(10 days)
This device is used for endoscopic removal of biliary stones and for contrast injection.
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 diameter sizes, 8.5 mm, 12 mm and 15 mm. 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 correspond 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.
The provided text describes a 510(k) premarket notification for a medical device called the "Tri-Ex Extraction Balloon with Multiple Sizing." This device is used for endoscopic removal of biliary stones and for contrast injection. The submission seeks to demonstrate substantial equivalence to a predicate device (Tri-Ex Extraction Balloon K170292).
However, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI device performance. It is a regulatory submission for a physical medical device, not an AI-powered one. Therefore, I cannotExtract the requested information about AI device acceptance criteria and study details from this document.
The document only states the following regarding performance:
- Performance Data: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended."
- Summary of non-clinical testing:
- Functional Testing/ Design Verification Testing
- Biocompatibility Assessment
- Fluoroscopic Visibility
This information indicates that bench testing was performed to demonstrate that the device meets its intended performance, but no specifics on "acceptance criteria" or detailed study results are provided, nor is there any mention of AI elements.
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December 13, 2019
Wilson-Cook Medical Inc. /Cook Endoscopy Theresa de Prat Regulatory Affairs Specialist II 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K193344
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: December 2, 2019 Received: December 3, 2019
Dear Theresa de Prat:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel G. Walter, Jr. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193344
Device Name
Tri-Ex 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)
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510(k) Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station RoadWinston-Salem, North Carolina 27105 |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist IITiffanny A. Thomas, Global Regulatory Affairs Specialist |
| Date: | December 2, 2019 |
| Trade Names: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Common Name: | Extraction Balloon |
| Classification Name: | Biliary Catheter and Accessories |
| 21 CFR §876.5010, GCA, Class II | |
| Predicate Devices: | Tri-Ex Extraction Balloon K170292, cleared 9/20/2017 |
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. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. 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 correspond 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:
A minor design change was made to the predicate Tri-Extraction Balloon with Multiple sizing cleared to market via K170292. This modification was a material change to the radiopaque markers.
Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended.
- Functional Testing/ Design Verification Testing ●
- Biocompatibility Assessment ●
- Fluoroscopic Visibility
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K193344 Page 2 of 2
Conclusion:
We believe that the subject device is substantially equivalent to the predicate device with respect to intended use, key operating principles, materials of construction, and technological characteristics. We consider the risks associated with the modifications to the subject devices to have been adequately addressed through our design control processes and do not affect the safety or effectiveness of the devices.
§ 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.