The single-use small incision disposable injector (model number R-INJ-06) is intended 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 small incision injector (model number R-INJ-06) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Rayner Single Use Small Incision Disposable Injector R-INJ-06) seeking substantial equivalence to a predicate device. It details non-clinical performance data but does not describe a study to prove acceptance criteria in the typical sense of a clinical trial or a statistically powered study with acceptance criteria for clinical outcomes.

Instead, the "acceptance criteria" discussed are implicitly met by the successful completion of various non-clinical tests. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical tests outlined in the document, which are used to demonstrate that the new device performs comparably to the predicate and meets safety and performance standards for its intended use.

Here's an breakdown based on the information provided, keeping in mind the limitations of a 510(k) summary for non-clinical data:

1. Table of Acceptance Criteria and Reported Device Performance

Since formal acceptance criteria values (e.g., "tear rate less than X%") are not explicitly stated with numerical targets, the table below lists the performance aspects tested and the general conclusion provided in the summary. The performance is "reported" as meeting these implicit criteria by the statement "The performance data indicates that the Rayner Single Use Disposable Soft Tipped Injector R-INJ-06 delivers those IOL models...without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens."

Acceptance Criteria (Performance Aspect Tested)	Reported Device Performance
Biocompatibility	Materials biocompatible/toxicologically safe for intended clinical application (limited exposure duration with device in contact with breached/compromised surface).
- Cytotoxicity (ISO 10993-5)	Passed
- Maximization Test (ISO 10993-10)	Passed
- Intracutaneous Reactivity (ISO 10993-10)	Passed
- Acute Systemic Toxicity (ISO 10993-11)	Passed
Visual Testing on Injected IOL	No significant impact on IOL visual integrity.
- No optic lens tears	Demonstrated
- No haptic damage	Demonstrated
- Absence of 'Fold lines' / deposits/debris	Demonstrated
- Haptic fixation recovery time (11 mm)	Demonstrated
Optical Testing on Injected IOL	No significant impact on IOL optical performance.
- Modulation Transfer Function (MTF)	Compliance demonstrated
- Dioptric power	Compliance demonstrated
- Spectral transmittance	Compliance demonstrated
Mechanical Testing on Injected IOL	No significant impact on IOL mechanical properties.
- Dimensions (per ISO 11979-3 & FDA IOL Guidance)	Compliance demonstrated
- Lens sagittal dimension	Compliance demonstrated
- Lens overall diameter	Compliance demonstrated
- Haptic compression force	Compliance demonstrated
- Dynamic fatigue durability	Compliance demonstrated
- Limb/loop pull strength	Compliance demonstrated
- Optic decentration	Compliance demonstrated
- Optic tilt	Compliance demonstrated
- Axial displacement	Compliance demonstrated
Visual/Mechanical on Injector (Self)	Functionally sound.
- Surface finish & dimensional check	Demonstrated
- Nozzle tip detachment from barrel/body	Demonstrated
Packaging Performance Testing	Maintained sterility and integrity.
- Sterility test	Passed
- Dye penetration	Passed
- Burst Test	Passed

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

Sample Size:
- IOL Testing (Optical and Mechanical): "performed on 10 lenses each of both the highest and lowest powers." This means 20 IOLs were tested for optical and mechanical properties after injection.
- Biocompatibility: The specific sample sizes for each test (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity) are not provided in this summary, only that these tests were undertaken.
- Packaging Performance: Specific sample sizes for Sterility, Dye Penetration, and Burst Tests are not provided.
Data Provenance: The data is non-clinical, originating from laboratory testing (in vitro/ex vivo). No country of origin for the testing itself is explicitly stated, but the manufacturer is Rayner Intraocular Lenses Ltd. (England). The context is a 510(k) submission to the US FDA, so the tests likely adhere to international standards (e.g., ISO, US Blue Book Memorandum). The data is retrospective in the sense that it was generated prior to submission for regulatory clearance.

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

This is not applicable for this type of non-clinical device submission. "Ground truth" in this context refers to objective measurements and adherence to established standards (e.g., ISO, FDA guidance documents) rather than expert consensus on subjective observations or diagnoses.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases, often involving human interpretation of medical images or symptoms. Here, the tests involve objective measurements and observations against pre-defined engineering and biological criteria.

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

Not applicable. This device is an injector for intraocular lenses, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

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

Not applicable. This device is a mechanical injector, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

International Standards: ISO 10993 (biocompatibility), ISO 11979-3 (IOL mechanical and optical properties).
Regulatory Guidance: US FDA Blue Book Memorandum G95-1 (biocompatibility), FDA IOL Guidance Document Oct 10th 1997.
Objective Measurements: Visual observations (e.g., absence of tears, haptic damage, fold lines), optical measurements (MTF, dioptric power, spectral transmittance), mechanical measurements (dimensions, compression force, durability, pull strength, decentration, tilt, axial displacement), and standard packaging tests (sterility, dye penetration, burst).
Predicate Device Comparison: Implicitly, the performance is also compared against the known performance characteristics of the predicate device (Rayner Single Use Soft Tipped Disposable Injector R-INJ-04) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set."

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

Not applicable. As noted above, there is no training set for this type of device.

Summary

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K081455

6654 Church Street Los Angeles, California 90042-1555 USA

Telephone: 1-800-905-0143

SEP - 5 2008

510(k) Summary

Submitted by

Rayner Intraocular Lenses Ltd.

Andrew Wells Quality Assurance & Regulatory Affairs Manager

Sackville Road Hove, East Sussex, BN3 7AN England

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

Summary prepared on May 12th 2008

Device Name

Trade/Proprietary Name: Rayner Single Use Small Incision Disposable Injector R-INJ-06 ●
Common Name: Rayner Single Use Small Incision 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: K062512 ●
Trade or Proprietary or Model Name: Rayner Single Use Soft Tipped Disposable Injector R-INJ-04 �
. Manufacturer: Rayner Intraocular Lenses Ltd.

Intended Use

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Image /page/0/Picture/22 description: The image shows the number 000017. The number is written in a simple, sans-serif font. The digits are evenly spaced and clearly visible. The number is likely a serial number, code, or identifier.

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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)

INJECTOR LOADING is described as follows: aseptically transfer the sterile field by tipping it from the tray. Fully retract the plunger ensuring that the tip does not protrude into the loading bay. Open the loading bay fialy 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. Rinse the IOL with sterile balanced salt solution. 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 down on lens 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, Excessive 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 is only to be depressed once.

The small incision injector (model number R-INJ-06) is a plastic, single-use disposable device.

The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white.

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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 DisposableSoft Tipped Injector R-INJ-04	Rayner Single Use SmallIncision Disposable InjectorR-INJ-06
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. The plunger ispolypropylene with athermoplastic elastomer soft tip.	Polypropylene barrel, flap, bush,nozzle and sleeve. The plunger ispolycarbonate.
Surface Treatment	None	None
Patient contact portion of thedevice	Nozzle and plunger tip	Same

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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. t
Visual and mechanical testing on injector.
Packaging performance testing .

The performance data indicates that the Rayner Single Use Disposable Soft Tipped Injector R-INJ-06 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, bush and sleeve are made from the same polypropylene material as the nozzle was tested in a previous version of the single use disposable injector (model R-INJ-02 / K052651). The plunger is a polycarbonate material which was tested in a previous version of the single use disposable injector (model R-INJ-02 / K052651. The injector is transparent and the plunger is white. 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 Injector shows the materials to be biocompatible/toxicologically safe for the intended clinical application (limited exposure duration with the device in contact with a breached/compromised 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
. Spectral transmittance
MECHANICAL TESTING
Dimensions .
. Lens sagittal dimension
. Lens overall diameter
. Haptic compression force

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. Dynamic fatigue durability
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 .

d) Packaging performance testing

The following tests were performed:

Sterility test .
Dye penetration .
Burst Test .

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Image /page/5/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2008

Rayner Surgical, Inc. c/o Mr. Andrew Wells Rayner Intraocular Lenses 6654 Church Street Los Angeles, CA 90042-1555

Re: K081455

Trade/Device Name: Rayner Single Use Small Incision Disposable Injector R-INJ-06 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: MSS Dated: August 8, 2008 Received: August 13, 2008

Dear Mr. Wells:

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.

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 (2 ) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electromic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egleston, 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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Rayner Surgical Inc.

510k submission

Indications for Use

510(k) Number (if known): K 08 14 5 5

Device Name Rayner Single Use Small Incision Disposable Injector R-INJ-06

Indications For Use:

Statement of Indications for use

"The single-use small incision disposable injector (model number R-INJ-06) 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)

Widnets Virran 9/3/08 Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic Ear, Division Throat Devises 510(k) Number_KO&THE 5

Page 1 of 1

May 12th 2008

000016

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.