The disposable single-use soft tipped injector (model number R-INJ-04) 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. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery.

The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device.

The injector components barrel, flap, nozzle and bush are made of polypropylene. The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip.

AI/ML Overview

The provided 510(k) summary for the Rayner Single Use Disposable soft Tipped Injector R-INJ-04 focuses on demonstrating substantial equivalence to a predicate device (Rayner Single Use Disposable Injector R-INJ-02) based on non-clinical performance data. It does not describe a study involving human readers, AI assistance, or expert consensus on image analysis. Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document in the context of AI/human reader studies.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various non-clinical tests rather than specific acceptance criteria with quantifiable pass/fail values directly linked to a table. However, the overall conclusion of these tests serves as the "reported device performance," aiming to demonstrate that the device delivers IOLs without significant impact on their properties.

Acceptance Criteria (Implied)	Reported (Implied Device Performance)
IOL Integrity (Visual)	No optic lens tears for properly loaded lenses. No haptic damage. Absence of 'Fold lines' and/or deposits/debris on the lens surface. Evaluation of haptic fixation recovery time, to 11 mm diameter dimension.
IOL Optical Performance	Satisfactory Modulation Transfer Function, Dioptric power, and Spectral transmittance. (Compliance with applicable optical requirements was demonstrated at 24+/-2 hours post folding/injection).
IOL Mechanical Performance	Satisfactory Dimensions (overall diameter, sagittal dimension), Haptic compression force, Dynamic fatigue durability, Limb/loop pull strength, Optic decentration, Optic tilt, Axial displacement. (Compliance with applicable mechanical requirements was demonstrated at 24+/-2 hours post folding/injection). Testing was performed on 10 lenses each of both the highest and lowest powers. The IOL was allowed to return to its original and designed configuration after being folded for a minimum of 3 minutes. The study performed as per FDA IOL Guidance document Oct 10th 1997 and ISO 11979-3, section 4.1.
Injector Biocompatibility	The materials (nozzle, plunger tip) were found to be biocompatible/toxicologically safe for the intended clinical application, as per ISO 10993-1 and US Blue Book Memorandum G95-1 (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity).
Injector Integrity (Visual/Production)	Satisfactory Surface finish & dimensional check.
Injector Integrity (Mechanical)	Satisfactory Nozzle tip detachment from barrel/main body of injector, Tensile testing on bond of the TPE tip to the shaft of the plunger.
Packaging Performance	Passing Sterility test, Dye penetration, and Burst Test.
Overall conclusion regarding IOL models	The device 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.

2. Sample Size Used for the Test Set and Data Provenance:

IOL Mechanical and Optical Testing: "10 lenses each of both the highest and lowest powers" for mechanical testing (Dioptric power). For other IOL tests (visual, optical, mechanical), the specific sample size is not explicitly stated.
Biocompatibility Testing: Not specified for individual tests, but conducted on the nozzle and plunger tip materials.
Injector Visual/Mechanical Testing: Not specified.
Packaging Performance Testing: Not specified.
Data Provenance: The studies were conducted by the manufacturer, Rayner Intraocular Lenses Ltd., in the UK (East Sussex, England). The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is an injector, and the testing involves physical and optical properties of the IOL and the injector itself, not interpretation of medical images by experts.

4. Adjudication Method for the Test Set:

Not applicable. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical engineering and materials testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

Not applicable. This document describes a non-clinical study for a medical device (IOL injector), not an AI-assisted diagnostic or interpretative system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was established by adherence to recognized standards and validated test methodologies:

IOL Integrity: Based on visual inspection, mechanical measurements (e.g., dimensions, force, recovery time), and optical assessments against established IOL specifications and performance criteria (e.g., FDA IOL Guidance document Oct 10th 1997, ISO 11979-3).
Biocompatibility: Based on results from standardized tests (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity) according to ISO 10993-1 and the US Blue Book Memorandum G95-1, with findings interpreted against established safety thresholds.
Injector Integrity & Packaging: Based on visual inspection, dimensional checks, mechanical strength tests, and sterility/integrity tests against defined product specifications and industry standards.

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or training set described in this document.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no AI model or training set described in this document.

Summary

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K062612

Image /page/0/Picture/1 description: The image shows the logo for Rayner Surgical, Inc. The logo consists of the word "RAYNER" in bold, sans-serif font, with the words "Surgical, Inc." underneath in a smaller font. Above the text is a triangular shape made up of several parallel lines. The lines are oriented diagonally, creating a pattern that resembles a stylized mountain range or a series of peaks.

6654 Church Street Los Angeles, California 90042-1555 USA

Telephone: 1-800-905-0143

DEC 1 3 2006

510(k) Summary

Submitted by

Rayner Intraocular Lenses Ltd.

Mark Mullaney Regulatory Affairs & Quality Assurance Director

Sackville Road Hove, East Sussex, BN3 7AN England

Telephone # 0044-1273-205 401 Fax # 0044-1273-324 623

Summary prepared on November 10th 2006

Device Name

Trade/Proprietary Name: Rayner Single Use Disposable soft Tipped Injector R-INJ-04
Common Name: Rayner Single Use Soft Tipped 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

. 510(k) Number: K052651
Trade or Proprietary or Model Name: Rayner Single Use Disposable Injector R-INJ-02 .
. Manufacturer: Rayner Intraocular Lenses Ltd.

Intended Use

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

INJECTOR LOADING is described as follows: aseptically transfer the injector to the sterile field by tipping it from the tray. Fully retract the plunger ensuring that the blue tip does not protrude into the loading bay. Open the loading bay flap fully to 90° and sparingly apply a commercially available viscoelastic inside the nozzle and to both grooves of the loading bay. Balanced salt solution alone should not be used as a lubricant. Carefully peel back the foil lid of the lens blister. Gently lift out the lens using parallel tipped, non-serrated forceps e.g. Kelman-McPherson. Position the lens in the loading bay in a "reverse - S" configuration. Ensure that the nearest edge of the optic is securely under the edge (lip) of the barrel. Hold open the flap and press with closed forceps to ensure the furthest edge of the optic is securely under the edge (lip) of the flap. Ensure the haptics are completely within the loading bay. While keeping the lens in position with open forceps, gently close the flaps of the injector ensuring that no part of the optic or haptics is trapped, before locking the flaps firmly together. Visually observe that the lens is symmetrically folded within the loading bay. Advance the plunger in a slow controlled manner. Anticipate an initial slight resistance could indicate a trapped lens. Observe that the lens stays symmetrically folded within the nozzle. When the lens exits the nozzle, stop depressing the plunger. The plunger is only to be depressed once.

The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device.

Image /page/1/Picture/7 description: The image contains the text "SC 300 '7". The text appears to be a combination of letters and numbers. The letters "SC" are followed by the number 300, and then a single quote followed by the number 7.

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

Characteristics	Rayner Single Use DisposableInjector R-INJ-02	Rayner Single Use SoftDisposable Soft Tipped InjectorR-INJ-04
Intended Use	Folds and delivers IOL into eyeduring normal small incisioncataract surgery	Same
Operating Principle	- Load IOL into the insertermechanically and insert IOLinto the eye- IOL delivered by directforward motion applied to asyringe type plunger	- Same
Folding Operation	IOL is loaded into cartridge andclosed. Opposing contact edgesare folded towards each other	Same
Folding Direction of the Lens	Lens decompresses in ahorizontal plane	Same
Cartridge design	None	None
Sterilization Method	EO for entire device	Same
Materials	Polypropylene barrel, flap, bushand nozzle. Polycarbonateplunger with stainless steelspring.	Polypropylene barrel, flap, bushand nozzle. The plunger ispolypropylene with athermoplastic elastomer soft tip.
Surface Treatment	None	None
Patient contact portion of thedevice	Nozzle and plunger tip	Same

Image /page/2/Picture/4 description: The image shows a series of six oval shapes, each resembling the letter 'O'. The ovals are arranged horizontally, with slight variations in size and spacing between them. The outlines of the ovals are somewhat rough, suggesting a hand-drawn or imperfectly printed quality.

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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 Soft Tipped Injector R-INJ-04 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 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 and plunger tip 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 nozzle was tested in the previous version of the single use disposable injector (model R-INJ-02 / K052651). The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip. Using the scheme as outlined in ISO 10993-1 and the US Blue Book Memorandum G95-1 the following tests have been 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 Soft Tipped Lens Injector (R-INJ-04) shows the materials to be biocompatible/toxicologically safe for the intended clinical application (limited 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.
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
Spectral transmittance .

MECHANICAL TESTING

Dimensions ●
Lens sagittal dimension .
Lens overall diameter .
Haptic compression force .
Dynamic fatigue durability .

Page 4 of 5

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Limb/loop pull strength ●
Optic decentration .
. Optic tilt
. Axial displacement

The aforementioned 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 .
. Tensile testing on bond of the TPE tip to the shaft of the plunger

d) Packaging performance testing

The following tests were performed:

Sterility test .
Dye penetration .
. Burst Test

Page 5 of 5

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Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2006

Rayner Surgical, Inc. c/o Mr. Mark B. Mullaney Regulatory Affairs Director Sackville Road Hove East Sussex United Kingdom BN3 7AN

Re: K062612

Trade Name: Rayner Single Use Soft Tipped Disposable Injector (Model R-INJ-04) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 10, 2006 Received: November 15, 2006

Dear Mr. Mullaney:

We have reviewed vour 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Mark B. Mullaney

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelman S.M.D

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) : K062612

Device Name: The disposable single-use, soft tipped injector (model number R-INJ-04)

Indications For Use:

The disposable single-use, soft tipped injector (model number R-INJ-04) 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.

Over-The-Counter Use Prescription Use x x AND/OR - -(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)

Paul Ormonde

510(K) Number K062612

Page 1 of

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
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.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.