(46 days)
The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Not Found
The provided text describes the 510(k) premarket notification for the Express® SD Biliary Monorail® Premounted Stent System. This document does not describe an AI/ML-driven medical device, but rather a traditional medical device (biliary stent). Therefore, much of the information typically requested for AI/ML device evaluations (such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable or present in this document.
However, I can extract the relevant information regarding the device's acceptance, testing, and comparison to a predicate device.
Device Name: Express® SD Biliary Monorail® Premounted Stent System
Intended Use/Indications for Use: Palliation of malignant neoplasms in the biliary tree.
Acceptance Criteria and Device Performance
The document functions as a 510(k) summary, which establishes substantial equivalence to a predicate device rather than setting specific performance acceptance criteria like sensitivity/specificity for an AI model.
The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device, especially regarding its Magnetic Resonance (MR) compatibility, which was the focus of the non-clinical testing.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Summary of Non-Clinical Test) |
|---|---|
| Safety and effectiveness comparable to predicate device | Bench testing performed to support determination of Magnetic Resonance compatibility. |
| No new safety or performance issues | The results provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. |
| Compatibility with Magnetic Resonance Environment | Labeling updated to include language and test data to support the Magnetic Resonance Environment conditions under which the Express SD Biliary device is compatible. |
Study Details (as inferable from the document):
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Bench testing was performed" but does not detail the number of stents or test configurations used.
- Data Provenance: The testing was "non-clinical bench testing" performed by Boston Scientific Corporation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, and the testing described is non-clinical (bench testing) for MR compatibility, not expert-adjudicated clinical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as it's not a clinical study requiring expert adjudication of results.
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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: Not applicable. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI models. For MR compatibility, the "ground truth" would be established by validated test methods and standards for assessing electromagnetic compatibility and material safety in MR environments.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Boston Scientific Corporation Anna Deraney Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K152607
Trade/Device Name: Express® SD Biliary Monorail® Premounted Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: September 10, 2015 Received: September 11, 2015
Dear Anna Deraney,
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 (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 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 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 yours.
Benjamin R. Fisher -S
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known) | K152607 |
|---|---|
| Device Name | Express® SD Biliary Monorail® Premounted Stent System |
| Indications for Use (Describe) | The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree. |
| 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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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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PSC Publishing Services (301) 443-6740 EF
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510k Summary
Per 21 CFR §807.92
| Common or UsualName | Biliary Stent and Balloon Dilatation Catheter |
|---|---|
| Trade Name(s) | Boston Scientific Express® SD Biliary Monorail® Premounted StentSystem |
| Product Code | FGE - Catheter, Biliary, Diagnostic |
| Classification ofDevice | Boston Scientific Corporation Express SD Biliary catheters andaccessories have been classified as Class II devices according to 21CFR 876.5010 |
| Submitter's Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566 |
| Contact Name andInformation | Anna DeraneyRegulatory Affairs SpecialistPhone: 763-494-1683Fax: 763-494-2222Email: anna.deraney@bsci.com |
| Section 514 of theAct PerformanceStandards | Currently no FDA mandated or voluntary performance standards existfor this device. |
| EstablishmentRegistrationNumbers | Owner /Operator:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058 |
| ManufacturingFacility:Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265 | |
| SterilizationFacilities:Synergy Health Ireland LimitedIDA Business & Technology ParkTullamore, County Offaly, Ireland | |
| BSC Coventry8 Industrial DriveCoventry, RI 02816, USA | |
| Predicate Devices | Express® SD Biliary Monorail® Premounted Stent System clearedMarch 30, 2004 |
| Intended Use/Indications for Use | The Express SD Biliary Monorail Premounted Stent System isindicated for palliation of malignant neoplasms in the biliary tree. |
| Comparison ofRequiredTechnologicalCharacteristics | The proposed Express SD Biliary device is substantially equivalent tothe existing Express SD Biliary device cleared by FDA underpremarket notification K040027 (March 30, 2004). Express SD hasthe same intended use, scientific technology, design, materials,sterilization method, and packaging materials (with the exception ofthe accessory kit) as the applicable predicate device. |
| The labeling (carton labels, pouch labels, and Directions for Use) arebeing updated to include language and test data to support theMagnetic Resonance Environment conditions under which theExpress SD Biliary device is compatible. | |
| Summary of Non-Clinical TestSummary | Bench testing was performed to support a determination of MagneticResonance compatibility. The results of these tests providereasonable assurance that the proposed device has been designedand tested to assure conformance to the requirements for its intendeduse. No new safety or performance issues were raised during thedevice testing. |
| Conclusion | Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Express SD BiliaryPremounted Stent System has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to theExpress SD Biliary Monorail Premounted Stent System (K040027). |
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§ 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.