(197 days)
Not Found
No
The device description focuses on mechanical and fluidic control systems, a graphical user interface, and an optional laser. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes.
The device is used for surgical procedures such as phacoemulsification, cataract removal, vitreoretinal surgery, photocoagulation, iridotomy, and trabeculoplasty, all of which are therapeutic interventions.
No
This device is described as a "multifunctional surgical instrument" and its indicated uses are for performing ophthalmic surgeries and procedures, not for diagnosis.
No
The device description clearly outlines a physical surgical instrument with various hardware components (handpieces, laser module, touchscreen, remote control, foot controllers) used for performing ophthalmic procedures. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The UNITY VCS and UNITY CS are surgical instruments used during ophthalmic surgery. They perform procedures like cutting tissue, emulsifying lenses, illuminating the eye, and applying diathermy. They are actively used within the body during a surgical procedure.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples taken from the patient. Its function is to facilitate and perform surgical actions directly on the eye.
Therefore, the UNITY VCS and UNITY CS fall under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
UNITY VCS:
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.
In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.
UNITY CS:
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
For UNITY VCS:
- HQE, HQC, HQF
For UNITY CS: - HQC
Device Description
The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuum-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.
An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device.
When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting.
The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.
When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation.
The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network.
Both devices are for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior segment, posterior segment (eye)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinic(s)/hospital(s)/surgical practice network.
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)
7.1 Non-Clinical Testing
Biocompatibility
The UNITY VCS and UNITY CS consoles are not intended to have patient contact. The materials used for the device consoles are common and widely used for ophthalmic and similar applications without reported heath concerns. Per ISO 10993-1, no further biocompatibility testing is required.
Alcon conducted biocompatibility testing on the patient-contacting accessories and met ISO 10993 requirements for chemical characterization, cytotoxicity, sensitization, and acute systemic toxicity. Packaging materials passed cytotoxicity requirements from ISO 11607-1 and ASTM F2475.
Sterilization and Shelf Life
The UNITY VCS and CS system consoles are provided non-sterile and are not intended to be sterilized during routine use. The system consoles are intended for use with sterile accessories.
Alcon performed sterilization testing on the accessories provided sterile to the user. Test results passed the predetermined acceptance criteria and met the appropriate sterilization standards.
Shelf life testing on the sterile accessories yielded successful test results for the latest pull point for the consumable accessories covered by this premarket notification.
Electromagnetic Compatibility (EMC )/ Wireless / Electrical Safety
Alcon assessed the EMC, wireless, and electrical / mechanical safety of the UNITY VCS and UNITY CS according to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-4-2, and the final FDA guidance documents "Electromagnetic Compatibility (EMC) of Medical Devices," issued June 6, 2022, and "Radio Frequency Wireless Technology in Medical Devices," issued on August 14, 2013. The subject devices met all requirements from the aforementioned standards and followed FDA recommendations where applicable from said guidance documents.
Software
Alcon developed and tested the UNITY VCS and UNITY CS device software functions according to ANSI / AAMI / IEC 62304, "Medical Device Software – Software Life Cycle Processes" and internal Alcon procedures that follow this standard. Premarket submission documentation was prepared in accordance with the final FDA guidance "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023. Testing met all requirements from IEC 62304, and all FDA recommendations for documentation were met.
Alcon also fulfilled FDA's cybersecurity recommendations for the subject devices in accordance with the final FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," dated September 2023.
Performance Testing
Alcon conducted performance tests on the UNITY VCS and UNITY CS devices to demonstrate safety, effectiveness, and substantial equivalence to predicate devices, in accordance with IEC 80601-2-58.
Safety tests of the UNITY VCS and UNITY CS demonstrated the compliance of the subject devices to the appropriate standards. Biocompatibility evaluations of materials coming into contact with the patient or patient fluid path demonstrated compliance with the appropriate standard from the ISO 10993 series or with ISO 16671:2015.
Sterile, single-use UNITY VCS and UNITY CS accessories have been shown to be sterilizable to a sterility assurance level (SAL) of 10-, and the sterilization process for these accessories has been validated per the required standard.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Like the predicate devices have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the subject devices are equivalent to the predicate devices.
7.2
The risk assessment for the subject devices did not require any animal or clinical testing as mitigation against any identified risks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4670 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 21, 2024
Alcon Laboratories, Inc. Ganesh Balachandar Regulatory Affairs Manager 6201 South Freeway Fort Worth, Texas 76134
Re: K233876
Trade/Device Name: UNITY VCS (8065000296); UNITY CS (8065000297) Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: May 17, 2024 Received: May 20, 2024
Dear Ganesh Balachandar:
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Claudine H. Krawczyk -S
Claudine Krawczyk 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
3
Indications for Use
510(k) Number (if known) K233876
Device Name UNITY VCS (8065000296) ; UNITY CS (8065000297)
Indications for Use (Describe) UNITY VCS
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.
In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures.
UNITY CS
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
In accordance with 21 CFR 807.92, Alcon hereby provides the 510(k) summary for the UNITY VCS and UNITY CS.
1. SUBMITTER
| Applicant | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Ganesh Balachandar, M.S.
Regulatory Affairs Manager
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 322-5101
ganesh.balachandar@alcon.com |
| Secondary Correspondent | Ophelia Biggs
Director, Regulatory Affairs
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 217-3854
ophelia.biggs@alcon.com |
| Date Prepared | June 21, 2024 |
5
2. SUBJECT DEVICES
| Device Trade Name | UNITY VCS (8065000296);
UNITY CS (8065000297) |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Number and Name
(Product Code in
Parentheses) | For UNITY VCS:
• 21 CFR 886.4150, Vitreous aspiration and cutting instrument
(HQE)
• 21 CFR 886.4670, Phacofragmentation system (HQC)
• 21 CFR 886.4690, Ophthalmic laser (HQF)
For UNITY CS:
• 21 CFR 886.4670, Phacofragmentation system (HQC) |
| Regulatory Class | II |
3. PREDICATE DEVICES
| FOR UNITY VCS: | |
|---|---|
| Predicate Device | CONSTELLATION Vision System |
| 510(k) Number | K141065 |
| Classification | |
| Number and Name | |
| (Product Code in | |
| Parentheses) | 21 CFR 886.4150, Vitreous aspiration and cutting instrument (HQE) 21 CFR 886.4670, Phacofragmentation system (HQC) |
| Regulatory Class | II |
| FOR UNITY VCS (Laser Functionality): | |
|---|---|
| Predicate Device | Next-Generation Laser |
| 510(k) Number | K062624 |
| Classification | |
| Number and Name | |
| (Product Code in | |
| Parentheses) | • 21 CFR 886.4390, Laser, Ophthalmic (HQF) |
| Regulatory Class | II |
| FOR UNITY CS: | |
|---|---|
| Predicate Device | CENTURION Vision System with Active Sentry |
| 510(k) Number | K161794 |
| Classification | 21 CFR 886.4670, Phacofragmentation system (HQC) |
6
| Number and Name
(Product Code in
| Parentheses) | |
|---|---|
| Regulatory Class | II |
7
DEVICE DESCRIPTION 4.
The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.
An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device.
When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting.
The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.
When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation.
The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network.
Both devices are for prescription use only.
INDICATIONS FOR USE ડાં
UNITY VCS:
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e.
8
vitreoretinal) ophthalmic surgery.
In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.
UNITY CS:
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
9
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE 6.
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Administrative | | | | |
| 510(k) | K141065 | K233876 | K161794 | K233876 |
| Intended Use | Anterior and posterior
segment ophthalmic
surgery | Same
(The subject device,
consisting of the console
and compatible devices, is
intended to facilitate
management of fluid and
gases, as well as removal,
grasping, cutting,
illumination, and
coagulation of ocular
materials)1 | Anterior segment
ophthalmic surgery | Same
(The subject device,
consisting of the console
and compatible devices, is
intended to facilitate
management of fluid as
well as removal, cutting,
and coagulation of ocular
materials)1 |
| Indications for Use | The CONSTELLATION®
Vision System is indicated
for the following:
The CONSTELLATION®
Vision System is an
ophthalmic microsurgical
system that is indicated for
both anterior segment (i.e.
phacoemulsification and | The UNITY VCS console,
when used with
compatible devices, is
indicated for use during
anterior segment (i.e.
phacoemulsification and
removal of cataracts) and
posterior segment (i.e.
vitreoretinal) ophthalmic | The Centurion Vision
System is indicated for
emulsification, separation,
irrigation, and aspiration
of cataracts, residual
cortical material and lens
epithelial cells, vitreous
aspiration and cutting
associated with anterior | The UNITY CS console,
when used with
compatible devices, is
indicated for use during
anterior segment (i.e.
phacoemulsification and
removal of cataracts)
ophthalmic surgery. |
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
| | removal of cataracts) and
posterior segment (i.e.,
vitreoretinal) ophthalmic
surgery in addition to the
indications included with
the optional Next-
Generation laser. The
AutoSert® IOL Injector
Handpiece is intended to
deliver qualified
ACRYSOF® intraocular
lenses into the eye
following cataract
removal.
The AutoSertⓇ
IOL Injector Handpiece
achieves the functionality
of injection of intraocular
lenses. The AutoSert is
indicated for use with
ACRYSOF® lenses
SN60WF, SN6AD1,
SN6AT3 through
SN6AT9, as well as
approved ACRYSOF®
lenses that are specifically
indicated for use with this
inserter as indicated in the | surgery.
In addition, with the
optional laser this system
is indicated for
photocoagulation (i.e.
vitreoretinal and macular
pathologies), iridotomy
and trabeculoplasty
procedures.2 | vitrectomy, bipolar
coagulation, and
intraocular lens injection.
The AutoSert IOL Injector
Handpiece is intended to
deliver qualified AcrySof
intraocular lenses into the
eye following cataract
removal.
The AutoSert IOL Injector
Handpiece achieves the
functionality of injection
of intraocular lenses. The
AutoSert IOL Injector
Handpiece is indicated for
use with the AcrySof
lenses SN60WF,
SNWAD1, SN6AT3
through SN6AT9,
as well as approved
AcrySof lenses that are
specifically indicated for
use with this inserter, as
indicated in the approved
labeling of those lenses. | |
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
| | approved labeling of those
lenses. | | | |
| Console Features | | | | |
| Monolith | Yes | Yes | Yes | Yes |
| Tray | Yes | Yes | Yes | Yes |
| Touch Panel Display | Yes | Yes | Yes | Yes |
| RFID for accessory
connections | Yes | Yes | No | Yes |
| e-Connectivity | Yes | Yes | Yes | Yes |
| User Interface | Touch panel display, foot
controllers, remote control | Same | Same | Same |
| Electrical Power
Specifications | 100-240 V AC, 50/60 Hz | Same | Same | Same |
| Operating
Temperature Range | 10-35°C | Same | Same | Same |
| Console Height,
Width and Depth | Height: 62.4"
Width: 30.3"
Depth: 36" | Height: 64.6"
Width: 25.4"
Depth:28.3" | Height:64.6"
Width:19.6'
Depth:31.6" | Height: 64.6"
Width: 25.4"
Depth:28.3" |
| Maximum Humidity
(RH = Relative
Humidity) | 95% RH non-condensing | Same | Same | Same |
| Fluidics Features | | | | |
| Push Prime | Yes | Yes | No | Yes |
| Infusion/Irrigation
Source Change | Yes | Yes | Yes | Yes |
| Aspiration Pressure
Control | Yes | Yes | Yes | Yes |
| Aspiration Flow
Control | Yes | Yes | Yes | Yes |
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
| Suction Flow
Control | Yes | Yes | No | No |
| Flow Control –
Irrigation | No | Yes | Yes | Yes |
| Flow Control –
Infusion | No | Yes | No | No |
| IOP-Controlled
Infusion/Irrigation | Yes | Yes | Yes | Yes |
| Pressurized Infusion
Irrigation | Yes | Yes | No | No |
| | Yes | Yes | Yes | Yes |
| Proportional Reflux | Yes | Yes | No | Yes |
| Continuous Reflux | Yes | Yes | Yes | Yes |
| Micro Reflux | Yes | Yes | No | Yes |
| Pneumatics Features | | | | |
| Anterior Vitrectomy | Yes | Yes | Yes | Yes |
| Posterior Vitrectomy | Yes | Yes | No | No |
| Proportional Forceps | Yes | Yes | No | No |
| Proportional Scissors | Yes | Yes | No | No |
| Multi-Cut Scissors | Yes | Yes | No | No |
| VFC Inject | Yes | Yes | No | No |
| VFC Extract | Yes | Yes | No | No |
| Fluid-Air Exchange | Yes | Yes | No | No |
| Auto-Gas Filling | Yes | No | No | No |
| Ultrasound Features | | | | |
| Longitudinal Phaco | Yes | Yes | Yes | Yes |
| Longitudinal Frag | Yes | Yes | No | No |
| Torsional Phaco | Yes | Yes | Yes | Yes |
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
| Torsional Frag | No | Yes | No | No |
| Active Sentry Phaco | No | Yes | Yes | Yes |
| 4D Phaco | No | Yes | No | Yes |
| Diathermy Features | | | | |
| Frequency | 1.5 MHz | Same | Same | Same |
| Rated Load | 75 Ω | Same | Same | Same |
| Maximum Power | 10 W | Same | Same | Same |
| Illumination Features | | | | |
| Illumination source | Xenon Bulb | RGB LED | None | None |
| Number of
Simultaneous
Outputs | 2 | 3 | None | None |
| Illumination Color | Fixed | Adjustable | None | None |
| Laser Features | | | | |
| Therapeutic laser
wavelength | 532 nm | Same | No | No |
| Single-spot power
output range | 30 mW to 2 W | Same | No | No |
| Laser Indirect
Ophthalmoscope
support | Yes | Yes | No | No |
| Includes Multi-Spot
Laser Probe (MSLP) | No | Yes | No | No |
| Integrated
Illumination (MSLP
only) | No | Yes | No | No |
| FMS and Accessory Device Packs | | | | |
| Single-Use | Yes | Yes | Yes | Yes |
| Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) |
| Sterilization method | Ethylene Oxide | Same | Same | Same |
| Includes Anterior
Pack | Yes | Yes | Yes | Yes |
| Includes Posterior
Pack | Yes | Yes | No | No |
| Includes
Combination Pack | Yes | Yes | No | No |
| Surgical Suite Integration | | | | |
| NGENUITY 3D
Visualization System | Yes | Yes | Yes | Yes |
| LuxOR microscope | No | Yes | Yes | Yes |
| Verion Image
Guided System | No | Yes | Yes | Yes |
' The proposed language for the subject devices' Intended Use statements are in parenthe manner of describing the medical pupose of the subject devices. Despite the difference in worder the same between the language in parentheses and the intended use language of the predicate devices (anterior and posterior segment ophthalmic surgery), because the actions of filud and gas management, removal, grasping, cutting, illumination, and coagulation of ocular materials can occur only during anterior or posterior segment ophthalmic surgery.
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2 The laser functionality of UNITY VCS is substantially equivalent to Alcon's Next-Generation Laser (K062624), cleared November 2007.
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SUMMARY OF STUDIES 7.
7.1 Non-Clinical Testing
Biocompatibility
The UNITY VCS and UNITY CS consoles are not intended to have patient contact. The materials used for the device consoles are common and widely used for ophthalmic and similar applications without reported heath concerns. Per ISO 10993-1, no further biocompatibility testing is required.
Alcon conducted biocompatibility testing on the patient-contacting accessories and met ISO 10993 requirements for chemical characterization, cytotoxicity, sensitization, and acute systemic toxicity. Packaging materials passed cytotoxicity requirements from ISO 11607-1 and ASTM F2475.
Sterilization and Shelf Life
The UNITY VCS and CS system consoles are provided non-sterile and are not intended to be sterilized during routine use. The system consoles are intended for use with sterile accessories.
Alcon performed sterilization testing on the accessories provided sterile to the user. Test results passed the predetermined acceptance criteria and met the appropriate sterilization standards.
Shelf life testing on the sterile accessories yielded successful test results for the latest pull point for the consumable accessories covered by this premarket notification.
Electromagnetic Compatibility (EMC )/ Wireless / Electrical Safety
Alcon assessed the EMC, wireless, and electrical / mechanical safety of the UNITY VCS and UNITY CS according to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-4-2, and the final FDA guidance documents "Electromagnetic Compatibility (EMC) of Medical Devices," issued June 6, 2022, and "Radio Frequency Wireless Technology in Medical Devices," issued on August 14, 2013. The subject devices met all requirements from the aforementioned standards and followed FDA recommendations where applicable from said guidance documents.
Software
Alcon developed and tested the UNITY VCS and UNITY CS device software functions according to ANSI / AAMI / IEC 62304, "Medical Device Software – Software Life Cycle Processes" and internal Alcon procedures that follow this standard. Premarket submission documentation was prepared in accordance with the final FDA guidance "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023. Testing met all requirements from IEC 62304, and all FDA recommendations for documentation were met.
Alcon also fulfilled FDA's cybersecurity recommendations for the subject devices in accordance
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with the final FDA guidance "Cybersecurity in Medical Devices: Ouality System Considerations and Content of Premarket Submissions," dated September 2023.
Performance Testing
Alcon conducted performance tests on the UNITY VCS and UNITY CS devices to demonstrate safety, effectiveness, and substantial equivalence to predicate devices, in accordance with IEC 80601-2-58.
Safety tests of the UNITY VCS and UNITY CS demonstrated the compliance of the subject devices to the appropriate standards. Biocompatibility evaluations of materials coming into contact with the patient or patient fluid path demonstrated compliance with the appropriate standard from the ISO 10993 series or with ISO 16671:2015.
Sterile, single-use UNITY VCS and UNITY CS accessories have been shown to be sterilizable to a sterility assurance level (SAL) of 10-, and the sterilization process for these accessories has been validated per the required standard.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Like the predicate devices have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the subject devices are equivalent to the predicate devices.
7.2
The risk assessment for the subject devices did not require any animal or clinical testing as mitigation against any identified risks.
CONCLUSION 8.
The subject devices share the same intended use as the predicate devices. Their indications for use are equivalent with each other. The technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Risk profiles are equivalent between the subject devices and the predicate devices. The predicate devices and the subject devices have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971. Non-clinical testing noted above demonstrated that the functional requirements were met, and that the subject devices are equivalent to the predicate devices.
Therefore, the UNITY VCS and UNITY CS are deemed substantially equivalent to their predicate devices, the CONSTELLATION Vision System, Alcon Next-Generation Laser (for the UNITY VCS laser functionality), and the CENTURION Vision System, respectively.