Easy-Load Lens Delivery System

K161012 · Bausch and Lomb, Inc., · MSS · Jul 6, 2016 · Ophthalmic

Device Facts

• Record ID: K161012
• Device Name: Easy-Load Lens Delivery System
• Applicant: Bausch and Lomb, Inc.,
• Product Code: MSS · Ophthalmic
• Decision Date: Jul 6, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

Device Story

Manual surgical instrument for folding and delivering three-piece silicone intraocular lenses (IOLs) into the eye. Operator places IOL into loading area; closes drawer to compress lens; advances plunger to detent position. Distal end filled with viscoelastic or balanced salt solution; inserted through incision into eye. Haptic puller positions leading haptic. Plunger advanced to express lens into capsular bag. Used by ophthalmic surgeons in clinical settings. Benefits include controlled, consistent IOL delivery during cataract or refractive surgery.

Clinical Evidence

Bench testing only. Testing included IOL surface/bulk homogeneity, lens power, image quality, dimensional requirements, delivery outcomes (no flipping, successful exit), insertion device damage, lubricant transfer, particle study, sterilization (EO transfer, endotoxin), and mechanical force testing. All tests passed.

Technological Characteristics

Manual surgical injector. Materials: Polypropylene (body, drawer, haptic puller, plunger, bearing) and Polyimide (cartridge). Single-use, sterile (Ethylene oxide, SAL 10^-6). Standards: ISO 11979-2, ISO 11979-3, ISO 11135.

Indications for Use

Indicated for folding and injection of Bausch + Lomb intraocular lenses in patients 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

• Easy-Load Lens Delivery System (K132481)
• Bausch + Lomb Injector System (K131958)

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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

July 6, 2016

Bausch and Lomb, Inc. Dr. Joyce Zhong Regulatory Affairs Specialist 50 Technology Drive Irvine, CA92618

Re: K161012

Trade/Device Name: Easy-load Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: June 3, 2016 Received: June 6, 2016

Dear Dr. Zhong:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 Alexander

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):

Device Name: Easy-Load Lens Delivery System

Indications for Use:

The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

Prescription Use 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)

Page 19

CONFIDENTIAL

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# 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:

Joyce Zhong, PhD Regulatory Affairs Specialist Bausch + Lomb 50 Technology Drive, Irvine, CA 92618 Phone: [phone] Fax: [phone]

Date Summary Prepared: April 7, 2016

#### 1. Subject Device:

| Trade name: | Easy-Load Lens Delivery System |
|----------------------|--------------------------------|
| Common Name: | Intraocular lens Guide |
| Classification Name: | 21 CFR 886.4300 |

#### Predicate Device: 2.

| Primary Predicate Device | K132481 | Easy-Load Lens Delivery System | EZ-28 |
|----------------------------|---------|--------------------------------|---------|
| Secondary Predicate Device | K131958 | Bausch + Lomb Injector System | BLIS-X1 |

#### 3. Device Description:

The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.

#### 4. Indications for Use:

The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

The indications for use of the proposed device are the same as the primary predicate device.

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

Nonclinical tests listed below were completed on the proposed Easy-Load Lens Delivery System (Model EZ-24) and results show the system to be in conformance with the requirements set forth by accepted ISO standards (ISO 11979-2, ISO 11979-3, and ISO 11135) where applicable.

| Item | TEST | Acceptance Criteria | RESULTS | |
|-------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Function<br>Performance | (Before and after<br>insertion) IOL surface &<br>bulk homogeneity | Free from surface and bulk defects and all<br>edges should appear smooth when viewed at<br>10X magnification | Pass | |
| | (Before and after<br>insertion) IOL lens power | The diopter power of the lenses shall be<br>within the allowed tolerance | Pass | |
| | (Before and after<br>insertion) IOL image<br>quality | The image quality of the lenses shall meet<br>or exceed the minimum resolution group<br>element of the Air Force target specified in<br>the protocol. | Pass | |
| | (Before and after<br>insertion) IOL dimensions | The lenses must meet the dimensional<br>requirements specified in the protocol. | Pass | |
| | IOL delivery outcome | The IOLs do not flip over upon delivery;<br>The IOL must exit inserter upon completion<br>of delivery; No cosmetic defects to the<br>IOL's haptic from folding and/or delivery | Pass | |
| | Damage to insertion<br>device | No damage to the insertion device due to<br>lens delivery | Pass | |
| | Lubricant transfer study | No detectable transfer | Pass | |
| | Particle study | Comparable to or lower than control | Pass | |
| Sterilization<br>verification | Comparative Resistance<br>Performance<br>Determination | | For a given exposure time the average<br>recovery of viable test organisms from<br>biological indicators placed within the<br>barrel of either the EZ-24 or the EZ-28 shall<br>differ by no more than one logarithm of the<br>average of the values determined for both<br>inserters. Alternatively, the average<br>recovery of viable test organisms from<br>biological indicators placed within the<br>barrel of the EZ-24 may be less than the<br>average recovery of viable test organisms<br>from biological indicators placed within the<br>barrel of the EZ-28 inserters | Pass |
| | EO transfer test | $\le$ 0.5μg EO per IOL | Pass | |
| | Endotoxin test | $\lt$ 0.2 EU/device | Pass | |
| Packaging<br>verification | Plunger push force and<br>cartridge detachment<br>testing | Cartridge detachment force is greater than<br>the force to disengage the plunger from the<br>detents in the injector body. | Pass | |

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#### 6. Comparative Analysis

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

| Characteristic | Primary Predicate Device<br>EZ-28 (K132481) | Proposed Device<br>EZ-24 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Easy-Load Lens Delivery System<br>is indicated for the folding and injection<br>of Bausch + Lomb intraocular lenses<br>identifying the Easy-Load Lens<br>Delivery System in their approved<br>labeling. | The Easy-Load Lens Delivery System<br>is indicated for the folding and<br>injection of Bausch + Lomb intraocular<br>lenses identifying the Easy-Load Lens<br>Delivery System in their approved<br>labeling. |
| Contraindications | None | None |
| Anatomical site | Eye | Eye |
| Injector configuration | Body, drawer, haptic puller, plunger | Body, cartridge, drawer, haptic puller,<br>plunger, bearing |
| Materials | Body, drawer, haptic puller, plunger:<br>Polypropylene | Body: drawer, haptic puller, plunger,<br>bearing: Polypropylene<br>Cartridge: Polyimide |
| How is the device<br>used | An IOL is placed into the loading area<br>and the drawer is closed. This<br>compresses the IOL. The plunger is<br>advanced until it stops at a detent<br>position. The distal end is filled with<br>viscoelastic or balanced salt solution<br>and placed through an incision into the<br>eye. The haptic puller is used to place<br>the leading haptic in the correct loading<br>position. Once the tip is in the eye, the<br>plunger is advanced until the lens is<br>fully expressed into the capsular bag. | An IOL is placed into the loading area<br>and the drawer is closed. This<br>compresses the IOL. The plunger is<br>advanced until it stops at a detent<br>position. The distal end is filled with<br>viscoelastic or balanced salt solution<br>and placed through an incision into the<br>eye. The haptic puller is used to place<br>the leading haptic in the correct loading<br>position. Once the tip is in the eye, the<br>plunger is advanced until the lens is<br>fully expressed into the capsular bag. |
| Single use? | Yes | Yes |
| Is the product sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance<br>level | 10-6 | 10-6 |

# Table 6-1: Comparison of Primary Predicate Device (Model EZ-28) to the Proposed Easy-Load Lens Delivery System (Model EZ-24)

#### 7. Conclusion

The results obtained from nonclinical tests performed on the proposed Easy Load Lens Delivery System have demonstrated that the proposed device is as effective, and performs at least as safely and effectively as the predicate devices, therefore the proposed Easy Load Lens Delivery System is substantially equivalent to the predicate devices.