(78 days)
Not Found
No
The summary describes a mechanical device (sphincterotome) and does not mention any software, algorithms, or data processing that would indicate the presence of AI/ML. The focus is on the physical structure and function of the device for cannulation and sphincterotomy.
Yes
The device is used for medical procedures (cannulation and sphincterotomy) on the ductal system, which are therapeutic interventions.
No
Explanation: The device is described as a sphincterotome used for cannulation and sphincterotomy, which are interventional procedures, not diagnostic ones. Its capability to allow simultaneous injection of contrast media is consistent with guiding an intervention, not solely for diagnosis.
No
The device description clearly describes a physical, triple-lumen sphincterotome, which is a hardware medical device used for surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for cannulation of the ductal system and for sphincterotomy." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The description details a physical instrument used for accessing and manipulating anatomical structures (ductal system).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVDs are typically tests, reagents, instruments, or systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Wilson-Cook's Tri-Tome Select Plus Sphincterotome is intended for cannulation of the ductal system and for sphincterotomy.
Used for cannulation of the ductal system and for sphincterotomy.
Product codes (comma separated list FDA assigned to the subject device)
78 KNS
Device Description
The proposed Tri-Tome Select Plus Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating a .035" wire guide while allowing simultaneous injection of contrast media through separate lumens.
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.
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/0 description: The image contains a handwritten string of characters. The string starts with a capital letter 'K', followed by the number '6', then '33', '2', '0', and finally '3'. The characters are written in a simple, slightly irregular style, typical of handwriting.
DEC 1 9 2003
ATTACHMENT D: 510(k) Summary of Safety and Effectiveness
SPONSOR:
CONTACT/SUBMITTER:
DATE OF SUBMISSION:
DEVICE:
Trade Name: Common Name: Classification:
PREDICATE DEVICES:
INTENDED USE:
DEVICE DESCRIPTION:
COMPARISON OF CHARACTERISITICS:
PERFORMANCE DATA:
Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105
Marge Walls-Walker Requlatory Affairs Specialist [336] -744-0157 Ex.290
September 30, 2003
Tri-Tome Select Plus
Tri-Tome Select Plus Sphincterotome Unit. Electrosurgical, Endoscopic w/w/o Accessories, Class II 21 CFR § 876.4300
Wilson-Cook Sphincterotome/Papillotome (K901443) Microvasive Autotome™ RX (K013153)
Wilson-Cook's Tri-Tome Select Plus Sphincterotome is intended for cannulation of the ductal system and for sphincterotomy.
The proposed Tri-Tome Select Plus Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating a .035" wire guide while allowing simultaneous injection of contrast media through separate lumens.
We believe the proposed device to be substantially equivalent to currently marketed triple-lumen transendoscopic sphincterotomes.
We believe the proposed device to be substantially equivalent to the named predicates in terms of performance characteristics tested and biocompatibility.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three curved lines that could be interpreted as wings or flowing fabric.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K033203
Trade/Device Name: Wilson-Cook Tri-Tome Select Plus Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Codc: 78 KNS Dated: September 30, 2003 Received: October 2, 2003
Dear Ms. Walls-Walker:
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 application (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.
2
i
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and your your e FDA finding of substantial equivalence of your device to a legally prematicated predicated 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 11 you done office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Other or other warket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K_________________________________________________________________________________________________________________________________________________
Device Name: Wilson-Cook Tri-Tome Select Plus Sphicterotome
Indications for Use:
Used for cannulation of the ductal system and for sphincterotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use Only
(Per 21 CFR § 801.109
David R. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devig
510(k) Number.
Over-the-Counter_____
States of States