The disposable single-use injector (model number R-INJ-02) 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.

Device Description

The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. The injector is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The disposable single-use injector is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Rayner Single Use Disposable Injector R-INJ-02. The document focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical performance data.

Crucially, the document does not detail specific "acceptance criteria" for the device's performance in terms of numerical thresholds or metrics that would be compared to reported device performance in a table. Instead, the non-clinical performance data section describes the types of tests conducted to ensure the device performs as intended and does not negatively impact the intraocular lens (IOL) it injects.

Therefore, I cannot generate a table of acceptance criteria and reported device performance as it is not present in the provided text.

Here's an analysis of the other requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not provide a table with explicit numerical acceptance criteria and corresponding reported performance values. It describes categories of tests and general conclusions about successful performance.

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

Sample Size for Test Set: For "Optical Testing" and "Mechanical Testing" of the injected IOL, the document states: "Testing as per FDA IOL Guidance document Oct 10th 1997, was performed on 10 lenses each of both the highest and lowest powers." This suggests a test set of 20 lenses for these specific tests. Other tests (biocompatibility, visual, packaging) do not specify sample sizes, but mention "testing on the final packaged and terminally sterilized Single Use Disposable Lens Injector" for biocompatibility.
Data Provenance: Not explicitly stated, but the submission is to the US FDA and references US FDA guidance documents, implying the testing was conducted in a manner compliant with US regulations. There's no mention of specific countries of origin for the data itself or whether it was retrospective or prospective. Given the nature of a 510(k) for a new device, the testing would generally be prospective.

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

Not applicable. This device is an injector, not a diagnostic tool that relies on expert interpretation of imaging or other medical data to establish ground truth. The "ground truth" for its performance relates to objective physical, optical, and biological parameters (e.g., IOL integrity, successful injection, biocompatibility).

4. Adjudication Method for the Test Set:

Not applicable. Since the device does not involve subjective interpretation or diagnosis, there is no mention of adjudication methods like 2+1 or 3+1. Performance is assessed against objective physical and chemical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. An MRMC study is designed for evaluating the performance of diagnostic devices often involving human readers. This document describes a medical device for injecting IOLs and focuses on non-clinical performance data. No human-in-the-loop performance or comparison with human readers is mentioned.

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

Not applicable. This is not an AI/algorithm-based diagnostic device. The performance evaluated is of the physical injector device itself.

7. The Type of Ground Truth Used:

Biocompatibility: Established through standard ISO 10993 series and US Blue Book Memorandum G95-1 tests (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity). The "ground truth" is that the materials are "biocompatible/toxicologically safe."
Visual, Optical, and Mechanical Testing on Injected IOL: The "ground truth" is established by comparing the injected IOLs to "non-injected lenses" (control lenses). The goal is "without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens."
- Visual: No optic lens tears, no haptic damage, absence of 'fold lines'/deposits/debris, evaluation of haptic fixation recovery time. This implicitly compares to an undamaged, clean IOL.
- Optical: Modulation Transfer Function, Dioptric power. Compared to the expected optical properties of the IOL.
- Mechanical: Dimensions, Optic decentration, Optic tilt, Dynamic fatigue durability, Limb/loon pull strength, Compression force, Axial displacement. Compared to the expected mechanical properties and integrity of the IOL. Compliance was demonstrated "at 24+/-2 hours post folding/injection" with "applicable mechanical and optical requirements" (referenced ISO 11979-3 and CDRH IOL Guidance Document Oct 10th 1997).
Visual and Mechanical Testing on the Injector: Surface finish & dimensional check, no nozzle tip detachment, no bush detachment. The "ground truth" is that the injector maintains its structural integrity and specified dimensions.
Packaging Performance Testing: Sterility, dye penetration, burst test. The "ground truth" is that the packaging maintains product sterility and integrity.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The performance evaluation is based on non-clinical testing of the physical device.

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

Not applicable, as there is no training set for this type of device.

Summary

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K052651

RAYNER
Surgical, Inc.

6654 Church Street Los Angeles, California 90042-1555 USA

Telephone: 1-800-905-0143

510(k) Summary

Submitted by

Rayner Intraocular Lenses Ltd.

Mark Mullaney Regulatory Affairs & Quality Assurance Manager

Sackville Road Hove, East Sussex, BN3 7AN England

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

Summary prepared on January 6th 2005

Device Name

Trade/Proprietary Name: Rayner Single Use Disposable Injector R-1NJ-02 .
Common Name: Rayner Single Use Disposable 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

JAN 1 9 2006

510(k) Number: K970727 .
Trade or Proprietary or Model Name: MPORT Foldable Lens Placement System .
. Manufacturer Chiron Vision Corporation

Intended Use

The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.

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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)

Open the flap on the loading area of the injector to an angle of 90°. When the injector barrel is held on a flat surface, the flaps of the IOL loading area will be orientated at the optimum angle for IOL loading. Place a bead of a commercially available viscoelastic in the two channels of the injector loading area and into the nozzle bore. Load the IOL by placing it into the loading area and positioning it about the centreline of the channels with the leading haptic positioned to enter the optic. Use non-toothed forceps to tamp the IOL down into the channels. Close the flap on the injector until it clicks shut, ensuring that the flaps on the injector do not trap the IOL. The folded lens can then be delivered into the eye by pushing the plunger.

The disposable single-use injector is a plastic, single-use disposable device.

The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.

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

Characteristics	MPORT Foldable Lens Placement System	Rayner Single Use Disposable Injector R-INJ-02
Intended Use	Folds and delivers IOL into eye during normal small incision cataract surgery	Same
Operating Principle	- Load IOL into the inserter mechanically and insert IOL into the eye- IOL delivered by direct forward motion applied to a syringe type plunger	Same
Folding Operation	IOL is loaded flat in unstressed state and laterally compressed by the closure of a slider. Contact edges are maintained in the same plane.	IOL is loaded into cartridge and closed. Opposing contact edges are folded towards each other
Folding Direction of the Lens	Lens decompresses in a horizontal plane	Same
Cartridge design	None	None
Sterilization Method	EO for entire device	Same
Materials	Polypropylene disposable tube, slide pusher and jackets. Silicone O-ring.	Polypropylene barrel, flap, bush and nozzle. Polycarbonate plunger with stainless steel spring.
Surface Treatment	None	None
Patient contact portion of the device	Tube tip and pusher tip	Same i.e. nozzle and plunger

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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 Injector R-INJ-02 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 control lenses for comparison are non-injected lenses.

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 & plunger 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 plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color. Using the scheme as outlined in ISO 10993-1 and the US Blue Book Memorandum G95-1 the following tests were 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 Lens Injector show the materials to be biocompatible/toxicologically safe for the intended climited 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. .
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 .

MECHANICAL TESTING

� Dimensions
Optic decentration .
. Optic tilt
Dynamic fatigue durability .
. Limb/loon pull strength
Compression force .
. Axial displacement

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All the above 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 .
. Bush 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/4/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Rayner Surgical Inc. c/o Mr. Donald Munro Chief Executive Officer 6654 Church Street Los Angeles, CA 90042-1555

Re: K052651

Trade/Device Name: Rayner single-use injector (R-INJ-02) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (general control) Product Code: MSS and HOY Dated: January 6, 2006 Received: January 11, 2006

Dear Mr. Munro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 commerce prior to may 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de nees that have been that do not require approval of a premarket approval application (PMA). and Cosmette ree (. rece) the device, subject to the general controls provisions of the Act. The r our may, increrer, mains of the Act include requirements for annual registration, listing of general controls profitiving 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 If your device is classified (vor as a virols. Existing major regulations affecting your device can may be subject to bach addrives, 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 I lease oe de nove a determination that your device complies with other requirements of the Act that 1127 has intate a aread regulations administered by other Federal agencies. You must of any I edetal statues and regionments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Erre rate 677, abones (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.

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Page 2 - Mr. Donald Munro

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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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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Single Use Disposable Injector R-INJ-02

Rayner Surgical Inc.

510k submission _

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Rayner Single Use Disposable Injector R-INJ-02

Indications For Use:

Statement of Indications for use

"The disposable single-use injector (model number R-INJ-02) 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division $en-Off
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number.

IDE G020115/ PMA M040018

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Page 1 of 1

December 15th 2005

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.