The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.

Device Description

The Infinitie Vision System with OZit® IP is an enhanced version of the Infinitie Vision System (K021566) that is modular in design and incorporates both the QZile IP feature and the Infiniti® UltraVit" Vitrectomy Probe and its associated software.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Infiniti® Vision System with OZil® IP.

Unfortunately, the provided text does not contain a study that proves the device meets specific performance acceptance criteria in terms of clinical effectiveness or comparison to human performance (AI vs. human).

The document is a 510(k) summary for a medical device seeking substantial equivalence to already marketed devices. The focus is primarily on safety, compliance with standards, and technological similarities to predicates, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

However, I can extract information related to the device's safety and compliance acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Electrical Safety	IEC 60601-1: 2003 UL	Compliance demonstrated
	IEC 60601-1-2: 2001	Compliance demonstrated
	IEC 60601-1-4: 2000	Compliance demonstrated
	IEC 60601-2-2: 1998	Compliance demonstrated
Biocompatibility	AAMI/ANSI/ISO 10993-1: 2003	Compliance demonstrated
	AAMI/ANSI/ISO 10993-5: 1999	Compliance demonstrated
	AAMI/ANSI/ISO 10993-7: 1995	Compliance demonstrated
	AAMI/ANSI/ISO 10993-10: 2002/A1:2006	Compliance demonstrated
	AAMI/ANSI/ISO 10993-11: 2006	Compliance demonstrated
	AAMI/ANSI/ISO 10993-12: 2007	Compliance demonstrated
Sterilization	AAMI/ISO 11135:2007 (EtO sterilization)	Process validated
Quality System	21 CFR 820	Compliance demonstrated
Risk Management	ISO 14971:2003	Compliance demonstrated
Functional Requirements	Not explicitly detailed, but stated	Functional requirements met, equivalent to predicate device.

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

The document does not describe a clinical performance study with a "test set" in the context of AI or diagnostic performance. The "tests" mentioned are primarily non-clinical engineering and biocompatibility evaluations, following established standards. Therefore, concepts like sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to the information provided.

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

This information is not provided because, as noted above, there's no mention of a human-centric performance test set requiring expert ground truth establishment for diagnostic or treatment outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no such test set or expert ground truth is described.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The device submission focuses on safety, standard compliance, and substantial equivalence to predicate devices, without presenting data on human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm but a surgical system. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently tied to its operation by a human surgeon. The "functional requirements" are met by the system itself and its components.

7. The Type of Ground Truth Used

For the safety, biocompatibility, and functional evaluations, the "ground truth" used is adherence to established national and international standards (IEC, ISO, AAMI, ANSI, 21 CFR) and successful execution of engineering tests. This is not "expert consensus, pathology, or outcomes data" in a typical clinical study sense, but rather compliance with engineering and manufacturing best practices.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical system, not an AI algorithm that undergoes "training."

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

Not applicable, as no training set for an AI algorithm is involved.

Summary of the document's content regarding acceptance criteria and studies:

The provided 510(k) summary for the Infiniti® Vision System with OZil® IP outlines the device's compliance with a comprehensive set of safety standards (electrical, electromagnetic compatibility, software safety, high-frequency surgical equipment safety), biocompatibility standards for materials in contact with the patient, sterilization validation standards, and adherence to quality system regulations (21 CFR 820) and risk management standards (ISO 14971:2003). The acceptance criteria for these aspects are the successful demonstration of compliance with each listed standard. The study demonstrating this is described as "Non-clinical testing" which "has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate device." This documentation is part of a submission for substantial equivalence to existing legally marketed devices, establishing that the new device is as safe and effective as its predecessors based on technological characteristics and adherence to established regulatory and engineering norms. It does not include clinical performance studies, AI-specific evaluations, or human-in-the-loop performance metrics.

Summary

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FEB 12 2009

Infiniti® Vision System with OZU® IP

K082845

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PREMARKET NOTIFICATION 510(k) SUMMARY 5.

This summary document is being prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76132. Phone: (817) 551-6810 Fax: (817) 551-4630

Device Subject to this 510(k):

Infiniti® Vision System Trade Name: Phacofragmentation System Common Name: Classification Name: Phacofragmentation System (per 21 CFR 886.4670)

Predicate Devices : 5.1.

The legally marketed devices(s) to which we are claiming equivalence to are:

510(k) Number	Device
K021566	Infiniti® Vision System
K981116	Sovereign* Cataract Extraction System
K063583	Alcon Vision System (Constellation)
K911808	Gemini Ophthalmic Surgery System(Marketed as the Series 20000® Legacy® (STTL) and Accurus®)

5.2. Device Description

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Indications for Use: 5.3.

The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectoriny, and bipolar coagulation.

Brief Summary of Nonclinical test and Results: 5.4.

Safety tests of the Infinit® Vision System with OZil® IP have demonstrated its compliance with applicable requirements of the following standards:

Standard	Title
60601-1: 2003 UL(Equivalent to IEC 60601-1:1998 with A1: 1991, A2:1995)	Medical Electrical Equipment, Part 1 -- GeneralRequirements for Safety
60601-1-2 :2001 IEC	Medical electrical equipment Part 1: Generalrequirements for safety 2. Collateral Standard:Electromagnetic compatibility-Requirements and test.
60601-1-4:2000 IEC	Medical Electrical Equipment, Part 1: GeneralRequirements for Safety, 4. Collateral standard:Programmable electrical medical systems.
60601-2-2: 1998 IEC	Medical electrical equipment - Part 2-2: Particularrequirements for the safety of high frequency surgicalequipment

Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:

Standard #	Title
10993-1: 2003 AAMI / ANSI / ISO	Biological Evaluation of Medical Devices --Part 1: Evaluation and testing
10993-5: 1999 AAMI / ANSI / ISO	Biological Evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity
10993-7: 1995 AAMI / ANSI / ISO	Biological Evaluation of Medical Devices --Part 7: Ethylene Oxide Sterilization Residuals
10993-10:2002/A1:2006 AAMI / ANSI / ISO	Biological Evaluation of Medical Devices --Part 10: Tests for irritation and delayed-typehypersensitivity
10993-11:2006 AAMI / ANSI / ISO	Biological Evaluation of Medical Devices --Part 11: Tests for systemic toxicity

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	Standard #19 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
	10993-12:2007 AAMI / ANSI / ISQ Biological Evaluation of Medical Devices --
	Part 12: Sample Preparation and Reference
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Complete Company Controller of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Comments of Ch.	and and the contract of the county of the country of the country of the country of

The Infiniti® UltraVit" Vitrectorry Probe is provided sterile and intended for single use only. This product is EtO sterilized and the process has been validated per AAMV ISO 11135:2007: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization and re-use of the handpieces are provided in the Directions for Use of the product.

Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Infiniti® Vision System with OZil® IP has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate device.

Trademark References:

*SOVEREIGN is a registered trademark of Allergan, Inc. Corp.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcon Research, Ltd. c/o Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Fort Worth, Texas 76134-2099

FEB 1 2 2009

Re: K082845

Trade/Device Name: Infiniti® Vision System with Ozil® IP Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HOC Dated: January 12, 2008 Received: January 13, 2008

Dear Mr. Buenger:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Evertins, mD

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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K082845 / Infiniti Vision System with Ozil IP Response to November 21, 2008 Deficiency Letter

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K082845

Device Name: Infiniti® Vision System with OZil® IP

Indications for Use:

The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectorny, and bipolar coagulation.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

`Concurrence of CDRH, Office of Device Evaluation (ODE)

HZB histolass

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(Division Sign-Off) ovision of Ophthalmic and Ear, Jose and Throat Devices

510(k) Number K082845

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.