(156 days)
Not Found
Not Found
No
The summary describes a mechanical device (papillotome/sphincterotome) and lacks any mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is used for a medical procedure (cannulation and sphincterotomy) on a human anatomical site (biliary ductal system), which characterizes it as a therapeutic device.
No
The intended use describes cannulation and infusion of contrast, which is a procedure that aids in visualization (diagnostic), but the device itself is for performing the procedure (interventional/surgical), not for interpreting images or providing a diagnosis.
No
The device description explicitly states "Three Lumen Papillotome/Sphincterotome," which is a physical medical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device is a "Three Lumen Papillotome/Sphincterotome," which is a surgical instrument used in these procedures.
- Anatomical Site: The anatomical site is the "biliary ductal system," which is an internal part of the body.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device is used within the body for a therapeutic or diagnostic procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
Product codes (comma separated list FDA assigned to the subject device)
78 KNS, FDI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
biliary ductal system
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, facing to the right. 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 in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HES 22 1936
Mr. John A. Chaves President & CEO Telemed Systems, Inc. 19 Brigham Street. Unit 1 Marlborough, MA 01752 Re: K992402 Three Lumen Papillotome/Sphincterotome Models 5102, 5104, 5106, 5108 and 5110 Dated: November 1. 1999 Received: November 1, 1999 Requlatory Class: II 21 CFR 876.4300/Procodes: 78 KNS and FDI
Dear Mr. Chaves:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
ATTAchment IT
Page 1
510(k) Number (If known)_K992402
Device Name: Three Lumen Papillotome/Sphincterotome
Indications For Use:Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON
ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR Over-The Counter Use (Optional Format 1-2-9) |
|---|---|
| -------------------------------------------------- | ----------------------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K992402 |
|---|---|
| --------------- | --------- |