(271 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and material properties, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is used for the "endoscopic removal of stones in the biliary system and foreign bodies," which is a diagnostic or interventional procedure, not a therapeutic one as it treats the symptom (stones) rather than the underlying disease.
No
The device description and intended use clearly state that this is a therapeutic device for removing stones and foreign bodies, not for diagnosing conditions.
No
The device description clearly outlines physical components (basket, catheter, handle) and mentions bench testing related to material properties and mechanical function, 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 "Endoscopic removal of stones in the biliary system and foreign bodies." This describes a procedure performed on the patient's body to remove physical objects.
- Device Description: The description details a physical tool (basket, catheter, handle) used for mechanical extraction.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with or remove objects from within the body. This device is a surgical/interventional tool.
N/A
Intended Use / Indications for Use
Endoscopic removal of stones in the biliary system and foreign bodies.
Product codes (comma separated list FDA assigned to the subject device)
LOR
Device Description
The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
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 Non-Lithotripsy Extraction Basket meets the performance criteria required to fulfill the intended use of the device. The following summarizes the non-clinical bench testing conducted:
- Stone and Foreign Body Capture Testing ●
- . Tensile Testing
- Flexibility Testing
- Post-Aging Functional 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
§ 876.5010 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.
0
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March 28, 2018
Wilson-Cook Medical, Inc. Ashley Howard Specialist I - Regulatory Affairs 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K171969
Trade/Device Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket. Non-Lithotripsy Extraction Basket Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories
Regulatory Class: II Product Code: LOR Dated: February 13, 2018 Received: February 14, 2018
Dear Ashley Howard:
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,
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)
Device Name
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
Indications for Use (Describe)
Endoscopic removal of stones in the biliary system and foreign bodies.
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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Non-Lithotripsy Extraction Basket
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: | Ashley Howard, Specialist I – Regulatory Affairs |
| Phone: | (336) 744-0157 ext. 6174 |
| Fax: | (336) 201-5994 |
Device Information
Trade Name: | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket |
---|---|
Common Name: | Dislodger, Stone, Biliary |
Classification Name: | Biliary Catheter and Accessories |
Regulation Number: | 21 CFR 876.5010 |
Product Code: | LQR |
Device Class: | Class II |
Review Panel: | Gastroenterology-Urology |
Predicate Device
Name: | Wilson-Cook Stone Extractor |
---|---|
510(k) Number: | K851965 |
Date: | Cleared July 29, 1985 |
Device Description
The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.
4
Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, with the registered trademark symbol to the right. Below "COOK" is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font.
Intended Use
Endoscopic removal of stones in the biliary system and foreign bodies.
Comparison to Predicate Device
The Non-Lithotripsy Extraction Basket has the same principles of operation and fundamental technologies as the predicate device. Changes to the subject device include labeling to incorporate the addition of Instructions for Use with contraindications, dimensions, materials, handle configuration, and an expanded indication for use. These changes do not raise new questions of safety or effectiveness.
Performance Data and Non-Clinical Testing
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Non-Lithotripsy Extraction Basket meets the performance criteria required to fulfill the intended use of the device. The following summarizes the non-clinical bench testing conducted:
- Stone and Foreign Body Capture Testing ●
- . Tensile Testing
- Flexibility Testing
- Post-Aging Functional Testing ●
Conclusion
We believe the risks associated with the modifications to the subject device were adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device. The information and data contained in this notification supports a determination of substantial equivalence.