(232 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical extraction balloon, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed for the mechanical removal of biliary stones and injection of contrast, which are diagnostic or interventional procedures, not therapeutic applications.
No
The device is described as being used for "endoscopic removal of biliary stones and contrast injection," which are interventional procedures, not diagnostic ones. While it uses fluoroscopic visualization, this is for guidance during the procedure, not for diagnosis.
No
The device description clearly details a physical medical device comprised of a catheter, balloon, lumens, radiopaque bands, and hubs. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic removal of biliary stones and contrast injection." This describes a therapeutic and diagnostic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (balloon catheter) used for mechanical manipulation and injection within the biliary system. This is consistent with a surgical or interventional device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the device's function and description clearly indicate it is an interventional medical device used within the body, not an in vitro diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
This device is used for endoscopic removal of biliary stones and for contrast injection.
Product codes
GCA
Device Description
The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location.
Anatomical Site
biliary
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)
A Risk Analysis was completed to assess the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended:
- Balloon Diameter
- Balloon Deflation
- Balloon Strength
- Shelf Life Testing
- Packaging Validation
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices- Evaluation and testing within risk management process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
K170292 Re:
Trade/Device Name: Tri-Ex Extraction Balloon With Multiple Sizing Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: GCA Dated: August 18, 2017 Received: August 21, 2017
Dear Tiffanny A. Thomas:
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 (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 (DICE) 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 (DICE) 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.
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
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Indications for Use
510(k) Number (if known) K170292
Device Name
Tri-Ex Extraction Balloon With Multiple Sizing
Indications for Use (Describe) This device is used for endoscopic removal of biliary stones and contrast injection.
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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510(k) SUMMARY
| Name: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist |
|---|---|
| Address: | Wilson-Cook Medical, Inc. |
| 4900 Bethania Station Road, Winston-Salem NC 27105 | |
| Phone: | 336-744-0157 |
| Date: | 1/30/2017 |
| Name of Device: | |
| Trade Name: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Common/Usual Name: | Extraction Balloon |
| Classification Name: | Catheter, Biliary Surgical |
| 21 CFR 876.5010, GCA, Class II | |
| Predicate Device: | Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing, |
| K040129, 02/27/2004 | |
| Intended Use |
This device is used for endoscopic removal of biliary stones and for contrast injection.
Device Description:
The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
Substantial Equivalence:
Minor design changes were made to the predicate Wilson-Cook Tri-Ex Extraction Balloon with Multiple sizing cleared to market via K040129. These changes include dimensional changes (catheter length and diameter) and the removal of wire guide access ports. The subject extraction balloon is equivalent to the predicate device with respect to intended use, technological characteristics, and materials.
Performance Data:
A Risk Analysis was completed to assess the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
Summary on Non-Clinical Testing:
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- Balloon Diameter
- Balloon Deflation ●
- Balloon Strength
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- Shelf Life Testing
- . Packaging Validation
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices- Evaluation and testing within risk management process.
Conclusions:
We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We believe the risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.