The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.

Device Description

Akreos Single Use Insertion Device, Model AI-28, previously known as Hydroport SI, is validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery. Future IOL models may also by qualified with the Akreos Single Use Insertion Device following fold and recovery validation studies. The device provides a small tubular pathway in which the Akreos Advanced Optics Aspheric Lens can be placed into the eye with one continuous forward motion. The Akreos Single Use Insertion Device consists of two parts: a syringe shaped tube (includes lens loading deck and lens cap) with a plunger, and a transition cell. The Akreos Single Use Insertion Device is a sterile (EtO), disposable plastic device, designed for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Akreos Single Use Insertion Device, Model AI-28, addressing your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The subject device met the acceptance criteria for fold and recovery testing of the Akreos Aspheric Optic IOL using the same principle of operation as the predicate device.	The Akreos Single Use Insertion Device, Model AI-28, was "validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery." The device "met the acceptance criteria for fold and recovery testing."
Stability testing for the plunger material showed no significant shifts in tensile and and flexural properties following sterilization.	"Stability testing for the plunger material met the acceptance criteria showing no significant shifts in tensile and flexural properties following sterilization."
Biocompatibility testing for the polypropylene material (main device) and polyphthalamide (new plunger material) demonstrates device safety.	"The Akreos Single Use Insertion Device, Model AI-28 was shown to be safe using the results of the biocompatibility testing for the polypropylene material as well as polyphthalamide, the new plunger material."
Sterilization and Shelf-life test results confirm equivalence to the predicate device.	"Sterilization and Shelf-life test results confirm that the subject device is substantially equivalent to the marketed predicate device."
Labeling differences regarding specified IOL types do not affect safety and effectiveness when used as labeled, as each insertion device is specifically made to fit the indicated IOL.	"The labeling for the Akreos Single Use Insertion Device, Model AI-28 and the Passport foldable lens placement system differ in the type of intraocular lens specified for use. These differences in the labeling that specify use, do not affect safety and effectiveness of the device when used as labeled because each insertion device is specifically made to fit the size and shape of the indicated intraocular lens."

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

The document does not specify the sample size used for the test set for any of the performance or safety tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not mention the involvement of any experts to establish ground truth for the device's performance testing. The reported performance refers to non-clinical performance data and testing rather than expert evaluations of clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, as the reported studies are primarily non-clinical performance and safety tests, not studies requiring expert interpretation or consensus on a dataset.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical instrument (an IOL insertion device), not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable to the Akreos Single Use Insertion Device. This device is a physical tool for delivering an IOL. It does not involve algorithms or AI. Its performance is inherent to its mechanical properties and design when used by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Non-clinical performance data: Specifically, the ability to successfully fold and deliver the specified IOL into an in vitro or simulated setting ("fold and recovery testing").
Material properties data: Results from stability testing (tensile and flexural properties).
Biocompatibility testing results: Demonstrating the safety of the materials.
Sterilization and Shelf-life test results: Confirming the device maintains its properties and sterility.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data from human use as "ground truth" for this specific submission's documented performance.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical instrument, not an AI model that requires a training set.

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

This question is not applicable, as there is no training set for this device.

Summary

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K063694

Bausch & Lomb ...

510(k) Summary

MAR 0 7 2007

Akreos Single Use Insertion Device, Model AI-28

SubmitterInformation	Owner:	Bausch & Lomb, Incorporated180 Via VerdeSan Dimas, CA 92886
	Telephone:Fax:	909 971 5394909 971 5148
	Contact:	Nanette CanepaAssociate Manager, Global Regulatory Affairs
Date Prepared	December 12, 2006
Subject devicename	Trade name: Akreos Single Use Insertion Device, Model AI-28Common name: Lens insertion guideClassification name: Intraocular lens guide (21CFR 886.4300,Product Code KYB)
Predicatedevice	Passport foldable lens placement system

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Subject device description	Akreos Single Use Insertion Device, Model AI-28, previouslyknown as Hydroport SI, is validated for folding and delivering theBausch & Lomb one-piece Akreos Advanced Optics AsphericIntraocular Lens (IOL) into the eye during cataract surgery. FutureIOL models may also by qualified with the Akreos Single UseInsertion Device following fold and recovery validation studies.
	The device provides a small tubular pathway in which the AkreosAdvanced Optics Aspheric Lens can be placed into the eye with onecontinuous forward motion. The Akreos Single Use Insertion Deviceconsists of two parts: a syringe shaped tube (includes lens loadingdeck and lens cap) with a plunger, and a transition cell.
	The Akreos Single Use Insertion Device is a sterile (EtO),disposable plastic device, designed for single use only.
Technological characteristics	The similarities between the Akreos Single Use Insertion Device,Model AI-28 and the Passport foldable lens placement system arethe overall design, components, intended use, operating principle,folding direction of the lens, cartridge design, sterilization methodsand component materials with the exception of the plunger material.
	The change in plunger material of the subject device has not alteredthe fundamental scientific technology of the predicate device.
Intended use	The intended use for the Akreos Single Use Insertion Device, ModelAI-28 is to fold and deliver a Bausch & Lomb IOL into the eyeduring normal small incision cataract surgery.

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Labeling The labeling for the Akreos Single Use Insertion Device, Model AI-28 and the Passport foldable lens placement system differ in the type of intraocular lens specified for use. These differences in the labeling that specify use, do not affect safety and effectiveness of the device when used as labeled because each insertion device is specifically made to fit the size and shape of the indicated intraocular lens. Substantial Substantial equivalence is based on non-clinical performance data Equivalence that show that the subject device met the acceptance criteria for fold discussion and recovery testing of the Akreos Aspheric Optic IOL using the same principle of operation as the predicate device. Stability testing for the plunger material met the acceptance criteria showing no significant shifts in tensile and flexural properties following sterilization. Therefore, the effectiveness is demonstrated for the indicated use of the subject device. -The Akreos Single Use Insertion Device, Model AI-28 was shown to be safe using the results of the biocompatibility testing for the polypropylene material as well as polyphthalamide, the new plunger material. Sterilization and Shelf-life test results confirm that the subject device is substantially equivalent to the marketed predicate device. Conclusion Based on the 510(k) summary and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device, is safe and effective under the Federal Food, Drug and Cosmetic Act.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb c/o Ms. Nanette Canepa Associate Manager, Global Regulatory Affairs 180 E. Via Verde Drive San Dimas, CA 91773

MAR 0 7 2007

Re: K063694

Trade/Device Name: Akreos Single Use Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: KYB Dated: February 7, 2007 Received: February 8, 2007

Dear Ms. Canepa:

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. Ilsting 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 – Ms. Nanette Canepa

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Eichelman SimD

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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Indications for Use

510(k) Number (if known):

K063694

Device Name:

Indications For Use:

Akreos Single Use Insertion Device

The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.

Prescription Use (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)

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

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510(k) Number K063694

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.