MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM

K073591 · Staar Surgical Co. · MSS · Mar 13, 2008 · Ophthalmic

Device Facts

• Record ID: K073591
• Device Name: MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
• Applicant: Staar Surgical Co.
• Product Code: MSS · Ophthalmic
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

Device Story

MicroSTAAR MSI Injector Foam Tip System; manual surgical instrument; used for folding and inserting STAAR Surgical one-piece and three-piece Collamer lenses into human eye. Device facilitates lens delivery during ophthalmic surgery. Operated by ophthalmologists in clinical/OR settings. Provides mechanical assistance for lens implantation; reduces risk of lens damage during insertion. No electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual surgical instrument; foam tip design for lens handling; intended for use with STAAR Surgical Collamer lenses. Class I (reserved) device; product code MSS. No energy source, software, or electronic components.

Indications for Use

Indicated for folding and inserting STAAR Surgical one and three piece Collamer® lenses into the human eye during surgical procedures.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

STAAR Surgical Co. c/o Ms. Diana Smith Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016

Re: K073591

Trade Name: MicroSTAARTM MSI Injector Foam Tip System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: February 12, 2008 Received: February 19, 2008

Dear Ms. Smith:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Maling B. Egleston, und

Malvina B. Eydelman, M.I 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 – Ms. Smith

## Indications for Use

510(k) Number (if known): K0703591

Device Name: MicroSTAAR™ MSI Injector Foam Tip System

Indications For Use:

The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

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)

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

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**510(k) Number** Ko 70359)