(22 days)
Not Found
No
The description focuses on the mechanical and electrical components of a papillotome for accessing the common bile duct. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes.
The device is used to access the common bile duct, facilitating medical interventions and therefore has a therapeutic purpose.
No
Explanation: The device description clearly states its purpose is for accessing the common bile duct and enhancing cannulation efforts using a cutting wire and electrocautery, which are interventional procedures, not diagnostic ones.
No
The device description clearly details a physical, triple-lumen catheter with a cutting wire and electrocautery connection, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "accessing the common bile duct when standard cannulation methods have been exhausted." This is a surgical or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a catheter with a cutting wire and electrocautery connection, designed for physical manipulation within the body. This is characteristic of a surgical or interventional device.
- Anatomical Site: The device is used within the "common bile duct," which is an internal anatomical structure. IVDs typically analyze samples (blood, urine, tissue, etc.) taken from the body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description. It is an interventional medical device.
N/A
Intended Use / Indications for Use
The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.
Product codes
78 KNS
Device Description
The proposed USW Needleknife Papillotome is a triple-lumen catheter, with one lumen dedicated to the cutting wire, wire guide access and contrast injection respectively. The wire guide lumen is compatible with a .035" wire quide. The 24 GA stainless steel cutting wire allows for the transfer of electric current enhance cannulation efforts when traditional cannulation efforts have been exhausted. The handle contains an electrocautery connection pin, which is compatible with a variety of active cords currently sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common bile duct
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)
Non-Clinical Testing was performed on characteristics of the USW Needleknife Papillotome deemed necessary to verify safety and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wilson-Cook Needleknife Papillotome (K972674)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY - 7 2004
ATTACHMENT F: 510(k) Summary
| SPONSOR:
CONTACT/SUBMITTER: | Wilson-Cook Medical
4900 Bethania Station Road
Winston-Salem, NC 27105
Marge Walls-Walker
Requlatory Affairs Specialist
[336] -744-0157 Ex.290 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE OF SUBMISSION:
DEVICE: | April 14, 2004
USW Needleknife Papillotome |
| Trade Name:
Common Name:
Classification: | Wilson-Cook USW Needleknife Papillotome
Needleknife, Precut
Unit, Electrosurgical Endoscopic w,w/o
Accessories. 21 CFR § 876.4300, 78 KNS |
| PREDICATE DEVICES: | Wilson-Cook Needleknife Papillotome (K972674) |
| INTENDED USE: | Wilson-Cook's USW Needleknife Papillotome is
intended for accessing the common bile duct
when standard cannulation methods have been
exhausted. This device is supplied sterile and
intended for single use. |
| DEVICE DESCRIPTION: | The proposed USW Needleknife Papillotome is
a triple-lumen catheter, with one lumen
dedicated to the cutting wire, wire guide access
and contrast injection respectively. The wire
guide lumen is compatible with a .035" wire
quide. The 24 GA stainless steel cutting wire
allows for the transfer of electric current
enhance cannulation efforts when traditional
cannulation efforts have been exhausted. The
handle contains an electrocautery connection
pin, which is compatible with a variety of active
cords currently sold separately. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be
substantially equivalent to the named predicate
in terms of Intended Use, Indications for Use,
performance characteristics tested, materials of
construction, operation and biocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed on
characteristics of the USW Needleknife
Papillotome deemed necessary to verify safety
and performance. |
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 a stylized graphic of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040981
Trade/Device Name: USW Needleknife Papillotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: April 14, 2004 Received: April 20, 2004
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 docs 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) r as lotter unfication. 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 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 by reference to premarket 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/cdrfv/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): K0409 8 (
Device Name: Wilson-Cook USW Needleknife Papillotome
Indications for Use:
The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Per 21 CFR § 801.109
OR
David A. Aymer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
Over-the-Counter_