(261 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of a surgical tool and its accessories, with no mention of AI or ML capabilities.
Yes
The device is used for medical procedures like cannulation and sphincterotomy, which are therapeutic interventions.
No
The device is described as being used for "cannulation of the ductal system and for sphincterotomy," indicating a therapeutic or interventional purpose (opening a passage), not a diagnostic one.
No
The device description clearly states it is a sterile, single-use physical device consisting of a plastic tube, wire, and active cords, used for surgical procedures. It undergoes extensive hardware-related performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "cannulation of the ductal system and for sphincterotomy." This is a surgical procedure performed in vivo (within the body) to access and modify anatomical structures. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a device used to perform a physical action (cutting with a wire) within the body. This is consistent with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory testing.
The device is clearly intended for a therapeutic and interventional procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.
Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The sphincterotomes described in this submission are a sterile, single use devices 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 wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.
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 nonclinical bench testing, as follows, demonstrate that the subject device meets the performance requirements to fulfill the intended use of the device:
- GLP Cytotoxicity 1X MEM ISO elution
- GLP ISO Intracutaneous irritation - 2 extracts
- GLP ISO Guinea Pig Maximization, 2 extracts
- IEC 60601-1: 2006 + A12: 2014 (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
- 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
- Ink visualization
- Visualization of Cutting Wire
- Orientation of Cutting Wire
- Fluoroscopic Visibility
- Drive Wire to Handle Joint Strength
- Brass Insert to Handle Joint Strength
- Active Cord to Pin Detachment
- Force to Bow
- Functional Age Testing
- Sterile Barrier and Functional Testing After Shipping
- Active Cord: Wire to Universal Insert Solder Joint Strength
- Active Cord: Wire to Banana Plug Solder Joint Strength
- Active Cord: Wire to Valley Lab Plug Solder Joint Strength
- Active Cord: Functional Testing at Time Zero
- Active Cord: Functional Testing after Shipping
- Sterilization validation
- ETO residual testing
- Packaging visual inspection
- Burst testing
- Dye leak testing
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
May 24, 2018
Wilson-Cook Medical, Inc. / Cook Endoscopy Theresa De Prat Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K172665
Trade/Device Name: Classic Cotton Cannulatome® CannulaTome II® Double Lumen Sphincterotome Cotton CannulaTome II® PC UTS® Ultra Taper Sphincterotome Tri-Tome pc® Triple Lumen Sphincterotome Howell D.A.S.H.® Sphincterotome with DomeTip® Billroth II Sphincterotome Soehendra® BII Sphincterotome Models ACU-1 and ACU-1-VL active cords Regulation Number: 21 CFR& 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: April 23, 2018 Received: April 24, 2018
Dear Theresa De Prat:
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.
1
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); 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 medical devices and radiation-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.
Joyce M. Whang -S
for
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) K172665
Device Name
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, and Models ACU-1 and ACU-1-VL active cords
Indications for Use (Describe)
Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASH-ACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Tri-Tome po® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-30M), Cotton Cannulatome II® PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20M. UTS-25, UTS-30, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.
Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.
| 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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K172665 Page 1 of 4
510(k) Summary
Sphincterotomes and Active Cords
Traditional 510(k) Premarket Notification
April 23, 2018
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| 4900 Bethania Station Road | |
| Winston-Salem, North Carolina 27105 | |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist II |
| Phone: | (336) 744-0157 ext. 396518 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Names: | Classic Cotton Cannulatome®
CannulaTome II® Double Lumen Sphincterotome
Cotton CannulaTome II® PC
UTS® Ultra Taper Sphincterotome
Tri-Tome pc® Triple Lumen Sphincterotome
Howell D.A.S.H.® Sphincterotome with DomeTip®
Billroth II Sphincterotome
Soehendra® BII Sphincterotome
Models ACU-1 and ACU-1-VL active cords |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names: | Papillotome, sphincterotome, active cord |
| Regulation 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: | Zimmon® Papillotome |
|---|---|
| 510(k) Number: | K901443 |
| Date: | Cleared June 18, 1990 |
Device Description
The sphincterotomes described in this submission are a sterile, single use devices 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
4
that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.
Intended Use
Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.
Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.
Comparison to Predicate Device
The subject device and predicate device have the same intended use and different technological characteristics.
5
| Characteristic | Zimmon® Papillotome (K901443) | Cook Sphincterotomes and Active Cords (K172665) |
|---|---|---|
| Intended Use | Used for endoscopic papillotomy/sphincterotomy. | This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. |
| Sterile/Non-Sterile | Sterile, EO | Same |
| Disposable/Reusable | Disposable | Same |
| Cutting Wire Length | 15-30 mm | 15-30 mm |
| Cutting Wire Diameter | 0.012" (braided) | 0.012" (braided) |
| 0.0075-0.010" (monofilament) | ||
| Handle configuration | Three Ring Handle | Same |
| Tip configuration | Straight or Tapered | Tapered or DomeTip |
| Wire Guide / Injection Port | ||
| Extension | No | Yes |
| Wire Control Port (WCP) with | ||
| Slide | No | Yes (on TriTome pc® Select) |
| Cutting Wire Material | 304 Stainless Steel | 303 stainless steel or 304 stainless steel; Parylene C added for "Protector" versions |
| Ink Marker Material | Gem Black | Black, Green, Blue, Silver, |
| Copper/Bronze, Gold | ||
| Packaging | PTEG Tray with Tyvek Lid | Tyvek and Mylar pouch |
| Catheter Design | Single lumen | Single, double or triple lumen |
| Catheter Design/Material | Polytetrafluoroethylene (PTFE) | Same |
| Catheter Length | 200 cm | 196 or 200 cm |
| Catheter Diameter | 5 Fr | 4-7 Fr |
| Wire Guide Compatibility | Not applicable | 0.021-0.035" |
Substantial Equivalence Comparison
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, as follows, demonstrate that the subject device meets the performance requirements to fulfill the intended use of the device.
6
- GLP Cytotoxicity 1X MEM ISO elution .
- GLP ISO Intracutaneous irritation - 2 extracts
- GLP ISO Guinea Pig Maximization, 2 extracts ●
- IEC 60601-1: 2006 + A12: 2014 (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
- 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
- Ink visualization
- Visualization of Cutting Wire ●
- Orientation of Cutting Wire
- Fluoroscopic Visibility ●
- Drive Wire to Handle Joint Strength
- Brass Insert to Handle Joint Strength ●
- Active Cord to Pin Detachment ●
- Force to Bow .
- Functional Age Testing
- Sterile Barrier and Functional Testing After Shipping ●
- Active Cord: Wire to Universal Insert Solder Joint Strength
- Active Cord: Wire to Banana Plug Solder Joint Strength ●
- Active Cord: Wire to Valley Lab Plug Solder Joint Strength
- Active Cord: Functional Testing at Time Zero ●
- Active Cord: Functional Testing after Shipping ●
- Sterilization validation ●
- ETO residual testing
- Packaging visual inspection ●
- . Burst testing
- Dye leak testing ●