(44 days)
CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRE™ RX Biliary Balloon Dilatation Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.
The CRE™ RX Biliary Balloon Dilatation Catheter is capable of inflating balloon to 3 distinct and progressively larger size diameters via controlled radial expansion. The specific balloon sizes are printed on each package and flag label. The CRE™ RX Biliary Balloon Dilatation Catheter is designed to pass through a 3.7 mm or greater working channel of a duodenoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. The CRE™ RX Biliary Balloon Dilatation Catheter has three lumens: balloon inflation lumen, guidewire lumen and contrast injection lumen. A FloSwitch™ Adapter is connected to the hub of the "Injection" lumen. The FloSwitch Adapter is to remain closed until distal contrast medium iniections are required.
This document describes a 510(k) premarket notification for the CRE™ RX Biliary Balloon Dilatation Catheter (K172520). The notification addresses the substantial equivalence of the proposed device to previously cleared predicate devices. The information provided focuses on the device's design, materials, and bench testing to demonstrate this equivalence, rather than a clinical study evaluating diagnostic accuracy or reader performance with AI. Therefore, much of the requested information about clinical studies with human readers, AI, and ground truth establishment is not applicable or cannot be extracted from this document.
However, the document does describe the device's acceptance criteria in the context of bench testing and the study conducted to demonstrate the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Inflate | Not explicitly stated, inferred to be successful and consistent with design (3 distinct and progressively larger diameters at or above 3 atm) | Passed |
| Deflate | Not explicitly stated, inferred to be successful | Passed |
| Shaft Kink Resistance | Not explicitly stated, inferred to meet functional requirements | Passed |
| Scope Insertion | Not explicitly stated, inferred to meet functional requirements (pass through 3.7 mm or greater working channel) | Passed |
| Scope Removal | Not explicitly stated, inferred to meet functional requirements | Passed |
| Shaft Tensile | Not explicitly stated, inferred to meet functional requirements | Passed |
| Tunnel Tensile | Not explicitly stated, inferred to meet functional requirements | Passed |
| Lumen Mandrel Removal | Not explicitly stated, inferred to meet functional requirements | Passed |
| Contrast Injection | Not explicitly stated, inferred to meet functional requirements (successful injection through the lumen) | Passed |
| Hub Luer Lock Fittings | Not explicitly stated, inferred to meet functional requirements | Passed |
| Biocompatibility (ISO 10993-1) | Meets requirements of ISO 10993-1 | Passed |
| Sterilization (ISO 11135-1) | Meets requirements of ISO 11135-1 | Passed |
| Ethylene Oxide Residuals (ISO 10993-7) | Meets requirements of ISO 10993-7 | Passed |
Note on Acceptance Criteria: The document frequently states that the acceptance criteria for these bench tests are "identical or similar to those of the predicate devices" rather than providing specific numerical thresholds or detailed descriptions. The reported device performance for all tests is simply "Passed" or "Acceptable."
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for individual bench tests. It refers to "the testing performed" on the "proposed CRE™ RX Biliary Balloon Dilatation Catheter." Given these are bench tests for device performance (e.g., inflation, deflation, tensile strength), the "test set" would consist of a statistical sample of manufactured devices. The data provenance is internal to Boston Scientific Corporation (manufacturer of the device) and is based on prospective bench testing of the device. Country of origin of data is not specified, but the submission is to the U.S. FDA by a U.S.-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a submission for a medical device (catheter) based on engineering bench tests, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus for ground truth, which is not the case here. The "adjudication" for bench tests is based on objective measurements against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical catheter, not an AI-powered diagnostic system or a device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical catheter and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is the objective measurement of the device's physical and functional characteristics against predetermined engineering specifications and industry standards (e.g., ISO standards for biocompatibility and sterilization).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set (no AI/ML involved), no ground truth was established for it.
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December 17, 2018
Boston Scientific Corporation Jia Huang Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K172520
Trade/Device Name: CRE™ RX Biliary Balloon Dilatation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 18, 2017 Received: August 21, 2017
Dear Jia Huang:
This letter corrects our substantially equivalent letter of October 4, 2017.
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.
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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.
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/MedicalDevicesforYou/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,
Charles Viviano -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) K172520
Device Name
CRE™ RX Biliary Balloon Dilatation Catheter
Indications for Use (Describe)
CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRF™ RX Biliary Balloon Dilatation Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.
| 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) |
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510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4360 Fax: 508-683-5939
| Contact: | Jia Huang |
|---|---|
| Senior Specialist, Regulatory Affairs | |
| Date Prepared: | August 17, 2017 |
2. Proposed Device:
| Trade Name: | CRE™ RX Biliary Balloon Dilatation Catheter |
|---|---|
| Classification Name: | Biliary Catheter and Accessories |
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
3. Predicate Device:
| Trade Name: | CRE™ PRO Wireguided Balloon Dilatation Balloon |
|---|---|
| 510(k) Number: | K112994 |
| Classification Name: | Biliary Catheter and Accessories |
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
| Trade Name: | Hurricane™ RX Biliary Balloon Dilatation Catheter |
| Trade Name: | Hurricane™ RX Biliary Balloon Dilatation Catheter |
| 510(k) Number: | K130484 |
| Classification Name: | Biliary Catheter and Accessories |
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
Reference Device:
| Trade Name: | CRET™ Pulmonary Balloon Dilatation Catheter |
|---|---|
| 510(k) Number: | K170759 |
| Classification Name: | Bronchoscope (flexible or rigid) and Accessories |
| Regulation Number: | 874.4680 |
| Product Code: | KTI |
| Classification: | Class II |
4. Proposed Device Description:
The CRE™ RX Biliary Balloon Dilatation Catheter is capable of inflating balloon to 3 distinct and progressively larger size diameters via controlled radial expansion. The specific balloon sizes are printed on each package and flag label.
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The CRE™ RX Biliary Balloon Dilatation Catheter is designed to pass through a 3.7 mm or greater working channel of a duodenoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen.
The CRE™ RX Biliary Balloon Dilatation Catheter has three lumens: balloon inflation lumen, guidewire lumen and contrast injection lumen. A FloSwitch™ Adapter is connected to the hub of the "Injection" lumen. The FloSwitch Adapter is to remain closed until distal contrast medium iniections are required.
5. Indications for Use:
CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRE™ RX Biliary Balloon Dilatation Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.
The indications for use are similar when compared to those of the predicates CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484).
6. Technological Characteristics:
The proposed CRE™ RX Biliary Balloon Dilatation Catheter has identical intended use as the predicates CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484). The proposed CRE™ RX Biliary Balloon Dilatation Catheter has similar technological characteristics as the predicates CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484) and reference CRE™ Pulmonary Balloon Dilatation Catheter (K170759).
Although the technological characteristics of the CRE™ RX Biliary Balloon Dilatation Catheter are not completely identical to either of the predicate devices, the technological characteristics of the proposed CRE™ RX Biliary Balloon Dilatation Catheter are the combination of the technological characteristics of the two predicates and can fulfil the identical intended use as that of the two predicate devices.
The proposed CRE™ RX Biliary Balloon Dilatation Catheter has the same design as predicate CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and reference CRETM Pulmonary Balloon Dilatation Catheter (K170759) in terms of balloon controlled radial expansion that the balloon will dilate to three distinct and progressively larger size diameters at or above 3 atm (304 kPa).
The proposed CRE™ RX Biliary Balloon Dilatation Catheter has the same design as predicate Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484) in terms of guidewire rapid exchange and contrast medium injection that the guidewire can exit the proposed CRE™ RX Biliary Balloon Dilatation Catheter at the guidewire exit port in order to be locked in place and the distal bile duct can be viewed fluoroscopically by contrast medium injection through the injection lumen of the proposed CRE™ RX Biliary Balloon Dilatation Catheter.
The proposed CRE™ RX Biliary Balloon Dilatation Catheter has the identical 3 cm length balloon as the 3 cm balloon of the reference CRE™ Pulmonary Balloon Dilatation Catheter (K170759) that will provide physician another length option to dilate the Sphincter of Oddi using the proposed CRE™ RX Biliary Balloon Dilatation Catheter.
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The proposed CRE™ RX Biliary Balloon Dilatation Catheter has similar material as predicates CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484) and reference CRE™ Pulmonary Balloon Dilatation Catheter (K170759).
7. Performance Data:
The proposed CRE™ RX Biliary Balloon Dilatation Catheter meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following bench tests were performed on the proposed CRE™ RX Biliary Balloon Dilatation Catheter: Inflate, Deflate, Shaft Kink Resistance, Scope Insertion, Scope Removal, Shaft Tensile, Tunnel Tensile. Lumen Mandrel Removal, Contrast Injection, Hub Luer Lock Fittings.
The testing performed demonstrated that the proposed device is substantially equivalent to the predicate devices because the acceptance criteria of these product specifications are identical or similar to those of the predicate devices.
8. Conclusion:
All biocompatibility tests conducted on the proposed CRE™ RX Biliary Balloon Dilatation Catheter passed. Therefore, the proposed device is considered biocompatible for its intended use.
All device bench test results were acceptable. The data demonstrate that the proposed CRE™ RX Biliary Balloon Dilatation Catheter sufficiently meets the design specifications and is suitable for the intended use.
Boston Scientific Corporation has demonstrated that the proposed CRE™ RX Biliary Balloon Dilatation Catheter is substantially equivalent to the currently marketed CRE™ PRO Wireguided Balloon Dilatation Catheter (K112994) and Hurricane™ RX Biliary Balloon Dilatation Catheter (K130484) and can be safely and effectively used for its proposed indications.
§ 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.