LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

K050638 · Lenstec, Inc. · MSS · May 31, 2005 · Ophthalmic

Device Facts

• Record ID: K050638
• Device Name: LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
• Applicant: Lenstec, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: May 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Lenstec IOL Injection system is intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

Device Story

The Lenstec Injector System is a manual, syringe-based surgical instrument designed for the implantation of Tetraflex™ intraocular lenses (IOLs). The system comprises a reusable, autoclavable titanium injector and single-use, sterile disposable cartridges (MicroGlide LC604220 or ViscoGlide LC604240) which may include a silicone cushion. The device is operated by a physician in a clinical setting. The surgeon loads the foldable IOL into the cartridge, which is then attached to the injector. The injector facilitates the controlled delivery and insertion of the lens through a small incision (2.2 mm or 2.8 mm) into the patient's capsular bag. By enabling a smaller incision size, the system aims to improve surgical outcomes and patient recovery. The device is restricted to use by or on the order of a physician.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing of all contact materials and performance testing with the Tetraflex™ intraocular lens.

Technological Characteristics

System consists of a reusable titanium injector and single-use disposable cartridges made of lubricated polypropylene. Some configurations include a medical-grade silicone cushion. The device is manual, syringe-based, and autoclavable. No software or electronic components.

Indications for Use

Indicated for implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

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

• Medicel MultiJect Injector for IOLs and MicroGlide Cartridge (K040837)
• STAAR Surgical Foam Tip™ Injector System (K980696)

Submission Summary (Full Text)

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K050638

000016

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2870 Scherer Drive · Suite 300 · St. Petersburg, FL 33716 · USA Telephone: [phone] · Fax: [phone] · E-mail: lenstec @lenstec.com

# 510(K) Summary

## Date Summary Prepared: March 8, 2005

# Lenstec. Inc. 510(k) Premarket Notification Submission Lenstec Injector System for Tetraflex™ Intraocular Lenses 510(K) Premarket Notification Summary

Trade/Device Name: Lenstec Injector System for Tetraflex™ Intraocular Lenses Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS

#### Labeling:

Federal (United States) Law restricts this device to sale by or on the order of a physician.

- 1. Applicant Information:
- a. Name: Lenstec, Inc.
- b. Address: 2870 Scherer Drive, Suite 300 St. Petersburg, FL 33716 Telephone Number: 727 571-2272 Fax: [phone]
- c. Contact Person: Luis A. Ruiz, Vice President, Quality Assurance
- d. Address: 2870 Scherer Drive, Suite 300 St. Petersburg, FL 33716 Telephone Number: 727 571-2272 Fax: [phone] Email: [e-mail]
- 2. Name of Device:
- a. Trade Name: Lenstec Injector System for Tetraflex™ Intraocular Lenses
- b. Common Name: Intraocular lens guide.
- Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, c. 886.4300)

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- 3. Substantially Equivalent legally-marketed devices:
- a. Medicel MultiJect Injector for IOLs and MicroGlide Cartridge K040837. June 17, 2004.
- b. STAAR Surgical Foam Tip™ Injector System K980696, Sept 11, 1998.
- 4. Device Description:

The system consists of the following components:

| Cartridge | Injector | Nominal<br>Incision Size (mm) | Used with Tetraflex™<br>Intraocular Lenses<br>Power Range (D) |
|------------|----------|-------------------------------|---------------------------------------------------------------|
| LC604220 | I 9000 | 2.8 | 5.0 - 36.0 |
| LC604240 | I 9007 | 2.2 | 5.0 - 26.0 |
| W/LS604500 | | | |

Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.

- 5. Use:
The Lenstec Injector System is to be used solely to insert the foldable Tetraflex™ intraocular lenses manufactured by Lenstec and is used in conjunction with the Medicel cartridges, MicroGlide LC604220 and ViscoGlide LC604240 (w/Silicone Cushion LS604500).

- 6. Indications for use:
The Lenstec IOL Injection system is intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

## 7. Technological characteristics:

The primary system has two major components: a reusable injector and a disposable cartridge LC604240. A secondary system also has three major components: a reusable injector and a disposable cartridge LC604220 and includes the use of a Silicone Cushion supplied with the LC604220 cartridge.

- The injector is manufactured of titanium and can be autoclaved. a.
- b. The cartridge is manufactured of lubricated polypropylene and is Single Use.
- c. The silicone tip is manufactured of medical grade polypropylene body and a silicone tip and also is Single Use.
- 8. Performance data:
- a. Non-clinical tests

All contact materials have been tested for biocompatibility. The system was tested with Tetraflex™ intraocular lenses.

- 9. Clinical tests:
Not required

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## 10. Conclusions

The Lenstec Injector System with MicroGlide cartridges are substantially equivalent in safety and efficacy to the legally marketed predicate device.

Luis A. Ruiz

Vice President, Quality Assurance

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2005

Lenstec Inc. c/o Mr. Luis A. Ruiz Vice President, Quality Assurance 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716

Re: K050638

Trade/Device Name: Lenstec Intraocular Lens (IOL) Injection System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: May 12, 2005 Received: May 13, 2005

Dear Mr. Ruiz:

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 such 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); 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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Page 2 - Mr. Luis A. Ruiz

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 marketed predicate 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/industry/support/index.html.

Sincerely yours.

David M. Whipple

Acting 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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Page 3 - Mr. Luis A. Ruiz

### Indications for Use

510(k) Number: K050638

Device Name: Lenstec Intraocular (IOL) Lens Injection System

Indications For Use: The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jivision Sign-Off Division of Ophthatinic Ear, Nose and Throat Devises

510(k) Number_LOS

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