(45 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical function, with no mention of AI/ML terms or data processing.
Yes
The device is used to access and open anatomical ducts (biliary or pancreatic orifices) for selective cannulation, which is a therapeutic intervention.
No
The device description states its purpose is to open the papilla and expose orifices for selective cannulation, and the intended use describes accessing the duct. This indicates an interventional/surgical tool rather than a device for diagnosing a condition.
No
The device description clearly states it is a physical device consisting of a plastic tube, wire, and uses high-frequency current, indicating it is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The Zimmon Needle Knife Papillotome is described as a device used for accessing ducts within the body during an endoscopic procedure. It uses a needle knife and high-frequency current to open the papilla.
- Intended Use: The intended use is to access ducts when standard methods of cannulation have been exhausted, which is a procedural intervention, not a diagnostic test performed on a specimen.
The device is an invasive surgical/interventional device used directly on the patient's anatomy, not an IVD.
N/A
Intended Use / Indications for Use
These devices are used for accessing the duct when standard methods of cannulation have been exhausted.
Product codes
KNS
Device Description
The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.
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)
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Zimmon Needle Knife Papillotome meets the performance requirements to fulfill the intended use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Wilson-Cook Medical, Inc. / Cook Endoscopy Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K171993
Trade/Device Name: Zimmon Needle Knife Papillotome Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: June 30, 2017 Received: July 3, 2017
Dear Doris A. Hawks:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171993
Device Name Zimmon Needle Knife Papillotome
Indications for Use (Describe)
These devices are used for accessing the duct when standard methods of cannulation have been exhausted.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in smaller, bold letters.
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
510(k) Summary 009.
Zimmon Needle Knife Papillotome
Traditional 510(k) Premarket Notification
June 30, 2017
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| 4900 Bethania Station Road | |
| Winston-Salem, North Carolina 27105 | |
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Phone: | (336) 744-0157 ext. 396293 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Zimmon Needle Knife Papillotome |
|---|---|
| Common Names: | Papillotome, sphincterotome |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |
Predicate Device
| Name: | Wilson-Cook Needle Knife Papillotome |
|---|---|
| 510(k) Number: | K972674 |
| Date: | Cleared August 15, 1997 |
Device Description
The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.
4
VINSTON-SALEM, NC 27105 WWW.COOKMEDICAL.COM
Intended Use
These devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted.
Comparison to Predicate Device
The subject device and predicate device have the same intended use and different technological characteristics. None of the differences in technological characteristics raise different questions of safety and effectiveness. Furthermore, performance data from acceptable scientific testing methods provide evidence that the subject device is substantially equivalent to the predicate device.
Performance Data
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Zimmon Needle Knife Papillotome meets the performance requirements to fulfill the intended use of the device.