(77 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The intended use and device description (though not found) relate to a mechanical process of folding and delivering an intraocular lens. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
This device is intended to deliver intraocular lenses into the eye for replacement of the human crystalline lens, which is a therapeutic intervention.
No
The intended use describes the device as a tool for folding and delivering intraocular lenses, not for identifying or analyzing a condition.
No
The intended use describes a device that folds and delivers intraocular lenses, which is a physical action requiring hardware. The lack of a device description prevents confirmation, but the intended use strongly suggests a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens." This describes a surgical instrument used in vivo (within the living body) to implant a medical device.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The device described is clearly used directly on the patient's eye during surgery, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens.
Product codes
MSS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
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 stylized eagle or bird symbol on the right side. To the left of the bird symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2006
Duckworth & Kent c/o Mr. Martin Lock Head of Quality Systems Terence House 7 Marquis Business Centre Royston Road Baldock, Hertfordshire United Kindgom 5G7 6XL
Re: K053176
Trade/Device Name: Duckworth & Kent Ltd. Cartridge Lens Delivery System. Model DK7797 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 10, 2005 Received: November 16, 2005
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 interstatc 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.
1
Page 2 - Mr. Martin Lock
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. 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/industry/support/index.html.
Sincerely yours,
M.B. Egolmes, mD
Malvina B. Evdelman, M.D. Acting Division Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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STATEMENT OF INDICATIONS FOR USE
6רו5356 S 10K Number (if known):
Device Name: Duckworth & Kent Ltd Cartridge Lens Delivery System DK7797
Indications for Use:
To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens.
Indications for Use Labelling:
INDICATION FOR USE
To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens
CARTRIDGE DELIVERY SY OK7797 NON-STERI
Duckworth & Kent Ltd, Baldock, SQ7 6XL. Engli
Prescription Use X
AND / 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)
Bud Cunningham
(Division Sign-Off)
€
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K053176