(7 days)
Not Found
No
The summary describes a mechanical device (sphincterotome) with lumens and specific tip technology, with no mention of AI, ML, image processing, or data-driven features.
No
This device is used for cannulation and sphincterotomy procedures, which are interventional rather than therapeutic in the sense of directly treating a disease or condition with a medical substance or energy.
No
The device is described as a sphincterotome used for cannulation and sphincterotomy, which are interventional procedures, not diagnostic ones. Its ability to allow injection of contrast media is for visualization during these procedures, not for primary diagnostic interpretation.
No
The device description clearly describes a physical, triple-lumen sphincterotome, which is a hardware medical device used for cannulation and sphincterotomy. 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 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 diagnostic information.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
cannulation of the ductal system and sphincterotomy.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" in diameter while allowing simultaneous injection of contrast media through separate lumens. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility.
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
Ko 5205/
AUG 5 - 2005
ATTACHMENT F: 510(k) Summary
SPONSOR: Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105 Marge Walls-Walker CONTACT/SUBMITTER: Regulatory Affairs Manager [800] 245-4707 Ex.6290 DATE OF SUBMISSION: July 28, 2005 DEVICE: OMNI™ Sphincterotome OMNI™ Sphincterotome Trade Name: Common Name: Sphincterotome Unit, Electrosurgical, Endoscopic w/w/o Classification: Accessories, Class II 21 CFR § 876.4300 Wilson-Cook Triple Tome Select Plus PREDICATE DEVICES: Sphincterotome (K033203) Wilson-Cook's OMNI™Sphincterotome is INTENDED USE: intended for cannulation of the ductal system and sphincterotomy. The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" DEVICE DESCRIPTION: in diameter while allowing simultaneous injection of contrast media through separate lumens. We believe the proposed device to be COMPARISON OF CHARACTERISITICS: substantially equivalent to currently marketed triple-lumen transendoscopic sphincterotomes with respect to Intended Use and Method of Operation. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.
PERFORMANCE DATA:
We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility.
1
Image /page/1/Picture/2 description: The image shows a partial view of a logo or emblem. The visible portion includes a stylized bird-like figure with flowing lines, possibly representing wings or movement. Surrounding the figure is text arranged in a circular pattern, though only fragments of the words are legible. The overall design appears to be from a government or organizational entity, given the formal and symbolic nature of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Ms. Marge Walls-Walker Regulatory Affairs Manager Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K052051
Trade/Device Name: Wilson-Cook OMNI™ Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 28, 2005 Received: July 29, 2005
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 (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 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
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms loter will and in your your finding of substantial equivalence of your device to a legally promatics motively on " 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 ir you don't if you of Compliance at one of the following numbers, based or the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot process nother general information on your responsibilities under the Act from the 001:37): " Col may overnin varies, 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/industry/support/index.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
Kus 2051
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Wilson-Cook OMNI™ Sphicterotome
Indications for Use:
Used for cannulation of the ductal system and sphincterotomy.
.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Leggrom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
Prescription Use Only_ (Per 21 CFR § 801.109
OR
Over-the-Counter_