(59 days)
ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.
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.
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).
§ 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.