The Zepto™ is an electrosurgical device indicated for use in performing anterior capsulotomies during cataract surgery. The Zepto™ Capsulotomy System consists of a console, disposable handpiece, and a fluid isolator assembly (consisting of the fluid isolator, roller dispenser, and clamp). The handpiece power cord connector is connected to the front panel of the console to provide power for the capsulotomy procedure. The medical grade PVC suction tubing from the handpiece is connected to the fluid isolator. The fluid isolator is then connected to the console's front panel to provide suction during the treatment to a silicone suction cup containing the capsulotomy element. The Zepto 110 console delivers pulsed DC energy from a storage capacitor to a circular capsulotomy element on the tip of the disposable handpiece for creation of a nominal 5mm diameter capsulotomy.

AI/ML Overview

The provided text doesn't describe a study that uses an AI/ML device, but rather a medical device (Zepto™) for anterior capsulotomy during cataract surgery. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, training set details, and expert adjudication of ground truth for AI) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the study that proves the device meets its performance goals based on the provided FDA 510(k) summary.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the primary safety and effectiveness endpoints and additional parameters evaluated. The document doesn't present a formal table of pre-defined acceptance criteria with pass/fail thresholds for each metric, but rather describes the achieved performance against certain target outcomes (e.g., matching historical rates for the "gold standard" technique).

Metric / Endpoint	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Primary Safety Endpoint:
Posterior capsule rupture and vitreous loss	Rate should be comparable to or better than "gold standard" CCC (historically derived).	0 out of 100 eyes treated with Zepto.	Meets implied criterion.
Primary Effectiveness Endpoint:
Completeness of capsulotomy (successful 360-degree capsulotomy)	High rate of completeness. Specific numerical target not explicitly stated but implied to be near 100%.	98 out of 100 cases (98%).	Two incomplete cases attributed to user error/suboptimal visualization, not device failure.
Additional Safety Parameters:
Anterior Capsule Tear	Low occurrence, ideally no vitreous loss.	2 out of 100 eyes. Neither had vitreous loss. One device-related.	Reported.
Corneal Touch	No cases reported.	0 cases reported.	Meets implied criterion.
Adverse Events	Low incidence, and few device-related.	Epithelial erosion, macular edema, anterior/posterior capsule tear, IOP elevation, ache. Only 1 case (AC/PC tear) was noted to be device-related.	Reported.
Additional Effectiveness Parameters:
Diameter of Capsulotomy	Consistent, nominal 5mm.	Mean 5.14 mm +/- 0.14 mm (range 4.9-5.5 mm).	Consistent and close to nominal.
Circularity of Capsulotomy	High rate of circularity.	99 out of 100 cases recorded as circular without zonular damage.	Meets implied criterion.
Pre- and Post Zepto Corneal Incision Size	Minimal increase.	Mean increase 0.0305 mm (range 0-0.2 mm).	Reported as minimal.
Ease of cortex removal	Similar or easier than manual capsulorhexis.	97 out of 100 cases reported as similar or easier.	Meets implied criterion.
Capsulotomy centration	High rate of centration.	96 out of 100 reported as centered.	High rate of centration.
IOL centration	100% intracapsular fixation and centered.	100% reported with IOL intracapsular fixation and centered.	Meets implied criterion.
BCVA at 1 month	Good visual outcome (e.g., 20/20).	Mean BCVA 20/20.	Meets implied criterion.
Capsular abnormalities / Slit lamp findings	No clinically significant abnormalities.	No capsular abnormalities reported. No clinically significant slit lamp exam findings.	Meets implied criterion.

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

Sample Size for Clinical Test Set: 100 eyes.
Data Provenance: The study was a "clinical trial" conducted specifically to evaluate the device performance, indicating it was prospective data collection. The document does not explicitly state the country of origin for the clinical data, but it's an FDA submission, implying the study was likely conducted under U.S. clinical trial regulations or internationally recognized standards for submission to FDA.

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

The study involved ophthalmic surgeons using the device. The "ground truth" (e.g., successful capsulotomy, complications) would have been established by the performing surgeons and/or study investigators who observed the procedures and patient outcomes. The document does not specify the number of experts/investigators who established the ground truth in terms of adjudication, nor their specific years of experience. It simply states the device is to be used by "ophthalmic surgeons."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus by independent readers) for the clinical study's outcomes. The reporting of safety and effectiveness parameters (e.g., "2 cases of incomplete capsulotomy," "2 of 100 eyes had anterior capsule tear") suggests that these were observed and reported by the clinical investigators as part of standard clinical trial data collection. There's no mention of an independent panel reviewing cases to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on diagnostic performance) is relevant for AI/ML diagnostic devices. The Zepto™ is a surgical device, not a diagnostic imaging AI. The clinical trial focused on the device's performance during surgery and post-operative outcomes, not on human diagnostic interpretation or improvement with AI assistance. The comparison was against the "historically derived rate for the 'gold standard' surgical technique" (CCC), not against human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable in the context of an AI/ML algorithm. The Zepto™ device itself is the "standalone" entity whose performance is being evaluated. It functions as a surgical instrument. The clinical study evaluates its performance in vivo when used by a surgeon.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical observation of surgical outcomes and patient follow-up data. This includes:
- Direct observation of capsulotomy completeness and characteristics during surgery.
- Observation of intraoperative complications (e.g., posterior capsule rupture, vitreous loss, anterior capsule tear).
- Post-operative patient outcomes (e.g., BCVA, IOL centration, slit lamp findings, adverse events).
For the pre-clinical studies, animal histopathology and biomechanical testing of human cadaver eyes were used to establish ground truth for specific parameters like endothelial cell condition, zonular stress, and capsule edge strength/extensibility.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device study with a "training set" in the machine learning sense. The device is a physical instrument.

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

Not applicable for the same reason as above. The "training" for this device largely comes from engineering design, bench testing, and pre-clinical studies (animal and cadaver). The clinical study served as a validation of its performance in humans.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

Mynosys Cellular Devices, Inc. Dan Marinsik VP, Quality, Clinical & Regulatory Affairs 46710 Fremont Blvd. Fremont, CA 94538-6538

Re: K170655

Trade/Device Name: Zepto Regulation Number: 21 CFR 886.4100 Regulation Name: Radiofrequency Electrosurgical Cautery Apparatus Regulatory Class: Class II Product Code: PUL Dated: April 25, 2017 Received: April 28, 2017

Dear Dan Marinsik:

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170655

Device Name Zepto™M

Indications for Use (Describe)

Zepto™ 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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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Mynosys Cellular Devices, Inc.46710 Fremont Blvd.Fremont, CA. 94538
Contact	Dan Marinsik
Phone Number	510-857-6296
FAX Number	510-689-2349
Date Prepared	5-26-17
TRADE NAME:	ZEPTO™
COMMON NAME:	Capsulotomy Device
DEVICE	Device Class - II
CLASSIFICATION:NAME:	Radiofrequency electrosurgical cautery apparatus
PRODUCT CODE	NCR
REGULATIONNUMBER:	21 CFR § 886.4100
PREDICATE DEVICE	The Fugo Blade(K001498)

SUBSTANTIALLY EQUIVALENT TO:

The Fugo Blade	(K001498)

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Description of the Device Subject to Premarket Notification:

Statement of Intended Use

The intended use for Zepto™ is as a surgical instrument to be used by ophthalmic surgeons for performing anterior capsulotomy during cataract surgery. The device includes durable hardware for multi-use, a disposable handpiece and fluid isolator assembly for single-patient use . The Zepto™ is a prescription (Rx) device to be used by, or on the order of a licensed physician.

Indication for Use

Zepto™ is indicated for use in performing anterior capsulotomy during cataract surgery.

Technological Characteristics Comparison

The Zepto™ shares many technological characteristics including indications and technological features to those of the predicate device, The Fugo Blade. The Zepto "" also utilizes the same mechanism of action to perform the capsulotomy and is therefore substantially equivalent to the legally marketed predicate device. Differences between the Zepto and the predicate device are well-defined and well-characterized and do not raise any new concerns of safety. Key characteristics are provided in the table below.

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510(K) SUMMARY

Attributes	Zepto™(K170655)	The Fugo Blade(K001498)	Comment
	INTENDED USE
Manufacturer	Mynosys CellularDevices	Medisurg Ltd.
Clearance Date	-	08/10/2000
Model Number	12684, 12430, 12686	M100
FDA Regulation	21 CFR 886.4100	21 CFR 886.4100	Same
Regulation Name	Radiofrequencyelectrosurgicalcautery apparatus	Radiofrequencyelectrosurgicalcautery apparatus	Same
FDA ClassificationProduct Code	NCR	NCR	Same
FDAMedical DeviceClassification	Class - II	Class - II	Same
Single UseDisposableComponent(s)	Zepto™ Handpieceand fluid isolatorassembly are singleuse disposables	The Fugo Blade tipis a single usedisposable	Same
Prescription(Rx)/Over-the-Counter (OTC)	Rx	Rx	Same
	TECHNOLOGICAL CHARACTERISTICS
Energy Type	Rectified RF Pulsed-DC	RF	Fugo Blade uses fullwave RF, Zepto™uses rectified RF
Induction of capsuletensile stress	Yes, by suctionpressure	Yes, by manipulationof probe tip againstcapsule tissue to becut	SE, induced bydifferent mechanicalmeans
Electrical	110 VAC 50-60 Hz	4 size "C"rechargable batteriesprovide DC currentfor the Fugo BladeBattery Charger:100-240 VAC, 50/60Hz, 1.0A	Same, bothelectrically powered
ElectricalClassification	Type BF	Type BF	Same
Attributes	Zepto™(K170655)	The Fugo Blade(K001498)	Comment
Control	Firmware and buttoncontrol	Firmware, footswitchand variable powerand intensity control	Both aremicroprocessorcontrolled. FugoBlade has power andintensity controls onthe console based onthe individualPhysician's speed inperformingCapsulotomy.Zepto™ has a factorypreset power outputthat is slightly lowerdue to the cuttingelement being circularin design.
System Components	Handpiece, controlconsole, fluid isolatorassembly(see Fig. 12.1)	Handpiece, controlconsole footswitch(see Fig. 12.1)	Equivalent
Dimensions (ControlBox)	$13.5" X 10" X 6.5"$	$10.00" X 7.05" X6.12"$	Both consoles areportable
Emergency Off	Yes	Yes	Same
Foot SwitchControlled	No	Yes	The Fugo Bladeutilizes a footswitch toprovide power to thetreatment tip. Thepower of the Zepto isdelivered via theCut/Release button
Procedure Halt UsingFoot Switch	No	Yes	The Fugo Bladeutilizes a footswitch,Zepto utilizes anemergency StopButton on console
On Switch	Yes	Yes	Same
Display Panel	Yes	Yes	Same
Mains Switch	Yes	Yes	Same
Disposable CuttingElement	Yes	Yes	Same
Attributes	Zepto™(K170655)	The Fugo Blade(K001498)	Comment
Cutting ElementShape	Circular	Straight	SE - Fugo Bladestraight cuttingelement requires 7-15seconds to performcapsulotomy, Zepto™circular cuttingelement completescapsulotomy in 4msec
Capsulotomy Size	5.0 mm (nominal)	Variable Dependenton Surgeon	SE - Fugo Bladecapsulotomy varies indiameter due tomanual circularmanipulation of thestraight cutting tip.Zepto™ has uniformcapsulotomy diameterbased on a circularcutting element
MANUFACTURING
Biocompatibility	The Zepto™Handpiece passedtesting performedaccording to ISO10993-5(Cytotoxicity), 10993-10 (Acute SystemicToxicity) and 10993-11(Sensitization andIrritation).	There is no mentionin the company'sliterature, website or510(k) summary asto whether the FugoBlade was tested forbiocompatibility.	The Zepto™ is madefrom Biocompatiblematerials, The FugoBlade is presumed tobe the same.
Sterilization	EtO	Heat Autoclave orEtO	Same - Both usevalidated sterilemethods presumed toprovide SAL of 1 X 10-6
Packaging	Zepto™ Handpiece:sterile singlepouched Tyvek® bag	Fugo Blade tip:single pouchedTyvek® bag in box of12 tips	Same
Shelf Life	12 months	Unknown	The Zepto™ has avalidated shelf life.The Fugo Blade Ipresumed to be thesame.

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510(K) SUMMARY

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510(K) SUMMARY

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Brief Summary of Nonclinical Tests and Results

Mynosys has developed the Zepto™ for use in anterior capsulotomy. Nonclinical testing included pre-clinical animal studies and bench testing.

Summary of Pre-Clinical Testing

A GLP study was conducted that demonstrated the effectiveness of the device in 20 out of 20 rabbit eyes. This study also verified that there was negligible temperature change in the anterior chamber during Zepto "" use. In addition, there were no differences in the endothelial cell condition and ocular histopathology of eyes or the overall condition of eyes that received a Zepto"10 capsulotomy compared to fellow eyes that received a CCC. The study also confirmed that there was no observable zonular stress during a Zepto "10 capsulotomy.

Summary of Bench Testing

A paired human cadaver eves study compared the strength and extensibility of the Zepto "" capsulotomy edge with that of femtosecond laser and CCC. (The predicate device was not available for this study.) This study demonstrated overall general safety of the Zepto™. The biomechanical testing of capsulotomy edge properties resulting from different methods of capsulotomy in paired human cadaver eves provides direct quantitative assessment of edge strength and extensibility. Pairwise comparison of Zepto 100 capsulotomies in one eve and either CCC or femtosecond laser capsulotomy in the fellow eye of the same donor provide the most scientifically rigorous evaluation of their relative performance and rule out confounding donor related factors.

The results of the Capsule Edge Strength Study (COCESS) using paired cadaver eyes show that the extensibility of the Zepto "" capsule edges as quantified by stretch ratios were significantly greater than that of capsule edges produced by CCC or by femtosecond laser. The data show that Zepto™ capsulotomies should also exhibit greater extensibility when compared to the predicate device.

Microcalorimetry Validation Test Report

Microcalorimetry testing demonstrated that the Zepto™ is equivalent to the predicate device in energy used during performance of capsulotomies in cataract surgery.

Brief Summary of Clinical Tests and Results

A clinical trial of the Zepto™ was conducted to evaluate its performance in the creation of anterior capsulotomies during cataract surgery. This clinical study was undertaken to address specific questions of safety and effectiveness related to demonstrating substantial

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equivalence.

Primary Safety Endpoint: Safety of the ZeptoTM was evaluated by comparing the observed event rate against the historically derived rate for the "gold standard" surgical technique of continuous curvilinear capsulorrhexis (CCC). No posterior capsule rupture and vitreous loss in 100 eyes treated with Zepto.

Primary Effectiveness Endpoint: Capsulotomy effectiveness was determined by evaluating the completeness of the Zepto capsulotomy. The effectiveness analysis revealed 2 cases of incomplete capsulotomy out of 100 cases performed. Successful Zepto 360 degree capsulotomy in 98 of 100 subjects treated with Zepto. Two eyes required manual capsulotomy, both with good visual outcome and IOL capsular fixation, and without adverse outcomes:

1 case was attributed to user error (simultaneous energy applied and suction release):
. 1 case with small tissue bridge observed after Zepto procedure was completed manually, attributed to suboptimal surgical microscope visualization, leading to application of Zepto energy before complete apposition of Zepto capsulotomy ring with the capsule was observed.

Additional Safety Parameters:

· AC Tear: 2 of 100 eyes treated with Zepto had anterior capsule tear, neither with vitreous loss:
- o 1 case noted at end of surgery with secondary PC tear extending during exchange of damaged IOL;
- o 1 case attributed to cataract chopping technique, did not extend to posterior capsule.
. Corneal Touch: No cases reported.
. Adverse Events: evithelial erosion and macular edema, anterior capsule tear. anterior and posterior capsule tear without vitreous loss, IOP elevation, and ache in treated eye. Only 1 case (ac/pc tear) was noted to be device-related.

Additional Effectiveness Parameters:

Diameter and Circularity of Capsulotomy: Mean anterior capsule diameter ● 5.14 mm +/- S.D. 0.14 mm (range 4.9-5.5 mm). 99 cases recorded as circular without zonular damage.
. Pre- and Post Zepto Corneal Incision Size: Mean increase in incision size post-Zepto treatment 0.0305 mm (range 0-0.2 mm).
. Ease of cortex removal: 97/100 cases reported as similar or easier ease of cortex aspiration as compared to manual capsulorhexis.
Capsulotomy centration: 96/100 reported as centered.
IOL centration: 100% reported with IOL intracapsular fixation and centered.

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Clinical Findings:

Mean BCVA at 1 month was 20/20 (Snellen equivalent to ETDRS assessment).
. No capsular abnormalities reported.
. No clinically significant slit lamp exam findings reported.

Diameter of Anterior Capsulotomy:

Mean diameter of ZeptoTM capsulotomies = 5.14 mm +/- S.D. 0.14 mm (median = 5.2 mm; range 4.9-5.5 mm).

Minimum Incision Size

The minimum incision size required to accommodate the Zepto Handpiece tip is 2.2 mm. The minimum incision size used during the clinical study was 2.4 mm.

Conclusion of Nonclinical and Clinical Tests and Results

In conclusion, the data from this study, combined with the rigorous lab, preclinical testing and OUS clinical experience demonstrate that the Mynosys Zepto™ Capsulotomy System is as safe and effective as the legally marketed predicate with which it is compared for regulatory purposes and is therefore substantially equivalent.

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.