C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02

K052651 · Rayner Surgical, Inc. · MSS · Jan 19, 2006 · Ophthalmic

Device Facts

• Record ID: K052651
• Device Name: C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
• Applicant: Rayner Surgical, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.

Device Story

Single-use disposable injector for small-incision cataract surgery; used by surgeons to fold and deliver IOLs into the capsular bag. Device consists of polypropylene barrel, flap, nozzle, bush; polycarbonate plunger; stainless steel spring. Surgeon loads IOL into injector channels using viscoelastic; closes flap to mechanically fold lens; delivers lens into eye via manual plunger pressure. Provides controlled, mechanical insertion of IOL; minimizes manual handling; facilitates small-incision delivery. Benefits include reduced surgical trauma and consistent lens placement.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1, -5, -10, -11), visual/optical/mechanical evaluation of injected IOLs (MTF, dioptric power, haptic recovery, compression force), and injector mechanical integrity. Results demonstrated that the injector delivers compatible IOLs without significantly impacting optical performance, dimensions, or cosmetic appearance. Packaging performance (sterility, dye penetration, burst test) was also verified.

Technological Characteristics

Single-use disposable injector. Materials: Polypropylene (barrel, flap, nozzle, bush), Polycarbonate (plunger), Stainless steel (spring). Mechanical folding principle. Manual operation via plunger. Sterilization: Ethylene Oxide (EO). Dimensions/form factor: Handheld syringe-type injector.

Indications for Use

Indicated for use by clinicians during small-incision cataract surgery to compress and insert specific compatible intraocular lens (IOL) models into the capsular bag.

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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K052651

**RAYNER**
Surgical, Inc.

6654 Church Street Los Angeles, California 90042-1555 USA

Telephone: [phone]

# 510(k) Summary

### Submitted by

Rayner Intraocular Lenses Ltd.

Mark Mullaney Regulatory Affairs & Quality Assurance Manager

Sackville Road Hove, East Sussex, BN3 7AN England

Telephone # [phone] Fax # [phone]

Summary prepared on January 6th 2005

### Device Name

- Trade/Proprietary Name: Rayner Single Use Disposable Injector R-1NJ-02 .
- Common Name: Rayner Single Use Disposable Injector .
- . Classification Name: Product Code is MSS. CRF section is TITLE 21, Part 886, Subpart E, Sec. 886.4300 Intraocular lens guide. Device class is Class I. Classification Panel is Ophthalmic

## Information on devices to which substantial equivalence is claimed

JAN 1 9 2006

- 510(k) Number: K970727 .
- Trade or Proprietary or Model Name: MPORT Foldable Lens Placement System .
- . Manufacturer Chiron Vision Corporation

### Intended Use

The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.

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#### Description of the device that is subject to of the application, including an explanation of how the device functions, basic scientific concepts, scientific physical and performance characteristics (design, material, physical properties)

The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. The injector is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery.

Open the flap on the loading area of the injector to an angle of 90°. When the injector barrel is held on a flat surface, the flaps of the IOL loading area will be orientated at the optimum angle for IOL loading. Place a bead of a commercially available viscoelastic in the two channels of the injector loading area and into the nozzle bore. Load the IOL by placing it into the loading area and positioning it about the centreline of the channels with the leading haptic positioned to enter the optic. Use non-toothed forceps to tamp the IOL down into the channels. Close the flap on the injector until it clicks shut, ensuring that the flaps on the injector do not trap the IOL. The folded lens can then be delivered into the eye by pushing the plunger.

The disposable single-use injector is a plastic, single-use disposable device.

The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.

### Summary of how the technological characteristics of the device compare with the predicate device identified - Device comparison table:

| Characteristics | MPORT Foldable Lens Placement System | Rayner Single Use Disposable Injector R-INJ-02 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use | Folds and delivers IOL into eye during normal small incision cataract surgery | Same |
| Operating Principle | - Load IOL into the inserter mechanically and insert IOL into the eye<br>- IOL delivered by direct forward motion applied to a syringe type plunger | Same |
| Folding Operation | IOL is loaded flat in unstressed state and laterally compressed by the closure of a slider. Contact edges are maintained in the same plane. | IOL is loaded into cartridge and closed. Opposing contact edges are folded towards each other |
| Folding Direction of the Lens | Lens decompresses in a horizontal plane | Same |
| Cartridge design | None | None |
| Sterilization Method | EO for entire device | Same |
| Materials | Polypropylene disposable tube, slide pusher and jackets. Silicone O-ring. | Polypropylene barrel, flap, bush and nozzle. Polycarbonate plunger with stainless steel spring. |
| Surface Treatment | None | None |
| Patient contact portion of the device | Tube tip and pusher tip | Same i.e. nozzle and plunger |

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### Non-clinical performance data - discussion and conclusions

Substantial equivalence is based on the assessment of non-clinical performance data

More specifically this contains the following information:

- Biocompatibility testing on the injector .
- . Visual, optical and mechanical testing on injected IOL.
- Visual and mechanical testing on injector. .
- Packaging performance testing .

The performance data indicates that the Rayner Single Use Disposable Injector R-INJ-02 delivers those IOL models, that allow use of this injector in their approved labeling, without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens.

The control lenses for comparison are non-injected lenses.

The following series of tests were conducted with the injection media Balanced Salt Solution (BSS) and a viscoelastic currently approved and used on the US market.

#### a) Biocompatibility testing on the injector

Biocompatibility testing on the injector was undertaken on the nozzle & plunger as these components incorporate the materials in contact with the tissues of the injector components barrel, flap and bush are made from the same polypropylene material as the nozzle. The plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color. Using the scheme as outlined in ISO 10993-1 and the US Blue Book Memorandum G95-1 the following tests were undertaken: Cytotoxicity (Quantitative Growth Inhibition Test (ISO 10993-5), Maximization Test according to Magnusson and Kligman (ISO 10993-10) Intracutaneous Reactivity (ISO 10993-10) and Acute Systemic Toxicity (ISO 10993-11). Testing on the final packaged and terminally sterilized Single Use Disposable Lens Injector show the materials to be biocompatible/toxicologically safe for the intended climited exposure duration with the device in contact with a breached/comprised surface).

#### b) Visual, optical and mechanical testing on injected IOL

#### VISUAL TESTING

Observation at magnification under optimal lighting conditions for the following:

- No optic lens tears for properly loaded lenses. .
- No haptic damage. .
- t Absence of 'Fold lines' and/or deposits/debris on the lens surface.
- . Evaluation of haptic fixation recovery time, to 11 mm diameter dimension.

OPTICAL TESTING

- Modulation Transfer Function .
- Dioptric power .

MECHANICAL TESTING

- � Dimensions
- Optic decentration .
- . Optic tilt
- Dynamic fatigue durability .
- . Limb/loon pull strength
- Compression force .
- . Axial displacement

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All the above mechanical testing is an assessment of the haptic function. Dioptric power does not affect the property tested. Therefore testing as per FDA IOL Guidance document Oct 10th 1997, was performed on 10 lenses each of both the highest and lowest powers.

Testing was carried out as per FDA guidelines in that the lens is folded for a minimum of 3 minutes. The IOL was allowed to return to its original and designed configuration. Compliance with applicable mechanical and optical requirements was demonstrated at 24+/-2 hours post folding/injection. (Reference ISO 11979-3, section 4.1 & CDRH IOL Guidance Document Oct 10th 1997).

#### c) Visual and mechanical testing on the single use disposable injector

#### VISUAL/PRODUCTION

- Surface finish & dimensional check .
#### MECHANICAL

- Nozzle tip detachment from barrel/main body of injector .
- . Bush detachment from barrel/main body of injector

#### d) Packaging performance testing

The following tests were performed:

- . Sterility test
- . Dye penetration
- Burst Test .

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Rayner Surgical Inc. c/o Mr. Donald Munro Chief Executive Officer 6654 Church Street Los Angeles, CA 90042-1555

Re: k052651

Trade/Device Name: Rayner single-use injector (R-INJ-02) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (general control) Product Code: MSS and HOY Dated: January 6, 2006 Received: January 11, 2006

Dear Mr. Munro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 commerce prior to may 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de nees that have been that do not require approval of a premarket approval application (PMA). and Cosmette ree (. rece) the device, subject to the general controls provisions of the Act. The r our may, increrer, mains of the Act include requirements for annual registration, listing of general controls profitiving 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 If your device is classified (vor as a virols. Existing major regulations affecting your device can may be subject to bach addrives, 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 I lease oe de nove a determination that your device complies with other requirements of the Act that 1127 has intate a aread regulations administered by other Federal agencies. You must of any I edetal statues and regionments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Erre rate 677, abones (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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Page 2 - Mr. Donald Munro

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrb/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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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Single Use Disposable Injector R-INJ-02

Rayner Surgical Inc.

510k submission _

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Rayner Single Use Disposable Injector R-INJ-02

Indications For Use:

## Statement of Indications for use

"The disposable single-use injector (model number R-INJ-02) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling."

Prescription Use Yes__ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No. No. (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division \$en-Off
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number.

IDE G020115/ PMA M040018

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December 15th 2005