(155 days)
No
The document describes a surgical system with standard functions (phacoemulsification, diathermy, irrigation/aspiration, vitrectomy) and mentions software validation, but there is no mention of AI, ML, or related concepts like image processing or data-driven decision making.
Yes
This device is designed to perform various functions (phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy) during anterior segment ophthalmic surgery to treat cataracts, which aligns with the definition of a therapeutic device.
No
The VERITAS™ Vision System is described as a modular ophthalmic microsurgical system intended for use in anterior segment (cataract) ophthalmic surgery, performing functions like phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy. It is a surgical tool, not a device used for diagnosis.
No
The device description explicitly lists "Hardware" as one of the components of the VERITAS™ Vision System, in addition to "Software". The system also includes physical components like a System Console, Wireless Remote Control, Advanced Foot Pedal, Single-Use Fluidics Pack/Infusion Pack, and Swivel Handpiece, all of which are hardware.
Based on the provided text, the VERITAS(TM) Vision System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate anterior segment (cataract) ophthalmic surgery. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device performs functions like phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy, all of which are surgical interventions.
- Lack of Diagnostic Purpose: The text does not mention the device being used to diagnose a condition, analyze samples (like blood, tissue, or urine), or provide information for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VERITAS(TM) Vision System is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HQC
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 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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior segment (i.e., cataract) ophthalmic surgery/eye
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained ophthalmic surgeons and their support staff under the direction of the surgeon.
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)
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.
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.
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.
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.
WhiteStar Signature Pro Phacoemulsification System, (K151636), OPO73 Dual Pump Fluidics Pack (K160236)
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.
WhiteStar Signature Phacoemulsification System, (K111697, WhiteStar Handpiece), Sovereign Cataract Extraction System, (K981116, Ellips Handpiece), Bausch and Lomb Stellaris Elite Phacoemulsification System, (K162342)
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
§ 886.4670 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.
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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
1
(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)
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.
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.
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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)
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.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."
4
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 Place
Santa Ana, CA 92705 USA
Phone: 408-723-5166
Fax: 408-273-5966 |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amanda Houston
Sr. Regulatory Affairs Specialist
ahousto1@its.jnj.com
512-789-8317 |
| 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 Predicate
Device:
VERITAS™ Vision
System | WhiteStar Signature Pro Phacoemulsification System, (K151636) |
| Secondary Predicate
Device: VERITAS™
Packs | OPO73 Dual Pump Fluidics Pack (K160236) |
| Reference Predicate
Devices:
VERITAS™ Vision
System | WhiteStar Signature Phacoemulsification System, (K111697, WhiteStar
Handpiece) |
| | Sovereign Cataract Extraction System, (K981116, Ellips Handpiece) |
| | Bausch and Lomb Stellaris Elite Phacoemulsification System, (K162342) |
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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 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 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 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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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.
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
7
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™ Vision
System |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| WhiteStar Signature
Phacoemulsification System,
(K111697, WhiteStar Handpiece) | The WhiteStar Signature
Phacoemulsification System, which
includes the WhiteStar Handpiece,
was the primary predicate device for
the WhiteStar Signature Pro
Phacoemulsification System | The WhiteStar Handpiece is
compatible with the VERITAS™
Vision System. |
| Sovereign Cataract Extraction
System (K981116, Ellips
Handpiece) | The Ellips handpiece was first
cleared for use as part of the
Sovereign Cataract Extraction
System. | The Ellips handpiece was a
component of the WhiteStar
Signature Pro Phacoemulsification
System, which is the primary
predicate device for the
VERITAS™ Vision System |
| Bausch and Lomb Stellaris Elite
Phacoemulsification System,
(K162342) | Gas Forced Infusion functionality | The VERITAS™ Vision System
includes Gas Forced Infusion
functionality to add supplemental
pressure 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 Device | |
| WHITESTAR | ||
| SIGNATURE® PRO | ||
| Phacoemulsification System | Subject Device | |
| VERITAS™ Vision System | ||
| 510(k) | K151636 | K203060 |
| Intended Use | Anterior Segment Ophthalmic | |
| Surgery | Same | |
| Indications for Use | Modular ophthalmic microsurgical | |
| system that facilitates anterior | ||
| segment (cataract) surgery. The | ||
| modular design allows the users to | ||
| configure the system to meet their | ||
| surgical requirements. | Same | |
| Predicate Device | Subject Device | |
| Attributes | WHITESTAR | |
| SIGNATURE® PRO | ||
| Phacoemulsification System | VERITAS™ Vision System | |
| Target Population | Adult patients with cataracts or adult | |
| patients undergoing anterior | ||
| segment ophthalmic surgery (e.g., | ||
| removal of the crystalline lens). | Same | |
| Intended User | Ophthalmologist and support staff | |
| operating under the direction of the | ||
| surgeon. | Same | |
| Energy Used | Ultrasonic energy | Same |
| Multifunction Wired/Wireless | ||
| Foot 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 user | ||
| interface (GUI) | Yes | Same |
| Wireless remote control | Yes | Same |
| Multifunction Wired/Wireless | ||
| Foot Pedal | Yes | Same |
| Accessories: | ||
| Tubing packs | Yes | Same |
| Phaco handpieces, tips, and | ||
| sleeves | Yes | Same |
| Pneumatic vitrectomy handpiece | Yes | Same |
| Irrigation/aspiration (I/A) | ||
| handpiece | Yes | Same |
| Diathermy forceps, pencil, and | ||
| cord | 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® PRO | |
| Phacoemulsification System | VERITAS™ Vision System | |
| Operating Temperature Range | +10 to +40°C | Same |
| Maximum Humidity (RH or | ||
| relative humidity) | 95% RH non-condensing | Same |
| Microprocessor-based | Yes | Same |
| Programmable for Multiple | ||
| Surgeons | 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 pump | |
| capabilities | Same | |
| Vacuum Range (in mm | ||
| mercury) | 0-650 (peristaltic) 0-600 | |
| (Venturi) | Same | |
| Anterior Vitrectomy | Yes | Same |
| Voice Confirmation | Yes | Same |
| Prime Mode | Yes | Same |
| Machine Width, Depth, Height | ||
| Hie | 24" W x 24" D x 54"H | 24" W x 24" D x 62" H |
| Hardware (Modular Design): - | ||
| System console, with active | ||
| matrix color LCD display | ||
| screen, Mayo stand/tray and | ||
| programmable IV pole | Yes | Hardware (Modular Design): |
| Same with 19" diagonal, active | ||
| matrix TFT LCD display screen. | ||
| Foot Pedal | ||
| Description | Programmable Foot Switch | Same |
| Purpose | Control and operation of programs | |
| and handpieces | Same | |
| Actuation | Single Linear; Dual Linear | Same |
| User Programmable Buttons | Four | Same |
| Wired/Wireless | Yes | Same |
| Attributes | Predicate Device | |
| WHITESTAR | ||
| SIGNATURE® PRO | ||
| Phacoemulsification System | Subject Device | |
| VERITAS™ Vision System | ||
| Battery Charging | Rechargeable | Same |
| Remote Control | ||
| Purpose | System control and program | |
| selection | Same | |
| Wired/Wireless | Wireless | Same |
| Number of Buttons | 12 | 11 |
| Battery Charging | Conductive Charge | None (User-replaceable AA |
| batteries) | ||
| 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 conventional | |
| autoclave 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 in | |
| Advanced Infusion and Advanced | ||
| Fluidics Pack with Veritas Swivel | ||
| Handpiece) | ||
| Smart Technology | No | Yes, EPROM to track number of |
| primes for assessing device usage |
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9
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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 PACK | |||
| MODEL OPO73 | VERITAS™ ADVANCED | ||
| FLUIDICS PACK | |||
| MODEL VRT-AF | VERITAS™ ADVANCED | ||
| INFUSION PACK | |||
| MODEL VRT-AI | |||
| 510(k) | K160236 | K203060 | K203060 |
| Intended Use | Cataract Surgery (Anterior | ||
| segment) | Same | Same |
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| Predicate Device | Subject Device | Subject Device | |
|---|---|---|---|
| Attributes | DUAL PUMP PACK | ||
| MODEL OPO73 | VERITAS™ ADVANCED | ||
| FLUIDICS PACK | |||
| MODEL VRT-AF | VERITAS™ ADVANCED | ||
| INFUSION PACK | |||
| MODEL VRT-AI | |||
| Indications for use | Perform irrigation and | ||
| aspiration during anterior | |||
| segment cataract surgery | Same | Same | |
| Size | 5.0" L x 4.375" W x 2.2" H | Same | Same |
| Peristaltic Aspiration | |||
| Support | Yes | Same | Same |
| Venturi Aspiration | |||
| Support | Yes | Same | Same |
| Pack Loading | Single-Step | Same | Same |
| Usage | Single-Use | Same | Same |
| Packaging | Thermoform tray with | ||
| Tyvek Lid | Same | Same | |
| Tray Components | Housing Manifold with I/A | ||
| Tubing | |||
| Touchscreen cover | |||
| Mayo tray stand cover | |||
| Pouched test chamber | Same | Same | |
| Function | Irrigation/Aspiration | Same | Same with Supplemental |
| Pressure | |||
| Shelf Life | Three (3) years | Two (2) years | Two (2) years |
| Compatible Surgical | |||
| System | VERITAS™ Vision System | ||
| WhiteStar Signature Pro | |||
| System | VERITAS™ Vision | ||
| System | VERITAS™ Vision | ||
| System |
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.