The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling.

Device Description

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular bag only those intraocular Lenses that allow use of this injector in their approved labelling. It is designed to mechanically fold the lens and insert it into the eye during normal, small incision (1.8mm) cataract surgery. The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device. The injector components harrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarhonate. The injector is transparent and the plunger is white.

AI/ML Overview

Here's an analysis of the provided text regarding the Rayner Single Use Small Incision Disposable Injector R-INJ-04/18, structured to answer your questions about acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Functional Performance	The injector functioned according to the requirements, specifically in its ability to compress and insert intraocular lenses into the capsular bag. The test results support a determination of substantial equivalence (implying it met its intended function without new safety/effectiveness concerns compared to the predicate).
Material Composition	The injector components (barrel, flap, nozzle, bush, sleeve) are made of polypropylene. The plunger is made of polycarbonate. This is a characteristic, not explicitly an acceptance criterion, but it's reported.
Safety	No unacceptable risks to the intended patient population or end-user were identified.
Effectiveness	The device performs as intended. Minor changes in nozzle dimensions do not raise new questions regarding safety or effectiveness.
Usability/Loading Process	The loading process is detailed, indicating specific steps (e.g., viscoelastic application, lens positioning, symmetrical folding, controlled plunger advancement) that are presumed to be achievable by the user and lead to successful insertion. While not explicitly stated as 'acceptance criteria,' successful execution of these steps is essential for the device to function.
Single Use & Disposal	The device is a plastic single-use disposable device. (Implicit acceptance that it functions for one procedure and is then discarded safely).
Substantial Equivalence	The device was found substantially equivalent to the predicate device (Rayner Single Use Soft Tipped Disposable Injector R-INJ-04), using a smaller incision and essentially identical technological characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "Mechanical testing was completed to ensure that the injector functioned according to the requirements."

Sample Size: The document does not specify the sample size used for the mechanical testing or any other tests.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location (Hove, East Sussex, UK) and the submission to the FDA, the testing was likely conducted in the UK or a facility approved by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide any information on the involvement of experts for establishing ground truth. The testing described is "mechanical testing," which implies objective, measurable parameters rather than expert-derived ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for test results. Mechanical testing typically involves predefinedPass/Fail criteria for objective measurements, rather than subjective agreement among adjudicators.

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

This section is not applicable to the provided document. The device is a mechanical injector for intraocular lenses, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable to the provided document. The device is a mechanical injector. There is no algorithm involved to perform in a standalone capacity. The "performance" described is the physical interaction of the device with an IOL and its insertion into a model or cadaveric eye as part of mechanical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "mechanical testing," the "ground truth" would likely be:

Engineering specifications/measurements: Confirmation that the injector could successfully compress and insert the specified IOL models through a 1.8mm incision without deforming the IOL or encountering excessive resistance, as per design requirements.
Visual inspection: "Visually observe that the lens is symmetrically folded within the loading bay" and for any trapped parts of the optic or haptics.
Functional outcome: Successful insertion of the IOL into a model or cadaveric capsular bag.

The document does not explicitly state these as "ground truth" but these are inferred based on the description of mechanical testing and device function.

8. The sample size for the training set

This section is not applicable. The device is a mechanical injector, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model. The device underwent design, development, and testing according to established procedures.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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K09, ISD 7

Rayner Intraocular Lenses Limited

Sackville Road

Hove
East Sussex
BN3 7AN

Telephone: +44 (0) 1273 205401
Fax: +44 (0) 1273 324023

510(k) Summary as required by 21 CFR 807.92

DEC - 4 2009

Submitted by

Rayner Intraocular Lenses Limited Address as letterhead Establishment registration: 9611165

Contact person: Roy Kemaghan Regulatory Affairs Manager Telephone # 0044-1273-740619 Fax # 0044-1273-324623 Email: roykernaghan@rayner.com

Summary propared on May 18, 2009

Device Information

· Trade/Proprietary Name: Rayner Single Use Small Incision Disposable Injector R-1NJ-04/18
· Common Name: Rayner Single Use Small Incision Injector
· Classification: Product Code is MSS. CRF section is TITLR 21. Part 886. Subpart E. Scc. 886.4300 Intraocular Lens guide. Device 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 Limited

Intended Use

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular hag only those Intraccular Lenses that allow use of this injector in their approved labelling.

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

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INJECTOR LOADING is described as follows:

Aseptically transfer the injector to the sterile fiche by upping it from the tray. Fully retract the plunger ensuring the tip does not protrude into the loading bay. Open the loading bay flup fully to 900 and sparingly apply a commercially available viscoelastic inside the norzele and to both grooves of the loading bay. Balanced salt solution alone should not be used as a lubricant. Carcfully pocl back the foil lid of the lens blister. Gently lift out the lens using parallel lipped, non serrated forcens e.g. Kelman-McPherson. Rinse the Intraccular Lens with sterile balanced salt solution. Position the lens in the injector loading bay in a "reverse S" configuration. Ensure that the nearest edge of the ontic is securely under the edge (lip) of the harrel. Hold open the flap and press down on the lens with closed forceps to ensure that the furthest edge of the optic is securely under the edge (lip) of the flap. Ensure that 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. hefore locking the flaps firmly logether. Visually observe that the lens is symmerrically folded within the loading bay. Advance the plunger in a slow controlled manner. Anticipate an initial stight 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 depression the planger. The plunger is only to be depressed once.

· The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device.

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

Summary of Testing

The Single Use Soft Tipped Disposable Injector R-INJ-04/18 was designed, developed and tested according to written procedures. Mechanical testing was completed to ensure that the injector functioned according to the requirements. The test results support a determination of substantial equivalence.

Conclusions

The Single Use Soft Tipped Disposable Injector R-INJ-04/18 has exactly the same intended use as the predicate device, using a smaller incision and essentially has identical technological characteristics. Minor changes in the dimensions of the injector norzhe do not raise any new questions regarding safety of effectiveness of the device. The R-INJ-04/18 Injector performs as intended and presents with no unacceptable risks to the intended patient population or end user. The R-IN3-04/18 is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Rayner Intraocular Lenses Limited c/o Mr. Roynan H. Kernaghan Sackville Road Hove East Sussex BN3 7 AN England

DEC - 4 2009

Re: K091507

Trade/Device Name: Rayner Single Use Soft Tipped Small Incision Disposable Injector R-INJ-04/18

Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: II Product Code: MSS Dated: October 1, 2009 Received: October 5, 2009

Dear Mr. Kernaghan:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Roynan H. Kernaghan

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 go to http://www.fdaggv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerere, yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Rayner R-IJN-04/18 Single Use Small Incision Disposable IOL Injèctor

INDICATIONS FOR USE

510(k) Number (if known): K091507

Device Name: Rayner Single Use Soft Tipped Small Incision Disposable Injector R-INJ-04/18

Indications For Use:

Statement of Indications for use

"The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling."

Federal U.S. Law restricts this device to sale by, or on the order of a physician.

Prescription Use Yes_√ No. V

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anna Postell

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091507

Page 1 of 1

ﮨ

May 5th 2009

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.