(30 days)
Not Found
No
The 510(k) summary describes a mechanical device for inserting intraocular lenses and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is described as an injector for intraocular lenses, which is a tool used during a surgical procedure to deliver a medical device (IOL) into the eye, not a device that itself provides therapy or treatment to the patient.
No
The device is described as an injector for intraocular lenses, which is a surgical tool for delivering a medical device, not for diagnosing conditions.
No
The device description clearly states the Rayner Injectors are physical, sterile, disposable plastic devices with a syringe-shaped body, nozzle, plunger, and loading bay. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling." This describes a surgical tool used during a procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a device for "folding and delivering Rayner C-flex intraocular lenses... into the eye." This further reinforces its role as a surgical instrument for implanting a medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Rayner Injectors are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
MSS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capsular bag (in the eye)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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)
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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
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.
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 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. |
| Contraindications | 1. Vitreous in the anterior
chamber.
2. Zonular insufficiency. | 1. Vitreous in the anterior
chamber.
2. Zonular insufficiency. |
| 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 |
| Primary Packaging (Tray) | Vacuum formed, blue tinted,
transparent 760μm PETG
L x W x D (mm):
165.0 x 55.0 x 23.5 | Vacuum formed, blue tinted,
transparent 760μm PETG
L x W x D (mm):
184.0 x 55.0 x 24.25 |
| 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 |
| 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.