(80 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and anatomical site suggest a physical device for intubation.
Yes
The device is indicated for the treatment of various medical conditions such as lacerations, stenoses, obstructions, and epiphora, which aligns with the definition of a therapeutic device.
No
The 'Intended Use / Indications for Use' section describes the treatment of conditions (e.g., lacerations, stenoses, obstructions), not the identification or diagnosis of those conditions. The device is used in the treatment (requiring intubation) and after treatment, suggesting a therapeutic or interventional role rather than a diagnostic one.
Unknown
The provided text is a 510(k) summary, but it lacks the "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes a physical procedure involving intubation, suggesting a hardware component is likely involved, but without the device description, a definitive determination cannot be made.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in surgical procedures involving the lacrimal duct and canaliculus. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Anatomical Site: The device is used directly on anatomical structures within the body (lacrimal duct, canaliculus). IVDs typically analyze samples taken from the body (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation.
Further indications are:
Congenital lacrimal duct obstructions
Canalicular lacerations
After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed.
After clacryocystorhinostomy Epiphora
Product codes
OKS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is completely white and does not contain any discernible features or objects. It appears to be a blank canvas or a solid white background. There are no shapes, lines, or textures visible in the image. The image lacks any contrast or variation in color.
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
DEC 16 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632-2402
Re: K061404
Trade/Device Name: Mono-Crawford Naso-lacrimal Intubation Device Regulatory Class: Unclassified Product Code: OKS Dated: May 15, 2006 Received: May 19, 2006
Dear Mr. Welch:
This letter corrects our substantially equivalent letter of August 7, 2006.
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 (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); 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.
1
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Malvina B. Egleston, wid
Malvina B. Eydelman. M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): __ K061404__________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation.
Further indications are:
Congenital lacrimal duct obstructions
Canalicular lacerations
After treatment of canaliculitis with concretions when curettage of a
canaliculus has been performed.
After clacryocystorhinostomy
Epiphora
Prescription Use
X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Moidulite Viswani
vision of Onhthalmir and Threat Dev
310(k) Number_Ko61404
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(Posted November 13, 2003)