(6 days)
No
The summary describes a mechanical device for stent removal and does not mention any AI/ML components or functionalities.
No.
The device is used to remove stents, which is a procedural/interventional function rather than a therapeutic function.
No
The device is described as a tool used to remove stents from biliary and pancreatic ducts, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components like a handle, cable, and tip, 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 to "remove stents from the biliary and pancreatic duct(s)". This is a therapeutic or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical tool used for mechanical removal of a medical device (a stent) from within the body. It does not describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for a therapeutic purpose, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Used to remove stents from the biliary and pancreatic duct(s) while maintaining wire guide placement.
Product codes
FGE
Device Description
The modified Soehendra Stent Retriever (subject device) represents modifications made to the Soehendra Stent Retriever (predicate device) currently cleared to market via 510k: K903420 by Wilson-Cook Medical, Inc. The subject device consists of a knob-like handle and irrotational 7 Fr diameter cable available in 183 cm total length (168 cm working length, the portion of cable that fits inside endoscope channel) with a tapered threaded screw type distal tip configuration. The subject device is compatible with a .018" or .035" wire guide and is available with 5, 7, 8.5, 10 or 11.5 Fr tip diameters. The various tip diameters are offered in order to facilitate the removal of different size plastic biliary and pancreatic stents. The subject device is used by placing the cable through an endoscope over a prepositioned wire guide that has been passed through the stent lumen. The tip is screwed into the subject device and stent are removed through the endoscope. If necessary, the wire guide can be left in place to allow placement of a new stent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary and pancreatic duct(s)
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
The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 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 flowing lines representing movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2016
Wilson-Cook Medical, Inc. Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K161203
Trade/Device Name: Soehendra Stent Retriever Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: April 27, 2016 Received: April 28, 2016
Dear Doris 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.
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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 yours,
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)
Device Name Soehendra Stent Retriever
Indications for Use (Describe)
Used to remove stents from the biliary and pancreatic duct(s) while maintaining wire guide placement
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/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background.
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. NE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
510(k) Summary
| Name: | Wilson-Cook Medical, Inc. / Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 ext. 6293 |
| Fax: | (336) 201-5994 |
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Date: | April 27, 2016 |
Device Name
| Trade Name: | Soehendra Stent Retriever |
|---|---|
| Common Name: | Stent Retriever |
| Classification Name: | Catheter, Biliary, Diagnostic |
| 21 CFR 876.5010, FGE, Class II |
Predicate Device
Soehendra Stent Retriever, K903420, cleared October 22, 1990
Intended Use
Used to remove stents from the biliary and pancreatic duct(s) while maintaining wire guide placement.
Device Description
The modified Soehendra Stent Retriever (subject device) represents modifications made to the Soehendra Stent Retriever (predicate device) currently cleared to market via 510k: K903420 by Wilson-Cook Medical, Inc. The subject device consists of a knob-like handle and irrotational 7 Fr diameter cable available in 183 cm total length (168 cm working length, the portion of cable that fits inside endoscope channel) with a tapered threaded screw type distal tip configuration. The subject device is compatible with a .018" or .035" wire guide and is available with 5, 7, 8.5, 10 or 11.5 Fr tip diameters. The various tip diameters are offered in order to facilitate the removal of different size plastic biliary and pancreatic stents. The subject device is used by placing the cable through an endoscope over a prepositioned wire guide that has been passed through the stent lumen. The tip is screwed into the subject device and stent are
4
removed through the endoscope. If necessary, the wire guide can be left in place to allow placement of a new stent.
Substantial Equivalence
Minor design changes were made to the predicate Soehendra Stent Retriever cleared to market via K903420. These changes include: additional tip sizes, cable length measurement, reusable to disposable, single use device, compatibility with a .018 wire guide and the wire guide is no longer sold with device. The modified Soehendra Stent Retriever (subject device) is substantially equivalent to the predicate with respect to the intended use, key operating principles, materials and technological characteristics.
Performance Data
The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
Conclusion
We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes. We believe that the subject device is substantially equivalent to the predicate device in terms of intended use and performance characteristics (key operating principles, materials and technological characteristics).