(106 days)
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Not Found
No
The summary describes a mechanical injector for a capsular tension ring and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an injector that facilitates the insertion and placement of a capsular tension ring. The ring itself would be the therapeutic device, as it is implanted in the body to treat a condition. The injector is a tool used during the procedure, but it does not directly provide therapy.
No
The device is described as an injector for a capsular tension ring, which facilitates the insertion and placement of the ring. This is a therapeutic or interventional function, not a diagnostic one.
No
The provided text describes an "injector" for a "Capsular Tension Ring," which are physical medical devices used in cataract surgery. There is no mention of software in the description.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the insertion and placement of a capsular tension ring during a cataract procedure. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not fit that description.
The device described is a surgical instrument used in an ophthalmic procedure.
N/A
Intended Use / Indications for Use
When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.
Product codes
NCE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2004
Duckworth & Kent, Ltd. c/o Mr. Martin Lock Head of Quality Systems Terrence House, 7 Marquis Baldock, Hertsfordshire, United Kingdom, SG7 6XL
Re: K042478
Trade/Device Name: Capsule Tension Ring Inserter Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: NCE Dated: December 9, 2004 Received: December 13, 2004
Dear Mr. Lock:
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 such 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); 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.
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Page 2 - Mr. Martin Lock
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) 594-4613. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Akaliji forenthal
A. Ralph Rosenthal, 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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Page 3 - Mr. Martin Lock
STATEMENT OF INDICATIONS FOR USE
K042478 510K Number (if known):
Device Name: Duckworth & Kent Ltd Capsule Tension Ring Inserter 7-810
Indications for Use:
When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure.
This injector will facilitate the insertion and proper placement of the ring in the capsular bag.
Indications for Use Labelling:
INDICATION FOR USE
Injector for Morcher Capsule Tension Ring.
Capsule Tension Ring Ins 7-810 NON-STERILE Duckworth & Kent Ltd, Baldock, SG7 SXL, England
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Raoul Cunningham
510(k) Number K942478