CRYSTALSERT DELIVERY SYSTEM

K132593 · Bausch & Lomb · MSS · Sep 17, 2013 · Ophthalmic

Device Facts

• Record ID: K132593
• Device Name: CRYSTALSERT DELIVERY SYSTEM
• Applicant: Bausch & Lomb
• Product Code: MSS · Ophthalmic
• Decision Date: Sep 17, 2013
• Decision: SESE
• Submission Type: Special
• 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 lens identifying the Crystalsert Delivery System in their approved labeling.

Device Story

Crystalsert Delivery System is a sterile, single-use, disposable plastic device designed for folding and delivering intraocular lenses (IOLs) into the eye. The device consists of a syringe-shaped body, a tip, a plunger, and a drawer. During ophthalmic surgery, a surgeon places the IOL into the device's tubular pathway; the device then folds and delivers the lens into the eye in one continuous motion. The system facilitates the surgical implantation of IOLs, potentially reducing surgical complexity and improving patient outcomes by ensuring controlled lens delivery.

Clinical Evidence

Bench testing only. No clinical data provided. The device was evaluated through functional and biocompatibility testing to demonstrate conformance with applicable standards.

Technological Characteristics

Materials: Polypropylene (body, drawer, plunger), stainless steel (spring). Form factor: Syringe-shaped delivery system with tubular pathway. Sterilization: Ethylene oxide (SAL 10^-6). Shelf life: 12 months. Connectivity: None. Software: None.

Indications for Use

Indicated for folding and delivery of Crystalens accommodating intraocular lenses and other compatible intraocular lenses into the eye during ophthalmic 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

• Crystalsert Delivery System (K123736)

Submission Summary (Full Text)

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# 32593

## 510(k) Summ

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

The submitter of the 510(k) is:

Yi Gao Regulatory Affairs Specialist Bausch & Lomb, Inc. 30 Enterprise, Suite 450 Aliso Viejo, CA Phone: [phone] Fax: [phone]

Date Summary Prepared: August 16, 2013

1 7 2013

### 1. Subject Device:

Trade name: Common Name: Classification Name: Crystalsert Delivery System Intraocular lens Guide 21 CFR 886.4300

### Predicate Device: 2.

K 123736, Crystalsert Delivery System

### 3. Device Description:

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens (AT-52SE, AT-50SE, HD520, HD500, AT50AO, AT52AO), Trulign™ Toric, and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

### Indications for Use: 4.

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

This is the same exact indications for use as the predicate device.

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## BAUSCH + LOMB

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

The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards.

### 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 Crystalsert Delivery |
|--------------------------------------------------------------------------------|
| System |

| Characteristic | Predicate K123736<br>Crystalsert Delivery System | "Crystalsert Delivery System<br>(Proposed Device) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | 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. | 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 |

### 7. Conclusion

The Crystalsert Delivery System is substantially equivalent to the predicate device.

CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in black.

### September 17, 2013

Public Health Service

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

Bausch & Lomb, Inc. Ms. Yi Gao Regulatory Affairs Specialist 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Re: K132593

Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Gao:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/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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Indications for Use Statement

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

K132593

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 lens identifying the Crystalsert Delivery System in their approved labeling.

X_____________________________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use Prescription 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)

Tieuvi 2013.0

CONFIDENTIAL