CRYSTALSERT DELIVERY SYSTEM

K123736 · Bausch & Lomb · MSS · May 16, 2013 · Ophthalmic

Device Facts

• Record ID: K123736
• Device Name: CRYSTALSERT DELIVERY SYSTEM
• Applicant: Bausch & Lomb
• Product Code: MSS · Ophthalmic
• Decision Date: May 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.

Device Story

Sterile, single-use intraocular lens (IOL) guide; provides tubular pathway through iris incision for IOL insertion into capsular bag. Device consists of body, drawer, and plunger; operated by surgeon during cataract or lens replacement surgery. Surgeon manually manipulates device to fold and inject lens. Benefits include controlled, consistent delivery of IOL into eye. No electronic or automated components.

Clinical Evidence

Bench testing only. Device performance verified through functional testing in conformance with ISO 11979-3, section 5, demonstrating successful IOL delivery.

Technological Characteristics

Materials: Polypropylene (body, drawer, plunger), stainless steel (spring). Single-use, sterile (ethylene oxide, SAL 10^-6). Form factor: Tubular delivery system. No software, electronics, or energy source.

Indications for Use

Indicated for folding and delivery of Crystalens accommodating intraocular lenses and other compatible intraocular lenses into the capsular bag during surgical procedures. No specific patient population age or gender restrictions; no contraindications.

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

• Crystalsert Crystalens Delivery System (K082944)

Submission Summary (Full Text)

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K123736

| 510(k) Summary | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | Bausch & Lomb, Inc.<br>30 Enterprise, Suite 450<br>Aliso Viejo, CA 92656 | K123736 |
| Contact Person: | Jason Smith<br>Global Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | MAY 1 6 2013 |
| Date Prepared: | December 4, 2012 | |
| Trade name: | Crystalsert Delivery System | |
| Classification<br>Name: | Intraocular lens guide (21 CFR 886.4300) | |
| Predicate<br>Devices: | K082944 Crystalsert Crystalens Delivery System | |
| Device<br>Description: | The Crystalsert Delivery System is a sterile, single-use<br>device used to fold and insert an intraocular lens through<br>surgical procedure into a human eye. The system<br>provides a tubular pathway through an incision over the<br>iris, allowing delivery of an IOL into the capsular bag. | |
| Indications for<br>Use: | The Crystalsert Delivery System is intended to be used to<br>fold and deliver the Crystalens accommodating<br>intraocular lens and other intraocular lenses identifying<br>the Crystalsert Delivery System in their approved labeling. | |
| Comparative<br>Analysis: | The Crystalsert Delivery System has been demonstrated<br>to be equivalent to the predicate device for its intended<br>use. | |
| Functional/Safety<br>Testing: | The Crystalsert Delivery System has successfully<br>undergone functional testing and was found to deliver<br>IOLs in conformance with the requirements set forth in<br>ISO 11979-3, section 5. | |
| Conclusion: | The Crystalsert Delivery System is substantially<br>equivalent to the predicate device. | |

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

| Characteristic | Predicate K082944<br>Crystalsert Crystalens Delivery<br>System | Crystalens Delivery System<br>(Proposed Device) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Crystalsert Crystalens delivery<br>system is intended to fold and deliver<br>the Crystalens (AT-52SE, AT-50SE,<br>HD520 and HD500) accommodating<br>intraocular lens into the capsular bag. | The Crystalsert delivery system is<br>intended to be used to fold and deliver<br>the Crystalens accommodating<br>intraocular lens and other intraocular<br>lenses identifying the Crystalsert<br>delivery system in their approved<br>labeling. |
| Contraindications | None | None |
| Materials | Body, drawer, plunger: polypropylene<br>Spring: stainless steel | Body, drawer, plunger: polypropylene<br>Spring: stainless steel |
| Single use? | Single use | Single use |
| Sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance<br>level | 10-6 | 10-6 |
| Shelf life | 12 months | 12 months |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

May 16, 2013

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

Bausch & Lomb Inc. % Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Re: K123736

Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: April 4, 2013 Received: April 5, 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. 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

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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/ReportalProblem/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.

. Kesia Y. Alexander -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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### BAUSCHELO

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

### Indications for Use Statement

510(k) Number (if known):

Device Name: Crystalsert Delivery System

Indications for Use:

The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.

Prescription Use ___X____ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Ophthalmic and Ear, Nose

and Throat Devices

510(k) Number K123736