(260 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a physical stone retrieval basket, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the removal of stones (calculi) or stone fragments from anatomic structures, which directly addresses a medical condition or ailment, indicating a therapeutic purpose.
No
Explanation: The device is intended for the removal of stones, which is a therapeutic intervention, not a diagnostic one. While it is used in the context of identifying and treating stones, its primary function as described in the "Intended Use" is to extract them.
No
The device description clearly outlines physical components made of materials like nitinol, fluorinated ethylene propylene, and polyethylene, and the performance studies detail testing of these physical components (tensile strength, radiopacity, kink radius, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, the Wittich Nitinol Stone Basket is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the removal of stones from anatomical structures within the body (gallbladder, biliary tract, renal pelvis, and ureter). This is an interventional procedure performed in vivo.
- Device Description: The description details a physical device designed for mechanical manipulation and retrieval of objects from within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. The Wittich Nitinol Stone Basket is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.
Product codes
LQR, FFL
Device Description
The Wittich Nitinol Stone Basket is comprised of a basket catheter with a loading sleeve, an introducer sheath, and a dilator. The basket is designed with a six-wire bulb configuration and is manufactured from nitinol wire. The nitinol wires are soldered together to a stylet wire which is secured inside the basket catheter shaft. The loading sleeve is used to support the insertion of the basket catheter into the introducer sheath.
The introducer sheath is manufactured from radiopaque fluorinated ethylene propylene and is designed with a radiopaque tip near the distal end of the introducer for tip visibility. Additionally, the distal end of the introducer sheath is angled to facilitate directional control. The matched dilator is manufactured from polyethylene tubing and is tapered for a smooth transitional fit within the matched introducer sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gallbladder, biliary tract, renal pelvis, and ureter
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)
The following tests have been performed to demonstrate that the application device met applicable design and performance requirements:
- Dimensional and Compatibility (Basket Catheter, Introducer, and Dilator) -. Testing showed that dimensions and component compatibility was adequate for clinical use.
- Multiple Stone Retrieval Testing Testing performed per FDA 510(k) Checklist . for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology showed the Basket Catheter with Loading Sleeve and the Introducer Sheath was able to track, deploy, and retrieve a simulated stone (approximately eight (8) mm in diameter) ten times through a tube bent at approximately ninety degrees, without damage to the test article.
- . Basket Catheter Shaft, Basket-to Basket Shaft Solder Joint, and Hub-To-Shaft Joint Tensile – Testing in accordance with JIS T 3244:2011 showed the peak load of catheter shaft section was greater than or equal to 10 N.
- . Basket Catheter Single Loop and Silicone Sphere to Basket Wire Joint Tensile Testing - Testing in accordance with JIS T 3244:2011 showed the peak load of a single loop of the basket catheter and silicone sphere to basket wire joint was greater than or equal to 10 N.
- Introducer Sheath Shaft, Introducer Sheath Hub-to-Shaft Testing in accordance . with BS EN ISO 11070: 2014 showed the peak load of the introducer sheath shaft and introducer sheath hub-to-shaft bond were greater than or equal to 15 N.
- . Introducer Distal Tip Bond Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of shaft-to-tip was greater than or equal to 15 N.
- Radiopacity Testing following the method described in ASTM F6540-12, “Standard Test Methods for Determining Radiopacity for Medical Use” showed the radiopacity of the Wittich Nitinol Stone Basket introducer sheath was determined to be non-inferior to the radiopacity of the selected comparative device.
- . Introducer Sheath Kink Radius - Testing showed the kink radius was less than or equal to 30 mm.
- Dilator Shaft/Hub-to-Shaft Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of the dilator shaft and the hub-to-shaft were greater than or equal to 10N and 15 N, respectively.
- Biocompatibility testing Per ISO 10993-1 and FDA guidance, testing for . cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity demonstrated the biocompatibility of the subject devices.
For these tests, all pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices do not raise new questions of safety or effectiveness and support a determination of substantially equivalence to the predicate device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 12, 2017
Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404
Re: K170898
Trade/Device Name: Wittich Nitinol Stone Basket Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LQR, FFFL Dated: November 8, 2017 Received: November 9, 2017
Dear Erum B. Nasir:
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be against a white background. The letters are clearly legible and evenly spaced.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Wittich Nitinol Stone Basket
Indications for Use (Describe)
The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.
510(k) Summary Section 1.0
Wittich Nitinol Stone Basket 21 CFR, §876.5010 Date Prepared: December 10, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Erum B. Nasir, MS |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102607 |
| Contact Fax Number: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Wittich Nitinol Stone Basket |
| Common Name: | Dislodger, Stone, Biliary |
| Dislodger, Stone, Basket, Ureteral, Metal | |
| Classification Name: | Biliary Catheter and Accessories |
| Ureteral Stone Dislodger | |
| Regulation: | 21 CFR, §876.5010 |
| 21 CFR, §876.4680 (510(k) exempt) | |
| Product Code: | LQR |
| FFL (510(k) exempt) | |
| Device Class: | II |
| Classification Panel: | Gastroenterology/Urology |
Predicate De vices:
The Wittich Nitinol Stone Basket is substantially equivalent to the predicate device, the Wittich Nitinol Stone Basket (K902944) cleared for market by FDA on September 12, 1990.
4
Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font, and is placed at the top of the logo. Below "COOK" is the word "MEDICAL" in white, bold, sans-serif font, and is placed on a gray background.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
De vice Description:
The Wittich Nitinol Stone Basket is comprised of a basket catheter with a loading sleeve, an introducer sheath, and a dilator. The basket is designed with a six-wire bulb configuration and is manufactured from nitinol wire. The nitinol wires are soldered together to a stylet wire which is secured inside the basket catheter shaft. The loading sleeve is used to support the insertion of the basket catheter into the introducer sheath.
The introducer sheath is manufactured from radiopaque fluorinated ethylene propylene and is designed with a radiopaque tip near the distal end of the introducer for tip visibility. Additionally, the distal end of the introducer sheath is angled to facilitate directional control. The matched dilator is manufactured from polyethylene tubing and is tapered for a smooth transitional fit within the matched introducer sheath.
Intended Use :
The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.
Comparison to Predicates:
The Wittich Nitinol Stone Basket and the predicate device, Wittich Nitinol Stone Basket (K902944), are substantially equivalent in that these devices are identical in principles of operation and fundamental technologies. The differences between the subject device and the predicate device, including materials, dimensions, and minor modification to the indications for use, do not raise any new issues of safety or effectiveness. The substantial equivalence of the modified subject device is supported by testing.
5
| | | Wittich Nitinol Stone Basket
(K902944) | Wittich Nitinol Stone Basket
(Subject of this submission) |
|----------------------------------|------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 21 CFR §876.5010 & 21 CFR
§876.4680 |
| Regulation Number | | 21 CFR § 876.5010 | §876.4680 |
| Product Code | | LQR | LQR & FFL |
| Classification | | Class II | Identical |
| Intended Use/Indications for Use | | Used for nonoperative removal
of stones fromthe biliary tract,
renal pelvis and ureter | Intended for placement through
a percutaneous tract for
removal of stones (calculi) or
stone fragments fromanatomic
structures such as the
gallbladder, biliary tract, renal
pelvis and ureter |
| Basket | Shaft | Polyethylene | Identical |
| | Basket Wire | Nitinol wire | Identical |
| | Shrink Tube | Gray Slate, Semi-Rigid | Identical |
| | Loading Sleeve | Tetrafluoroethylene | Identical |
| | Solder | Allstate | Identical |
| | | Silweld Solder | Identical |
| | Sphere | Tevdek Suture | Silicone Elastomer |
| | Notched Cannula | Stainless Steel | Identical |
| | Stylet Wire | Stainless Steel | Identical |
| | Inner Coil | Stainless Steel | Identical |
| | Outer Diameter
(cm) | 2.0 | 1.8 and 2.2 |
| Length (cm) | 4.5 | 2.5 and 4.5 | |
| Introducer
Sheath | Shaft | Radiopaque Fluorinated
Ethylene Propylene | Identical |
| | Connector Cap | Polyamide Nylon 6 | Identical |
| | Adapter | Polyamide Nylon 6 | Identical |
| | Adhesive | Loctite | Identical |
| | Distal End | Tungsten/Rhenium Band | Fluorinated Ethylene Propylene
Tungsten |
| | Outer Diameter
(Fr) | 12 | 8.5 and 12.0 |
| | Length (cm) | 24 | 24 and 50 |
| | Dilator | Shaft | Polyethylene |
| | | Adapter | High Density Polyethylene |
| Cap | | Acetal | Identical |
| Packaging | | Polyethylene-Polyester/Tyvek | Identical |
| Sterilization | | Ethylene oxide | Identical |
| Sterility Assurance Level (SAL) | | 10-6 | Identical |
Table 2.0-1 Substantial Equivalence Comparison
6
Test Data:
The following tests have been performed to demonstrate that the application device met applicable design and performance requirements:
- Dimensional and Compatibility (Basket Catheter, Introducer, and Dilator) -. Testing showed that dimensions and component compatibility was adequate for clinical use.
- Multiple Stone Retrieval Testing Testing performed per FDA 510(k) Checklist . for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology showed the Basket Catheter with Loading Sleeve and the Introducer Sheath was able to track, deploy, and retrieve a simulated stone (approximately eight (8) mm in diameter) ten times through a tube bent at approximately ninety degrees, without damage to the test article.
- . Basket Catheter Shaft, Basket-to Basket Shaft Solder Joint, and Hub-To-Shaft Joint Tensile – Testing in accordance with JIS T 3244:2011 showed the peak load of catheter shaft section was greater than or equal to 10 N.
- . Basket Catheter Single Loop and Silicone Sphere to Basket Wire Joint Tensile Testing - Testing in accordance with JIS T 3244:2011 showed the peak load of a single loop of the basket catheter and silicone sphere to basket wire joint was greater than or equal to 10 N.
- Introducer Sheath Shaft, Introducer Sheath Hub-to-Shaft Testing in accordance . with BS EN ISO 11070: 2014 showed the peak load of the introducer sheath shaft and introducer sheath hub-to-shaft bond were greater than or equal to 15 N.
- . Introducer Distal Tip Bond Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of shaft-to-tip was greater than or equal to 15 N.
- Radiopacity Testing following the method described in ASTM F6540-12, ● "Standard Test Methods for Determining Radiopacity for Medical Use" showed the radiopacity of the Wittich Nitinol Stone Basket introducer sheath was determined to be non-inferior to the radiopacity of the selected comparative device.
- . Introducer Sheath Kink Radius - Testing showed the kink radius was less than or equal to 30 mm.
- Dilator Shaft/Hub-to-Shaft Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of the dilator shaft and the hub-to-shaft were greater than or equal to 10N and 15 N, respectively.
7
- Biocompatibility testing Per ISO 10993-1 and FDA guidance, testing for . cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity demonstrated the biocompatibility of the subject devices.
For these tests, all pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices do not raise new questions of safety or effectiveness and support a determination of substantially equivalence to the predicate device.