RAYSERT PLUS INJECTOR

K141091 · Rayner Intraocular Lenses , Ltd. · MSS · May 28, 2014 · Ophthalmic

Device Facts

• Record ID: K141091
• Device Name: RAYSERT PLUS INJECTOR
• Applicant: Rayner Intraocular Lenses , Ltd.
• Product Code: MSS · Ophthalmic
• Decision Date: May 28, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is intended 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

RaySert PLUS is a sterile, single-use, manual injector for folding and delivering intraocular lenses (IOLs) into the eye. Device consists of a syringe-shaped body, nozzle, loading bay with a mobile flap, and a soft-tipped plunger. Operation involves manual loading of the IOL into the bay, followed by a single continuous action where the plunger compresses the lens and pushes it through a narrow circular lumen into the capsular bag. Used by ophthalmic surgeons in a clinical setting. The device facilitates minimally invasive IOL delivery, reducing incision size requirements. No electronic or automated components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polypropylene (barrel, flap, nozzle, shaft, guide bush), TPE/Santoprene (plunger tip). Principle: Manual mechanical compression and delivery. Energy: None (manual). Form factor: Syringe-style injector. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients requiring intraocular lens (IOL) implantation. Contraindicated in patients with vitreous in the anterior chamber or 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)
• Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model: R-INJ-04/18) (K132002)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "K141091" at the top, followed by "MAY 28 2014" in a smaller font. Below that, the word "Rayner" is printed in a large, bold font, with a small triangle of vertical lines to the left of the word. The text appears to be part of a document or label, possibly indicating a date or identification number associated with the name Rayner.

# 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:

Daniel Peek, Regulatory Affairs Manager, 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: May 27, 2014

#### Subject Device

| Trade Name: | RaySert PLUS Small Incision Single Use Soft-Tipped Injecto |
|-----------------------|------------------------------------------------------------|
| 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 devices are the Single Use Soft Tipped Disposable Injector (Model: R-INJ-04), and the Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model: R-INJ-04/18), both with 510(k) number K132002, concurrence date March 27, 2014.

## Device Description

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector is a device for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the RaySert PLUS in their approved labeling into the eye. The RaySert PLUS consists of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The RaySert PLUS is a sterile, disposable plastic device, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. RaySert PLUS is designed for single use only.

## Indication for Use

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is 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.

{1}------------------------------------------------

With the exception of the model name and number, this is the same indication for use as the predicate device.

# Comparison of Devices

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

| Characteristic | Predicate K132002<br>(Models R-INJ-04 and R-INJ-<br>04/18) | Subject Device<br>(Model R-INJ-10) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The single use disposable<br>injectors (Model R-INJ-04, and<br>Model R-INJ-04/18) are intended<br>to be used to compress and<br>insert into the capsular bag only<br>those intraocular lenses that<br>allow the use of these injectors<br>in their approved labeling. | The single use disposable<br>injector (Model R-INJ-10) is<br>intended to be used to compress<br>and insert into the capsular bag<br>only those intraocular lenses<br>that allow the use of these<br>injectors in their approved<br>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 |
| 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 | 2 Years (with protocol in place to<br>extend to 5 years as testing is<br>completed) |

# Conclusion

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

.

.

{2}------------------------------------------------

Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 28, 2014

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: K141091

Trade/Device Name: Single Use Soft Tipped Disposable Injector (Model R-INJ-10) Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lens (IOL.) Regulatory Class: Class 1 Product Code: MSS Dated: April 23, 2014 Received: April 28, 2014

Dear Dr. Cook:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstale for use stated in the encreative to regard manated to of the Medical Device Amendments, or 10 conninered provide to they 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter rearly rever the device, subject to the general controls provisions of the Act. The I our may, dictere, maines of the Act include requirements for annual registration, listing of general controls provincies. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

{3}------------------------------------------------

Page 2 - Dr. Juliette E. Cook

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 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/Resources/orYou/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

{4}------------------------------------------------

# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

### 510(k) Number (if known) K141091

#### Device Name

Ravner RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10)

### Indications for Use (Describe)

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is 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)

2 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)

An Z

# Andrew Yang -S 2014.05.23 15:41:47 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

1980 Publicitions Scrivices (10) ) 443-6740 EF