RE-USEABLE MICROSTAAR INJECTOR, MSI-S

K032412 · Staar Surgical Co. · KYB · Jun 10, 2004 · Ophthalmic

Device Facts

• Record ID: K032412
• Device Name: RE-USEABLE MICROSTAAR INJECTOR, MSI-S
• Applicant: Staar Surgical Co.
• Product Code: KYB · Ophthalmic
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The Collamer 3 Piece Injector is an intraocular lens guide used to fold and insert STAAR Surgical's 3 Piece Collamer intraocular lenses for surgical placement in the human eye.

Device Story

The Collamer 3 Piece Injector is a reusable titanium alloy and PEEK instrument used by ophthalmic surgeons during cataract surgery. It functions as a mechanical guide to fold and insert 3-piece Collamer intraocular lenses (IOLs). The device operates by placing the IOL into a polypropylene cartridge; a plunger and plunger rod mechanism then pushes the folded lens through the cartridge and into the patient's eye. The device is provided non-sterile and is designed for steam sterilization. By facilitating controlled lens insertion, it assists the surgeon in placing the IOL into the capsular bag or ciliary sulcus, aiding in visual restoration following cataract removal.

Clinical Evidence

Bench testing only. The device was designed and tested in accordance with applicable safety standards and demonstrated mechanical performance and behavior equivalent to the predicate device.

Technological Characteristics

Materials: Titanium (6-Aluminum, 4-Vanadium) and PEEK (polyetheretherketone). Mode of operation: Mechanical plunger-based insertion. Form factor: Reusable manual injector. Sterilization: Steam sterilizable. Connectivity: None. Software: None.

Indications for Use

Indicated for folding and inserting STAAR Surgical 3 Piece Collamer intraocular lenses into the capsular bag or ciliary sulcus following cataract 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

• MS1-P Elastic Lens Injector (K861085)

Submission Summary (Full Text)

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K032 4/2

### Section 15

# Summary of Safety and Effectiveness

The 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| 1. Submitter's name, address, telephone number, contact person, and date<br>summary prepared: | |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| a. | Submitter: STAAR Surgical Company<br>1911 Walker Avenue<br>Monrovia, CA 91016<br>[phone] |

| b. Contact Person: | Helene Lamielle |
|--------------------------|-----------------|
| c. Date Summary Prepared | May 14, 2004 |

## 2. Name of device, including trade name and classification name:

| a. | Trade/Proprietary Name: | Collamer 3 Piece Injector |
|----|-------------------------|---------------------------|
| b. | Classification Name: | Intraocular Lens Guide |

- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed.

| a. | Company: | STAAR Surgical Company |
|----|---------------|-----------------------------|
| b. | Device: | MS1-P Elastic Lens Injector |
| c. | 510(K): | K861085 |
| d. | Date Cleared: | 5/28/1986 |

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- 4. A description of the device that is the subject of the 510(K) including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

#### 5. Statement of intended use:

The Collamer 3 Piece Injector is an intraocular lens guide used to fold and insert STAAR Surgical's 3 Piece Collamer intraocular lenses for surgical placement in the human eye. " ------------------------------------------------------------------------------------------------------------------------------------------------

- 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

| CHARACTERISTICS | Collamer 3 Piece Injector | MS1-P Elastic<br>Lens Injector |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use | For Surgical placement of an intraocular<br>lens in the human eye | Same |
| Material | Titanium, 6-Aluminum, 4-Venadium, and<br>PEEK (polyetheretherketone) | Titanium |
| Sterilization | Provided non-sterile, may be steam<br>sterilized | Provided non-sterile;<br>may be steam sterilized |
| Mode of Operation | Intraocular lenses are folded and placed<br>inside a lens cartridge made from<br>polypropylene. The lens is then pushed<br>down via a plunger and plunger rod and<br>expelled from the lens cartridge into the<br>human eye. | Same |
| Single Use or Re-useable | Re-usable | Same |

#### Comparative Technological Characteristics

#### 7. Brief summary of non-clinical tests and results:

The Collamer 3 Piece Injector has been designed and tested in accordance with applicable safety standards. In addition, the Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector with respect to mechanical performance and mechanical behavior.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

STAAR Surgical Company c/o Helene Lamielle, M.D. 1911 Walker Ave. Monrovia, CA 91016

Re: K032412

Trade/Device Name: Collamer 3 Piece Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Ophthalmic lens guide Regulatory Class: Class I Product Code: KYB Dated: May 14, 2004 Received: May 17, 2004

Dear Dr. Lamielle:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosal of togally to togens the Medical Device Amendments, or to commerce prof to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices may have been recuire approval of a premarket approval application (PMA). and Cosmetic Ace (71ct) that as novice, subject to the general controls provisions of the Act. The r ou may, dicterore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 classified (600 a00 70) als. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may or found in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsualled by our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cacrates and regulations and limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CTK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality !!)Stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – K032412

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/dsma/dsmamain.html

Sincercly yours,

Akeiji Korentthal

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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Page 3 - K032412

## Indications for Use

510(k) Number (if known):_K032412

Device Name: STAAR Surgical Collamer 3 Piece Injector

:

Indications For Use:

The Collamer 3 Piece IOL Injector, is an intraocular lens guide The Collamer 3 I a man Surgical 3 Piece Collamer used to ford and into the capsular bag or ciliary sulcus following cataract 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)

| Copc@rrenee-of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------|-----------|
| | |
| - Division of Ophthalmic Ear.<br>Nose and Throat Devises | |
| 510(k) Number_KO32412 | Page 1 of |