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.

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.

AI/ML Overview

The provided text does not describe acceptance criteria for an AI/ML device in the traditional sense, nor does it detail a study proving such a device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (a phacofragmentation system and its foot pedal) that does not incorporate AI/ML.

The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device." This clearly indicates that the device being reviewed is not an AI/ML device requiring complex performance studies.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the product described in the input document.

The "Performance Data" section (Page 3) discusses:

Design verification and validation testing, including electromagnetic compatibility testing: This ensures the physical device (foot pedal) works as intended and is compatible with the system.
Software validation: This was performed on a proposed software version with minor changes to accommodate the new foot pedal, ensuring the software functions correctly with the new component.
Acceptance criteria for these engineering and software tests were met. Without further details, these acceptance criteria are likely related to electrical safety, functional performance (e.g., foot pedal response time, correct input recognition), and electromagnetic compatibility limits.

The document concludes that the new closed-toe foot pedal is substantially equivalent to the predicate open-toe foot pedal based on these non-clinical bench tests and software validation.

Summary

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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.

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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 (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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.1700 East Saint Andrew PlaceSanta Ana, CA 92705USAPhone: 408-723-5166Fax: 408-273-5966
Contact Person:	Larry BoucherProject Manager, Regulatory Affairslbouche1@its.jnj.comPhone: 714-247-8391Fax: 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 designverification and validation testing, including electromagneticcompatibility testing, to demonstrate compatibility with theproposed closed-toe foot pedal. In addition, software validationwas performed on the proposed software version. All testingdemonstrated that the closed-toe foot pedal met acceptancecriteria.No animal or clinical studies were performed as there is nochange to the indications for use or the fundamental scientifictechnology when compared to the predicate device.
Conclusion:	The closed-toe foot pedal is substantially equivalent to thecurrently cleared COMPACT INTUITIV™ Four Button FootPedal based on the completion of non-clinical bench testing,software validation, as well as similar principles of design,operation, and indications for use.

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Device Description

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:

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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
DeviceDescription	COMPACT INTUITIVTMSystem with closed-toefoot pedal	COMPACT INTUITIVTMSystem with open-toe footpedal	Sovereign CompactPhacoemulsificationSystem with closed-toefoot pedal
510(k)Number	Not assigned	K113155	K111446
RegulationNumber	886.4670	886.4670	866.4670
RegulationName	Photofragmentationsystem	Photofragmentationsystem	Photofragmentationsystem
RegulatoryClass	Class II	Class II	Class II
Product Code	HQC	HQC	HQC
Indications forUse	The COMPACTINTUITIVTM System is anAC-powered device witha fragmenting needle forcataract surgery to disrupta cataract with ultrasoundand extract the cataract	The COMPACTINTUITIVTM System is anAC-powered device witha fragmenting needle forcataract surgery to disrupta cataract with ultrasoundand extract the cataract.	The Sovereign CompactPhacoemulsificationSystem is an AC-powereddevice with a fragmentingneedle intended for use incataract surgery to disrupta cataract with ultrasoundand extract the cataract.
Purpose ofFoot Pedal	Determines the functiondelivered by thehandpiece, which dependson the mode selected(diathermy,phacoemulsification,irrigation/aspiration, orvitrectomy )	Determines the functiondelivered by thehandpiece, which dependson the mode selected(diathermy,phacoemulsification,irrigation/aspiration, orvitrectomy )	Determines the functiondelivered by thehandpiece, which dependson the mode selected(diathermy,phacoemulsification,irrigation/aspiration, orvitrectomy )
Description	Single Linear	Single Linear	Single Linear
Size	9.82" W x 15.57" D x4.88" H	9.82" W x 15.57" D x4.88" H	9.82" W x 15.57" D x4.88" H
User-ProgrammableButtons	Three buttons (one eachto the right and left, thirdabove the foot) andtreadle	Three (one each on theright and left, third to theright of the pedal)	Three buttons (one eachto the right and left, thirdabove the foot) andtreadle
ConnectorType	12-pin connector	12-pin connector	12-pin connector
Power Cord	Detachable	Detachable	Detachable
Power CordLength	11.5 feet	12.0 feet	11.5 feet
System Type	PhacoemulsificationSystem	PhacoemulsificationSystem	PhacoemulsificationSystem

The subject foot-pedal utilizes same functionality, performance, technology and intended use as the predicate foot pedal (K113155, COMPACT INTUITIV™ System).

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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.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.