BAUSCH & LOMB INJECTOR SYSTEM

K131958 · Bausch & Lomb · MSS · Jan 9, 2014 · Ophthalmic

Device Facts

• Record ID: K131958
• Device Name: BAUSCH & LOMB INJECTOR SYSTEM
• Applicant: Bausch & Lomb
• Product Code: MSS · Ophthalmic
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.

Device Story

Bausch + Lomb Injector System (BLIS) facilitates folding and delivery of intraocular lenses (IOLs) into the eye. System comprises reusable handpiece (titanium body, plunger tip, knob; stainless steel shaft/threads) and single-use, sterile, disposable cartridge (coated with Medicoat A). Surgeon places IOL into loading cartridge; snaps cartridge into handpiece; uses screw plunger to advance IOL through cartridge, which folds lens, then injects it into the eye. Used in clinical/surgical settings by ophthalmologists. Benefits include controlled, consistent IOL delivery during surgery.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including cleaning, sterilization, shipping/handling, stability, and biocompatibility testing. Mechanical properties evaluated per ISO 11979-3.

Technological Characteristics

Handpiece: Titanium body, plunger tip, knob; stainless steel plunger shaft/threads. Cartridge: Coated polyamide (Medicoat A). Energy source: Manual. Connectivity: None. Sterilization: Handpiece (steam/autoclave by user), Cartridge (ethylene oxide). Compliance: ISO 11979-3 (Mechanical Properties).

Indications for Use

Indicated for the folding and injection of Bausch + Lomb intraocular lenses in patients undergoing cataract surgery or other procedures requiring IOL implantation.

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)
• Alcon Monarch III IOL Delivery System (K063155)

Submission Summary (Full Text)

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K131958 Bausch + Lomb Injector System

JAN - 9 2014

## 510(K) SUMMARY

This summary document has been prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Jason Smith Global Regulatory Affairs Manager : Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 Phone: [phone] Fax: [phone]

Date Summary Prepared: January 7, 2014

#### Subject Device: 1.

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

#### 2. Predicate Devices:

K113852, Bausch + Lomb IOL Injector K063155, Alcon Monarch III IOL Delivery System

#### 3. Device Description:

The Bausch + Lomb Iniector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.

#### 4. Indications for Use:

The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling..

Note: This is almost the same indications for use as the predicate Bausch + Lomb IOL Injector (K113852). The differences between the two indications are differences in describing which Bausch + Lomb IOLs are appropriate for use with these injectors. The subject device adds more detail to this description than the subject K113852 device. This difference is not critical to the intended therapeutic or surgical use of the device.

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K 131958 Bausch + Lomb Injector System

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

The proposed Bausch + Lomb Injector System was evaluated using cleaning, sterilization, sterilization residual, shipping and handling, biocompatibility, and bench testing. Cleaning validation covered the manual and automated cleaning processes described in the labeling for the Bausch + Lomb Iniector System Handpiece. Sterilization validation included the autoclave methods described in the labeling for the Bausch + Lomb Injector System Handpiece and the ethylene oxide process for the Bausch + Lomb Injector System Cartridge. Ethylene oxide residual testing for a device equivalent to the Bausch + Lomb Injector System Cartridge was included in the 510(k).

Shipping and handling validations were performed on both the Bausch + Lomb Injector System Handpiece and Cartridge. Stability testing validated the Bausch + Lomb Injector System Cartridge over the shelf life of the device.

Biocompatibility testing was performed the Bausch + Lomb Injector System Handpiece and cartridge, and both were found to be biocompatible.

Bench testing was performed on both components of the Bausch + Lomb Injector System to demonstrate compliance with ISO 11979-3, Mechanical Properties.

#### 6. Comparative Analysis

A table comparing the proposed device to the predicate devices is provided on the following page.

#### 7. Conclusion

The Bausch + Lomb Injector System is substantially equivalent to the predicate devices

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K131958 Bausch + Lomb Injector System

mparison of Predicate Devices to the Proposed Bausch + Lomb Iniector Syste C

| Characteristic | K113852 Bausch + Lomb IOL<br>Injector | K063155 Alcon Monarch III<br>Delivery System. | Bausch+ Lomb Injector System<br>(Proposed Device) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Folding and injection of Bausch + Lomb IOLs that have the use of this injector in their labeling. | Handpiece: For use with Alcon Monarch III cartridges as specified in the table below (product number 8065977763) for the surgical implantation of Alcon Foldable IOLs. | The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling. |
| | | Cartridge: Implantation of Alcon qualified ACrySoft Foldable IOLs. No unqualified lenses should be used with the Monarch III IOL Delivery System.. | |
| Contraindications | None | None | None |
| Anatomical site | Eye | Eye | Eye |
| Injector configuration<br>(reusable) | Not applicable | Titanium shaft with a titanium screw plunger | Titanium body, plunger tip, knob; stainless steel plunger shaft, plunger threads |
| Injector configuration (single use) | A syringe-shaped ABS body, coated polyamide tip, ABS push plunger and polypropylene cartridge. | Cartridge | Coated polyamide cartridge |
| How is the device used? | The IOL is placed in the loading chamber. A plunger pushes the IOL into the tip, which folds the IOL. Pushing the plunger further advances the IOL out through the tip into the eye. | The IOL is placed in the loading cartridge. The catridge is snapped into the handpiece. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. | The IOL is placed in the loading cartridge. The catridge is snapped into the handpiece. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. |
| Single Use | Yes | Handpiece: No<br>Cartridge: Yes | Handpiece: No<br>Cartridge: Yes |
| Characteristic | | En K113852 Bausch + Lomb IOL K063155 Alcon Monarch Illing Bausch+ Lomb Injector System | |
| he product steri | Yes | Handpiece: shipped nonsterilized/resterilized by<br>useı | landpiece: shipped nonsterile, to be<br>usei |
| | | artridge: shipped steri | Cartridge: shipped steri |
| ow Sterilize | Ethylene oxide | Handpiece: steam (by user) Cartridge: Ethylene oxide (by | Handpiece: steam (by user) Cartridge: Ethylene oxide (by |
| Coating | Hydrophilic coating (Medicoat | Handpiece: None | Handpiece: None Cartridge: Hydrophilic coating (Medicoat A) |
| low Supplie | acks of 10 | Handpiece: single Cartridge: packs of 1 | Handpiece: single Cartridge: Packs of 10 |

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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 9, 2014

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

Re: K131958

Trade Name: Bausch + Lomb Injector System, BLIS Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: November 22, 2013 Received: November 25, 2013

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.

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Page 2 - Mr. Jason Smith

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 (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,

# Deborah L. Falls -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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### 5 Indications for Use Statement

510(k) Number (if known): 131958

Device Name: Bausch + Lomb Injector System (BLIS)

Indications for Use:

The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.

Prescription Use __ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Claudine 2014.01.07 -05'00'

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