(132 days)
Not Found
None
No
The summary describes a physical medical device (intubation set) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to treat epiphora by addressing meatic and canalicular pathologies, indicating a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated in treatments of epiphora," indicating a therapeutic rather than diagnostic purpose.
No
The device description "Self-Retaining Bicanaliculus Intubation Set" clearly indicates a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (bicanalicular intubation) to treat a physical condition (epiphora) by addressing anatomical issues (meatic and canalicular pathologies). This is a therapeutic intervention performed directly on the patient.
- Device Description: The device is described as a "Self-Retaining Bicanaliculus Intubation Set," which is consistent with a surgical instrument used for intubation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of:
- Meatic pathologies (meatic atresia)
- Canalicular pathologies (canalicular stricture)
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
adults (not to be used in infants)
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)
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
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DEC 16 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632
Re: K041869
Trade/Device Name: Self Retaining Bicanaliculus Intubation Set Regulatory Class: Unclassified Product Code: OKS Dated: October 8, 2004 Received: October 15, 2004
Dear Mr. Welch:
This letter corrects our substantially equivalent letter of November 18, 2004.
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 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,
Mahina B. Egleston, MD
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
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Page 3 – Mr. Hillard Welch
Indications for Use
510(k) Number (if known): K041869
Device Name: Self-Retaining Bicanaliculus Intubation Set
Indications For Use:
Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of:
- Meatic pathologies (meatic atresia) ー
Canalicular pathologies (canalicular stricture) -
Prescription Use Counter Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ben Riemenschneider
Page 1 of
510(k) Number K041869