(260 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical safety and performance, with no mention of AI or ML capabilities, image processing, or data-driven algorithms.
Yes.
The device is used for surgical procedures (cannulation and sphincterotomy) to treat medical conditions, indicating a therapeutic purpose.
No
The device is used for cannulation and sphincterotomy, which are interventional procedures, not diagnostic ones. Its function is to facilitate access and perform a surgical cut, not to identify or assess a medical condition.
No
The device description clearly outlines physical components (plastic tube, wire) and mentions bench testing related to these physical components and electrical safety, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (cannulation and sphincterotomy) within the body, not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The device is a tool used for a physical intervention (cutting tissue with high-frequency current), not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing diagnostic results based on such analysis.
The device is clearly a surgical instrument used for a therapeutic procedure during an ERCP (Endoscopic Retrograde Cholangiopancreatography).
N/A
Intended Use / Indications for Use
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The Fusion® OMNI Sphincterotome (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 high- frequency current through the wire, 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
Ductal system (biliary or pancreatic orifices)
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 non-clinical bench testing demonstrate that the Fusion® OMNI Sphincterotome meets the performance requirements to fulfill the intended use of the device.
Summary of Non-Clinical Testing:
- Shelf Life Testing
- Packaging Validation
- Non-clinical, bench testing of the subject devices methods included: sterile barrier inspection, functional testing, drive wire to handle joint strength, brass insert to handle joint strength, fluoroscopic visibility, active cord pin detachment.
- The electromagnetic compatibility and electrical safety of the subject devices were assessed in accordance with the following standards: IEC 60601-1: 2005 + A1: 2012 (3.1 edition)- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-2: 2017 (6.0 edition) - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories, and IEC 60601-2-18: 2009 (3.0 edition) - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- Biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and FDA Guidance: Use of International Standard ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2018
Wilson-Cook Medical, Inc./ Cook Endoscopy Sierra Lowe Regulatory Affairs Specialist - I 4900 Bethania Station Road Winston Salem. NC 27105
Re: K172288
Trade/Device Name: Fusion® OMNI™ Sphincterotome Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: March 6, 2018 Received: March 7, 2018
Dear Sierra Lowe:
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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
2
Indications for Use
510(k) Number (if known)
Device Name
Fusion® OMNITM Sphincterotome
Indications for Use (Describe)
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K172288 Page 1 of 3
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COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
510(k) Summary
Fusion® OMNI Sphincterotome
Traditional 510(k) Premarket Notification
March 6, 2018
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy
4900 Bethania Station Road
Winston-Salem, North Carolina 27105 |
|------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Sierra Lowe, Specialist I - Regulatory Affairs |
| Phone: | (336) 744-0157 ext. 396506 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Fusion® OMNI Sphincterotome |
|---|---|
| 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 OMNI TM Sphincterotome |
|---|---|
| 510(k) Number: | K052051 |
| Date: | Cleared June 18, 1990 |
Intended Use
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
4
Device Description
The Fusion® OMNI Sphincterotome (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 high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
Substantial Equivalence
Minor changes have been made to the predicate sphincterotomes cleared to market via K052051. The most notable changes to the subject devices include: Slightly different catheter diameters and compatible wire guide diameters to accommodate a range of endoscope channels and/or smaller papilla, inclusion of a wire guide port at the distal end (patient contacting end) of the device in order to facilitate an additional option to perform a device exchange, slightly decreased maximum rated input voltage in order to be representative of the electrical testing conducted on the subject devices.
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 non-clinical bench testing demonstrate that the Fusion® OMNI Sphincterotome meets the performance requirements to fulfill the intended use of the device.
Summary of Non-Clinical Testing
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- . Shelf Life Testing
- . Packaging Validation
- Non-clinical, bench testing of the subject devices methods included: sterile barrier ● inspection, functional testing, drive wire to handle joint strength, brass insert to handle joint strength, fluoroscopic visibility, active cord pin detachment.
- The electromagnetic compatibility and electrical safety of the subject devices were . assessed in accordance with the following standards: IEC 60601-1: 2005 + A1: 2012 (3.1
5
edition)- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-2: 2017 (6.0 edition) - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories, and IEC 60601-2-18: 2009 (3.0 edition) - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- Biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and FDA . Guidance: Use of International Standard ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".