BAUSCH & LOMB IOL INJECTOR

K113852 · Bausch & Lomb, Inc. · MSS · Sep 28, 2012 · Ophthalmic

Device Facts

• Record ID: K113852
• Device Name: BAUSCH & LOMB IOL INJECTOR
• Applicant: Bausch & Lomb, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Bausch + Lomb IOL Injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.

Device Story

Bausch + Lomb IOL Injector (INJ100) is a sterile, single-use manual surgical instrument. It provides a tubular pathway to fold and inject an IOL into the capsular bag of a human eye through a surgical incision. The device is a pre-assembled, integrated unit consisting of an injector and plunger. It is operated by a surgeon during cataract removal procedures. The device facilitates the delivery of the IOL, which benefits the patient by enabling minimally invasive lens implantation. No assembly is required by the user.

Clinical Evidence

Bench testing only. The device underwent functional testing to verify IOL delivery performance in conformance with ISO 11979-3, section 5 requirements.

Technological Characteristics

Manual, single-use, sterile, tubular IOL injector. Pre-assembled unit (injector and plunger). Sterilized via ethylene oxide. Complies with ISO 11979-3, section 5 for functional delivery requirements.

Indications for Use

Indicated for folding and injection of Bausch + Lomb intraocular lenses (IOLs) approved for use with the device during cataract surgery.

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

• Medicel Naviject Sub2-1P IOL Injector Set (K092023)
• Alcon Monarch III IOL Delivery System (K063155)

Submission Summary (Full Text)

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K113852

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## 510(k) Summary

. .

| (k) Summary | SEP 2 8 2012 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bausch & Lomb, Inc.<br>30 Enterprise, Suite 450<br>Aliso Viejo, CA 92656 |
| Contact Person: | Jason Smith<br>Global Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 27, 2012 |
| Trade name: | Bausch + Lomb IOL Injector, INJ100 |
| Classification<br>Name: | Intraocular lens guide (21 CFR 886.4300) |
| Predicate<br>Devices: | 1.<br>K092023 Medicel Naviject Sub2-1P IOL Injector Set<br>2.<br>K063155 Alcon Monarch III IOL Delivery System |
| Device<br>Description: | The Bausch + Lomb IOL Injector is a sterile, single-use<br>device used to fold and insert an intraocular lens through<br>surgical procedure into a human eye. The system<br>provides a tubular pathway through an incision over the<br>iris, allowing delivery of an IOL into the capsular bag. |
| Indications for<br>Use: | The Bausch + Lomb IOL injector is indicated for folding<br>and injection of Bausch + Lomb IOLs approved for use<br>with this injector. |
| Comparative<br>Analysis: | The Bausch + Lomb IOL Injectors have been<br>demonstrated to be equivalent to the predicate devices<br>for their intended use. |
| Functional/Safety<br>Testing: | The Bausch + Lomb IOL Injectors have successfully<br>undergone functional testing and are found to deliver the<br>Bausch + Lomb IOLs in conformance with the<br>requirements set forth in ISO 11979-3, section 5. |
| Conclusion: | The Bausch + Lomb IOL Injectors are substantially<br>equivalent to the predicate devices. |

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#### Characteristic Predicate K092023 Predicate K063155 Bausch + Lomb Medicel Naviject Sub2-Alcon Monarch III IOL IOL Injector 1P IOL. Injector Set Delivery System (Proposed Device) Indications for use Insertion only of models of Implantation of Alcon The Bausch + Lomb intraocular lens that allow use qualified Acrysof intraocular IOL injector is of this injector in their labeling lenses into the eye following indicated for folding cataract removal and injection of Bausch + Lomb IOLs approved for use with this injector. Contraindications The use of this injector None None system with other intraocular implants or cartridges, that have not been tested or approved for use by STAAR Surgical Company. Injector User has to assemble three User has to assemble two No user assembly configuration items: items: the cartridge, tip, Injector with plunger 1. Cartridge and injector are all 1. 2. Cartridge/tip 2. Handpiece one unit assembly 3. Loader Single use? All three pieces are single-The cartridge is single use, Single use use only. the handpiece is reusable. Sterile? Sterile Sterile Sterile How sterilized Ethylene oxide (cartridge) Ethylene oxide Ethylene oxide Steam (handpiece) Coating? No Hydrophilic coating Hydrophilic coating How sold? Packs of ten Cartridges are sold in packs Packs of ten of ten

Comparison of Predicate Devices to the Proposed Bausch + Lomb IOL Injector

# KIL 3852 125 2 = 2 = 2

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 28 2012

Bausch & Lomb, Inc. c/o Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viego, CA 92656

Re: K113852

Trade/Device Name: Bausch + Lomb IOL Injector. INJ100 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, Reserved Product Code: MSS Dated: September 13, 2012 Received: September 14, 2012

#### Dear Mr. 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. 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.

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

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K113852

### Indications for Use Statement

510(k) Number (if known):

Device Name: Bausch + Lomb IOL Injector

Indications for Use:

The Bausch + Lomb IOL Injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.

Prescription Use x (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)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K113852

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