The Subject Device consists of a Power Console, Disposable Handpiece, and a disposable Fluid Isolator. The Disposable Handpiece's power cord connector is connected to the front panel of the Power Console to provide power for the capsulotomy procedure. The suction tubing from the Disposable Handpiece is connected to the Fluid Isolator. The Fluid Isolator is then connected to the Power Console's front panel to provide suction during the treatment to a suction cup containing the cutting element. The functional portion used for capsulotomy is the capsulotomy tip located at the distal end of the Disposable 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.

Prior to conducting the capsulotomy, the Disposable Handpiece's suction line is primed Balanced Salt Solution (BSS).

The capsulotomy tip is elongate by sliding the finger slider distally, this allows 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 on the Power Console, which provides vacuum at the capsulotomy tip to properly seat the cutting element to anterior capsule.

Once suction is achieved, enerqy is initiated on the Power Console. 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. Suction is then vented to atmosphere. The capsulotomy is nominally 5mm.

A nurse assistant will, upon command from the physician, introduce a small amount of BSS into the suction cup to allow for a gentle release of the suction cup from the capsule, and to allow the free-floating capsule button to stay behind in the anterior chamber for manual removal with forceps. This is done by advancing the fluid displacement syringe forward. Upon completion of the capsulotomy, the capsulotomy tip is removed from the anterior chamber of the eye through the corneal incision.

The Disposable Handpiece with Fluid Isolator is packaged in a sterile barrier thermoform trav. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ZEPTO Precision Capsulotomy System, based on the provided FDA 510(k) summary:

This document primarily describes the substantial equivalence of the Subject Device (K221188) to a Predicate Device (K210827), which is also the "ZEPTO Precision Capsulotomy System." The information presented focuses on demonstrating that the new device is essentially the same as the previously cleared one. Therefore, the "reported device performance" and details about separate clinical studies for this specific 510(k) submission are limited.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for this specific 510(k) submission (K221188). Instead, it relies on demonstrating substantial equivalence to a predicate device (K210827) that presumably met those criteria previously.

The document indicates that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use." This is a general statement affirming compliance, not a detailed report of specific performance metrics against pre-defined acceptance criteria.

The key performance characteristic mentioned for both the Subject and Predicate Devices is:

Capsulotomy Size: 5.0mm (nominal)

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness studies. The "Summary of Testing Performed" mentions "A program of design verification and validation testing," indicating engineering and software testing. It does not refer to clinical studies with patient data to establish performance anew for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. As noted, there's no mention of a clinical test set requiring expert ground truth for this submission.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without a described clinical test set, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

This information is not provided in the document. No MRMC study is mentioned, nor is there any discussion of AI assistance or human reader improvement. The device described is a physical surgical tool, not an AI diagnostic or assistive software.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable to the "ZEPTO Precision Capsulotomy System," as it is an electrosurgical device for performing a physical procedure, not an algorithm.

7. Type of Ground Truth Used

Based on the nature of the device (a surgical tool), the ground truth for its performance would typically involve:

Physical measurements: E.g., verifying the actual size and circularity of the created capsulotomy.
Histopathology/Gross examination: Examining the cut edges for cleanliness and integrity.
Clinical outcomes data: Assessing post-operative complications related to the capsulotomy (e.g., capsule tears, IOL decentration).

However, the provided text does not explicitly detail the type of ground truth used for this specific submission. It relies on the substantial equivalence to the predicate device, which would have established such ground truth in its own clearance process.

8. Sample Size for the Training Set

This information is not provided in the document. "Training set" is typically relevant for machine learning algorithms, which is not the nature of this device. The documentation focuses on engineering and performance validation of the physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as there is no mention of a "training set" in the context of the ZEPTO Precision Capsulotomy System.

In summary:

The provided 510(k) summary for the ZEPTO Precision Capsulotomy System (K221188) primarily focuses on demonstrating substantial equivalence to its predicate device (K210827). It confirms that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use" through a "program of design verification and validation testing," which includes software testing. However, it does not offer detailed quantitative acceptance criteria, specific clinical study sample sizes, expert qualifications, or ground truth establishment methods for this particular submission, as these were presumably established and accepted during the clearance of the predicate device. The device itself is a physical surgical tool, not an AI-driven diagnostic or assistive system, which explains the absence of information related to AI-specific metrics (e.g., MRMC studies, training sets).

Summary

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June 23, 2022

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

Re: K221188

Trade/Device Name: ZEPTO Precision Capsulotomy System Regulation Number: 21 CFR 886.4100 Regulation Name: Radiofrequency Electrosurgical Cautery Apparatus Regulatory Class: Class II Product Code: PUL Dated: April 22, 2022 Received: April 25, 2022

Dear Mr. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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-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,

Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221188

Device Name ZEPTO Precision Capsulotomy System

Indications for Use (Describe)

ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract 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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Centricity Vision

K221188 – 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:	June 20, 2022

Device Identification

Device Trade Name:	ZEPTO Precision Capsulotomy 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
ZEPTO PrecisionCapsulotomySystem	886.4100 - Apparatus, Cutting,Radiofrequency, Electrosurgical, AC-Powered	PUL	K210827	12/14/2021

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Device Description

Prior to conducting the capsulotomy, the Disposable Handpiece's suction line is primed Balanced Salt Solution (BSS).

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forward. Upon completion of the capsulotomy, the capsulotomy tip is removed from the anterior chamber of the eye through the corneal incision.

The Disposable Handpiece with Fluid Isolator is packaged in a sterile barrier thermoform trav. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.

Indications for Use

ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.

Comparison Feature	Subject Device	Predicate Device
Device name	ZEPTO Precision CapsulotomySystem	ZEPTO Precision CapsulotomySystem
Manufacturer	Centricity Vision, Inc	Centricity Vision, Inc
Device classification	2	2
Indications for Use	ZEPTO Precision CapsulotomySystem is indicated for use inperforming anterior capsulotomyduring cataract surgery.	ZEPTO Precision CapsulotomySystem is indicated for use inperforming anterior capsulotomyduring cataract surgery.
System components	• Power Console• Disposable Handpiece• Disposable Fluid Isolator	• Power Console• Disposable Handpiece• Disposable Fluid Isolator
Patient contactsystem component	Capsulotomy Tip of the DisposableHandpiece	Capsulotomy Tip of the DisposableHandpiece
Single-use	• Disposable Handpiece• Disposable Fluid Isolator	• Disposable Handpiece• Disposable Fluid Isolator
Sterile	• Disposable Handpiece• Disposable Fluid Isolator	• Disposable Handpiece• Disposable Fluid Isolator
Method ofsterilization, SAL	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6
Packaging, SterileBarrier	Thermoform Tray/Tyvek LiddingStock	Thermoform Tray/Tyvek LiddingStock
System controlcomponent	Power Console	Power Console
SoftwareEnvironment	Cooperative, Non-PreemptiveScheduler	State Machine (Yakindu)
Electrical	100-240 volts AC, 50-60Hz, 1.66amps	100-240 volts AC, 50-60Hz, 1.66amps
Energy Type	Rectified RF Pulsed - DC	Rectified RF Pulsed - DC
Induction of TensileStress	By Suction Pressure	By Suction Pressure
Control Method	• Front Panel• Footswitch (Wired or Wireless)	• Front Panel• Footswitch (Wired or Wireless)
Cutting ElementShape	Circular	Circular
Comparison Feature	Subject Device	Predicate Device
Device name	ZEPTO Precision CapsulotomySystem	ZEPTO Precision CapsulotomySystem
Capsulotomy Size	5.0mm (nominal)	5.0mm (nominal)

Comparison of Technological Characteristics of Predicate and Subject Devices

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Summary of Testing Performed

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

Software
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.