MicroSTAAR Injector System Cartridges

K152357 · STAAR Surgical Company · KYB · Oct 30, 2015 · Ophthalmic

Device Facts

• Record ID: K152357
• Device Name: MicroSTAAR Injector System Cartridges
• Applicant: STAAR Surgical Company
• Product Code: KYB · Ophthalmic
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

Device Story

The MicroSTAAR® Injector System (MSI) cartridge is a single-use, sterile, polypropylene device designed to facilitate the loading, folding, and delivery of Collamer® phakic and aphakic 1-piece intraocular lenses (IOLs) into the human eye through a small incision. The cartridge features a funnel-shaped loading area and a tapered tip. During surgery, a clinician loads the IOL into the cartridge, which is then locked into a compatible injector system. The injector mechanism folds the lens and presses it forward through the tapered tip for insertion into the eye. The device is used in an ophthalmic surgical setting by a surgeon. The cartridge ensures the lens is delivered safely without damage, facilitating minimally invasive cataract or refractive surgery.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, intraocular irritation) confirmed the new polypropylene material is biocompatible. Feasibility testing demonstrated successful lens delivery without cartridge or lens damage. FTIR analysis confirmed material composition. Accelerated aging (1 month) confirmed shelf-life stability. Sterilization validation achieved a sterility assurance level of 10^-6 with negligible EO/ECH residuals.

Technological Characteristics

Single-use, funnel-shaped cartridge manufactured from polypropylene (MG03BDS). Operates via mechanical folding and delivery of IOLs. Sterilized via Ethylene Oxide (EtO). Designed for use with MicroSTAAR® Injector System. No software or electronic components.

Indications for Use

Indicated for the surgical placement of STAAR Surgical Company Collamer phakic and aphakic 1-piece intraocular lenses into the human eye.

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 Cartridges (K101782)

Submission Summary (Full Text)

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Image /page/0/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 symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three intertwined figures that suggest human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2015

STAAR Surgical Company Mr. Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016

Re: K152357

Trade/Device Name: MicroSTAAR® Injector System Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS, KYB Dated: September 29, 2015 Received: September 30, 2015

Dear Mr. Coggan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for 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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Image /page/2/Picture/0 description: The image shows the logo for STAAR Surgical. The logo consists of a star-shaped symbol on the left and the text "STAAR" on the right. Below the word STAAR is the word "SURGICAL" in a smaller font. The star symbol is a golden color, while the text is a dark blue color.

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K152357

Device Name: MicroSTAAR® Injector Cartridge

The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

Prescription Use _________________________________________________________________ (Part 21 CI-1 (801 Subpart D)

(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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Image /page/3/Picture/0 description: The image shows the logo for STAAR Surgical. The logo consists of a star-shaped symbol on the left and the text "STAAR" in a bold, sans-serif font on the right. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font. The star symbol is made up of three intersecting lines that form a six-pointed star.

### 510 (k) SUMMARY

Submitter Information

Company Registration Number Submission Correspondent

Date Summary Prepared

Classification Name

STAAR Surgical Company Contact: Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, California 91016 Phone: [phone] ex. 2616 Fax: [phone]

2023826

STAAR Surgical Company Contact: Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, California 91016 Phone: [phone] ex. 2616 Fax: [phone]

September 16, 2015

Lens, Guide, Intraocular Class I KYB 21 CFR 886.4300 Folders and Injectors, Intraocular Lens (IOL) Class I MSS 21 CFR 886.4300

Common/Usual Name

Device Trade Name

Intraocular Lens Injector Cartridge

MicroSTAAR® Injector System Model: SFC 45

The primary device used for comparison in this summary is MicroSTAAR® Injector System Cartridges (K101782).

### INTENDED USE

The intended use of the MSI Cartridge in this submission is substantially equivalent to the intended use of the predicate cartridges (K101782). Please refer to the Directions for Use for the predicate device, which will also be used with the proposed MSI cartridge.

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Image /page/4/Picture/0 description: The image shows the logo for STAAR Surgical. The logo features a stylized star-like symbol on the left, with the word "STAAR" in a bold, sans-serif font to the right of the symbol. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font.

The intended use of the modified device, as described in its labeling has not changed as a result of this modification. The MicroSTAAR® Injector System is intended to fold and insert STAAR Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement in the human eye.

### DESCRIPTION (Device)

The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System.

The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.

The new polypropylene material used for manufacturing the SFC-45 cartridges is substantially equivalent to that of the predicate device's polypropylene material. The proposed material will be supplied by the same supplier in Japan. The material will be shipped to STAAR Monrovia, USA, to be forwarded to a molding contractor in the USA. The molded MSI cartridge will be returned to STAAR Monrovia for the rest of the manufacturing process. There will be no changes to the in-process or the final release specifications and all manufacturing processes of the MSI Cartridges will be the same as those of the predicate cartridges.

The product description for the MSI Cartridge is substantially equivalent to that of the predicate devices.

### TECHNOLOGICAL CHARACTERISTICS

The MSI Cartridge has substantially equivalent technological characteristics to the predicate device. Refer to Table 7 in the following section, entitled Device Comparison, for a summation of the technological characteristics such as design.

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Image /page/5/Picture/0 description: The image shows the logo for STAAR Surgical. The logo features a stylized star-like symbol on the left, with the word "STAAR" in a dark blue, sans-serif font to the right of the symbol. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font.

| Description | Predicate MicroSTAAR Injector System<br>Cartridges | New MicroSTAAR Injector System Cartridge<br>(SFC-45) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K101782 | N/A |
| Models | SFC 45 | SFC 45 |
| Product<br>Description | System is designed to facilitate the<br>loading, folding and delivery of an<br>intraocular lens (ICL) into the human eye<br>through a small incision. | Identical |
| Intended Use | Intended to fold and insert STAAR<br>Surgical Company 1-piece Collamer®<br>intraocular lenses for surgical placement in<br>the eye. | Identical |
| Design<br>Control<br>Activities | Single use cartridge to be used in<br>conjunction with appropriate injector<br>system and 1-piece Collamer® lenses for<br>surgical placement of lens into eye. | Identical |
| Materials | Cartridge is manufactured from<br>Polypropylene MG05 (which contains<br>GMS) and polypropylene MG03 (which<br>does not contain GMS) purchased from a<br>supplier in Japan. | Cartridge is manufactured from a new<br>polypropylene MG03BDS formulation (which<br>contains GMS) material is purchased from the<br>same supplier in Japan |
| Manufacturing | Utilization of contract manufacturers for<br>polypropylene material and cartridge<br>molding. | Identical |
| Operating<br>Principle | Depending on the cartridge the ICL is<br>either loaded into the loading<br>area and folded shut, or it is pressed<br>forward towards the tip. | Identical |
| Packaging | Cartridge is placed in a tray, sealed with<br>Tyvek lid and label is placed on a Tyvek<br>pouch. utilizing STAAR Monrovia's USA<br>packaging supplier | Identical |
| Sterilization | Sterile Ethylene Oxide (EtO) | Identical |
| Manufacturer | STAAR Surgical Company | Identical |

### Table 7 Device Comparison

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Image /page/6/Picture/0 description: The image shows the STAAR Surgical logo. The logo consists of a stylized star-like symbol on the left and the text "STAAR" in a larger, bolder font on the right. Below "STAAR" is the word "SURGICAL" in a smaller font. The star symbol is a golden color, while the text is a dark blue color.

### PERFORMANCE DATA:

The non-clinical tests summary that was performed to validate and verify the change in the polypropylene formulation is summarized below:

### Biocompatibility Study:

The SFC Cartridge manufactured using the new GMS (MG03BDS) passed the biocompatibility study that Namsa Laboratory tested for the cytotoxicity tests, sensitization test and intraocular irritation test. The cytotoxicity test article extract showed no evidence of causing cell lysis or toxicity. The sterilization test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea. The intraocular irritation test showed there were no differences in ocular observations between eyes treated with test article extract and those treated with the control vehicle It is concluded that the SFC45 cartridge material used in the new GMS material (MG03BDS) is biocompatible.

### Feasibility Test:

The feasibility test results of the cartridges manufactured using the new MG03BDS material were found to be substantially equivalent to the cartridges manufacture using the current material. The SFC-45 cartridge manufactured with the new MG03BDS material successfully delivered the lenses without any damage to the cartridge. Therefore, it was concluded that the MG03BDS material is an adequate replacement for the current material.

### Fourier-transform infrared Fourier-transform infrared spectroscopy (FTR):

An analysis of the new polypropylene formulation change was performed using the Fouriertransform infrared spectroscopy (FTIR) The FTIR resulting spectra showed the typical makeup for the polypropylene copolymer material. The main difference between all materials was related to the amount of additives.

### Shelf-life:

Shelf-life testing of the SFC-45 cartridge after 1 months accelerated aging indicated the cartridges manufactured with the new MG03BDS material are comparable to the cartridges manufactured using the current material and passed within the manufacturer's specifications. The delivery of the lenses was smooth and there was no damage to the cartriges or lenses.

### Sterilization:

Sterilization study indicated that cartridges sterilization was successful and provided a minimum sterility assurance level of 1 x 10 probability of less than on non-sterile unit out of each one million units sterilized.). All biological indicators indicated that bacteriostatic characteristics were not associated with the product EO/ECH residuals were negligible.