The Naviject Sub2-1P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

Device Description

The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Naviject™ Sub2-1P IOL Injector Set. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical trial for a novel AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI assistance effect size, standalone performance, training set details) are not applicable to this type of submission.

The "acceptance criteria" in this context are the demonstration of substantial equivalence to a legally marketed predicate device, as outlined in the comparison table, rather than quantifiable performance metrics against a predefined threshold. The "study" proving acceptance criteria is the comparison analysis itself.

Here's the information that can be extracted or inferred from the provided text:

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

Feature/Acceptance Criteria (Demonstrated Substantial Equivalence To)	Reported Device Performance (Naviject Sub2-1P IOL Injector Set)
Product Description: Sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye, providing a tubular pathway for IOL delivery.	Same as predicate, except for use with different IOLs.
Intended Use: Indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.	Same as predicate, except for use with different IOLs.
Design: Syringe type injector with a silicone cushion tip plunger, a cartridge tip, and a loading block.	Device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33° bevel down cartridge tip, and a loading block. (Predicate had a 40° bevel up cartridge tip).
Materials: Plastic materials: ABS, Polydimethilsiloxane (Silicone) and Polypropylene with GMS additive.	Same as predicate.
Mechanical Safety: Validated for STAAR Surgical phakic Visian ICL intraocular lenses.	Same as predicate, except with different IOLs.
Manufacturing: Per internal operating procedures.	Same as predicate.
Operating Principle: IOL loaded into cartridge, pushed through cartridge and delivered into human eye through surgical incision.	IOL is loaded into the cartridge, then pushed through the cartridge and delivered into a human eye through a 2.2 mm surgical incision. (Same as predicate).
Packaging: Labeled blister trays with Tyvek material lids and boxes.	Same as predicate.
Sterility: Sterile (EO).	Same as predicate.
Manufacturer: Medicel AG	Same as predicate.

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

Not Applicable. This submission is based on a comparison analysis to a predicate device, not a performance study involving a patient or clinical test set. The validation for mechanical safety (mentioned in the table) would involve testing the device with the specific IOLs, but no details on sample size or provenance are provided in this regulatory document.

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

Not Applicable. No ground truth established by experts for a test set is discussed. The "ground truth" for this type of submission is the legally marketed status and characteristics of the predicate device.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication method described.

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 device, and no MRMC study was conducted.

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

Not Applicable. This is not an AI device.

7. The type of ground truth used:

Primarily comparison to a legally marketed predicate device's characteristics and intended use. The mechanical safety aspects would have involved bench testing against defined specifications, but the specifics of that "ground truth" are not detailed here beyond "Validated for STAAR Surgical phakic Visian ICL intraocular lenses."

8. The sample size for the training set:

Not Applicable. This is not an AI device.

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

Not Applicable. This is not an AI device.

Summary

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JUL 8 8 2008

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 Wolfhalden CH 9427 Switzerland Phone: 41-71-727-1057 Fax: 41-71-727-1055

FDA Registration Number: 9681862

Medicel AG Contact: Volker Dockhorn (Official Correspondent)

Medsys Inc. Contact: Dr. George Myers President Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Phone: 201-727-1703 Fax: 201-727-1708

Date Summary Prepared:

Submission Correspondent:

Classification Name:

Common/Usual Name:

Device Trade Name:

Equivalent legally-marketed devices:

February 20, 2009

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

Intraocular Lens Guide

Naviject™ Sub2-1P IOL Injector Set

K070669, IOL Intraocular Injector Set, Medicel AG

Section 1

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1. Intended Use:

2. Description:

3. Technological Characteristics:

The Naviject Sub2-1P IOL Injector Set has substantially equivalent 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.

4. Comparison Analysis:

The overall design of the Naviject Sub2-1P IOL Injector Set is substantially equivalent to the predicate device. See Table 1 for a comparison of the new Naviject Sub2-1P IOL Injector Set and the predicate device.

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Feature	Naviject Sub2-1P IOL Injector Set	K070669	SubstantiallyEquivalent
ProductDescription	This Injector and Cartridge Set is asterile, single-use device intended tofold and insert a STAAR SurgicalVisian ICL phakic intraocular lensthrough surgical procedure in a humaneye. The system provides a tubularpathway through an incision over theiris, allowing delivery of an IOL intothe human eye.	Same, except foruse with differentIOLs	Yes
Intended Use	The Naviject Sub2-1P IOL Injector andCartridge Set for intraocular lenses isindicated for the insertion only ofmodels of intraocular lenses that allowuse of this injector in their approvedlabeling.	Same, except foruse with differentIOLs	Yes
Design	This device has 3 basic components: asyringe type injector with a siliconecushion tip plunger, a 33° bevel downcartridge tip and a loading block.	Same, except forthe 40° bevel upcartridge tip	Yes
Materials	Plastic materials: ABS,Polydimethilsiloxane (Silicone) andPolypropylene with GMS additive	Same	Yes
MechanicalSafety	Validated for STAAR Surgical phakicVisian ICL intraocular lenses	Same, exceptwith differentIOLs	Yes
Manufacturing	Per internal operating procedures	Same	Yes
OperatingPrinciple	An IOL is loaded into the cartridge, thenpushed through the cartridge anddelivered into a human eye through a2.2 mm surgical incision.	Same	Yes
Packaging	Labeled blister trays with Tyvekmaterial lids and boxes	Same	Yes
Sterility	Sterile (EO)	Same	Yes
Manufacturer	Medicel AG	Medicel AG	Yes

Table 1: Summary of Design Comparison

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicel AG c/o George Myers, M.D 377 Route 17 South Hasbrouck Heights, NJ 07604

JUL 2 8 2009

Re: K092023

Trade/Device Name: Naviject™ Sub2-1P IOL Injector Set Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: April 3, 2009 Received: July 6, 2009

Dear Dr. Myers:

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.

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 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.

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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/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 (240) 276-3150 or at its Internet address

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

Sincerely vours.

Jue C. Calloway for

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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Indications for Use

510(k) Number (if known): K092023

Device Name: Naviject™ Sub2-1P IOL Injector Set

Indications For Use:

The Naviject Sub2-1P IOL Injector and Cartridge Set for intraccular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

Prescription Use X (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)

Brad Ramsey

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

Page 1 of

510(k) Number K092023

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.