(197 days)
Not Found
No
The description focuses on the mechanical function of a disposable injector for intraocular lenses and does not mention any computational or learning capabilities.
No.
The device is an injector used to insert intraocular lenses during cataract surgery; it does not directly treat a disease or condition itself.
No
The device is described as an injector for intraocular lenses, designed to mechanically fold and insert lenses during cataract surgery. Its function is to facilitate a surgical procedure, not to diagnose a medical condition.
No
The device description clearly states it is a "plastic single use disposable device" with specific components made of polypropylene and polycarbonate, indicating it is a physical hardware device, not software.
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" intraocular lenses. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device is described as a "disposable single use soft tipped small incision injector" designed to "mechanically fold the lens and insert it into the eye." This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MSS
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,
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Capsular bag
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
r
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)
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,
1
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.
2
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
3
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
4
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
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May 5th 2009