EASY-LOAD LENS DELIVERY SYSTEM

K132481 · Bausch & Lomb · MSS · Dec 27, 2013 · Ophthalmic

Device Facts

• Record ID: K132481
• Device Name: EASY-LOAD LENS DELIVERY SYSTEM
• Applicant: Bausch & Lomb
• Product Code: MSS · Ophthalmic
• Decision Date: Dec 27, 2013
• Decision: SESE
• Submission Type: Traditional
• 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

Easy-Load Lens Delivery System is a single-use, sterile, manual surgical instrument for folding and injecting Bausch + Lomb intraocular lenses (IOLs) into the eye. Operation involves placing an IOL into the loading area, closing the drawer to compress the lens, and advancing a plunger to a detent position. The distal end is filled with viscoelastic or balanced salt solution; a haptic puller assists in positioning the leading haptic. The plunger is then advanced to express the lens into the capsular bag. Used by surgeons during small incision cataract surgery. Benefits include controlled, consistent delivery of IOLs into the eye.

Clinical Evidence

Bench testing only. Evaluations included biocompatibility testing of materials, surface and bulk homogeneity of delivered IOLs, delivery outcome, and injector visual inspection. All tests met acceptance criteria.

Technological Characteristics

Manual lens delivery system. Materials: polypropylene (body, drawer, haptic puller, plunger) and stainless steel (spring). Single-use, sterile, ethylene oxide sterilized (SAL 10^-6). No electronic components or software.

Indications for Use

Indicated for folding and injecting Bausch + Lomb intraocular lenses 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

• MPORT Foldable Lens Placement System (K970727)

Submission Summary (Full Text)

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# DEC 2 7 2013

### 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: December 23, 2013

#### Subject Device: 1.

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

#### 2. Predicate Device:

K970727, MPORT Foldable Lens Placement System

#### 3. Device Description:

The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IQL 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.

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

The Easy-Load Lens Delivery System was evaluated via biocompatibility and bench testing. Biocompatibility testing was performed on the new Easy-Load Lens Delivery System materials and they were found to be biocompatible. Bench testing (surface and bulk homogeneity of delivered IOLs, delivery outcome, and injector visual inspection) was performed on Easy-Load Lens Delivery Systems with the new materials. All the nonclinical tests met the acceptance criteria.

#### Comparative Analysis 6.

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

| | Table 6-1: Comparison of Predicate Device to the Proposed Easy-Load | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Lens Delivery System | | | | |
| AL --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

| Characteristic | Predicate K970727<br>MPORT Foldable Lens Placement<br>System | Easy-Load Lens Delivery System<br>(Proposed Device) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The MPORT Foldable Lens Placement<br>System is a Class I device indicated for<br>compressing and inserting a Soflex<br>(formerly Chiroflex II) series multi-piece<br>intraocular lens into the eye during<br>small incision cataract surgery. | 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 Delivery<br>System in their approved labeling. |
| Contraindications | None | None |
| Materials | Body, drawer, haptic puller, plunger:<br>polypropylene<br>Spring: stainless steel | Body, drawer, haptic puller, plunger:<br>polypropylene<br>Spring: stainless steel |
| Is the product single<br>use? | Single use | Single use |
| Is the product sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance<br>level | 10-6 | 10-6 |
| Shelf life | 12 months | 12 months |

#### 7. Conclusion

The Easy Load Lens Delivery System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

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

December 27, 2013

Bausch + Lomb % Mr. Jason Smith Manager, Global Regulatory Affairs 50 Technology Drive Irvine, CA 92618

Re: KI32481

Trade/Device Name: Easy-Load Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: November 19, 2013 Received: November 20, 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.

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 - Mr. Jason Smith

"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 (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 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): 132481

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 _ 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)

Susanna W. Jones -S 2013.12.23 13:26:27 -05'00'

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CONFIDENTIAL

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