← Product Code [PUL](/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL) · K210827 # ZEPTO Precision Capsulotomy System (K210827) _Centricity Vision, Inc. · PUL · Dec 14, 2021 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K210827 ## Device Facts - **Applicant:** Centricity Vision, Inc. - **Product Code:** [PUL](/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL.md) - **Decision Date:** Dec 14, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4100 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery. ## Device Story System comprises Power Console, disposable handpiece, and disposable fluid isolator. Handpiece features distal silicone suction cup and circular cutting element. Surgeon inserts tip into anterior chamber via corneal incision; suction applied via console to seat cutting element on anterior capsule. Console delivers 4ms electrical pulses to cutting element; rapid phase transition of water molecules between element and capsule creates 5mm capsulotomy. Nurse assistant introduces BSS via fluid displacement syringe to release suction; capsule button removed manually with forceps. Used in clinical setting by ophthalmologists. Benefits include precise, circular capsulotomy during cataract surgery. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical design verification and validation testing, including biocompatibility, sterility, packaging integrity, transportation, electromagnetic compatibility, electrical safety, shelf-life, performance/functionality, software, and human factors evaluation. ## Technological Characteristics System uses rectified RF pulsed DC energy. Components include power console, disposable handpiece with silicone suction cup, and fluid isolator. Sterile via Ethylene Oxide (SAL 10^-6). Connectivity includes wired/wireless footswitch. Dimensions produce 5.0mm nominal capsulotomy. Software-controlled power delivery. ## Regulatory 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. ## Predicate Devices - ZEPTO ([K170655](/device/K170655.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs. 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). 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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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The overall effect is reminiscent of a stylized sun or a complex, geometric flower. # Centricity Vision ## K210827 – 510(K) SUMMARY ## Submitter Information | Company Name: | Centricity Vision, Inc. | |--------------------|-------------------------------------------------------------------------------------------------------| | Company Address: | 1939 Palomar Oaks Way, Suite A
Carlsbad, CA 92011 | | Company Phone: | (760) 456-5015 | | Company Facsimile: | (760) 579-6116 | | Contact Person: | Neal Hartman
Vice President, Regulatory Affairs/Quality Assurance
nhartman@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 | Product
Code | 510(K)
Number | Clearance
Date | |-------------|-------------------------------------------------------------------------------|-----------------|------------------|-------------------| | ZEPTO | 886.4100 - Apparatus, Cutting,
Radiofrequency, Electrosurgical, AC-Powered | PUL | K170655 | 6/2/2017 | {4}------------------------------------------------ |--|--|--|--|--| #### Device Description 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 {5}------------------------------------------------ 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 Capsulotomy
System | ZEPTO | | Shape | | | | Capsulotomy Size | 5.0mm (nominal) | 5.0mm (nominal) | #### Comparison of Technological Characteristics of Predicate and Subject Devices {6}------------------------------------------------ ### 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. --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K210827](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/PUL/K210827) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com