack Model OPO73 (K160236) based on completion of non-clinical bench testing, software validation, as well as similar principles of design, operation, and indications for use.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.