LENSTEC LC INJECTION SYSTEM

K063802 · Lenstec, Inc. · MSS · May 7, 2007 · Ophthalmic

Device Facts

• Record ID: K063802
• Device Name: LENSTEC LC INJECTION SYSTEM
• Applicant: Lenstec, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer posterior chamber intraocular lens model CC4204BF, and is used in conjunction with Lenstec LC 16 cartridge (with silicone cushion) or LC 24 cartridge (with silicone cushion).

Device Story

The Lenstec LC Injection System is a manual, syringe-based surgical instrument used by ophthalmologists during cataract surgery. It facilitates the implantation of the STAAR Collamer posterior chamber intraocular lens (model CC4204BF) into the patient's capsular bag. The system comprises a reusable, autoclavable titanium injector (model I-9011) and single-use, sterile disposable cartridges (LC-16 or LC-24) equipped with a silicone cushion. The surgeon loads the IOL into the cartridge, which is then attached to the injector. The device mechanically folds and delivers the lens through a small incision. By enabling controlled delivery of the IOL, the system assists the surgeon in restoring vision following extracapsular cataract extraction.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing of all contact materials and performance verification of the injection system with the STAAR Collamer Intraocular Lens model CC4204BF.

Technological Characteristics

System consists of a reusable titanium injector (autoclavable) and single-use disposable cartridges (lubricated medical-grade polypropylene) with a medical-grade polypropylene silicone cushion. Tip diameters are 1.6mm and 2.4mm. Manual mechanical operation; no energy source or software.

Indications for Use

Indicated for the implantation of STAAR Collamer Intraocular Lens model CC4204BF 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

• Lenstec Injection System for Tetraflex Intraocular lenses (K050638)
• Lenstec Injection System for Softec Injection System (K060533)

Submission Summary (Full Text)

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K063802

Image /page/0/Picture/1 description: The image shows a logo for a company called "LENS TEC". The logo is in a bold, sans-serif font, with the letters outlined in black. To the right of the text is a circle, which is also outlined in black. The letters are stacked on top of each other, with "LENS" on top and "TEC" on the bottom.

MAY - 7 2007

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

## 510(k) Summary

Date Summary Prepared: December 20th, 2006

Lenstec Inc.

## 510(k) Premarket Notification Submission Lenstec LC Injection System for STAAR Collamer Plate Intraocular Lenses 510(k) Premarket Notification Summary

Trade/Device Name: Lenstec LC Injection System for STAAR Collamer Intraocular Lens Model CC4204BF 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: [phone] Fax Number: [phone]
- Contact Person: Jimmy Chacko, Vice President, Regulatory Affairs C.
- d. Address: 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716 Telephone Number: [phone] Fax Number: [phone] Email: [e-mail]
- 2. Name of Device
- Trade Name: Lenstec LC Injection System for STAAR Collamer ಡ.. Intraocular Lens Model CC4204BF
- Common Name: Intraocular Lens guide b.
- Classification Name: Folders and Injectors, intraocular lens (IOL) (MSS, C. 886.4300)

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- 3. Substantially Equivalent legally-marketed devices:
- a. Lenstec Injection System for Tetraflex Intraocular lenses (K050638)
- b. Lenstec Injection System for Softec Injection System (K060533)
- 4. Device Description

The system consists of the following components:

| Cartridge | Injector | Tip Diameter<br>(mm) | STAAR IOL<br>Power range (D) |
|---------------------------------------------|----------|----------------------|------------------------------|
| LC-16<br>w/ Silicone Cushion<br>(SIC-01-02) | I-9011 | 1.6 | 10.5 - 34.0 |
| LC-24<br>w/ Silicone Cushion<br>(SIC-01-02) | I-9011 | 2.4 | 10.5 - 34.0 |

One type of injector is provided: it is syringe based and is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.

- 5. Use:
The Lenstec LC Injection System is intended for use in implantation of STAAR Collamer posterior chamber intraocular lens model CC4204BF, and is used in conjunction with Lenstec LC 16 cartridge (with silicone cushion) or LC 24 cartridge (with silicone cushion).

- 6. Indications for use:
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.

- 7. Technological characteristics:
The system has two major components: a reusable injector and one of two disposable cartridges (LC 16, LC 24) with a silicone cushion (SIC-01-02)

- a. the injector is manufactured of titanium and can be autoclaved
- b. the cartridge is manufactured of lubricated medical grade polypropylene and is single use
- the silicone tip is manufactured of medical grade polypropylene and is C. single use
- 8. Performance data:
- a. Non clinical tests

All contact materials have been tested for biocompatibility. The system was tested with STAAR Collamer Intraocular Lens model CC4204BF

- 9. Clinical tests: Not required

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10. Conclusions:

The Lenstec LC Injection System is substantially equivalent in safety and efficacy to the legally marketed predicate device.

Jimmy Chacko

Jimmy Chackoff
Vide President, Regulatory Affairs
Lenstec Inc.

DECEMBER 20th, 2006

Date

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font and the text is black.

Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2007

Lenstec, Inc. c/o Mr. Jimmy Chacko Vice President, Regulatory Affairs 2870 Scherer Drive, suite 300 St. Petersburg, FL 33716

Re: K063802

Trade/Device Name: Lenstec LC Injection System for STAAR Collamer Intraocular Lens Model CC4204BF

Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: April 5, 2007 Received: April 9, 2007

Dear Mr. Chacko:

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 (OS) 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. Jimmy Chacko

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,

M.B. Eickelmin S.W.D

Malvina B Eydelman, 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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## INDICATION FOR USE

The Lenstec LC Injection System is intended for use in the implantation of STAAR The Lenster Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.

K

Jimmy Chacko Vice President, Regulatory Affairs Venstec Inc.

DECEMBER 21, 2006

Date

11 (Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K063802