MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

K040837 · Medicel AG · MSS · Jun 17, 2004 · Ophthalmic

Device Facts

• Record ID: K040837
• Device Name: MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
• Applicant: Medicel AG
• Product Code: MSS · Ophthalmic
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.

Device Story

The MultiJect injector is a reusable surgical instrument designed for the insertion of specific foldable intraocular lenses (IOLs) into the eye. It is used in conjunction with a single-use, sterile MicroGlide cartridge. The system is available in two configurations: a syringe-type injector and a screw-type injector. The injector body is constructed from titanium and is designed to be autoclaved for reuse, while the cartridge is made of lubricated polypropylene. The device is operated by a surgeon during ophthalmic procedures to facilitate the controlled delivery of the IOL into the eye. By providing a consistent delivery mechanism, the device assists in the surgical implantation process, potentially improving procedural efficiency and lens placement accuracy.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing of contact materials and functional testing with the specified intraocular lenses.

Technological Characteristics

Two-component system: reusable injector and single-use sterile cartridge. Injector material: titanium. Cartridge material: lubricated polypropylene. Injector is autoclavable. Mechanical operation (syringe or screw type).

Indications for Use

Indicated for the insertion of foldable intraocular lenses (specifically Pharmacia CeeOn 913A and Tecnis Z9000) when used with the MicroGlide cartridge.

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

• Allergan Phacoflex (K961242)
• Alcon Monarch (K003768)

Submission Summary (Full Text)

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Page A2

K04-0837

JUN 1 7 2004

Medicel A.G. 510(k) Submission MultiJect Reusable Injector For Intraocular lenses 510(K) Summary March 19, 2004

(1) Submitter Information

Name: Medicel AG

Address: Noellenstrasse 15a CH - 9443 Widnau Switzerland

Telephone Number: 41-71-727-1050 Fax: [phone]

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: December 12, 2003??

(2) Name of Device:

Trade Name: MultiJect Injector for IOLs and MicroGlide Cartridge Common Name: Intraocular lens guide. Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300)

(3) Equivalent legally-marketed devices:

Allergan Phacoflex K961242 Alcon Monarch K003768

## (4) Description

The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses.

) Intended Use ·

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e Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.

(6) Technological characteristics

The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector can be autoclaved. The cartridge is made of lubricated polypropylene.

(b) Performance data

(1) Non-clinical tests

All contact materials have been tested for biocompatibility. The device was tested with each of the recommended intraocular lenses.

(2) Clinical tests

Not required

(3) Conclusions

The MultiJect injector and MicroGlide cartridge are equivalent in safety and efficacy to the legally varketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Medicel AG c/o Dr. George Myers Medsys Inc. 377 Rt. 17S Hasbrouck Heights, NJ 07604

Re: K040837

Trade/Device Name: MultiJet Injector and MicroGlide Cartridge Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: March 23, 2004 Received: March 31, 2004

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications ferenced above and nave determined I marketed predicate devices marketed in interstate for use stated in the encrosure) to regars chemic date of the Medical Device American of to commerce price to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (1101) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, market are a et include requirements for annual registration, listing of general controls provisions of cactice, 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 If your device is onastined (600 world). Existing major regulations affecting your device can may or subject to basil acaderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou louic in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITCase oc advised that I Dris a lossantes verour device complies with other requirements of the Act that I DT has made a assumations administered by other Federal agencies. You must of any I edelul statutes the soguirements, including, but not limited to: registration and listing Confire will and the Hot req21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), laceming (21 CFR Part 820); and if applicable, the electronic rorth in the quant) bytvol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Dr. George Myers

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatics noticated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalgi Rosenthal

A. Ralph Rosenthal, 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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. age _______ of______________________________________________________________________________________________________________________________________________________________

Indications for Use

510(k) Number (if known): K 040837

Device Namc: MultiJect Injector and MicroGlide Cartridge

Indications for Use:

The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses " Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dos Calogero

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K040837