The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

Device Description

The Abbott Medical Optics (AMO) irrigation sleeve is a device that is intended to direct irrigation solution across the shaft of the phacoemulsification tip, allowing the irrigation solution to enter the eye during ocular surgery. It is a small, molded component that is placed over the phacoemulsification tip. The proposed irrigation sleeve is made of silicone, with a hardness specification of 80+/-5 durometer units. The flow rate of the sleeve is greater than or equal to 18cc, with a length of 0.75 -1.50 inches.

AI/ML Overview

The provided text describes the K103023 510(k) summary for the AMO Irrigation Sleeve. This device is a medical accessory, not an AI/ML powered device, so several of the requested sections (e.g., MRMC study, human reader improvement, AI assistance, standalone algorithm performance, AI training data) are not applicable.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material: Silicone, Hardness	80 +/- 5 durometer units (Meets specification)
Flow Rate: ≥ 18 cc	Greater than or equal to 18cc (Meets specification)
Length: 0.75 - 1.50 inches	0.75 - 1.50 inches (Meets specification)
Biocompatibility: Conformance to ISO 10993-1:2003	In compliance (Reported as "In compliance")
Sterilization: Conformance to ISO 11137 Series (Parts 1, 2, 3)	In compliance (Reported as "In compliance")
Risk Management: Conformance to ISO 14971:2007	In compliance (Reported as "In compliance")
Product Integrity after Sterilization:	Tested (Reported as "product integrity after sterilization")
Durometer and Tensile Strength:	Validated (Reported as "validation of the durometer and tensile strength")

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the testing of the AMO Irrigation Sleeve. The testing appears to be conducted in-house by Abbott Medical Optics, Inc. ("The proposed AMO irrigation sleeve has undergone testing..."). The provenance is therefore internal to the manufacturer. This is a non-clinical device so the concept of retrospective or prospective data does not apply in the same way as it might for a diagnostic AI device; the device is tested against established engineering and biological safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a device like an irrigation sleeve, "ground truth" would likely be established through engineering specifications, validated test methods, and compliance with recognized standards (e.g., ISO for biocompatibility and sterilization), rather than expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This device is an accessory that has its performance evaluated against engineering specifications and compliance with standards, not through clinical adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The AMO Irrigation Sleeve is a medical device accessory, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The AMO Irrigation Sleeve is a medical device accessory, not an AI algorithm.

7. The type of ground truth used

The ground truth for this device is based on:

Engineering Specifications: Defined parameters for hardness, flow rate, and length.
International Standards (ISO): Compliance with ISO 10993-1 (biocompatibility), ISO 11137 (sterilization), and ISO 14971 (risk management).
Validated Test Methods: Procedures to verify durometer, tensile strength, flow rate, and product integrity after sterilization.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for it in that context. The "ground truth" for its performance is established through adherence to manufacturing specifications and compliance with recognized industry and regulatory standards.

Summary

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KIO3023

JUN - 1 2011

510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.

Applicant Name:	Abbott Medical Optics, Inc.1700 E. St. Andrew PlaceSanta Ana CA 92705, USAEstablishment Registration Number: 2020664
Contact Person:	Evelyn De La VegaManager, Regulatory AffairsTel: (714) 247-8487Fax: (714) 247-8784
Date of Summary Preparation:	March 22, 2011
Device Trade Name:	AMO Irrigation Sleeve
Device Classification:	CDRH Device Class II
Classification Code:	HQC21 CFR 886.4670Unit, Phacofragmentation

Reviewing Panel: Ophthalmic Devices

Devices to Which Substantial Equivalence is Claimed:

510(k) Number	Trade Name	Manufacturer
K844373	Ultra Phaco	OMS*
K840695	Phacoemulsification Kits	Allergan ISP*

AMO currently owns the rights to these devices.

DEVICE DESCRIPTION

Abbott Medical Optics Inc.

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INDICATIONS FOR USE

The proposed irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

STATEMENT OF COMPARISON TO PREDICATE DEVICES

The physical and performance characteristics of the proposed irrigation sleeve are substantially equivalent to those of the predicate devices cleared under K844373, and K840695.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS

The proposed AMO irrigation sleeve has undergone testing and is in compliance with the following standards; ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing, ISO 11137-1:2006 Sterilization of Health Care Product Requirements for Validation and Routine Control- Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices, ISO 11137-2:2006 Sterilization of Health Care Product Requirements for Validation and Routine Control- Part 2 Establishing Dose, ISO 11137-3:2006 Sterilization of Health Care Product Requirements for Validation and Routine Control- Part 3 Guidance on Dosimetric Aspects, and ISO 14971:2007 Medical Devices- Application of Risk Management to Medical Devices. Testing of the sleeve included validation of the durometer and tensile strength, flow rate, and product integrity after sterilization. The AMO irrigation sleeve was found to perform equivalently to the predicate irrigation sleeves. Thus, the proposed AMO irrigation sleeve and the predicate devices have similar effectiveness and performance profiles and are considered substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Abbott Medical Optics, Inc. % Ms. Evelyn De La Vega Regulatory Affairs Manager 1700 St. Andrew Place Santa Ana, CA 92705

JUN -1 201

Re: K103023

Trade/Device Name: Phacofragmentation Unit Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC Dated: May 23, 2011 Received: May 24, 2011

Dear Ms. De La Vega:

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.

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: AMO Irrigation Sleeve

Indication for Use:

The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use

(Per 21 CFR 801.109)
96)

Over-The-Counter

(Optional Format 1-2-

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

510(k) Number. K103023

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.