The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.

Device Description

The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "MicroSTAAR Injector System Cartridge, Model CQ." This submission is a "Special 510(k) Notification" for a design modification of an already cleared predicate device (K101782). The key modification is in the polypropylene formulation composing the device.

Therefore, the studies and acceptance criteria presented focus on demonstrating that this material change does not negatively impact the device's performance, safety, and effectiveness compared to the predicate.

Here's an analysis of the acceptance criteria and the studies, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric/Condition	Reported Device Performance (Subject Device)	Met?
Material Performance	Lenses must recover to specifications after being folded and deformed by the cartridge (per ISO 11979-3:2012, Section 5).	The change in material formulation does not impact the performance characteristics of the cartridge or lens. Intraocular lenses recovered to specifications.	Yes
Shelf-Life Stability	Cartridge performance maintained over stated shelf-life under real-time and accelerated conditions (per ISO 11979-6:2014).	The change in material formulation does not impact the performance characteristic of the cartridge over the stated shelf life. (Study initiated and ongoing)	Yes
Biocompatibility	The new material formulation must meet requirements for biological evaluation of medical devices (per ISO 10993-1:2009 and FDA Guidance).	The biocompatibility tests performed on the modified formulation model CQ cartridge met all acceptance criteria.	Yes
Intended Use	Device folds and inserts STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.	Implicitly met by design; primary focus of studies is on material change, not a change in fundamental function.	N/A*
Device Configuration/Usage	Single-use, sterile, Ethylene Oxide (EtO) sterilized, specific packaging. Same as predicate.	Claimed to be identical to predicate beyond material; therefore, implicitly met. No specific performance criteria stated for these aspects.	N/A*

* N/A here means these were claimed as "same" or design specifications rather than performance metrics requiring specific numeric acceptance criteria and measurement after the material change. The primary focus of the studies was to confirm the material change did not alter the existing performance.

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

The document does not explicitly state the exact sample sizes (number of cartridges or IOLs) used for each non-clinical test (Recovery of Properties, Biocompatibility, Shelf-Life). It only mentions "validation testing" and "tests performed."

Regarding data provenance:

The studies were non-clinical (laboratory/bench testing).
There is no mention of country of origin of data or whether it was retrospective or prospective in the context of human data, as these are bench tests. For the shelf-life study, it states it was "initiated and on-going" for "real time and accelerated conditions," indicating a prospective study design for that specific test.

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

Not applicable. This device is an intraocular lens injector cartridge, and the studies described are non-clinical (bench testing) to verify material performance, shelf-life, and biocompatibility. There is no "ground truth" established by human experts in the way it would be for diagnostic AI/CADe devices. The "ground truth" is based on established ISO standards and performance specifications for the mechanical and biological properties of the device and lens interaction.

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies are non-clinical, involving physical and chemical testing against established standards. There is no human adjudication process involved.

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. This is a physical medical device (an injector cartridge), not an AI/CADe system designed for image analysis or diagnosis. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for these non-clinical studies is defined by:

Performance Specifications: The intraocular lenses must recover to their intended specifications after being folded and deformed by the cartridge, as mandated by Section 5 of ISO 11979-3:2012.
Standard Requirements: The modified material must meet the biocompatibility requirements laid out in ISO 10993-1:2009 and relevant FDA Guidance.
Stability Standards: The device must demonstrate stability over its stated shelf-life according to ISO 11979-6:2014.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

Not applicable. See point 8.

Summary

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

September 6, 2017

STAAR Surgical Company Kate Ueda, JD Manager of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016

Re: K172375

Trade/Device Name: MicroSTAAR Injector System Cartridge, Model CQ Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: August 4, 2017 Received: August 7, 2017

Dear Kate Ueda, JD:

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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Denise L. Hampton -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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Indications for Use

510(k) Number (if known) K172375

Device Name

MicroSTAAR Injector System Cartridge, Model CQ

Indications for Use (Describe)

The MicroSTAAR® Injector System Cattridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary document has been prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Owner's Name:	STAAR Surgical Company
Address:	1911 Walker AvenueMonrovia, California 91016
Contact Person:	Kate Ueda
Title:	Manager of Regulatory Affairs
Phone:	626.303.7902 ext. 2316
Email:	kueda@Staar.com
Date Summary Prepared:	August 4, 2017

A. Subject Device:

Trade name:	MicroSTAAR® Injector System Cartridge, Model CQ
Common Name:	Intraocular Lens Injector Cartridge
Classification Name:	Folders & Injectors, Intraocular Lens (IOL)
Class:	Class I – MSS, 21 CFR 886.4300

B. Predicate Device:

MicroSTAAR108 Injector System Cartridge, K101782 is used as the predicate device for this Special 510(k) Notification. There are three (3) models cleared in K101782, SFC-45, SFC-25, and the CQ Cartridge. This Special 510(k) Notification addresses a design modification of the model CQ Cartridge only.

C. Device Description:

D. Indications for Use:

The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye. These are the same indications for use as the predicate model CQ Cartridge.

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E. Summary of Technological Characteristics

The MicroSTAAR Injector System Cartridge, Model CQ is a single use polypropylene cartridge designed to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to fold and deliver the STAAR Surgical Collamer® 3-piece (IOL) in the human eye. It is identical in design, dimensions, processing and packaging as the predicate device. The only difference is the polypropylene formulation composing the device. The following table provides a comparison to the predicate device.

Characteristic	Predicate Device	Subject Device
	MicroSTAARTM Injector System CartridgesK 101782	Proposed MicroSTAAR®Injector System CartridgeModel CQ
Indications for use	The MicroSTAARTM Injector System Cartridges is a deviceintended to fold and insert STAAR Surgical CompanyCollamer® phakic and aphakic one-piece and 3-piece IntraocularLenses for surgical placement in the eye.	Same(As modified for the modelCQ cartridge only-The MicroSTAAR® InjectorSystem Cartridge, ModelCQ is a device intended tofold and insert STAARSurgical CompanyCollamer® aphakic 3-pieceIntraocular Lenses forsurgical placement in theeye.)
Contraindications	Use of the MicroSTAAR Injector with other intraocular implantsand cartridges that have not been tested or approved for use withthe MicroSTAAR Injector System and Cartridges	Same
Anatomical site	The human eye	Same
Injectorconfiguration(single use)	The MicroSTAAR Injector Cartridges are used in conjunctionwith appropriate injector systems with 1-piece and 3-piecephakic and aphakic Collamer lenses.	Same(As modified for the modelCQ cartridge only)
How is the deviceused	The lens is placed into the loading area of the cartridge andfolded shut. Then the cartridge is loaded onto the injector. Whenthe injector is advanced, the lens is ejected from the cartridgenozzle into the human eye.	Same
Single use?	The MicroSTAAR Injector Cartridges are intended for singleuse only	Same
Is the productsterile?	The MicroSTAAR Injector Cartridges are supplied sterile	Same
How sterilized	Ethylene Oxide (EtO)	Same
How supplied	The MicroSTAAR Injector Cartridge is placed in a tray, sealedwith a Tyvek lid and labeled. The tray is sealed in a pre-printed,labeled Tyvek pouch and terminally sterilized.	Same

COMPARISON OF PREDICATE DEVICE TO THE PROPOSED DEVICE

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The technological characteristics of the modified CQ Cartridge are substantially equivalent to the predicate CQ Cartridge, cleared in K101782. As demonstrated above, the modified and predicate CQ Cartridges share the same intended use, indications, operating principle, design, packaging and sterilization method.

F. Brief Summary of Nonclinical Test and Results:

Results from validation testing of the modified MicroSTAAR Injector CQ Cartridge demonstrate that the cartridge functions as intended. In accordance with applicable tests in ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods (i.e., Section 5, Recovery of Properties following simulated surgical manipulation), intraocular lenses recovered to specifications after being folded and deformed by the cartridge.

A shelf-life study was initiated and is on-going for the modified cartridge under real time and accelerated conditions in accordance with applicable tests in ISO 11979-6:2014, Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability testing.

The CQ Cartridge composed of the modified polypropylene formulation has been tested for biocompatibility to ensure that the new material formulation meets the requirements of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry and Food and Drug Administration Staff dated June 16, 2016, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

Conclusions Drawn from Non-clinical Studies G.

A summary of the results of the non-clinical studies is provided below.

Study	Result	Is the Subject Deviceas safe and effective asthe Predicate Device?
Recovery of Properties	The change in material formulation doesnot impact the performance characteristicsof the cartridge or lens.	Yes
Shelf-Life	The change in material formulation doesnot impact the performance characteristicof the cartridge over the stated shelf life.	Yes
Biocompatibility	The biocompatibility tests performed on themodified formulation model CQ cartridgemet all acceptance criteria.	Yes

Non-Clinical Study Results

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The data generated from the non-clinical studies of the modified MicroSTAAR Injector cartridge, Model CQ support the subject device substantial equivalence to the predicate device.

The comparison of technical characteristics and data generated from the non-clinical studies demonstrate the substantial equivalence of the subject device and the predicate device.

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.