The Subject Device is basically Predicate, which is currently on the market, but integrated with OEM Ultrasonic Phacoemulsification (USP) system. The Subject Device and the USP are both required to complete the capsulotomy. The Subject Device includes the following system components:

. Power Console with Power Supply
. Reusable Pneumatic Connection, USP VIT-to-ZeptoLink
. Disposable Handpieces
USP Support Mounts .
The Power Console includes a LCD touchscreen display, which can rotate for viewing at different angles. The console is mounted to the USP with customized support mounts design for various USPs. The console includes hardware and software, which the software establishes a safe state in the event of faults. The safe state is redundant electrical isolation components and pressure isolation. Low positive pressure irrigation is allowed in the safe state to ensure release from the lens capsule. This mimics USP system's safe state architecture.
No electricity is shared between the Power Console and USP. The console is connected to an electrical outlet via a separate 12V power adapter module "power brick". The Disposable Handpiece's power cord is connected to the console. Energy delivery to the handpiece's capsulotomy tip is solely provided through the console.
Priming the handpiece's suction line, the suction used to create apposition of the capsulotomy tip, and positive pressure irrigation used to release the capsulotomy tip after capsulotomy are all performed with the USP's fluidics (i.e., irrigation and aspiration). The handpiece suction line is connected to the irrigation/aspiration lines of the USP's pack. A 0.22-micron filter incorporated on the suction line is inserted into the pressure sensing module located on the console's front panel. The filter provides a sterile barrier between the suction path of the handpiece and the console.
Initial priming of the suction line is conducted by pressing the USP continuous irrigation icon on the user interface, or by pressing the fill functions icon in the USPs vitrectomy state. Should additional priming be required, the vitrectorny fill icon can be pressed more than once. If the suction line requires additional priming just prior to surgery, the surgeon can accomplish this by pressing the USP's footswitch to position one (1) to generate irrigation.
The surgeon initiates suction by pressing the USP's footswitch to position two (2), which triggers the console to pinch off the irrigation line. Suction is maintained with continued pressure to the footswitch. The delivery of energy will not be authorized until a threshold vacuum pressure for a specified duration has been achieved. Note: To stop suction, the surgeon simply releases pressure from the footswitch.
To release the capsulotomy tip after capsulotomy, the Surgeon releases pressure from the foot pedal. The console will release "un-pinch" the irrigation line after energy delivery.
There are a couple of ways to initiate energy delivery. The first method is to press the associated icon on the console's touch screen, which the sterile nurse will perform with verbal communication from the surgeon. The second method is through the USP's footswitch, which sends a signal through the vitrectomy port to the console, via the reusable pneumatic connection. The pneumatic pulse signal is recognized by the console and initiates energy delivery. The surgeon controls energy delivery with the second method. In both methods, energy delivery cannot occur without the suction parameters being met and the energy being unlocked, either manually by depressing the energy unlock icon on the console.
The Disposable Handpiece part of the Subject Device is identical to the Predicate with the exception of extending the suction line to incorporate the irrigation/ aspiration connections to the USP's disposable pack and 0.22-micron filter. The functional portion that executes that capsulotomy is the capsulotomy tip located at the distal end of the handpiece, which consists of a circular, silicone suction cup, and circular cutting element. Energy pulses are delivered to the cutting element to create the capsulotomy. This is identical to the Predicate.
Other than the above-mentioned procedural activities, the capsulotomy procedure is identical to the Predicate.The capsulotomy tip is elongate by sliding the finger slider distally, this allow it to be easy inserted into the anterior chamber through the corneal incision. Once inserted into the anterior chamber, the finger slider is pulled back to return the suction cup/cutting element to their original circular shapes. After centering the cutting element at the desired location on the anterior capsule, suction is initiated, which the capsulotomy tip will applanate, seating the cutting element to anterior capsule.
Once suction is achieved, energy is initiated. A series of electrical pulses lasting a total of 4 milliseconds is delivered to the cutting element causing rapid phase transition of water molecules trapped between the bottom edge of the cutting element and the anterior capsule. The rapid volume expansion results in the capsule cutting action. Depending on which handpiece configuration is used the capsulotomy size is nominally 5.1 or 5.4mm.
The surgeon will remove the capsulotomy tip from the anterior chamber through the corneal incision when it releases from the capsule button will either come out when the capsulotomy tip is removed or be free-floating in the chamber where manual removal with forceps is required.
The Disposable Handbiece and the sterile drape for the Power Console display are packaged in a sterile barrier thermoform tray with Tyvek lid. Ten (10) packaged devices are inserted into an inner carton with the IFU then inserted into a shipper box. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.
The Power Console is packaged into an ESD protective bag and foam protectors are positioned of both side of the console then inserted into a shipper box. The power supply, power cord, and user manual are also provided in the shipper.
Reusable pneumatic connection and USP support mounts are be packaged separately.

AI/ML Overview

The provided document is a 510(k) summary for the "ZeptoLink IOL Positioning System." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets said criteria in the format requested.

The document states that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use" and "The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate Devices as it pertains to the indications for use and device performance." but does not provide the quantitative values that constitute these "safety and performance requirements" or the data from the evaluations.

Therefore, I cannot populate the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(e.g., Capsulotomy Diameter Accuracy: ±0.1mm)	(e.g., Achieved an average capsulotomy diameter of 5.10mm ± 0.05mm)
(e.g., Success Rate of Complete Capsulotomy: >95%)	(e.g., 98% success rate in simulated use)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "Simulated Use (Human Factors Evaluation)" as one of the tests performed, which suggests laboratory or simulated environment testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified. The document does not mention the use of experts to establish ground truth for testing.

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

Not specified.

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:

Not applicable/Not specified. This document is for a medical device (capsulotomy system), not an AI-assisted diagnostic or interpretive system that involves "readers" in the typical sense of MRMC studies. The device performs a physical action (capsulotomy), and its safety and performance would be assessed through objective measurements and functional tests, not reader studies.

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

Not applicable/Not specified. The device is not an algorithm-only system; it's a physical medical device. The "Software" testing mentioned would be for the device's control system, not a standalone diagnostic algorithm. There is a "Human Factors Evaluation" (simulated use) listed, indicating human involvement in the device's interaction.

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

Not specified. Given the nature of the device (capsulotomy), ground truth would likely involve objective measurements of the capsulotomy's characteristics (e.g., diameter, circularity, completeness) achieved in simulated environments or animal models, rather than expert consensus on images, pathology, or direct patient outcomes in this particular documentation context.

8. The sample size for the training set:

Not applicable/Not specified. The document is for a medical device, not an AI system that undergoes a "training set" in the machine learning sense. The software mentioned would be deterministic control software, not a learned model.

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

Not applicable/Not specified. (See point 8).

Summary

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April 11, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Centricity Vision, Inc. Neal Hartman Vice President, Regulatory Affairs/Quality Assurance 1939 Palomar Oaks Way, Suite A Carlsbad, California 92011

Re: K223763

Trade/Device Name: ZeptoLink IOL Positioning System Regulation Number: 21 CFR 886.4100 Regulation Name: Radiofrequency Electrosurgical Cautery Apparatus Regulatory Class: Class II Product Code: PUL Dated: March 10, 2023 Received: March 13, 2023

Dear Neal Hartman:

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 (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Elvin Y.

For Tieuvi Nguyen, Ph.D. 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) K223763

Device Name ZeptoLink IOL Positioning System

Indications for Use (Describe)

The ZeptoLink IOL Positioning System is indicated for use in performing anterior capsulotomy during cataract surgery.

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)

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Centricity Vision

K223763 – 510(K) SUMMARY

Submitter Information

Company Name:	Centricity Vision, Inc.
Company Address:	1939 Palomar Oaks Way, Suite ACarlsbad, CA 92011
Company Phone:	(760) 456-5015
Company Facsimile:	(760) 579-6116
Contact Person:	Neal HartmanVice President, Regulatory Affairs/Quality Assurancenhartman@centricityvision.com
Date:	April 11, 2023

Device Identification

Device Trade Name:	ZeptoLink IOL Positioning System
Common Name:	Capsulotomy Device
Classification Name(s):	Apparatus, Cutting, Radiofrequency, Electrosurgical,AC-Powered
Regulation(s):	886.4100
Device Class:	Class II
Product Code(s):	PUL
Advisory Panel:	Ophthalmic

ldentification of Predicate Devices

The Subject Device is substantially equivalent to the following device:

Device Name	Classification Regulation	ProductCode	510(K)Number	ClearanceDate
ZEPTOPrecisionCapsulotomySystem	886.4100 - Apparatus, Cutting,Radiofrequency, Electrosurgical, AC-Powered	PUL	K210827	12/14/2021

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Device Description

. Power Console with Power Supply
. Reusable Pneumatic Connection, USP VIT-to-ZeptoLink
. Disposable Handpieces
USP Support Mounts .

The Power Console includes a LCD touchscreen display, which can rotate for viewing at different angles. The console is mounted to the USP with customized support mounts design for various USPs. The console includes hardware and software, which the software establishes a safe state in the event of faults. The safe state is redundant electrical isolation components and pressure isolation. Low positive pressure irrigation is allowed in the safe state to ensure release from the lens capsule. This mimics USP system's safe state architecture.

No electricity is shared between the Power Console and USP. The console is connected to an electrical outlet via a separate 12V power adapter module "power brick". The Disposable Handpiece's power cord is connected to the console. Energy delivery to the handpiece's capsulotomy tip is solely provided through the console.

Priming the handpiece's suction line, the suction used to create apposition of the capsulotomy tip, and positive pressure irrigation used to release the capsulotomy tip after capsulotomy are all performed with the USP's fluidics (i.e., irrigation and aspiration). The handpiece suction line is connected to the irrigation/aspiration lines of the USP's pack. A 0.22-micron filter incorporated on the suction line is inserted into the pressure sensing module located on the console's front panel. The filter provides a sterile barrier between the suction path of the handpiece and the console.

Initial priming of the suction line is conducted by pressing the USP continuous irrigation icon on the user interface, or by pressing the fill functions icon in the USPs vitrectomy state. Should additional priming be required, the vitrectorny fill icon can be pressed more than once. If the suction line requires additional priming just prior to surgery, the surgeon can accomplish this by pressing the USP's footswitch to position one (1) to generate irrigation.

The surgeon initiates suction by pressing the USP's footswitch to position two (2), which triggers the console to pinch off the irrigation line. Suction is maintained with continued pressure to the footswitch. The delivery of energy will not be authorized until a threshold vacuum pressure for a specified duration has been achieved. Note: To stop suction, the surgeon simply releases pressure from the footswitch.

To release the capsulotomy tip after capsulotomy, the Surgeon releases pressure from the foot pedal. The console will release "un-pinch" the irrigation line after energy delivery.

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There are a couple of ways to initiate energy delivery. The first method is to press the associated icon on the console's touch screen, which the sterile nurse will perform with verbal communication from the surgeon. The second method is through the USP's footswitch, which sends a signal through the vitrectomy port to the console, via the reusable pneumatic connection. The pneumatic pulse signal is recognized by the console and initiates energy delivery. The surgeon controls energy delivery with the second method. In both methods, energy delivery cannot occur without the suction parameters being met and the energy being unlocked, either manually by depressing the energy unlock icon on the console.

The Disposable Handpiece part of the Subject Device is identical to the Predicate with the exception of extending the suction line to incorporate the irrigation/ aspiration connections to the USP's disposable pack and 0.22-micron filter. The functional portion that executes that capsulotomy is the capsulotomy tip located at the distal end of the handpiece, which consists of a circular, silicone suction cup, and circular cutting element. Energy pulses are delivered to the cutting element to create the capsulotomy. This is identical to the Predicate.

Other than the above-mentioned procedural activities, the capsulotomy procedure is identical to the Predicate.The capsulotomy tip is elongate by sliding the finger slider distally, this allow it to be easy inserted into the anterior chamber through the corneal incision. Once inserted into the anterior chamber, the finger slider is pulled back to return the suction cup/cutting element to their original circular shapes. After centering the cutting element at the desired location on the anterior capsule, suction is initiated, which the capsulotomy tip will applanate, seating the cutting element to anterior capsule.

Once suction is achieved, energy is initiated. A series of electrical pulses lasting a total of 4 milliseconds is delivered to the cutting element causing rapid phase transition of water molecules trapped between the bottom edge of the cutting element and the anterior capsule. The rapid volume expansion results in the capsule cutting action. Depending on which handpiece configuration is used the capsulotomy size is nominally 5.1 or 5.4mm.

The surgeon will remove the capsulotomy tip from the anterior chamber through the corneal incision when it releases from the capsule button will either come out when the capsulotomy tip is removed or be free-floating in the chamber where manual removal with forceps is required.

The Disposable Handbiece and the sterile drape for the Power Console display are packaged in a sterile barrier thermoform tray with Tyvek lid. Ten (10) packaged devices are inserted into an inner carton with the IFU then inserted into a shipper box. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.

The Power Console is packaged into an ESD protective bag and foam protectors are positioned of both side of the console then inserted into a shipper box. The power supply, power cord, and user manual are also provided in the shipper.

Reusable pneumatic connection and USP support mounts are be packaged separately.

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Indications for Use

ZeptoLink IOL Positioning System is indicated for use in performing anterior capsulotomy during cataract surgery.

Comparison of Technological Characteristics with Predicate and Reference Devices

ComparisonFeature	Subject Device	Predicate Device	Differences
Device name	ZeptoLink IOL PositioningSystem	ZEPTO PrecisionCapsulotomy System	N/A
Manufacturer	Centricity Vision, Inc	Centricity Vision, Inc	None
Deviceclassification	2	2	None
Product Code	PUL	PUL	None
Indications forUse	ZeptoLink IOL PositioningSystem is indicated for usein performing anteriorcapsulotomy duringcataract surgery.	ZEPTO PrecisionCapsulotomy System isindicated for use inperforming anteriorcapsulotomy during cataractsurgery.	None
Systemcomponents	• Power Console• Disposable Handpiece• PneumaticCommunicationConnection, USPVitrectomy Port-to-PowerConsole	• Power Console• Disposable Handpiece• Disposable Fluid Isolator	The Subject Device requires acommunication line between theconsole and the USP in order toallow the surgeon to executecapsulotomy energy from theUSP footswitch. The steriletechnician can only executecapsulotomy energy from theconsole with the Predicate.Note: Execution of capsulotomyenergy can also be conduct atthe console display with theSubject Device.The Subject Device does notrequire a fluid isolator becauseliquid isolation is conductedwithin console's suction sensor.
Patientcontactsystemcomponent	Capsulotomy Tip of theDisposable Handpiece	Capsulotomy Tip of theDisposable Handpiece	None
Single-use	• Disposable Handpiece	• Disposable Handpiece• Disposable Fluid Isolator	None, disposable systemcomponents are not reusable
Sterile	• Disposable Handpiece	• Disposable Handpiece• Disposable Fluid Isolator	None, disposable systemcomponents are terminallysterilized.
Method ofsterilization,SAL	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6	None
Packaging,Sterile Barrier	Thermoform Tray/TyvekLidding Stock	Thermoform Tray/TyvekLidding Stock	None
Systemcontrolcomponent	Power Console	Power Console	Both the Subject Device andPredicate control the executionof capsulotomy energy the same,
ComparisonFeature	Subject Device	Predicate Device	Differences
Device name	ZeptoLink IOL PositioningSystem	ZEPTO PrecisionCapsulotomy System	N/A
			however they control suctiondifferently. The Predicate suctionsources is within the powerconsole and controls pressurethrough internal software andelectric controlled pressureregulator. The Subject Deviceuses the functionality of the USPfor suction and monitors thepressure output through suctionsensor in the power console viadisposable handpiece's suctionline. If high suction threshold isreached, the power console willocclude the disposablehandpiece's suction line, via apinch valve, to prevent excessivesuction at the anterior capsule.
Electrical	100-240 volts AC, 50-60Hz,1.66 amps	100-240 volts AC, 50-60Hz,1.66 amps	None
Energy Type	Rectified RF Pulsed - DC	Rectified RF Pulsed - DC	None
Induction ofTensileStress	By Suction Pressure	By Suction Pressure	None
User Interface	• Touchscreen Display(Power Console• Footswitch (USP)	• Front Panel (PowerConsole)• Footswitch (PowerConsole)	The Predicate can initiate suctionand execute capsulotomy energyfrom the front panel of the powercontrol. Optional, a footswitchaccessory can be connected tothe power console and thesefunctions can be controlledthrough the footswitch.The Subject Device requiredenergy to be unlock, whenacceptable suction has beenachieved, on the power console'stouchscreen display in order toexecute capsulotomy energy.Execution of capsulotomy energyis then performed on thetouchscreen display. Initiatingand maintaining suction, optionalexecuting capsulotomy energy,and aiding with release of thedisposable handpiece'scapsulotomy tip from the anteriorcapsule is conducted through theUSP footswitch.
CuttingElementShape	Circular	Circular	None
CapsulotomyDiameter(Nominal)	5.0mm or 5.4mm	5.0mm or 5.4mm	None, there is two (2) handpiececonfigurations for the SubjectDevice and Predicate. Eachconfiguration produces adifferent nominal capsulotomydiameter.

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Summary of Testing Performed

A program of design verification and validation testing was performed that includes the following:

. Biocompatibility
Sterility and EO Residual
Packaging Integrity (i.e., Sterile Barrier) ●
LAL Endotoxin Testing ●
Transportation ●
Electromagnetic Compatibility and Electrical Safety
Stability/Shelf-Life
Performance/Functionality/Safety
Software
Simulated Use (Human Factors Evaluation) .

Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.

Conclusions Drawn from Nonclinical Evaluation

The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate Devices as it pertains to the indications for use and device performance.

Regulation Number and Section

§ 886.4100 Radiofrequency electrosurgical cautery apparatus.

(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.