FOAM TIP INJECTOR

K980696 · Staar Surgical Co. · MSS · Sep 11, 1998 · Ophthalmic

Device Facts

• Record ID: K980696
• Device Name: FOAM TIP INJECTOR
• Applicant: Staar Surgical Co.
• Product Code: MSS · Ophthalmic
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.

Device Story

Foam Tip™ Injector System facilitates folding and insertion of silicone intraocular lenses (IOLs) into human eye; used by surgeons during cataract or lens replacement surgery. Device consists of reusable sterile injector body and single-use sterile disposable foam-tipped plunger insert. Plunger insert features hydrated sponge tip to provide controlled ejection of lens through cartridge. Mechanism utilizes plunger-push or threaded-cap design to advance lens. Holder protects sponge tip and acts as wrench for plunger removal post-implantation. System improves surgeon control during lens delivery; ensures proper lens placement; minimizes risk of haptic or lens damage.

Clinical Evidence

Bench testing only. Functional ejection testing performed on 40 single-piece UV-ELASTIC™ silicone lenses across various injector/cartridge combinations. Endpoints included lens tears, haptic damage, and resolution efficiency; all samples passed. Particulate evaluation showed no particles >10 microns. Accelerated aging studies (dust drum, dye penetration, burst tests) confirmed sterile barrier integrity. Cytotoxicity (USP 23 <87>) and LAL testing for bacterial endotoxins confirmed biocompatibility.

Technological Characteristics

System comprises reusable injector body and single-use foam-tipped plunger insert. Materials include silicone (lens contact) and sponge. Sterilization via E-Beam. Mechanical operation via manual plunger-push or threaded-cap advancement. No electronic components or software.

Indications for Use

Indicated for the folding and insertion of STAAR Surgical UV-ELASTIC™ silicone intraocular lenses into the human eye during surgical procedures. Prescription use only.

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

• MicroSTAAR™ Injector System (K980696)

Submission Summary (Full Text)

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Kg80696

#### PREMARKET NOTIFICATION [510(k)] SUMMARY SEP 1 1 1998 FOR FOAM TIP™ INJECTOR SYSTEM K980696 :

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| Trade name: | Foam Tip™ Injector System |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Foldable Intraocular Lens Injector System |
| Classification name: | Intraocular Lens Guide per 21 CFR, Section 886.4300 |
| | Ophthalmic sponge per 21 CFR, Section 886.4790 |
| Submitted by: | STAAR Surgical Company<br>1911 Walker Avenue<br>Monrovia, CA 91016<br>Phone: (626) 303 - 7902<br>FAX: [phone] |
| Contact Person: | Steven L. Ziémba<br>Vice-President, Regulatory Affairs<br>Phone: (626) 303 - 7902, ext. 2308 |
| Date Summary Prepared: | 8/12/98 |
| Legally Marketed Predicate<br>Device: | MicroSTAAR™ Injector System (reusable and<br>disposable) manufactured by STAAR Surgical Company. |
| Intended Use of the<br>Device: | The Foam Tip™ Injector is a device used to fold and insert<br>STAAR Surgical UV-ELASTIC™ silicone lenses for surgical<br>placement in the human eye. |
| Device Description: | STAAR Surgical Company's Foam Tip™ Injector is used to fold<br>and insert STAAR Surgical UV-ELASTIC™ silicone intraocular<br>lenses for surgical placement into the human eye. The new Foam<br>Tip™ Injector utilizes the same design principles (i.e. a plunger<br>pushing or threaded mechanism) to push the IOL through a<br>cartridge for injection into the eye as the existing MicroSTAART™<br>injectors. The new injector system differs from the<br>MicroSTAART™ injector in that it contains a disposable Foam<br>Tip™ plunger insert which may be attached to the sterilized<br>injector body prior to lens loading. This attachable Foam Tip™<br>plunger insert is encapsulated inside a holder that protects the<br>sponge from damage. The holder acts to guide the plunger as it<br>slides into the injector body and performs as a wrench to remove<br>the plunger from the injector once the lens has been implanted.<br>Once the sponge portion of the foam plunger insert is hydrated, it |

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K980694

enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.

#### Nonclinical Performance Testing:

### Functional Testing

I unctional of 40 functional ejection tests were conducted on STAAR Surgical single-piece UV-ELASTIC™ silicone lenses. A matrix was used to define the injector/lens/cartridge combinations, with a minimum of ten lenses per injector/cartridge combination. Two types of injectors were tested with the Foam Tip™ plunger inserts, the plunger design and the threaded design. (The plunger type injector requires that the user push on the knob cap to move the plunger. The threaded plunger requires that the user turn the threaded cap clockwise or counterclockwise to move the plunger.)

Acceptance Criteria for the Lens Injection Test for Foam Tip™ Injectors included:

- No lens tears (an indication that the lens was properly loaded)
- All post-ejected lenses meet STAAR's minimum resolution efficiency requirements
- No haptic damage
- Gross particulate evaluation

All 40 functional test lens ejections passed minimum resolution testing. There was no evidence of haptic damage or lens tears. Particulates were noted in both the Test and Control samples. None appeared to be greater than 10 microns in size.

## Accelerated Aging Studies

The following tests were performed :

- Dust Drum Microbial Challenge
- Dye Penetration tests:
- Seal Strength -
- Burst Test -
- Cytotoxicity per USP 23 <87> -
- -FTIR
- Sponge degradation Analysis -
- Package integrity -

The results of the accelerated aging tests, specifically the Microbial Challenge Dust Drum Test, Dye Penetration and Burst tests indicate that both sample groups (baseline versus six month) provided an acceptable microbial barrier and kept product sterile within. Slight variations in seal strength were within an acceptable range and did not appear to have compromised the sterile barriers or the integrity of the product.

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Cytotoxicity tests showed that the material was non-toxic and along with the FTIR demonstrated that E-Beam sterilization was an acceptable method of sterilization.

LAL testing was also performed which indicated that bacterial endotoxins were not above FDA limits, thereby providing acceptable results.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 1998

Mr. Steven Ziémba Vice-President, Regulatory Affairs STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016

Re: K980696 Trade Name: Foam Tip™ Injector System Regulatory Class: I Product Code: MSS Dated: August 12, 1998 Received: August 14, 1998

Dear Mr. Ziémba:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Steven L. Ziémba

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl lorentthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: K980696

Foam Tip™ Injector Device Name:

Indications For Use:

The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-The Fount Tip - Infoscee silicone lenses for surgical placement in the human eye.

There are no marketing claims for this device at this time.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use ﺳ (Per 21 CFR 801.109) OR

Over-The-Counter Use __

(Optional Format 1-2-96)

Claudine d. Krawczyk for DRL
(Division Sign. Off.)

Division of Ophthalmic Devices
510(k) Number K980696