(87 days)
No predicate devices were identified in the provided text. The field "Predicate Device(s)" explicitly states "Not Found".
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended for the treatment of epiphora, canalicular pathologies, dacryocysorhinostomy, and imperforation of the nasolacrimal duct, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" describes conditions that would be treated by a device, not diagnosed by it. The device is indicated for addressing epiphora and canalicular pathologies, as well as for dacryocystorhinostomy and imperforation of the nasolacrimal duct, all of which are interventions or procedures, not diagnostic activities.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of conditions related to the tear drainage system (epiphora, canalicular pathologies, nasolacrimal duct issues). This involves a procedure performed on the patient's body, not the examination of samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of these samples
- Using reagents or kits for testing
The intended use clearly points towards a device used in a surgical or interventional procedure to address anatomical issues, which is not the domain of IVDs.
N/A
Intended Use / Indications for Use
Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or lacerations) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant .
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
infants or adults
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
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are left-aligned.
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
DEC 112008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne Bohsack Vice President. General FCI Ophthalmics, Inc. P.O. Box 465 76 Prospect Street Marshfield Hills. MA 02051
Re: K991238
Trade/Device Name: FCI Crawford Probe Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: April 6, 1999 Received: April 12, 1999
Dear Ms. Bohsack:
This letter corrects our substantially equivalent letter of July 8, 1999.
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 the reporting 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, ind
Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Crawford Probe Device Name:
Indications For Use:
....
. .
.:
Epiphora in infants or adults, particularly in cases of
canalicular pathologies (stenosis, obstruction or lacerations)
dacryocysorhinostomy (conventional or laser)
imperforation of the nasolacrimal duct in an infant .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashlin Barliave
(Division Sign-Off)
of Ophthalmic Devices
k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
・・。
(Optional Format 1-2-96)