The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.

Device Description

The Aero Z Cartridge IOL Delivery System is a two-part device comprised of a reusable handpiece and single use disposable cartridge. The single use disposable cartridge is , fabricated from polypropylene with a glyceryl monostearate (GMS) agent incorporated for lubricity. It is intended for single use only and is provided sterile. The reusable handpiece is titanium, is supplied non-sterile and is designed to accommodate the cartridge and lens for delivery of the lens into the eye. The reusable handpiece is supplied in both a push-and-turn and screw type configuration.

AI/ML Overview

Here's an analysis of the provided text regarding the AERO™ Z Cartridge IOL Delivery System, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from text)	Reported Device Performance (from text)
Biocompatibility	Non-cytotoxic	Device was found to be non-cytotoxic.
	Non-sensitizing	Device was found to be non-sensitizing.
	Non-irritating	Device was found to be non-irritating.
Functional Performance	Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on optical or mechanical performance	Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the optical or mechanical performance of the lens.
	Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on dimensions	Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the dimensions of the lens.
	Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on cosmetic appearance	Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the cosmetic appearance of the lens.

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

The provided text does not explicitly state a specific sample size used for the test set associated with the performance studies (e.g., how many IOLs were tested for optical/mechanical impact).

The data provenance is retrospective in the sense that the testing was conducted on samples of the device and IOLs. There is no mention of prospective clinical trials. The country of origin for the data is not specified.

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

The provided text does not mention the use of experts to establish ground truth for the test set in the context of the reported non-clinical tests. The tests performed (biocompatibility and functional performance for IOL delivery) are typically objective laboratory measurements against defined standards (e.g., ISO 10993-1, ISO 11979-3) rather than interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

As the evaluation primarily relies on objective laboratory tests against ISO standards, an adjudication method (like 2+1 or 3+1) for expert consensus is not applicable and not mentioned in the provided text.

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 delivery system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, there's no mention of an effect size for human readers improving with or without AI assistance.

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

N/A. This question is applicable to AI algorithms. The Aero Z Cartridge IOL Delivery System is a medical device for physically delivering intraocular lenses, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply.

7. The Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on objective measurements against established international standards.

Biocompatibility: Conformance to ISO 10993-1:2009 for non-cytotoxicity, non-sensitization, and non-irritation.
Functional Performance: Conformance to ISO 11979-3 for demonstrating delivery of IOLs (Models EC-3 and EC-3 PAL) without significant impact on their optical performance, mechanical performance, dimensions, or cosmetic appearance.

8. The Sample Size for the Training Set

The provided information does not refer to a "training set" in the context of an algorithm or AI. This device is a mechanical delivery system, and its development and testing do not involve machine learning training sets.

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

Since there is no "training set" in the context of this device, this question is not applicable.

Summary

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S10(K) Summary

APR 1 5 2013

Submitter's Name, Address, Telephone Number, Contact Person, and Date 5.1 Summary Prepared

A.	Company Name:	Aaren Scientific Inc.
B.	Company Address:	4290 E. Brickell St., Bldg. A.Ontario, CA 91761
C.	Company Phone:	1 (909) 937-1033
D.	Contact Person:	Robert K. SheehanVice President, Regulatory Affairs andQuality SystemsAaren Scientific Inc.4290 East Brickell St., Bldg. A

Ontario, CA 91761 USA

Phone +1 (909) 937-1033 ext. 108 Email: rksheehan@aareninc.com

5.2 Date Summary Prepared

January 5, 2013

Name of Device, Including Trade Name and Classification Name 5.3 A. Device Trade Name: Aero Z Cartridge IOL Delivery System B. Common Name: Small Incision Injector ். Classification Name(s): Intraocular lens guide D. Classification Regulation: 21 CFR 886.4300 Class I E. Product Code: MSS F. Advisory Panel: Ophthalmic

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5.4 Predicate Devices

The Aero Z Cartridge IOL Delivery System is substantially equivalent to the Monarch III IOL Delivery System (C Cartridge) device cleared under 510(k) K112977 with respect to indications for use, materials and mechanism of action.

Device Description ર્સ્ડ

5.6 Indications for Use

The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.

5.7 Comparison of Technological Characteristics

The Aero Z Cartridge IOL Delivery System has the same indications for use, materials and mechanism of action as the predicate device (Alcon Research Monarch III IOL Delivery System, C Cartridge) device.

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Table 3.1: Comparison of Z Cartridge IOL Delivery System with Predicate Device
Device Name	Aaren ScientificZ Cartridge IOL DeliverySystem	Alcon ResearchMonarch® III IOL DeliverySystem (C Cartridge)
510(k) Number	K123888	K112977
Substantial Equivalence Characteristics
Intended Use	The Z Cartridge IOL DeliverySystem is indicated to fold andinsert Aaren Scientific ModelsEC-3 and EC-3 PAL intraocularlenses into the posteriorchamber of the eye	Folding and injection ofAcrySof® intraocular lensesinto the posterior chamber ofthe eye
Anatomical Site of Use	Posterior chamber of the eye	Posterior chamber of the eye
Components	Reusable handpiece and single-use, sterile Cartridge	Reusable handpiece and single-use, sterile Cartridge
Handpiece
Material	Titanium alloy	Titanium alloy
Lens Injecting Mechanism	Syringe-like (Push style) andPush-and-turn rotational(Screw style)	Push and turn
Configuration	Barrel and plunger assembly,the barrel has a chamber toaccept the Cartridge and theplunger advances the lens forinjection	Barrel and plunger assembly,the barrel has a chamber toaccept the Cartridge and theplunger advances the lens forinjection
Sterilization	Flash autoclave or steamsterilization by user	Flash autoclave or steamsterilization by user
Cartridge
Material	Polypropylene with a glycerolmonostearate (GMS) lubricityagent	Polypropylene with apolyvinylpyrrolidone (PVP)coating on the inner lumen
Loading Chamber	Lumen with wings for folding	Internal Cartridgegeometry
Configuration	Lens loading and folding areaconnected to a lens injectingnozzle	Lens loading and folding areaconnected to a lens injectingnozzle
Sterilization	Ethylene oxide (EtO)	Ethylene oxide (EtO)

Table 5.1: Comparison of Z Cartridge IOL Delivery System with Predicate Device

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Brief Summary of Nonclinical Tests and Results 5.8

In accordance with ISO 10993-1:2009, cytotoxicity, sensitization and irritation testing were performed on the IOL Delivery System. The device was found to be non-cytotoxic. non-sensitizing, and non-irritating. Testing conducted in accordance with ISO 11979-3 demonstrated that the Aero Z Cartridge IOL Delivery System can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the optical or mechanical performance, dimensions or the cosmetic appearance of the lens.

Based on the indications for use and the technological characteristics, it can be concluded that the Aero Z Cartridge IOL Delivery System is substantially equivalent to the predicate device.

Substantial Equivalence 5.8

On the basis of the same indications for use, materials and mechanism of action, the Aero Z Cartridge IOL Delivery System is substantially equivalent to the predicate device (Monarch III IOL Delivery System, C Cartridge).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

April 15, 2013

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

Aaren Scientific, Inc. % Mr. Robert Sheehan . Vice President of Regulatory Affairs and Quality Systems 4290 East Brickell Street, Bldg A Ontario, CA 91761-1569

Re: K123888

Trade/Device Name: AERO™ Z Cartridge IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: March 7, 2013 Received: March 11, 2013

Dear Mr. Sheehan:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Robert Sheehan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Sincerely yours,

Kesia YAlexander -S

for 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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Aero Z Cartridge IOL Delivery System Device Name:

Indications for Use:

The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.

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

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)

Tieuvi Hī 2013.04.05 1:5 5:07 -04'00'

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

510(k) Number: K123888

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.