The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is 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 RaySert PLUS Small Incision Single Use Soft-Tipped Injector is a device for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the RaySert PLUS in their approved labeling into the eye. The RaySert PLUS consists of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The RaySert PLUS is a sterile, disposable plastic device, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. RaySert PLUS is designed for single use only.

AI/ML Overview

This document describes a 510(k) premarket notification for the RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10). The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance metrics with defined thresholds. Instead, it focuses on demonstrating substantial equivalence by comparing characteristics of the subject device to a legally marketed predicate device (K132002). The "reported device performance" is implicit in the statement of equivalence for each characteristic.

Characteristic	Acceptance Criteria (Implicit: Equivalence to Predicate)	Reported Device Performance (Subject Device)
Indication for Use	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.	The single use disposable injector (Model R-INJ-10) is 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 to predicate)
Contraindications	1. Vitreous in the anterior chamber.2. Zonular insufficiency.	1. Vitreous in the anterior chamber.2. Zonular insufficiency. (Identical to predicate)
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 (Identical to predicate)
Number of Uses	Single Use	Single Use (Identical to predicate)
Sterility	Supplied Sterile	Supplied Sterile (Identical to predicate)
Sterilization Method	Ethylene Oxide	Ethylene Oxide (Identical to predicate)
Sterility Assurance Level	10^-6	10^-6 (Identical to predicate)
Shelf Life	5 Years	2 Years (with protocol in place to extend to 5 years as testing is completed) (Subject device has temporary shorter shelf life with plans to extend upon further testing)

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

The document does not describe any specific clinical or performance test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for demonstrating efficacy or safety. The submission focuses on demonstrating substantial equivalence through comparison of device characteristics and intended use with a predicate device.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The submission is based on a comparison to a predicate device's existing regulatory approval.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study involving adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in this submission. This type of study would be relevant for assessing the impact of AI on human readers, which is not the subject of this 510(k) submission.

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

A standalone performance study of an algorithm was not done and is not mentioned in this submission. This device is a manual, single-use surgical instrument, not an AI or algorithmic medical device.

7. The Type of Ground Truth Used

The concept of "ground truth" as it relates to expert consensus, pathology, or outcomes data is not applicable to this 510(k) submission. The "truth" or basis for approval here is the previously established substantial equivalence and safety/efficacy profile of the predicate device, to which the subject device is being compared.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe any machine learning or AI algorithm development that would involve a training set.

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

This information is not applicable as there is no training set mentioned in the document.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K141091" at the top, followed by "MAY 28 2014" in a smaller font. Below that, the word "Rayner" is printed in a large, bold font, with a small triangle of vertical lines to the left of the word. The text appears to be part of a document or label, possibly indicating a date or identification number associated with the name Rayner.

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:

Daniel Peek, Regulatory Affairs Manager, 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: May 27, 2014

Subject Device

Trade Name:	RaySert PLUS Small Incision Single Use Soft-Tipped Injecto
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 devices are the Single Use Soft Tipped Disposable Injector (Model: R-INJ-04), and the Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model: R-INJ-04/18), both with 510(k) number K132002, concurrence date March 27, 2014.

Device Description

Indication for Use

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is 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.

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With the exception of the model name and number, this is the same indication for use as the predicate device.

Comparison of Devices

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

Characteristic	Predicate K132002(Models R-INJ-04 and R-INJ-04/18)	Subject Device(Model R-INJ-10)
Indication for Use	The single use disposableinjectors (Model R-INJ-04, andModel R-INJ-04/18) are intendedto be used to compress andinsert into the capsular bag onlythose intraocular lenses thatallow the use of these injectorsin their approved labeling.	The single use disposableinjector (Model R-INJ-10) isintended to be used to compressand insert into the capsular bagonly those intraocular lensesthat allow the use of theseinjectors in their approvedlabeling.
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
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	2 Years (with protocol in place toextend to 5 years as testing iscompleted)

Conclusion

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

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Image /page/2/Picture/0 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 an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 28, 2014

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: K141091

Trade/Device Name: Single Use Soft Tipped Disposable Injector (Model R-INJ-10) Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lens (IOL.) Regulatory Class: Class 1 Product Code: MSS Dated: April 23, 2014 Received: April 28, 2014

Dear Dr. Cook:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstale for use stated in the encreative to regard manated to of the Medical Device Amendments, or 10 conninered provide to they 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter rearly rever the device, subject to the general controls provisions of the Act. The I our may, dictere, maines of the Act include requirements for annual registration, listing of general controls provincies. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

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Page 2 - Dr. Juliette E. Cook

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

510(k) Number (if known) K141091

Device Name

Ravner RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 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)

An Z

Andrew Yang -S 2014.05.23 15:41:47 -04'00'

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FORM FDA 3881 (1/14)

1980 Publicitions Scrivices (10) ) 443-6740 EF

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.