The Rayner Injectors (Models STW01 and RSP01) are 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 Description

The Rayner Injectors are devices for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the Rayner Injectors in their approved labeling into the eye. The Rayner Injectors consist of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The Rayner Injectors are sterile, disposable plastic devices, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. Rayner Injectors are designed for single use only.

AI/ML Overview

This document describes the Rayner Injectors (Models STW01 & RSP01), which are intraocular lens (IOL) folders and injectors. The submission is a 510(k) premarket notification, indicating the intent to market the device by demonstrating its substantial equivalence to a legally marketed predicate device.

The information provided does not include details of a clinical study or detailed performance acceptance criteria in the way one might expect for an AI algorithm or a diagnostic device. Since this is an intraocular lens guide (Class I device), the evidence for substantial equivalence primarily relies on design, material, and functional comparisons to a predicate device, along with verification and validation testing, usually non-clinical.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable (N/A) in the context of this 510(k) submission for a Class I medical device like an IOL injector. These types of detailed studies are more common for higher-risk devices or software as a medical device (SaMD) where clinical performance or diagnostic accuracy is the primary concern.

However, I will extract and present the relevant information that is available in the document.

Acceptance Criteria and Reported Device Performance

The document states that the Rayner Injectors are substantially equivalent to the predicate device (Single Use Soft Tipped Disposable Injector, Model R-INJ-04). Substantial equivalence itself serves as the overarching "acceptance criterion" for a 510(k) submission.

The specific characteristics compared, which inherently function as acceptance criteria for demonstrating equivalence, are detailed in the "Comparison of Devices" table. The device meets these criteria by being identical or having minor differences that do not raise new questions of safety or effectiveness.

Characteristic	Acceptance Criteria (Equivalent to Predicate)	Reported Device Performance (Subject Device)
Indication for Use	"The single use disposable injector (Model R-INJ-04) is intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of this injector in their approved labeling."	"The single use disposable injectors (Model STW01 and RSP01) are 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." (Identical)
Contraindications	1. Vitreous in the anterior chamber. 2. Zonular insufficiency.	1. Vitreous in the anterior chamber. 2. Zonular insufficiency. (Identical)
Materials	Barrel: Polypropylene; Flap: Polypropylene; Nozzle: Polypropylene; Plunger tip: TPE, Santoprene; Plunger shaft: Polypropylene; Guide Bush (x 2): Polypropylene	Barrel: Polypropylene; Flap: Polypropylene; Nozzle: Polypropylene; Plunger tip: TPE, Santoprene; Plunger shaft: Polypropylene; Guide Bush (x 2): Polypropylene. (Identical)
Primary Packaging (Tray)	Vacuum formed, blue tinted, transparent 760μm PETGL x W x D (mm): 165.0 x 55.0 x 23.5	Vacuum formed, blue tinted, transparent 760μm PETGL x W x D (mm): 184.0 x 55.0 x 24.25 (Slight dimensional difference, which is implied to not affect safety or effectiveness for substantial equivalence)
Primary packaging (Lid)	Tyvek grid TG 7307 spun bonded polyolefin 75g/m² grid pattern lacquer coating.L x W (mm): 184.0 x 55.0	Tyvek grid TG 7307 spun bonded polyolefin 75g/m² grid pattern lacquer coating.L x W (mm): 184.0 x 55.0 (Identical, despite the tray size difference)
Number of Uses	Single Use	Single Use (Identical)
Sterility	Supplied Sterile	Supplied Sterile (Identical)
Sterilization Method	Ethylene Oxide	Ethylene Oxide (Identical)
Sterility Assurance Level	$10^{-6}$	$10^{-6}$ (Identical)
Shelf Life	5 Years	5 Years (Identical)

Study Information (Based on the provided document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance evaluation. For devices like this, testing typically involves mechanical, material, and sterilization validation, which would involve samples but not in the same way as a diagnostic test.
- Data Provenance: The submission is from Rayner Intraocular Lenses Ltd., located in the United Kingdom. The testing data would likely originate from their internal R&D and quality assurance processes, conducted in the UK. This is prospective for the device's development but not a retrospective analysis of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For a mechanical device like an IOL injector, "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant. Performance is established through engineering and material testing standards.
Adjudication method for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations by experts (e.g., image reading). This device's performance is objectively measured.
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:
- N/A. This is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm. Therefore, standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the aspects considered in this submission (material compatibility, sterility, shelf-life, and mechanical function), the "ground truth" is derived from established engineering standards, biocompatibility testing, sterilization validation protocols, and physical testing (e.g., force required for injection, IOL integrity after injection). It's not based on expert clinical consensus or pathology in the diagnostic sense, but rather objective measurement against predefined specifications.
The sample size for the training set:
- N/A. There is no "training set" in the context of AI or machine learning for this device. Device development involves iterative design, prototyping, and testing, but not in a "training set" paradigm.
How the ground truth for the training set was established:
- N/A. As there is no training set, this is not applicable.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

December 18, 2014

Public Health Service

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

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: K143307

Trade/Device Name: Raysert Plus Injector, Single Use Soft Tipped Disposable Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 10, 2014 Received: November 24, 2014

Dear Dr. Cook:

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. Please note: CDRH does 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.

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

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

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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

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

Indications for Use

510(k) Number (if known) K143307

Device Name

Rayner RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model RSP01) Rayner Single Use Soft-Tipped Disposable Injector (Model STW01)

Indications for Use (Describe)

The Rayner Injectors (Models STW01 and RSP01) are 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)

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)

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 PRAStaff(@fda.hhs.gov

"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."

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

Image /page/3/Picture/0 description: The image shows the word "Rayner" in a serif font, with a triangle to the left of the word. The triangle is divided into vertical stripes, with every other stripe colored yellow. The word "Rayner" is in black.

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:

Agnieszka Drzewiecka, Regulatory Affairs Specialist, Rayner Intraocular Lenses Limited, 1-2 Sackville Trading Estate, Sackville Road, Hove, East Sussex, BN3 7AN United Kingdom

Tel: +44 1273 205 401 Fax: +44 1273 324 623

Date Summary Prepared: December 11, 2014

Subject Device

Trade Name:	Rayner Injectors (Models STW01 & RSP01)
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 device is the Single Use Soft Tipped Disposable Injector (Model R-INJ-04), concurrence date March 27, 2014.

Device Description

Intended Use

The Rayner Injectors are 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.

This is the same indication for use as the predicate device.

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

Comparison of Devices

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

Characteristic	Predicate K132002(Model R-INJ-04)	Subject Devices(Models STW01 & RSP01)
Indication for Use	The single use disposable injector(Model R-INJ-04) is intended to beused to compress and insert intothe capsular bag only thoseintraocular lenses that allow the useof this injector in their approvedlabeling.	The single use disposable injectors(Model STW01 and RSP01) areintended to be used to compressand insert into the capsular bag onlythose intraocular lenses that allowthe use of these injectors in theirapproved labeling.
Contraindications	1. Vitreous in the anteriorchamber.2. Zonular insufficiency.	1. Vitreous in the anteriorchamber.2. Zonular insufficiency.
Materials	Barrel: PolypropyleneFlap: PolypropyleneNozzle: PolypropylenePlunger tip: TPE, SantoprenePlunger shaft: PolypropyleneGuide Bush (x 2): Polypropylene	Barrel: PolypropyleneFlap: PolypropyleneNozzle: PolypropylenePlunger tip: TPE, SantoprenePlunger shaft: PolypropyleneGuide Bush (x 2): Polypropylene
Primary Packaging (Tray)	Vacuum formed, blue tinted,transparent 760μm PETGL x W x D (mm):165.0 x 55.0 x 23.5	Vacuum formed, blue tinted,transparent 760μm PETGL x W x D (mm):184.0 x 55.0 x 24.25
Primary packaging (Lid)	Tyvek grid TG 7307 spun bondedpolyolefin 75g/m² grid patternlacquer coating.L x W (mm): 184.0 x 55.0	Tyvek grid TG 7307 spun bondedpolyolefin 75g/m² grid patternlacquer coating.L x W (mm): 184.0 x 55.0
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	5 Years

Conclusion

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

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.