CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

K082944 · Bausch & Lomb, Inc. · MSS · Oct 16, 2008 · Ophthalmic

Device Facts

• Record ID: K082944
• Device Name: CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
• Applicant: Bausch & Lomb, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

Device Story

The Crystalsert™ Crystalens® Delivery System is a single-use manual surgical instrument used by ophthalmologists during cataract surgery. It consists of a plunger, body, drawer, and 2.8 mm inserter tip. The surgeon places the intraocular lens (IOL) into the device's loading dock, closes the drawer to position the lens, and uses the plunger to fold and deliver the lens through the inserter tip into the patient's capsular bag. The device facilitates controlled IOL insertion through a small incision. It eliminates the need for a separate haptic puller compared to the predicate device. The system is validated for use with specific Bausch & Lomb Crystalens models and Amvisc Plus viscoelastic.

Clinical Evidence

Bench testing only. The device was validated for use with Crystalens models (AT-50SE, AT-52SE, HD520, HD500) and Bausch & Lomb Amvisc Plus viscoelastic. No clinical data provided.

Technological Characteristics

Single-use manual inserter. Materials: Medical grade polypropylene (Huntsman, BP Amoco) with InCon GMB#2 lubricant; stainless steel spring. Dimensions: 2.8 mm inserter tip. Principle: Mechanical folding and delivery via syringe-type plunger. Sterilization: EtO (SAL 10^-6).

Indications for Use

Indicated for folding and delivering Crystalens® (AT-50SE, AT-52SE, HD520, HD500) accommodating intraocular lenses into the capsular bag 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

• MPort (MP-30) (K970727)

Submission Summary (Full Text)

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K082944

# OCT 1 6 2008

## Section 15

## SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

#### Submitter's name, address, telephone number, contact person, and date 1. summary prepared

- -Bausch & Lomb Incorporated દ્યા. 1400 N. Goodman Street Rochester, N.Y. 14609 [phone]
- Contact Person: David U. Thomas, M.S., R.A.C. b. Manager, Global Regulatory Affairs
- Date Summary Prepared: September 4, 2008. C.
- Name of device, including trade name and classification name: 2.
- Crystalsert™ Crystalens® Delivery System Trade/Proprietary Name: a.
- Intraocular lens guide b. Classification Name:
- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company: | Chiron Vision Corporation (currently acquired by Bausch & Lomb Corporation |
|---------------|----------------------------------------------------------------------------|
| Device: | MPort (MP-30) |
| 510(k) | K970727 |
| Date Cleared: | December 17, 1997 |

- A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant

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Bausch & Lomb Incorporated Crystalsert™ Crystalens® Delivery System

## physical and performance characteristics (design, material, physical properties):

The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.

#### 5. Statement of intended use:

The Crystalsert™ Crystalens delivery system is intended to be used to fold and deliver the Crystalens® (AT-50SE and AT-52SE) accommodating intraocular lens into the capsular bag.

#### 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

| MPort (MP-30) | Crystalsert Inserter |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | |
| Lens is loaded into inserter through<br>loading deck and then pushed into<br>position by closing drawer. Lens is<br>laying flat in loading deck when<br>drawer is closed. Haptic puller is<br>used to place leading haptic in<br>correct loading position. | Lens is loaded into loading dock<br>in unfolded flat state. Lens is put<br>in proper position for loading by<br>closing drawer. No haptic puller<br>is necessary. |
| Lens is delivered by direct forward<br>motion of syringe-type plunger | same |
| Single lens is inserted through a 3<br>mm inserter tip. Lens is folded<br>when pushed through tip. | Single lens is inserted through<br>2.8 mm inserter tip. Lens is<br>folded when pushed through tip. |
| Design | |
| The inserter consists of plunger,<br>inserter body, drawer and haptic puller. | The inserter consists of plunger,<br>inserter body, and drawer. A loading |
| | |
| A loading dock is attached to the end of<br>the inserter body. | dock is attached to end of inserter<br>body. Additional notch is cut in<br>loading area to allow for correct<br>haptic placement. |
| <b>Material</b> | |
| The inserter is single use and consists<br>of Medical Grade Polypropylene with<br>PA-208 lubricant. The plunger return<br>spring is stainless steel and the plunger<br>O-ring consists of silicone. | The body and drawer consist Medical<br>Grade Polypropylene material<br>((Huntsman) with 1% by weight<br>InCon GMB#2 Lubricant) and the<br>Plunger is medical grade<br>polypropylene from BP Amoco.<br>Plunger return spring is stainless<br>steel. No plunger O-ring is used with<br>this plunger. |
| <b>Labeling</b> | |
| Indications for Use: | Indications for Use: |
| The Mport Foldable Lens Placement<br>system is indicated for compressing and<br>inserting a Soflex™ series multi-piece<br>intraocular lens into the eye during<br>small incision cataract surgery. | The Crystalsert™ Crystalens delivery<br>system is intended to be used to fold<br>and deliver the Crystalens® (AT-<br>50SE, AT-52SE, HD520 and HD500)<br>accommodating intraocular lens into<br>the capsular bag. |
| <b>Cleaning/Sterilization Information</b> | |
| Product is EtO sterilized to a SAL of<br>10-6. No cleaning is necessary or<br>recommended.<br><br>Product is Single-Use only.<br><br>The inserter will be labeled with a 6<br>month shelf life. | same |
| <b>Validations</b> | |
| Validated for use with LI61U, LI51U,<br>C31UB and Silens6/Soflex 2. Bausch<br>& Lomb Ocucoat Viscoelastic and<br>Amvisc viscoelastics can used. | Validated with Crystalens models<br>AT-50SE or AT-52SE and validated<br>with Bausch & Lomb Viscoelastic<br>Amvisc Plus. |

#### Technical Comparison Matrix

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2008

Bausch & Lomb, Inc. c/o Jay Y. Kogoma Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K082944

Trade/Device Name: Cystalsert™ Crystalens® Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: IOL Inserter/Injector Regulatory Class: I Product Code: MSS Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Kogoma:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Edwards, und

Malvina B, Eydelman, M 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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# Indications for Use

K082944 510(k) Number (if known):

Device Name: Crystalsert™ Crystalens® Delivery System

Indications For Use:

The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Hexander
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K082944

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