(73 days)
Not Found
No
The device description and intended use focus on a mechanical and electrosurgical tool for cannulation, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is used to cannulate a pancreatic pseudocyst, which is a medical procedure to treat a condition, indicating a therapeutic purpose.
No
The device is described as an electrosurgical accessory used for cannulation, which is a therapeutic intervention, not for diagnosing a condition.
No
The device description clearly outlines physical components like an inner wire, sheaths, a diathermic ring, and a handle with connectors, indicating it is a hardware device.
Based on the provided information, the Wilson-Cook Cystotome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Wilson-Cook Cystotome is a surgical accessory used within the body to perform a procedure (cannulating a pancreatic pseudocyst). It is an electrosurgical tool used for cutting and accessing a specific anatomical site.
The description clearly indicates its use in a surgical context for a therapeutic/interventional purpose, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to electrosurgically cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract. It is supplied sterile and is intended for single use.
Product codes (comma separated list FDA assigned to the subject device)
78 KNS
Device Description
The Wilson-Cook Cystotome consists of an inner wire with needle knife tip, a 5 Fr inner sheath, and a 10 Fr outer sheath equipped with a diathermic ring at its distal tip. The proximal end of the device will include a handle with connectors for active cords and a fitting to provide for injection of contrast fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transgastric or transduodenal wall, pancreatic pseudocyst, gastrointestinal tract
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)
The Wilson-Cook Cystotome underwent electrical testing, simulated use testing, and clinical testing. Test results provide reasonable assurance the device will perform in accordance with its intended use.
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
OCT 1 7 2002
510(k) for Wilson-Cook Cystotome
K022595 -12-
Page 1 of 1
9. 510(K) SUMMARY
Submitted By:
Margaret J. Posner, Regulatory Affairs Specialist Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105-4191 336-744-0157 July 29, 2002
Names of Device:
Trade Name: Common/Usual Name: Classification Name:
Wilson-Cook Cystotome Endoscopic electrosurgery device Endoscopic electrosurgery accessory 21 CFR 876.4300 (78KNS); Class II
Predicate Devices:
The Wilson-Cook Cystotome is comparable to predicate devices including the Wilson-Cook Needle Knife Papillotome (K972674); the Boston Scientiffic Autotome™ RX (K013153); and the Boston Scientific Microvasive Gold Probe (K970278).
Device Description:
The Wilson-Cook Cystotome consists of an inner wire with needle knife tip, a 5 Fr inner sheath, and a 10 Fr outer sheath equipped with a diathermic ring at its distal tip. The proximal end of the device will include a handle with connectors for active cords and a fitting to provide for injection of contrast fluid.
Intended Use:
The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to electrosurgically cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract. It is supplied sterile and is intended for single use.
Substantial Equivalence:
The Wilson-Cook Cystotome is comparable to predicate devices with similar technological characteristics and intended use, specifically to perform electrosurgical procedures through an endoscope.
Discussion of Tests and Test Results:
The Wilson-Cook Cystotome underwent electrical testing, simulated use testing, and clinical testing. Test results provide reasonable assurance the device will perform in accordance with its intended use.
Conclusions Drawn from Tests:
Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Cystotome meets the requirements for 510(k) substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services.
OCT 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret J. Posner Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K022595
Trade/Device Name: Wilson-Cook Cystotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories
Regulatory Class: II Product Code: 78 KNS Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Posner:
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
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon
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): K02259
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is 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)
Daniel A. Lehman
(Division Sign-Off) Division of Reproductive and Radiological Device. 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use (Optional Format 1-2-96)