(219 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML algorithms for image analysis, decision support, or other functions.
No.
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for removal of biliary stones and contrast injection, which serves a diagnostic purpose (identifying stones) and an interventional purpose (removing stones), but not a therapeutic one as it does not treat a disease or condition.
No
Explanation: The device is described as an extraction balloon used for the endoscopic removal of biliary stones and for contrast injection. Its stated purpose involves treatment (stone removal) and enabling visualization (contrast injection, fluoroscopic visualization of the balloon's location), rather than diagnosing a condition. It facilitates a therapeutic procedure.
No
The device description clearly details physical components such as a balloon, catheter, handle, ports, and radiopaque bands, 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 for "endoscopic removal of biliary stones and for contrast injection." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device (balloon, catheter, handle, ports) used for a physical intervention (stone removal, injection). It does not describe reagents, analyzers, or other components typically associated with in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for a therapeutic and imaging procedure.
In vitro diagnostics are tests performed on samples taken from the body to diagnose diseases or conditions. This device is used for a medical procedure within 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 (comma separated list FDA assigned to the subject device)
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. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon.
The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
- Functional Testing
- Balloon Inflation
- Distal Ink Marking Validation
- 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): 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.
Tri-Ex Extraction Balloon with Multiple Sizing, K170292
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 logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
July 6, 2018
Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K173659
Trade/Device Name: Howell D.A.S.H Extraction Balloon With Multiple Sizing Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: GCA Dated: June 7, 2018 Received: June 11, 2018
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 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 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,
Glenn B. Bell -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
Howell D.A.S.H Extraction Balloon With Multiple Sizing
Indications for Use (Describe)
This device is used for endoscopic removal of biliary stones and for 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)
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
510(k) SUMMARY
| Name :
Address:
Phone:
Date: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist
Wilson-Cook Medical, Inc.
4900 Bethania Station Road, Winston-Salem NC 27105
336-744-0157
11/2/2017 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device:
Trade Name:
Common/Usual Name: | Howell D.A.S.H Extraction Balloon with Multiple Sizing
Extraction Balloon |
| Classification Name: | Biliary Catheter and Accessories
21 CFR 876.5010, GCA, Class II |
| Predicate Device: | Tri-Ex Extraction Balloon with Multiple Sizing,
K170292, 09/20/2017 |
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. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon.
The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.
Substantial Equivalence:
Minor design changes were made to the predicate Tri-Ex Extraction Balloon with Multiple Sizing. These changes on the subject device include a reduced catheter length and diameter, along with new additional ink markings on the catheter. The subject extraction balloon is equivalent to the predicate device with respect to intended use, technological characteristics, and materials of construction.
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.
4
K173659 Page 2 of 2
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.
- . Functional Testing
- Balloon Inflation
- . Distal Ink Marking Validation
- Shelf Life Testing
- Packaging Validation ●
The subject extraction balloon developed utilizing our internal Design Control procedures as required by 21 CFR § 820.30. Design Control Procedures are inclusive of the following elements:
- Design Planning
- Risk Analysis
- . Design Input
- Design Output
- Design Review ●
- Design Verification
- . Design Validation
- Process Validation
- DFMECA/ PFMECA ●
- Design Changes ●
- Design Transfer
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.