The Subject Device consists of a Power Console. Disposable Handbiece, 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 an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them:

The provided text describes the ZEPTO Precision Capsulotomy System and its 510(k) clearance by the FDA. However, it does not explicitly detail specific acceptance criteria values or a "study" in the sense of a clinical trial with a test set, ground truth, expert adjudication, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will indicate where information is not provided or inferred from the types of tests mentioned.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Met safety and performance requirements
Sterility	Met safety and performance requirements (Ethylene Oxide, SAL 10-6)
EO Residual	Met safety and performance requirements
Packaging Integrity (Sterile Barrier)	Met safety and performance requirements (Thermoform Tray/Tyvek Lidding Stock)
Transportation	Met safety and performance requirements
Electromagnetic Compatibility & Electrical Safety	Met safety and performance requirements
Stability/Shelf-Life	Met safety and performance requirements
Performance/Functionality/Safety	Met safety and performance requirements
Software	Met safety and performance requirements
Simulated Use (Human Factors Evaluation)	Met safety and performance requirements
Capsulotomy Size	5.0mm (nominal)
Cutting Element Shape	Circular
Patient Contact Component	Capsulotomy Tip of the Disposable Handpiece
Single-use Components	Disposable Handpiece, Disposable Fluid Isolator

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "Summary of Testing Performed" but does not specify sample sizes for these tests. The nature of these tests (e.g., biocompatibility) suggests in-vitro or bench testing, not a clinical "test set" in the context of AI/diagnostic device evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This device is a surgical instrument, not a diagnostic AI. The "ground truth" for its performance would be engineering specifications and successful operation, not expert consensus on medical images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a surgical device, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. Not an AI algorithm. Its performance is inherent to the device's mechanical and electrical design.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is based on engineering specifications, regulatory standards (e.g., biocompatibility, electrical safety), and successful functional operation during various performance and simulated use tests. For capsulotomy size and shape, the ground truth would be precise measurements against design specifications.
The sample size for the training set:
- Not applicable/Not provided. This is not an AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI device.

Summary of the Study:

The "study" described is a design verification and validation testing program rather than a clinical study with a patient test set. The testing covered:

Biocompatibility
Sterility and EO Residual
Packaging Integrity (Sterile Barrier)
Transportation
Electromagnetic Compatibility and Electrical Safety
Stability/Shelf-Life
Performance/Functionality/Safety
Software
Simulated Use (Human Factors Evaluation)

The results of these evaluations demonstrated that the Subject Device met the safety and performance requirements as it relates to its indication for use and was substantially equivalent to the predicate device. The provenance of the data is not specified but would typically be from in-house or contracted laboratory testing (bench testing, in-vitro testing).

Summary

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December 14, 2021

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

Re: K210827

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: November 3, 2021 Received: November 5, 2021

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.

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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 (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 titled "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-devices/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/medical-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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210827

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

K210827 – 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:	November 22, 2021

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	886.4100 - Apparatus, Cutting,Radiofrequency, Electrosurgical, AC-Powered	PUL	K170655	6/2/2017

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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 Capsulotomy System	ZEPTO
Manufacturer	Centricity Vision, Inc	Centricity Vision, Inc. (Previously known as Mynosys Cellular Devices, Inc.)
Device classification	2	2
Indications for Use	ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.	Zepto is indicated for use in performing anterior capsulotomy during cataract surgery.
System components	Power Console Disposable Handpiece Disposable Fluid Isolator	Power Console Disposable Handpiece Disposable Fluid Isolator
Patient contact system component	Capsulotomy Tip of the Disposable Handpiece	Capsulotomy Tip of the Disposable Handpiece
Single-use	Disposable Handpiece Disposable Fluid Isolator	Disposable Handpiece Disposable Fluid Isolator
Sterile	Disposable Handpiece Disposable Fluid Isolator	Disposable Handpiece
Method of sterilization, SAL	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6
Packaging, Sterile Barrier	Thermoform Tray/Tyvek Lidding Stock	Tyvek Pouch
System control component	Power Console	Power Console
Electrical	100-240 volts AC, 50-60Hz, 1.66 amps	100-240 volts AC, 50-60Hz, 1.66 amps
Energy Type	Rectified RF Pulsed - DC	Rectified RF Pulsed - DC
Induction of Tensile Stress	By Suction Pressure	By Suction Pressure
Control Method	Front Panel Footswitch (Wired or Wireless)	Front Panel
Cutting Element	Circular	Circular
Comparison Feature	Subject Device	Predicate Device
Device name	ZEPTO Precision CapsulotomySystem	ZEPTO
Shape
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:

Biocompatibility ●
Sterility and EO Residual
Packaging Integrity (i.e., Sterile Barrier) ●
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.