The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

Device Description

The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye. This device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33º bevel down cartridge tip and a loading block.

AI/ML Overview

This submission describes a medical device, the Visian® nanoPOINT™ 2.0 Injector System, and its substantial equivalence to a previously cleared device. Therefore, a traditional acceptance criteria and study section as seen with AI/ML devices or novel technologies is not fully applicable. However, I can extract the relevant information from the provided text to structure an answer that addresses your requested categories based on the nature of this 510(k) submission.

Nature of the Device and Submission:

The Visian® nanoPOINT™ 2.0 Injector System is an intraocular lens injector system, a Class I medical device. This 510(k) submission (K101134) is a declaration of substantial equivalence to a predicate device (K092023, Naviject Sub2-1P Injector Set) rather than a novel device requiring extensive de novo clinical trials to prove efficacy against specific acceptance criteria. The key argument for substantial equivalence is that the new device is identical to the predicate device in its technological characteristics, design, materials, and operating principle, with only a modification to the indications for use to specifically name the lens model it is intended for.

Given this, the "acceptance criteria" and "study" are framed around demonstrating that the new device is as safe and effective as the predicate device because it is essentially the same device.

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

The "acceptance criteria" for the Visian® nanoPOINT™ 2.0 Injector System were met by demonstrating its substantial equivalence to the predicate device (K092023, Naviject Sub2-1P IOL Injector Set). The performance reported is that the device is identical to the predicate device in all critical aspects.

Feature / Acceptance Criteria Category	Predicate Device Specification (K092023)	Reported Device Performance (Visian® nanoPOINT™ 2.0 Injector System)	Meets Criteria?
Product Description	Sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® phakic one piece intraocular lens. The system provides a tubular pathway through a corneal incision.	Identical	Yes
Intended Use	Insertion of intraocular lenses as per approved labeling.	Folding and insertion of STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL.	Yes (only difference is the specific lens name)
Design	3 basic components: syringe type injector with silicone cushion tip plunger, 33º bevel down cartridge tip, loading block.	Identical	Yes
Materials	ABS, Polydimethylsiloxane (Silicone), Polypropylene with GMS additive.	Identical	Yes
Mechanical Safety	Validated for specific IOL models.	Validated for STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL (V08-138).	Yes
Manufacturing	Per internal operating procedures.	Identical	Yes
Operating Principle	Phakic IOL loaded into cartridge, pushed through and delivered into human eye through 2.2 mm surgical incision.	Identical	Yes
Packaging	Blister trays with labeled Tyvek material lids and labeled boxes.	Blister trays with pre-printed labeling on Tyvek material lids and boxes.	Yes
Biocompatibility	Biocompatibility tests for K092023, substantially equivalent to K070669.	Injector materials are the same as previously cleared K070669 IOL injector. Biocompatibility tests for that injector were acceptable.	Yes
Shelf Life	Three years.	Identical (Three years)	Yes
Sterility	Sterile (EO).	Identical (Sterile (EO))	Yes
Manufacturer	Medicel AG.	Identical (Medicel AG)	Yes

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical or performance test set. The submission relies on the established performance and safety of the legally marketed predicate device (K092023).
Data Provenance: The "data" primarily comes from the regulatory clearance of the predicate device (K092023) and an earlier device (K070669) from which the biocompatibility data was carried forward. This is retrospective in nature, drawing from previous approvals and pre-existing validation reports. The country of origin for the earlier validation studies is not specified in this document, but Medicel AG is based in Switzerland.

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

Not applicable. The ground truth for this type of submission is based on regulatory precedent and the established safety and effectiveness of a predicate device, as determined by the FDA. It does not involve expert consensus on new data for this specific submission, beyond the FDA's regulatory review process itself.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the context of clinical or performance testing requiring adjudication. The adjudication was the FDA's regulatory review process determining substantial equivalence.

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 device is not an AI/ML diagnostic tool, nor does it involve "human readers" or "AI assistance." It is a mechanical device for implanting intraocular lenses.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this substantial equivalence determination is regulatory precedent and established safety/effectiveness data of the predicate device. Specifically:

The Visian® nanoPOINT™ 2.0 Injector System is declared "identical" to the K092023 Naviject Sub2-1P IOL Injector Set.
Biocompatibility data was inherited from the previously cleared K070669 IOL injector, which was deemed substantially equivalent to K092023.
Mechanical safety was validated for the specific lens model, building on validations done for the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Summary

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Medicel AG

Visian® nanoPOINT™ 2.0 Injector System

KIO1134

510(k) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR & 807.92.

Submitter Information:

Medicel AG Contact: Volker Dockhorn Chief Operating Officer Luchten 1262 Wolfhaden CH 9427 Switzerland Phone: 41-71-727-1057 Fax: 41-71-727-1055

FDA Registration Number: 9681862

Medicel AG Contact: John Coggan (Official Correspondent) STAAR Surgical 1911 Walker Ave Monrovia, CA 91016 USA

Date Summary Prepared:

Submission Correspondent:

Classification Name:

Common/Usual Name:

April 5, 2010

Folders and Injectors, Intraocular Lens (IOL) (Class I) - MSS 21 CFR 886.4300

Intraocular Lens Guide

Device Trade Name:

Visian® nanoPOINT™ 2.0 Injector System

Equivalent legally-marketed devices: K092023, IOL Intraocular Injector Set,

Medicel AG (Naviject Sub2-1P Injector Set)

1. Intended Use:

Description:

AUG - 9 2010

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3. Technological Characteristics:

nanoPOINT™ 2.0 Injector System has substantially equivalent The Visian® technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material. There are no differences in any of the technological characteristics of this device as compared to the cleared predicate device and therefore the safety and effectiveness of this device are not compromised.

4. Comparison Analysis:

The overall design of this Visian® nanoPOINT™ 2.0 Injector System is the same as the predicate device since it is the same injector. The indications for use and labeling were modified to clearly specify the lens model for which it is intended.

Performance Data

Non Clinical Tests: All materials have been tested for biocompatibility. These (1) tests were performed in the previously cleared device, the K070669 injector set, which was substantially equivalent to K092023 and therefore equivalent to the newly submitted 510(k) device. These tests were all acceptable.
The validation (non-clinical) tests for the previously cleared K092023. Naviject Sub2-1P IOL Injector Set, are the same for this newly submitted device, the Visian® nanoPOINT™ 2.0 Injector System, since it is the anne injector and it is intended for the folding and insertion of the same lens. See Table 1 for a comparison of the new and the previous K092023, Naviject Sub2-1P IOL Injector Set.

Shelf Life for the previously submitted devices was set at three years based on tests performed on equivalent injectors. This new device will have the same shelf life. .

1. Clinical Tests: (Not required)
1. Conclusions: In conclusion the newly submitted device is as safe, as effective and performs as safely and effectively as the legally marketed device as it is

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. .

the same device and there were no changes to the technological characteristics of the device.

Feature	Visian® nanoPOINTTM 2.0 InjectorSystem	K092023	SubstantiallyEquivalent
ProductDescription	This Injector and Cartridge System isa sterile, single-use device intendedto fold and insert a STAAR SurgicalCollamer® phakic one pieceintraocular lens, Model Visian® ICLthrough surgical procedure in ahuman eye. The system provides atubular pathway through a cornealincision allowing delivery of a phakicIOL into the human eye.	Identical	Yes
Intended Use	The Visian® nanoPOINTTM 2.0Injector System is a device intendedto fold and insert a STAAR SurgicalCollamer® phakic one pieceintraocular lens, Model Visian® ICL,for surgical placement in the humaneye.	The Naviject SUB2-1P IOLInjector and Cartridge Set forintraocular lenses is indicatedfor the insertion only of modelsof intraocular lenses that allowuse of this injector in theirapproved labeling.	Yes, the onlydifference is inthe inclusion ofthe specific lensname for whichit is intended
Design	This device has 3 basic components: asyringe type injector with a siliconecushion tip plunger, a 33º bevel downcartridge tip and a loading block.	Identical	Yes
Materials	Plastic materials: ABS,Polydimethilsiloxane (Silicone) andPolypropylene with GMS additive	Identical	Yes
MechanicalSafety	Validated for STAAR SurgicalCollamer® Phakic One PieceIntraocular Lenses, Model Visian®ICL (V08-138)	Identical	Yes
Manufacturing	Per internal operating procedures	Identical	Yes
OperatingPrinciple	A phakic IOL is loaded into thecartridge, then pushed through thecartridge and delivered into a humaneye through a 2.2 mm surgicalincision.	Identical	Yes
Packaging	Blister trays with pre-printed labelingon Tyvek material lids and boxes	Blister trays with labeledTyvek material lids and labeledboxes	Yes
Biocompatibility	Injector materials are the same as thepreviously cleared K070669 IOLinjector. Biocompatibility tests forthat injector were acceptable.	Biocompatibility forK092023, substantiallyequivalent to K070669, shallbe identical to the newlysubmitted device	Yes
Shelf Life	Three years	Identical	Yes
Sterility	Sterile (EO)	Identical	Yes
Manufacturer	Medicel AG	Medicel AG	Yes

Table 1: Summary of Design Comparison

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

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

AUG - S 2010

Re: K101134

Trade/Device Name: Visian® nanoPOINT™ 2.0 Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lenses Regulatory Class: Class I (reserve) Product Code: MSS Dated: July 14, 2010 Received: July 16, 2010

Dear Mr. Coggan:

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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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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

Enclosure

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Visian® nanoPOINT™ 2.0 Injector System

Medicel AG

Indications for Use Statement

AUG - 9 2010

510(k) Number (if known): ___K 101134

Device Name: Visian® nanoPOINT™2.0 Injector System

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)

Signature

Page I of I

Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101134

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.