(59 days)
Not Found
No
The description focuses on mechanical and electrical processes for cutting the capsule, with no mention of AI/ML for decision-making, image analysis, or adaptive control.
Yes
The device is used to perform anterior capsulotomy, a surgical procedure, during cataract surgery, which directly addresses a medical condition to restore or improve a bodily function.
No
The device description clearly states its purpose is to perform anterior capsulotomy during cataract surgery, which is a surgical procedure, not a diagnostic one. It describes the physical action of cutting and removing part of the capsule, not detecting or assessing a condition.
No
The device description clearly outlines multiple hardware components including a Power Console, Disposable Handpiece, Disposable Fluid Isolator, suction tubing, and a cutting element. The device's function relies on the interaction of these physical components to perform the capsulotomy procedure. While software is mentioned in the performance studies, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for performing anterior capsulotomy during cataract surgery. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device is a surgical tool that physically cuts the anterior capsule of the eye using energy pulses and suction. It interacts directly with the patient's tissue.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not analyze such specimens.
The ZEPTO Precision Capsulotomy System is a surgical device used in vivo (within the living body) for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.
Product codes (comma separated list FDA assigned to the subject device)
PUL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior capsulotomy, anterior chamber, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nurse assistant, physician
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)
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.
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.
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
§ 886.4100 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.
0
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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
1
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
2
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 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: | 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 | Product
Code | 510(K)
Number | Clearance
Date |
|------------------------------------------|-----------------------------------------------------------------------------------|-----------------|------------------|-------------------|
| ZEPTO Precision
Capsulotomy
System | 886.4100 - Apparatus, Cutting,
Radiofrequency, Electrosurgical, AC-
Powered | PUL | K210827 | 12/14/2021 |
4
Device Description
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
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 Precision Capsulotomy | |
| System | ||
| Manufacturer | Centricity Vision, Inc | Centricity Vision, Inc |
| Device classification | 2 | 2 |
| Indications for Use | ZEPTO Precision Capsulotomy | |
| System is indicated for use in | ||
| performing anterior capsulotomy | ||
| during cataract surgery. | ZEPTO Precision Capsulotomy | |
| System 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 | |
| • Disposable Fluid Isolator | ||
| Method of | ||
| sterilization, SAL | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 |
| Packaging, Sterile | ||
| Barrier | Thermoform Tray/Tyvek Lidding | |
| Stock | Thermoform Tray/Tyvek Lidding | |
| Stock | ||
| System control | ||
| component | Power Console | Power Console |
| Software | ||
| Environment | Cooperative, Non-Preemptive | |
| Scheduler | State Machine (Yakindu) | |
| 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 | |
| • Footswitch (Wired or Wireless) | ||
| Cutting Element | ||
| Shape | Circular | Circular |
| Comparison Feature | Subject Device | Predicate Device |
| Device name | ZEPTO Precision Capsulotomy | |
| System | ZEPTO Precision Capsulotomy | |
| System | ||
| 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:
- 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.