BAUSCH + LUMB, VIS100 INJECTOR SYSTEM

K133146 · Bausch & Lomb · MSS · Jan 3, 2014 · Ophthalmic

Device Facts

• Record ID: K133146
• Device Name: BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
• Applicant: Bausch & Lomb
• Product Code: MSS · Ophthalmic
• Decision Date: Jan 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.

Device Story

The Bausch + Lomb VIS100 Injector System is a sterile, single-use manual surgical instrument. It consists of an injector body, plunger with a silicone cushion tip, and a cartridge with a hydrophilic coating. The device is operated by a surgeon during ophthalmic procedures. The surgeon places an intraocular lens (IOL) into the cartridge; the plunger pushes the IOL through a tubular pathway, compressing and folding the lens as it enters the tip for delivery into the capsular bag through an incision. The device facilitates controlled IOL implantation, reducing surgical trauma and improving patient outcomes.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 11979-3 (mechanical properties) and biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) demonstrated safety and performance.

Technological Characteristics

Manual injector system. Materials: Polyamide cartridge with Medicoat A coating, ABS injector body/shooter, silicone plunger tip, stainless steel spring. Principle: Mechanical plunger-driven compression and folding of IOL. Sterile, single-use, ethylene oxide sterilization (SAL 10^-6).

Indications for Use

Indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector in patients undergoing 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

• Bausch + Lomb IOL Injector (K113852)

Submission Summary (Full Text)

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JAN - 3 2014

## 510(k) Summary

The submitter of the 510(k) is:

Shivani K. Chitalia Regulatory Affairs Specialist Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA - 92618 Phone: [phone] Fax: [phone]

Date Summary Modified: January 02, 2014

## 1. Subject device

Trade name: Bausch + Lomb VIS100 Injector System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300

2. Predicate Device:

K113852, Bausch + Lomb IOL Injector

#### 3. Device Description:

The Bausch + Lomb VIS100 Injector System is a sterile, single-use device used to fold and insert an IOL into the human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

#### 4. Indications for Use:

The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.

The indications for use are identical to the indications for use of the predicate device.

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#### 5. Brief Summary of Nonclinical Test and Results:

Bench testing was performed on the Bausch + Lomb VIS100 Injector System to determine compliance with ISO 11979-3 (Ophthalmic Implants - Intraocular Lenses -Part 3: Mechanical Properties and Test Methods).

Biocompatibility testing was performed on the Bausch + Lomb VIS100 Injector System and the device was found to be biocompatible.as per ISO 10993-5 (Biological Evaluation of medical devices – Part 3: Tests for in vitro cytotoxicity and ISO 10993 -10 (Biological Evaluation of Medical Devices - Part 10 - Tests for Irritation and Skin Sensitization).

## 6. Clinical Studies

A clinical study was not performed on the Bausch + Lomb VIS100 Injector System.

# 7. Comparative Analysis

A table comparing the proposed device to the predicate devices is provided below.

| Characteristic | Predicate K113852 | Subject |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bausch + Lomb IOL<br>Injector, INJ100 | Bausch + Lomb VIS100 Injector<br>System |
| Indications for use | The Bausch + Lomb IOL<br>Injector is indicated for<br>folding and injection of<br>Bausch + Lomb intraocular<br>lenses approved for use with<br>this injector. | The Bausch + Lomb VIS100<br>Injector System is indicated for<br>folding and injection of Bausch +<br>Lomb intraocular lenses approved<br>for use with this injector. |
| Contraindications | None | None |
| Fundamental Scientific Technology | A single use plunger with a<br>silicone cushion tip is used<br>to push forward and insert<br>the IOL that has been<br>placed in a single use<br>cartridge into the capsular<br>bag. The cartridge has a | A single use plunger with a silicone<br>cushion tip is used to push forward<br>and insert the IOL that has been<br>placed in a single use cartridge into<br>the capsular bag. The cartridge has<br>a hydrophilic coating. As the IOL<br>enters the tip, it is compressed and |

#### Table 1: Comparison of Predicate Device to the Proposed Bausch + Lomb VIS100 Injector System

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| | hydrophilic coating. As the<br>IOL enters the tip, it is<br>compressed and folded. | folded. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Materials | Cartridge tip: polyamide with<br>Medicoat A coating<br>Injector body, plunger body:<br>ABS<br>Plunger tip: silicone<br>Cartridge loading chamber:<br>polypropylene<br>Spring: stainless steel | Cartridge: polyamide with Medicoat<br>A coating<br>Plunger body, shooter: ABS<br>Plunger tip: silicone<br>Spring: stainless steel |
| Single use? | Single use | Single use |
| Sterile? | Sterile | Sterile |
| Method of Sterilization | Ethylene oxide | Ethylene oxide |
| Sterility assurance level | 10-6 | 10-6 |
| Shelf life | 12 months | 1 month |

# 8. Conclusion

:

The Bausch + Lomb VIS100 Injector System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 3, 2014

Bausch + Lomb Ms. Shivani K. Chitalia Regulatory Affairs Specialist 50 Technology Drive Irvine, CA 92618

Re: K133146

Trade/Device Name: Bausch + Lomb VIS 100 Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: MSS Dated: December 4, 2013 Received: December 5, 2013

Dear Ms. Chitalia:

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 or any Federal statutes and regulations administered by other Federal agencies.

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# Page 2 - Ms. Shivani K. Chitalia

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Bradley S. Cunningham -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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# BAUSCH + LOMB

30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com

# Section 5 - Statement of Indications for Use

510(k) Number (if known):

Bausch + Lomb VIS100 Injector System Device Name:

Indications for Use: The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.

Over-The-Counter Use AND/OR x Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Tieuvi H. Nguyen 2013.12.30 12:09:32 -05'00'

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