NAVIJECT SUB2-1P, MODEL: LP604430

K092023 · Medicel AG · MSS · Jul 28, 2009 · Ophthalmic

Device Facts

• Record ID: K092023
• Device Name: NAVIJECT SUB2-1P, MODEL: LP604430
• Applicant: Medicel AG
• Product Code: MSS · Ophthalmic
• Decision Date: Jul 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 Story

Naviject Sub2-1P IOL Injector Set is a sterile, single-use surgical instrument for folding and inserting STAAR Surgical Visian ICL phakic intraocular lenses. Device consists of a syringe-type injector, silicone cushion tip plunger, 33° bevel-down cartridge tip, and loading block. During surgery, surgeon loads IOL into cartridge; pushes IOL through tubular pathway via 2.2 mm incision over iris into eye. Device facilitates controlled IOL delivery; minimizes incision size; reduces surgical trauma. Used in clinical/surgical settings by ophthalmologists.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design comparison, material analysis, and mechanical safety validation for the intended IOL models.

Technological Characteristics

Materials: ABS, Polydimethilsiloxane (Silicone), Polypropylene with GMS additive. Design: Syringe-type injector with silicone cushion tip plunger, 33° bevel-down cartridge tip, and loading block. Operation: Manual mechanical insertion. Sterilization: Ethylene Oxide (EO). Form factor: Single-use sterile device.

Indications for Use

Indicated for the insertion of intraocular lenses (IOLs) into the human eye, specifically models compatible with this injector per their approved labeling.

Regulatory Classification

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.

Predicate Devices

• IOL Intraocular Injector Set (K070669)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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: [phone] Fax: [phone]

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:

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.

## 2. 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.

### 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 | Substantially<br>Equivalent |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------|
| Product<br>Description | This Injector and Cartridge Set is a<br>sterile, single-use device intended to<br>fold and insert a STAAR Surgical<br>Visian ICL phakic intraocular lens<br>through surgical procedure in a human<br>eye. The system provides a tubular<br>pathway through an incision over the<br>iris, allowing delivery of an IOL into<br>the human eye. | Same, except for<br>use with different<br>IOLs | Yes |
| Intended Use | The Naviject Sub2-1P IOL Injector and<br>Cartridge Set for intraocular lenses is<br>indicated for the insertion only of<br>models of intraocular lenses that allow<br>use of this injector in their approved<br>labeling. | Same, except for<br>use with different<br>IOLs | Yes |
| Design | This device has 3 basic components: a<br>syringe type injector with a silicone<br>cushion tip plunger, a 33° bevel down<br>cartridge tip and a loading block. | Same, except for<br>the 40° bevel up<br>cartridge tip | Yes |
| Materials | Plastic materials: ABS,<br>Polydimethilsiloxane (Silicone) and<br>Polypropylene with GMS additive | Same | Yes |
| Mechanical<br>Safety | Validated for STAAR Surgical phakic<br>Visian ICL intraocular lenses | Same, except<br>with different<br>IOLs | Yes |
| Manufacturing | Per internal operating procedures | Same | Yes |
| Operating<br>Principle | An IOL is loaded into the cartridge, then<br>pushed through the cartridge and<br>delivered into a human eye through a<br>2.2 mm surgical incision. | Same | Yes |
| Packaging | Labeled blister trays with Tyvek<br>material 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 [phone] or [phone] 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

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510(k) Number K092023