COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". August 16, 2019 Johnson & Johnson Surgical Vision, Inc. Larry Boucher Regulatory Affairs Project Manager 1700 East Saint Andrew Place Santa Ana, CA 92705 Re: K191933 Trade/Device Name: COMPACT INTUITIV™ System, COMPACT INTUITIV™ Wireless Remote Control, COMPACT INTUITIV™ Four-Button Foot Pedal, COMPACT INTUITIV™ Closed-Toe Foot Pedal Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC Dated: July 17, 2019 Received: July 19, 2019 Dear Larry Boucher: 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. {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 (reporting of medical devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-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, for Malvina B. Eydelman, M.D. Director 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) Device Name COMPACT INTUITIV™ System Indications for Use (Describe) The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. Type of Use (*Select one or both, as applicable*) | <div> <span style="font-size: 10pt;"></span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |---------------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt;"></span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | 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 The following 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92: | Applicant: | Johnson & Johnson Surgical Vision, Inc.<br>1700 East Saint Andrew Place<br>Santa Ana, CA 92705<br>USA<br>Phone: 408-723-5166<br>Fax: 408-273-5966 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Larry Boucher<br>Project Manager, Regulatory Affairs<br>lbouche1@its.jnj.com<br>Phone: 714-247-8391<br>Fax: 714-566-3785 | | Date Prepared: | July 17, 2019 | | Trade Name of Device: | COMPACT INTUITIV™ System | | Classification of Device: | 21 CFR 886.4670 – Class II | | Product Code | HQC | | Predicate Device: | COMPACT INTUITIV™ System, 510(k) #: K133115 | | Performance Data: | The COMPACT INTUITIV™ System has undergone design<br>verification and validation testing, including electromagnetic<br>compatibility testing, to demonstrate compatibility with the<br>proposed closed-toe foot pedal. In addition, software validation<br>was performed on the proposed software version. All testing<br>demonstrated that the closed-toe foot pedal met acceptance<br>criteria.<br><br>No animal or clinical studies were performed as there is no<br>change to the indications for use or the fundamental scientific<br>technology when compared to the predicate device. | | Conclusion: | The closed-toe foot pedal is substantially equivalent to the<br>currently cleared COMPACT INTUITIV™ Four Button Foot<br>Pedal based on the completion of non-clinical bench testing,<br>software validation, as well as similar principles of design,<br>operation, and indications for use. | {4}------------------------------------------------ ### Device Description The COMPACT INTUITIV™ System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80. The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference. ### Intended Use The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. #### Substantial Equivalence The subject COMPACT INTUITIV™ Closed-Toe Foot Pedal is substantially equivalent to the predicate COMPACT INTUITIV™ Open-Toe Foot Pedal which was cleared under premarket notification K113155 (cleared February 27, 2014), in terms of: - · Indications for use - · Intended use - · Fundamental technological characteristics The COMPACT INTUITIV™ Closed-Toe Foot Pedal is identical to that cleared for use with the Sovereign Compact Phacoemulsification System (K111446, cleared December 21, 2011), the reference device. Table 1 provides a comparison of the characteristics of the closed-toe foot pedal, the predicate device, and the reference device: {5}------------------------------------------------ Table 1: Comparison of COMPACT INTUITIV™ system with Open- and Closed-Toe Foot Pedals and Sovereign Compact Phacoemulsification Device with Closed-Toe Foot Pedal | Attribute | Subject Device | Predicate Device | Reference Device | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device<br>Description | COMPACT INTUITIVTM<br>System with closed-toe<br>foot pedal | COMPACT INTUITIVTM<br>System with open-toe foot<br>pedal | Sovereign Compact<br>Phacoemulsification<br>System with closed-toe<br>foot pedal | | 510(k)<br>Number | Not assigned | K113155 | K111446 | | Regulation<br>Number | 886.4670 | 886.4670 | 866.4670 | | Regulation<br>Name | Photofragmentation<br>system | Photofragmentation<br>system | Photofragmentation<br>system | | Regulatory<br>Class | Class II | Class II | Class II | | Product Code | HQC | HQC | HQC | | Indications for<br>Use | The COMPACT<br>INTUITIVTM System is an<br>AC-powered device with<br>a fragmenting needle for<br>cataract surgery to disrupt<br>a cataract with ultrasound<br>and extract the cataract | The COMPACT<br>INTUITIVTM System is an<br>AC-powered device with<br>a fragmenting needle for<br>cataract surgery to disrupt<br>a cataract with ultrasound<br>and extract the cataract. | The Sovereign Compact<br>Phacoemulsification<br>System is an AC-powered<br>device with a fragmenting<br>needle intended for use in<br>cataract surgery to disrupt<br>a cataract with ultrasound<br>and extract the cataract. | | Purpose of<br>Foot Pedal | Determines the function<br>delivered by the<br>handpiece, which depends<br>on the mode selected<br>(diathermy,<br>phacoemulsification,<br>irrigation/aspiration, or<br>vitrectomy ) | Determines the function<br>delivered by the<br>handpiece, which depends<br>on the mode selected<br>(diathermy,<br>phacoemulsification,<br>irrigation/aspiration, or<br>vitrectomy ) | Determines the function<br>delivered by the<br>handpiece, which depends<br>on the mode selected<br>(diathermy,<br>phacoemulsification,<br>irrigation/aspiration, or<br>vitrectomy ) | | Description | Single Linear | Single Linear | Single Linear | | Size | 9.82" W x 15.57" D x<br>4.88" H | 9.82" W x 15.57" D x<br>4.88" H | 9.82" W x 15.57" D x<br>4.88" H | | User-<br>Programmable<br>Buttons | Three buttons (one each<br>to the right and left, third<br>above the foot) and<br>treadle | Three (one each on the<br>right and left, third to the<br>right of the pedal) | Three buttons (one each<br>to the right and left, third<br>above the foot) and<br>treadle | | Connector<br>Type | 12-pin connector | 12-pin connector | 12-pin connector | | Power Cord | Detachable | Detachable | Detachable | | Power Cord<br>Length | 11.5 feet | 12.0 feet | 11.5 feet | | System Type | Phacoemulsification<br>System | Phacoemulsification<br>System | Phacoemulsification<br>System | The subject foot-pedal utilizes same functionality, performance, technology and intended use as the predicate foot pedal (K113155, COMPACT INTUITIV™ System). {6}------------------------------------------------ #### Summary of Bench and Animal Performance Testing The functionality of the closed-toe foot pedal was tested to determine the compatibility with the COMPACT INTUITIV™ System. Testing included connectivity of the foot pedal to the COMPACT INTUITIV™ System. foot pedal modes. functionality of the tactile feedback and the programmable switches. Functional bench Testing demonstrated that the closed-toe foot pedal met all acceptance criteria. Software specific bench testing of the COMPACT INTUITIV™ System for a proposed software version which contains minor changes to accommodate use of the System with the closed-toe foot pedal, was conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes. Electromagnetic compatibility (EMC) testing was performed in conformance with IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests and test results demonstrated that the closed-toe foot pedal when used with the COMPACT INTUITIV™ System met all requirements of the standard. The results of the bench testing, EMC testing, and software validation demonstrates that the use of the closed-toe foot pedal with the COMPACT INTUITIV™ System is substantially equivalent to the currently cleared open-toe foot pedal.