Zepto

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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.<br>46710 Fremont Blvd.<br>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:<br>NAME: | Radiofrequency electrosurgical cautery apparatus | | PRODUCT CODE | NCR | | REGULATION<br>NUMBER: | 21 CFR § 886.4100 | | PREDICATE DEVICE | The Fugo Blade<br>(K001498) | ## SUBSTANTIALLY EQUIVALENT TO: | The Fugo Blade | (K001498) | | |----------------|-----------|--| | | | | | | | | | | | | {4}------------------------------------------------ ## Description of the Device Subject to Premarket Notification: 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. ### 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. {5}------------------------------------------------ # 510(K) SUMMARY | Attributes | Zepto™<br>(K170655) | The Fugo Blade<br>(K001498) | Comment | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | INTENDED USE | | | | Manufacturer | Mynosys Cellular<br>Devices | 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 | Radiofrequency<br>electrosurgical<br>cautery apparatus | Radiofrequency<br>electrosurgical<br>cautery apparatus | Same | | FDA Classification<br>Product Code | NCR | NCR | Same | | FDA<br>Medical Device<br>Classification | Class - II | Class - II | Same | | Single Use<br>Disposable<br>Component(s) | Zepto™ Handpiece<br>and fluid isolator<br>assembly are single<br>use disposables | The Fugo Blade tip<br>is a single use<br>disposable | Same | | Prescription<br>(Rx)/Over-the-<br>Counter (OTC) | Rx | Rx | Same | | | TECHNOLOGICAL CHARACTERISTICS | | | | Energy Type | Rectified RF Pulsed-<br>DC | RF | Fugo Blade uses full<br>wave RF, Zepto™<br>uses rectified RF | | Induction of capsule<br>tensile stress | Yes, by suction<br>pressure | Yes, by manipulation<br>of probe tip against<br>capsule tissue to be<br>cut | SE, induced by<br>different mechanical<br>means | | Electrical | 110 VAC 50-60 Hz | 4 size "C"<br>rechargable batteries<br>provide DC current<br>for the Fugo Blade<br>Battery Charger:<br>100-240 VAC, 50/60<br>Hz, 1.0A | Same, both<br>electrically powered | | Electrical<br>Classification | Type BF | Type BF | Same | | Attributes | Zepto™<br>(K170655) | The Fugo Blade<br>(K001498) | Comment | | Control | Firmware and button<br>control | Firmware, footswitch<br>and variable power<br>and intensity control | Both are<br>microprocessor<br>controlled. Fugo<br>Blade has power and<br>intensity controls on<br>the console based on<br>the individual<br>Physician's speed in<br>performing<br>Capsulotomy.<br>Zepto™ has a factory<br>preset power output<br>that is slightly lower<br>due to the cutting<br>element being circular<br>in design. | | System Components | Handpiece, control<br>console, fluid isolator<br>assembly<br>(see Fig. 12.1) | Handpiece, control<br>console footswitch<br>(see Fig. 12.1) | Equivalent | | Dimensions (Control<br>Box) | $13.5" X 10" X 6.5"$ | $10.00" X 7.05" X6.12"$ | Both consoles are<br>portable | | Emergency Off | Yes | Yes | Same | | Foot Switch<br>Controlled | No | Yes | The Fugo Blade<br>utilizes a footswitch to<br>provide power to the<br>treatment tip. The<br>power of the Zepto is<br>delivered via the<br>Cut/Release button | | Procedure Halt Using<br>Foot Switch | No | Yes | The Fugo Blade<br>utilizes a footswitch,<br>Zepto utilizes an<br>emergency Stop<br>Button on console | | On Switch | Yes | Yes | Same | | Display Panel | Yes | Yes | Same | | Mains Switch | Yes | Yes | Same | | Disposable Cutting<br>Element | Yes | Yes | Same | | Attributes | Zepto™<br>(K170655) | The Fugo Blade<br>(K001498) | Comment | | Cutting Element<br>Shape | Circular | Straight | SE - Fugo Blade<br>straight cutting<br>element requires 7-15<br>seconds to perform<br>capsulotomy, Zepto™<br>circular cutting<br>element completes<br>capsulotomy in 4<br>msec | | Capsulotomy Size | 5.0 mm (nominal) | Variable Dependent<br>on Surgeon | SE - Fugo Blade<br>capsulotomy varies in<br>diameter due to<br>manual circular<br>manipulation of the<br>straight cutting tip.<br>Zepto™ has uniform<br>capsulotomy diameter<br>based on a circular<br>cutting element | | MANUFACTURING | | | | | Biocompatibility | The Zepto™<br>Handpiece passed<br>testing performed<br>according to ISO<br>10993-5<br>(Cytotoxicity), 10993-<br>10 (Acute Systemic<br>Toxicity) and 10993-<br>11(Sensitization and<br>Irritation). | There is no mention<br>in the company's<br>literature, website or<br>510(k) summary as<br>to whether the Fugo<br>Blade was tested for<br>biocompatibility. | The Zepto™ is made<br>from Biocompatible<br>materials, The Fugo<br>Blade is presumed to<br>be the same. | | Sterilization | EtO | Heat Autoclave or<br>EtO | Same - Both use<br>validated sterile<br>methods presumed to<br>provide SAL of 1 X 10-6 | | Packaging | Zepto™ Handpiece:<br>sterile single<br>pouched Tyvek® bag | Fugo Blade tip:<br>single pouched<br>Tyvek® bag in box of<br>12 tips | Same | | Shelf Life | 12 months | Unknown | The Zepto™ has a<br>validated shelf life.<br>The Fugo Blade I<br>presumed to be the<br>same. | {6}------------------------------------------------ # 510(K) SUMMARY {7}------------------------------------------------ # 510(K) SUMMARY {8}------------------------------------------------ # 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 {9}------------------------------------------------ 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. {10}------------------------------------------------ # 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.