The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.

Device Description

The injector system is designed to facilitate the loading, folding and delivery of an intraocular lens (IOL) into the human eye through a small incision. The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile.

AI/ML Overview

The provided text describes the MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES, a Class I device (Intraocular Lens Injector Cartridge). The submission is a 510(k) premarket notification, which seeks to establish substantial equivalence to predicate devices, rather than prove efficacy through extensive clinical studies with acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone), sample sizes for test and training sets, and expert-established ground truths for performance evaluation of a diagnostic or AI-driven device is not applicable to this submission.

This document focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and materials.

Here's an attempt to answer the questions based on the available information, highlighting where the requested details are not present for this type of device submission:

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

For a 510(k) submission for a Class I device like the MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Performance is evaluated in terms of meeting functional requirements and material specifications comparable to the predicate.

General "acceptance criteria" for demonstrating substantial equivalence for this type of device would typically revolve around:

Identical Intended Use: The device must have the same intended use as the predicate.
Similar Technological Characteristics: The device must have similar design, materials, operating principles, and manufacturing processes as the predicate.
No New Questions of Safety or Effectiveness: Any differences in technological characteristics must not raise new questions of safety or effectiveness.
Functional Equivalence: The device must perform its intended function equivalently to the predicate.

The provided document extensively details the "Comparison Analysis" which serves as the "study" to prove the device meets these substantial equivalence criteria.

Acceptance Criteria Category	Reported Device Performance (vs. Predicate Devices)
Intended Use	Same: Intended to fold and insert STAAR Surgical Company 1-piece and 3-piece Collamer intraocular lenses for surgical placement in the human eye. (Compared to predicate K940593, K980696, K073586 having the same intended use for 1-piece or 3-piece Collamer IOLs, and K090161 for 3-piece Silicone IOLs, with the MSI aligning more closely with the Collamer IOLs).
Product Description	Same: System is designed to facilitate the loading, folding and delivery of an IOL into the human eye through a small incision.
Design	Same: Single cartridge to be used in conjunction with appropriate injector system and 1-piece or 3-piece Collamer lenses for surgical placement of lens into eye.
Materials	Same: Cartridge is manufactured from Polypropylene MG05 and Polypropylene MG03 purchased from Japan Supplier. (While predicate K940593, K980696, K073586 used US Supplier material, the new device uses the same material and supplier as predicate K090161). The document states "Cartridge is fabricated from polypropylene mixed with Glycerol Monostearate (GMS)."
Operating Principle	Same: The IOL is either placed into the loading area and folded shut or pressed forward towards the tip, then the cartridge is loaded onto the injector. (Similar to predicate devices).
Manufacturing	Similar: Utilization of contract manufacturers and in-house processing at STAAR Japan facility, while molding process is still done by a US contractor. (Similar to predicate K090161 which used STAAR Japan facility, and predicate K940593, K980696, K073586 which used US contract manufacturers and Monrovia facility).
Packaging	Similar: Cartridge is placed in tray, sealed with Tyvek lid and labeled. Tray is placed in Kraft paper pouch. Japanese Packaging supplier. (Similar to predicate K090161 which used Japanese Packaging Supplier; differing from predicate K940593, K980696, K073586 which used US Packaging Supplier and included a foil pouch). Differences are not deemed to raise new questions of safety/effectiveness as sterility is maintained.
Sterility	Same: Sterile Ethylene Oxide (EtO) by STAAR Japan. (Similar to predicate K090161; differing from predicate K940593, K980696, K073586 which used Subcontractor EtO. The method (EtO) is the same, only the facility differs, which is typically controlled by validated processes).
Manufacturer	Same: STAAR Japan (Similar to predicate K090161; differing from predicate K940593, K980696, K073586 which was STAAR Surgical. The critical point is that the processes are controlled/validated).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission for a Class I medical device, particularly for an IOL injector cartridge, does not typically involve a "test set" in the context of clinical performance data or AI model evaluation. The submission relies on comparative analysis of technological characteristics and safety data, often through bench testing (not detailed here) and biocompatibility, rather than human subject testing to establish performance metrics. The data provenance is generally from the device manufacturer or its suppliers as outlined in the "Manufacturing" and "Materials" sections.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As explained above, there is no "test set" or "ground truth" established by experts in the context of diagnostic accuracy for this type of device submission. The FDA reviews the technical documentation and comparison to predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no "test set" requiring adjudication in this context.

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 not an AI-driven or diagnostic device. Therefore, MRMC studies and AI assistance effect sizes are irrelevant to this submission.

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

Not Applicable. This is not an AI-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For this type of device, "ground truth" is not established in the clinical diagnostic sense. Instead, the "truth" is whether the device meets its design specifications, performs its intended function reliably, and is safe for use when compared to already-marketed predicate devices. This is typically established through engineering tests, material analyses, and biocompatibility assessments, which are not detailed in this summary document beyond the characteristics comparison.

8. The sample size for the training set

Not Applicable. This is not an AI-driven device, so there is no training set.

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

Not Applicable. This is not an AI-driven device, so there is no training set and therefore no ground truth for it.

In summary, this 510(k) notification focuses on demonstrating that the MicroSTAAR™ MSI Injector System Cartridges are "substantially equivalent" to existing legally marketed devices. The "study" that proves the device meets the acceptance criteria is the detailed "Comparison Analysis" presented in the document, which systematically compares the new device's intended use, technological characteristics, and safety aspects against predicate devices. The approval letter from the FDA confirms that this comparison was deemed sufficient to establish substantial equivalence.

Summary

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MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES

K101782

510(k) SUMMARY

Submitter Information	STAAR Surgical CompanyContact: Jack CogganDirector of Regulatory Affairs1911 Walker AvenueMonrovia, California 91016Phone: 626.303.7902 ext 2616Fax: 626.303.2962
Company Registration Number	2023826
Submission Correspondent	STAAR Surgical CompanyContact: Jack CogganDirector of Regulatory Affairs1911 Walker AvenueMonrovia, California 91016Phone: 626.303.7902 ext 2616Fax: 626.303.2962
Date Summary Prepared	January 4, 2011
Classification Name	Lens, Guide, Intraocular(Class I) - KYB 21 CFR 886.4300Folders and Injectors, Intraocular Lens (IOL)(Class I) - MSS 21 CFR 886.4300
Common/Usual Name	Intraocular Lens Injector Cartridge
Device Trade Name	MicroSTAAR™ MSI Injector SystemModels: CQ, SFC 25, SFC 45

The primary devices used for comparison in this summary are: Epiphany Injector System (K090161) and MicroSTAAR™ Indigo Injector System (K073586).

Intended Use

The MicroSTAAR MSI Injector System is intended to fold and insert STAAR Surgical Company Collamer phakic and aphakic 1-piece and 3-piece Collamer® intraocular lenses for surgical placement in the human eye. The MSI Cartridges in this submission are just one component of the MicroSTAAR MSI Injector System.

The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). Please refer to Attachment 1 for a copy of the Directions for Use for the predicate devices which will be the same for the MSI Cartridges.

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Description

Technological Characteristics

The MicroSTAAR™ MSI injector System Cartridge has substantially equivalent technological characteristics to the predicate device. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, specifications and materials.

	MicroSTAAR Injector SystemK940593, K980696, K073586	Epiphany Injector SystemK090161Epiphany	MicroSTAAR MSI InjectorSystem Cartridges	SubstantiallyEquivalent
ProductDescription	System is designed to facilitatethe loading, folding anddelivery of an intraocular lens(IOL) into the human eyethrough a small incision.	System is designed to facilitatethe loading, folding anddelivery of an intraocular lens(IOL) into the human eyethrough a small incision.	System is designed to facilitatethe loading, folding anddelivery of an intraocular lens(IOL) into the human eyethrough a small incision.	Same
Intended Use	Intended to fold and insertSTAAR Surgical Company 1-piece or 3-piece Collamerintraocular lenses for surgicalplacement in the eye.	Intended to fold and insertSTAAR Surgical Company 3-piece Silicone intraocularlenses for surgical placement inthe eye.	Intended to fold and insertSTAAR Surgical Company 1-piece and 3-piece Collamerintraocular lenses for surgicalplacement in the eye.	Same
Design	Single cartridge to be used inconjunction with appropriateinjector system and 1-piece or3-piece Collamer lenses forsurgical placement of lens intoeye.	A single component medicaldevice used in conjunction with3-piece silicone lenses forsurgical placement in the eye.	Single cartridge to be used inconjunction with appropriateinjector system and 1-piece or3-piece Collamer lenses forsurgical placement of lens intoeye.	Same
Materials	Cartridge is manufactured fromPolypropylene purchased fromUS Supplier.	Cartridge is manufactured fromPolypropylene MG05 andPolypropylene MG03purchased from Japan Supplier.	Cartridge is manufactured fromPolypropylene MG05 andPolypropylene MG03purchased from Japan Supplier.	Same
MechanicalSafety
Manufacturing	Utilization of contractmanufacturers and in-houseprocessing at Monrovia facility	Utilization of contractmanufacturers and in-houseprocessing at the STAAR Japanfacility	Utilization of contractmanufacturers and in-houseprocessing at the STAAR Japanfacility, while molding processis still done by a US contractor.	Similar

Comparison Analysis

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MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES

510(k)	MicroSTAAR Injector SystemK940593, K980696, K073586	Epiphany Injector SystemK090161Epiphany	MicroSTAAR MSI Injector System Cartridges	Substantially Equivalent
OperatingPrinciple	The IOL is placed into theloading area and folded shut orgently pressed towards tip.Then cartridge is loaded ontothe injector.	The cartridge is part of theEpiphany Injector. The lens isloaded into the cartridge,snapped shut, and pushed intopre-operative position.	Depending on the cartridgetype, the IOL is either placedinto the loading area and foldedshut, or it is pressed forwardtowards the tip. Then cartridgeis loaded onto the injector.	Same
Packaging	Cartridge is placed in tray,sealed with Tyvek lid andlabeled. Tray is placed in Kraftpaper pouch and then a foilpouch, and labeled again. USPackaging Supplier.	The Epiphany injector is placedinto a tray, which is labeled.This unit is placed inside apouch which is sealed. Thesealed pouch is then put into abox with a package insert.Japanese Packaging Supplier.	Cartridge is placed in tray,sealed with Tyvek lid andlabeled. Tray is placed in Kraftpaper pouch. JapanesePackaging supplier.	Similar
Sterility	Sterile Ethylene Oxide (EtO)by Subcontractor	Sterile Ethylene Oxide (EtO)by STAAR Japan	Sterile Ethylene Oxide (EtO)by STAAR Japan	Same
Manufacturer	STAAR Surgical	STAAR Japan	STAAR Japan	Same

8 .

Table 1 – Summary of Design comparison for 21 CFR § 807.87(f)

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

FEB - 7 2011

STAAR Surgical Company c/o Mr. Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016

Re: K101782

Trade/Device Name: MicroSTAAR Injector System Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserve Product Code: MSS Dated: December 2, 2010 Received: December 6, 2010

Dear Mr. Coggan:

This letter corrects our substantially equivalent letter of December 22, 2010.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocasined 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 commerce provided to May 20, 1977, the oncordance with the provisions of the Federal Food, Drug, devices that have occh require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the devices subject to eno gements for annual registration, listing of devices, controls provisions of the frect merade song prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (000 as ) Existing major regulations affecting your device can be may be subject to additions, 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 Please be advised that I DA s issuated or wouldevice complies with other requirements of the Act that I DA has made a acterimansions administered by other Federal agencies. You must of any I cuthal saltutes and regulations and limited to: registration and listing (21 Comply with an the For 8 requirements (01); medical device reporting (reporting of medical

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Page 2 - Mr. Jack Coggan

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 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.

Sincerely yours,

Kesia Alexander

Image /page/5/Picture/7 description: The image shows a handwritten word, "for", in cursive script. The letter "f" is elongated with a large loop extending below the baseline, and the letters "o" and "r" are connected in a fluid, continuous stroke. The writing appears to be done with a pen or marker, and the ink is dark and bold.

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

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Indications for Use

510(k) Number (if known): K101782

Device Name: MicroSTAAR™ Injector System Cartridge

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jennifer Brown

Page 1 of

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

510(k) Number K101782

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.