(80 days)
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
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Mono-Crawford Naso-lacrimal Intubation Device." This type of document primarily focuses on establishing substantial equivalence to a predicate device based on indications for use and technological characteristics.
It is crucial to understand that 510(k) submissions typically do not involve the kind of rigorous performance studies or acceptance criteria that are described in the prompt's questions for AI/diagnostic devices. The clearance is based on the device being as safe and effective as a legally marketed predicate, not necessarily on a new, comprehensive study demonstrating meeting specific performance metrics with statistical rigor.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not present in this document because they are not typically part of a 510(k) premarket notification for a physical medical intubation device.
However, I can extract the information that is available:
Acceptance Criteria and Study for Mono-Crawford Naso-lacrimal Intubation Device
Based on the provided 510(k) clearance letter (K061404), the "acceptance criteria" for a device applying for 510(k) clearance is primarily that it demonstrates substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This typically does not involve the quantitative performance metrics and statistical studies common for AI/diagnostic tools.
Here's a breakdown of the requested information, acknowledging the limitations of a 510(k) document for this type of device:
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion (for 510(k) equivalence) Reported Device Performance (as implied by clearance) Substantial Equivalence to Predicate Device Achieved (FDA issued substantial equivalence letter) Same Intended Use as Predicate Yes (Indications for Use are similar to common intubation devices) Similar Technological Characteristics as Predicate Implied (not detailed in this letter, but reviewed in 510(k) submission) Safety and Effectiveness at least equivalent to Predicate Implied (FDA found device to be safe and effective) Biocompatibility Implied (not detailed in this letter, but reviewed in 510(k) submission for sterility and materials) Sterility Implied (not detailed in this letter, but reviewed in 510(k) submission) -
Sample size used for the test set and the data provenance:
- Not Applicable. This document pertains to a physical medical intubation device, not a diagnostic or AI device that would utilize a "test set" in the context of performance evaluation with data. The 510(k) process involves a comparison to a predicate device, often through engineering analysis, material testing, and sometimes small clinical data if there are new safety/effectiveness questions that cannot be addressed by comparison alone. This letter does not mention any specific clinical study data in this regard.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. The "ground truth" here is regulatory compliance and demonstrating equivalence to a predicate device, which is evaluated by FDA reviewers.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical intubation device, not an AI or diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical intubation device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for 510(k) clearance is that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness for its stated indications for use. This "ground truth" is established through the FDA's regulatory review process, primarily based on documentation provided by the manufacturer (engineering drawings, materials specifications, comparisons to the predicate, sometimes non-clinical testing results, and very occasionally, limited clinical data if specific new questions arise).
-
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
{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
Page | of |
(Posted November 13, 2003)
N/A