RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector

K143307 · Rayner Intraocular Lenses , Ltd. · MSS · Dec 18, 2014 · Ophthalmic

Device Facts

• Record ID: K143307
• Device Name: RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
• Applicant: Rayner Intraocular Lenses , Ltd.
• Product Code: MSS · Ophthalmic
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Rayner Injectors are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

Device Story

Rayner Injectors (Models STW01 and RSP01) are sterile, single-use, disposable plastic devices designed for folding and delivering intraocular lenses (IOLs) into the eye. The device features a syringe-shaped body, a nozzle, a loading bay with a mobile flap, and a soft-tipped plunger. During surgery, the clinician places the IOL into the loading bay; the device compresses the lens as it is advanced through the narrow circular lumen by the plunger in a single continuous action. Used by ophthalmologists in clinical settings, the device facilitates minimally invasive IOL implantation. The soft-tipped plunger is designed to minimize trauma during lens delivery. By enabling small-incision surgery, the device supports efficient IOL placement, potentially improving patient recovery outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polypropylene (barrel, flap, nozzle, plunger shaft, guide bush), TPE/Santoprene (plunger tip). Design: Syringe-shaped, single-use, sterile, disposable. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for compression and insertion of compatible intraocular lenses into the capsular bag. Contraindications include vitreous in the anterior chamber and zonular insufficiency.

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

• Single Use Soft Tipped Disposable Injector (Model R-INJ-04) (K132002)

Submission Summary (Full Text)

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December 18, 2014

Public Health Service

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

Rayner Intraocular Lenses Ltd. Dr. Juliette E. Cook Director of Quality and Regulatory Affairs 1-2 Sackville Trading Estate Sackville Road Hove, East Sussex BN3 7AN United Kingdom

Re: K143307

> Trade/Device Name: Raysert Plus Injector, Single Use Soft Tipped Disposable Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 10, 2014 Received: November 24, 2014

Dear Dr. Cook:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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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# Indications for Use

510(k) Number (if known) K143307

#### Device Name

Rayner RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model RSP01) Rayner Single Use Soft-Tipped Disposable Injector (Model STW01)

#### Indications for Use (Describe)

The Rayner Injectors (Models STW01 and RSP01) are intended to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

Agnieszka Drzewiecka, Regulatory Affairs Specialist, Rayner Intraocular Lenses Limited, 1-2 Sackville Trading Estate, Sackville Road, Hove, East Sussex, BN3 7AN United Kingdom

Tel: [phone] Fax: [phone]

Date Summary Prepared: December 11, 2014

## Subject Device

| Trade Name: | Rayner Injectors (Models STW01 & RSP01) |
|-----------------------|-----------------------------------------------|
| Classification Panel: | Ophthalmic |
| Product Code: | MSS |
| Common Name: | Folders and Injectors, Intraocular Lens (IOL) |
| Classification Name: | 21 CFR 886.4300 |
| Device Class: | Class I |

## Predicate Device

The predicate device is the Single Use Soft Tipped Disposable Injector (Model R-INJ-04), concurrence date March 27, 2014.

## Device Description

The Rayner Injectors are devices for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the Rayner Injectors in their approved labeling into the eye. The Rayner Injectors consist of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The Rayner Injectors are sterile, disposable plastic devices, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. Rayner Injectors are designed for single use only.

## Intended Use

The Rayner Injectors are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

This is the same indication for use as the predicate device.

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## Comparison of Devices

Please see the table below for a comparison of the subject device to the predicates.

| Characteristic | Predicate K132002<br>(Model R-INJ-04) | Subject Devices<br>(Models STW01 & RSP01) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The single use disposable injector<br>(Model R-INJ-04) is intended to be<br>used to compress and insert into<br>the capsular bag only those<br>intraocular lenses that allow the use<br>of this injector in their approved<br>labeling. | The single use disposable injectors<br>(Model STW01 and RSP01) are<br>intended to be used to compress<br>and insert into the capsular bag only<br>those intraocular lenses that allow<br>the use of these injectors in their<br>approved labeling. |
| Contraindications | 1. Vitreous in the anterior<br>chamber.<br>2. Zonular insufficiency. | 1. Vitreous in the anterior<br>chamber.<br>2. Zonular insufficiency. |
| Materials | Barrel: Polypropylene<br>Flap: Polypropylene<br>Nozzle: Polypropylene<br>Plunger tip: TPE, Santoprene<br>Plunger shaft: Polypropylene<br>Guide Bush (x 2): Polypropylene | Barrel: Polypropylene<br>Flap: Polypropylene<br>Nozzle: Polypropylene<br>Plunger tip: TPE, Santoprene<br>Plunger shaft: Polypropylene<br>Guide Bush (x 2): Polypropylene |
| Primary Packaging (Tray) | Vacuum formed, blue tinted,<br>transparent 760μm PETG<br>L x W x D (mm):<br>165.0 x 55.0 x 23.5 | Vacuum formed, blue tinted,<br>transparent 760μm PETG<br>L x W x D (mm):<br>184.0 x 55.0 x 24.25 |
| Primary packaging (Lid) | Tyvek grid TG 7307 spun bonded<br>polyolefin 75g/m² grid pattern<br>lacquer coating.<br>L x W (mm): 184.0 x 55.0 | Tyvek grid TG 7307 spun bonded<br>polyolefin 75g/m² grid pattern<br>lacquer coating.<br>L x W (mm): 184.0 x 55.0 |
| Number of Uses | Single Use | Single Use |
| Sterility | Supplied Sterile | Supplied Sterile |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ |
| Shelf Life | 5 Years | 5 Years |

## Conclusion

The Rayner Injectors described in this submission are substantially equivalent to the predicate devices.