(46 days)
Not Found
No
The 510(k) summary describes a stent system, a mechanical device, and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on bench testing for magnetic resonance compatibility, not algorithmic performance.
Yes
The device is indicated for "palliation of malignant neoplasms in the biliary tree," which describes a therapeutic purpose to alleviate symptoms or slow the progression of a disease.
No
Explanation: The device is indicated for "palliation of malignant neoplasms in the biliary tree," which means it is used for treatment or symptom relief, not for diagnosis.
No
The device is described as a "Stent System," which is a physical implantable device. The performance studies mention "Bench testing" and "Magnetic Resonance compatibility," which are typical evaluations for hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body, not a test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the name "Stent System" strongly suggests a device implanted or used within the body.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on laboratory analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically open a blocked passage in the biliary tree, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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)
Bench testing was performed to support a determination of Magnetic Resonance compatibility. The results of these tests 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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are depicted in a single, continuous line. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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 SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
CENSEANS SECOUNDERS US TAGESTAN PORTAL P
געוואלא אויפטעמענען אונגענען געגענען געבוירעט
TANSEERS SERVER SERVER PRODUCT AND AND A SECURITIES A SECURITER POLICE A PARA PARA A PARA A PARA A PARA A PA
NATURE FACTORING WATERSED AND POSTED AND POSTED AND POSTED AND PARTER FEE
ristinester
конковкомиссия продушу представляется по представляется предправления предправления представленным представленным продоженным продоженным продоженным продорожниками сельности
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510k Summary
Per 21 CFR §807.92
| Common or Usual
| Name | Biliary Stent and Balloon Dilatation Catheter |
|---|---|
| Trade Name(s) | Boston Scientific Express® SD Biliary Monorail® Premounted Stent |
| System | |
| Product Code | FGE - Catheter, Biliary, Diagnostic |
| Classification of | |
| Device | Boston Scientific Corporation Express SD Biliary catheters and |
| accessories have been classified as Class II devices according to 21 | |
| CFR 876.5010 | |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and | |
| Information | Anna Deraney |
| Regulatory Affairs Specialist | |
| Phone: 763-494-1683 | |
| Fax: 763-494-2222 | |
| Email: anna.deraney@bsci.com | |
| Section 514 of the | |
| Act Performance | |
| Standards | Currently no FDA mandated or voluntary performance standards exist |
| for this device. | |
| Establishment | |
| Registration | |
| Numbers | Owner /Operator: |
| Boston Scientific Corporation | |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 | |
| Manufacturing | |
| Facility: | |
| Boston Scientific Corporation | |
| Two Scimed Place | |
| Maple Grove, MN 55311 | |
| ERN: 2134265 | |
| Sterilization | |
| Facilities: | |
| Synergy Health Ireland Limited | |
| IDA Business & Technology Park | |
| Tullamore, County Offaly, Ireland | |
| BSC Coventry | |
| 8 Industrial Drive | |
| Coventry, RI 02816, USA | |
| Predicate Devices | Express® SD Biliary Monorail® Premounted Stent System cleared |
| March 30, 2004 | |
| Intended Use/ | |
| Indications for Use | The Express SD Biliary Monorail Premounted Stent System is |
| indicated for palliation of malignant neoplasms in the biliary tree. | |
| Comparison of | |
| Required | |
| Technological | |
| Characteristics | The proposed Express SD Biliary device is substantially equivalent to |
| the existing Express SD Biliary device cleared by FDA under | |
| premarket notification K040027 (March 30, 2004). Express SD has | |
| the same intended use, scientific technology, design, materials, | |
| sterilization method, and packaging materials (with the exception of | |
| the accessory kit) as the applicable predicate device. | |
| The labeling (carton labels, pouch labels, and Directions for Use) are | |
| being updated to include language and test data to support the | |
| Magnetic Resonance Environment conditions under which the | |
| Express SD Biliary device is compatible. | |
| Summary of Non- | |
| Clinical Test | |
| Summary | Bench testing was performed to support a determination of Magnetic |
| Resonance compatibility. The results of these tests 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. | |
| Conclusion | Based on the indications for use, technological characteristics, and |
| safety and performance testing, the proposed Express SD Biliary | |
| Premounted Stent System has been shown to be appropriate for its | |
| intended use and is considered to be substantially equivalent to the | |
| Express SD Biliary Monorail Premounted Stent System (K040027). |
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