Crystalsert Lens Delivery System

K173480 · Bausch & Lomb, Inc. · MSS · Dec 11, 2017 · Ophthalmic

Device Facts

• Record ID: K173480
• Device Name: Crystalsert Lens Delivery System
• Applicant: Bausch & Lomb, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Dec 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Crystalsert Lens Delivery System (CI-26) is a sterile, single-use, disposable plastic device for folding and delivering intraocular lenses (IOLs) into the eye. Device consists of a syringe-shaped body, cartridge, drawer, plunger, bearing, and haptic guide. Operation: IOL is placed into loading area; drawer is closed to compress lens; plunger is advanced to detent position; haptic guide is removed; distal end is filled with viscoelastic or balanced salt solution; device is inserted through incision; plunger is advanced to express lens into capsular bag. Used by surgeons in clinical settings. Benefits include controlled, continuous-motion delivery of IOLs during cataract or refractive surgery.

Clinical Evidence

Bench testing only. No clinical or animal data required. Testing included IOL surface/bulk homogeneity, lens power, image quality, dimensions, delivery outcome, insertion device damage, coating transfer, particle counting, sterilization/packaging verification, shelf life, biocompatibility (ISO 10993-1, 10993-18), EO/ECH residuals (ISO 10993-7), and bacterial endotoxin validation (EN ISO 13485). All tests passed.

Technological Characteristics

Materials: Polypropylene (body, drawer, plunger, bearing) and Polyimide (cartridge). Principle: Mechanical folding and manual injection. Form factor: Syringe-shaped. Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 11135:2014, AAMI TIR 28:2009, ISO 10993 series, EN ISO 13485:2012.

Indications for Use

Indicated for folding and delivery of Crystalens accommodating intraocular lenses and other compatible intraocular lenses into the eye. No specific patient population or contraindications stated.

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 Lens Delivery System CI-28 (K132593)

Submission Summary (Full Text)

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December 11, 2017

Bausch & Lomb, Inc Gary Rauvola Regulatory Affairs Manager 3365 Tree Ct. Industrial Blvd. St. Louis, Missouri 63122

Re: K173480

Trade/Device Name: Crystalsert Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 2, 2017 Received: November 13, 2017

Dear Gary Rauvola:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Denise L. Hampton -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

510(k) Number (if known)

Device Name

Crystalsert Lens Delivery System CI-26

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

Gary Rauvola Regulatory Affairs Manager Bausch + Lomb 3365 Tree Court Industrial Blvd St. Louis, MO. 63122 Phone: [phone]

Date Summary Prepared: November 02, 2017

#### 1. Subject Device:

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

#### 2. Predicate Device:

| Primary Predicate Device | K132593 | Crystalsert Lens Delivery System | CI-28 |
|--------------------------|---------|----------------------------------|-------|
|--------------------------|---------|----------------------------------|-------|

#### 3. Device Description:

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens 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.

#### 4. 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.

The indications for use of the proposed device are identical to the primary predicate device.

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

Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Crystalsert Lens Delivery System (Model Cl-26). No animal or clinical testing was required for this submission. Please refer to the summary table shown below.

| Item | Test | Results |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Function<br>Performance | (Before and after insertion) IOL surface & bulk<br>homogeneity | Pass |
| | (Before and after insertion) IOL lens power | Pass |
| | (Before and after insertion) IOL image quality | Pass |
| | (Before and after insertion) IOL dimensions | Pass |
| | IOL delivery outcome | Pass |
| | Damage to insertion device | Pass |
| | Coating transfer study | Pass |
| | Particle counting study | Pass |
| Sterilization<br>verification | Evaluation and rationale for inclusion in "family grouping" of<br>similar devices per ISO11135:2014 and AAMI TIR 28:2009 | Pass |
| Packaging verification | Evaluation and rationale for inclusion in "family grouping" of<br>similar devices. | Pass |
| Product shelf life | Evaluation and rationale for inclusion in "family grouping" of<br>similar devices for a one-year shelf life. | Pass |
| Biocompatibility | Evaluation and rationale was performed per ISO 10993-<br>1:2009 and ISO 10993-18:2005. Components are either the<br>same part or considered to be materially equivalent to parts<br>in the predicate device. As such, no additional<br>biocompatibility testing was warranted or conducted. | Pass |
| EO/ ECH residuals<br>transfer test | Lab testing per ISO 10993-7:2008 with protocols and<br>acceptance criteria previously reviewed by FDA. | Pass |
| Bacterial Endotoxin<br>Validation pre- and<br>post-sterilization | Lab testing per EN ISO 13485:2012 | Pass |

Device functional performance testing all passed and demonstrates equivalence to predicate device. EO/ ECH residual transfer tests all passed. Endotoxin validation testing passed. Sterilization evaluation, packaging verification, shelf-life evaluation, biocompatibility evaluation all met requirements and demonstrated equivalence to the predicate device. All results support the conclusion that the proposed device (Model Cl-26) is as safe and as effective, and therefore equivalent to the predicate device (Model CI-28).

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#### 6. Comparative Analysis

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

| Table 6-1: Comparison of Crystalsert Lens Delivery System Predicate Device | | |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Model CI-28) to the Proposed Minor Modification (Model CI-26) | | |
| Characteristic | Primary Predicate Device<br>CI-28 (K132593) | Proposed Device<br>CI-26 |
| 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 |
| Anatomical site | Eye | Eye |
| Injector configuration | Body, drawer, plunger, bearing | Body, cartridge, drawer, plunger,<br>bearing, haptic guide |
| Materials | Body, drawer, plunger, bearing:<br>Polypropylene | Body: drawer, plunger, bearing:<br>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. 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 haptic guide is removed<br>and distal end is filled with viscoelastic<br>or balanced salt solution and placed<br>through an incision into the eye. Once<br>the tip is in the eye, the plunger is<br>advanced until the lens is fully<br>expressed into the capsular bag. |
| Single use? | Yes | Yes |
| Is the product sterile? | Sterile | Sterile |
| How sterilized/SAL | Ethylene oxide/ 10-6 | Ethylene oxide/ 10-6 |
| Shelf life | 12 months | 12 months |

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#### 7. Conclusion

The proposed Crystalsert Lens Delivery System CI-26 is substantially equivalent to the CI-28 predicate device.