The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

Device Description

The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting along with bipolar coagulation. The Infiniti" system is a modification of the Alcon Series 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.

AI/ML Overview

Here's an analysis of the provided text regarding the Infiniti™ Cataract Extraction System's acceptance criteria and studies:

Summary of Device Acceptance Criteria and Performance Studies

The provided 510(k) summary for the Infiniti™ Cataract Extraction System does not offer specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria in terms of efficacy on patients. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and biocompatibility standards.

The acceptance criteria here primarily revolve around:

Compliance with Safety Standards: Meeting established electrical safety and electromagnetic compatibility standards.
Biocompatibility: Ensuring materials in contact with patients are biologically safe.
Sterilization and Reprocessing Validation: Confirming the effectiveness of sterilization methods for single-use components and reprocessing instructions for reusable parts.
Functional Equivalence: Demonstrating that the system's technological characteristics and functional requirements are similar to predicate devices, and that specifications are fulfilled.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance/Study Outcome
Electrical Safety	IEC 60601-1: 1988 (Medical Electrical Equipment, Part 1 - General Requirements for Safety)	"Safety tests... will demonstrate its compliance with applicable requirements." (Implies successful testing or intent to successfully test before commercial release).
	IEC 60601-1: A1:1991-11 + A2:1995 -03 (Amendment - Medical Electrical Equipment, Part 1 - General Requirements for Safety)	"Safety tests... will demonstrate its compliance with applicable requirements."
	UL 2601-1: 1997 (Medical Electrical Equipment, Part 1 - General Requirements for Safety)	"Safety tests... will demonstrate its compliance with applicable requirements."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: 1993 (Medical electrical equipment Part 1: General Requirements for Safety 2. Collateral Standard: ElectroMagnetic Compatibility - Requirements and tests)	"Safety tests... will demonstrate its compliance with applicable requirements."
Biocompatibility	AAMI/ANSI/ISO 10993-1: 1997 (Biological evaluation of medical devices, Part 1: Evaluation and Testing)	"Biocompatibility evaluations... will be performed to the following standards." (Implies successful evaluation or intent to successfully evaluate).
	AAMI/ANSI/ISO 10993-5: 1999 (Biological evaluation of medical devices, Part 5: Test for cytotoxicity: in vitro methods)	"Biocompatibility evaluations... will be performed to the following standards."
	AAMI/ANSI/ISO 10993-7: 1995 (Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization methods)	"Biocompatibility evaluations... will be performed to the following standards."
	AAMI/ANSI/ISO 10993-10: 1995 (Biological evaluation of medical devices, Part 10: Tests for irritation and sensitization)	"Biocompatibility evaluations... will be performed to the following standards."
Sterilization Efficacy	AAMI/ISO 11135:1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) for single-use consumable products. Validated reprocessing instructions for reusable handpieces (cleaning, sterilization, re-use).	"The Infiniti™ consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard." "Reusable handpieces are not provided sterile. Validated reprocessing instructions... will be provided in the Directions for Use."
Functional Performance / Equivalence	Similar technological characteristics to predicate devices. Functional requirements met and system specifications fulfilled.	"Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed." "Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release."

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

The document does not specify any clinical test set sample size in terms of patient data or a specific number of procedures.
The studies mentioned are primarily non-clinical (bench testing, biocompatibility, sterilization validation).
Data Provenance: Not applicable as no clinical test set data is presented. The non-clinical tests would have been performed in a laboratory setting, likely in the US where Alcon Research, Inc. is located. The submission states the device "will be developed and manufactured in compliance with FDA and ISO quality system requirements," indicating the testing environment follows established quality control.

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

Not applicable. The submission does not describe a clinical study requiring expert-established ground truth for patient outcomes or diagnostic accuracy. Instead, the "ground truth" for the non-clinical tests comes from adherence to established engineering and medical device standards (e.g., passing specific electrical tests or biocompatibility assays).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set involving human interpretation or outcome assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a surgical device, not an imaging or diagnostic aid that would typically involve human reader performance. Its approval is based on substantial equivalence to existing predicate devices for safety and performance characteristics, rather than demonstrating improved human reader performance with AI assistance.

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

Not applicable. The "Infiniti™ Cataract Extraction System" is a surgical instrument system, not an AI algorithm. Its performance is evaluated through its physical and functional characteristics and safety profile, not as a standalone AI.

7. The Type of Ground Truth Used

For the non-clinical studies described, the "ground truth" is defined by compliance with recognized international standards (IEC, UL, ISO, AAMI) for safety, biocompatibility, and manufacturing quality. For functional performance, it's defined by meeting internal system specifications that are deemed equivalent to predicate devices. There is no mention of pathology, expert consensus on patient outcomes, or other clinical ground truth, as this is a device for performing a surgical procedure, not for diagnosis or prediction.

8. The Sample Size for the Training Set

Not applicable. The Infiniti™ Cataract Extraction System is a physical medical device, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for an AI/ML model.

Summary

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K021566

JUL - 2 2002

Premarket Notification 510(k) Summary

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, Inc. 6201 South Freeway Fort Worth, TX 76132 Phone: (817) 551-6810 Fax: (817) 551-4630

Date Summary Prepared: May, 1, 2002

Device Subject to this 510(k)

Trade Name:	Infiniti ™ Cataract Extraction System
Common Name:	Phacofragmentation System
Classification Name:	Phacofragmentation System (per 21 CFR 886.4670)

1. Predicate Devices:

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

510(k) Number	Device
K911808	Gemini Ophthalmic Surgery System(Marketed as the Series 20000® Legacy® (STTL) and Accurus®)
K981116	Sovereign* Cataract Extraction System
K961310	Storz Premiere* II Microsurgical System
K980292	Cataract Liquefracture Device (Marketed as AquaLase™)
K925631	Phacotron Gold* Multifunction Ultrasonic (Tmesis*) Handpiece

2. Device Description

The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting The Infiniti" system is a modification of the Alcon Series along with bipolar coagulation. 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.

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3. Indications for Use:

The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

4. Brief Summary of Nonclinical test and Results:

Safety tests of the Infinitit" Cataract Extraction System will demonstrate its compliance with applicable requirements of the following standards:

IEC 60601-1: 1988	Medical Electrical Equipment, Part 1 - General Requirements forSafety.
IEC 60601-1:A1:1991-11 +A2:1995 -03	Amendment - Medical Electrical Equipment, Part 1 - GeneralRequirements for Safety
IEC 60601-1-2 : 1993	Medical electrical equipment Part 1: General Requirements forSafety 2. Collateral Standard: ElectroMagnetic Compatibility -Requirements and tests.
UL 2601-1: 1997	Medical Electrical Equipment, Part 1 - General Requirements forSafety

Biocompatibility evaluations of materials coming in contact with the patient fluid path in the Infiniti" system will be performed to the following standards:

AAMI/ ANSI/ ISO	Biological evaluation of medical devices, Part 1: Evaluation and
10993-1: 1997	Testing
AAMI/ ANSI/ ISO	Biological evaluation of medical devices, Part 5: Test for
10993-5: 1999	cytotoxicity: in vitro methods.
AAMI/ ANSI/ ISO	Biological evaluation of medical devices, Part 7: Ethylene oxide
10993-7: 1995	sterilization methods.
AMI/ ANSI/ ISO	Biological evaluation of medical devices, Part 10: Tests for irritation
10993-10: 1995	and sensitization.

The Infiniti" consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard: AAMI/ ISO 11135:1994: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning. sterilization and re-use will be 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" Cataract Extraction System will be developed and manufactured in compliance with FDA and ISO quality system requirements. Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release.

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Trademark References:

*PHACOTRON GOLD is a registered trademark of Chiron Corporation *PREMIERE is a registered trademark of Storz Ophthalmics, Inc. Corp. *SOVEREIGN is a registered trademark of Allergan, Inc. Corp. *TMESIS is a registered trademark of Azia Y. Anis *SYNERGIST is a registered trademark of Chiron Corporation

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

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

Re: K021566

Trade/Device Name: Infiniti™ Cataract Extraction System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HOC: HOR: MLZ Dated: May 10, 2002 Received: May 13, 2002

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 (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.

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Page 2 - Mr. Michael Buenger

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known): ¥021566

Device Name: _ Infiniti™ Cataract Extraction System___

Indications for Use:

The intended use of this device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Donna L. Vedner, for DMW/ARR
(Division Sign Off)

ision of Ophthaln Nose and Throat De

510(k) Number K021566

(Optional Format 3-10-98)

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.