(44 days)
Not Found
No
The summary describes a traditional medical device (a stent system) and does not mention any AI or ML components, image processing, or data analysis that would typically indicate the presence of such technology.
Yes
The device is a stent system intended to palliate malignant neoplasms and maintain patency of biliary strictures, which directly treats a medical condition.
No
Explanation: The device description clearly states that the Express SD Biliary Monorail Premounted Stent System is a "stent that is balloon expandable intended to maintain patency of biliary strictures produced by malignant neoplasms". Its intended use is for "palliation of malignant neoplasms in the biliary tree". This indicates a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a "Stent System" consisting of a "delivery system and a stent," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a stent system used to maintain patency of biliary strictures within the biliary tree. It is an implantable device used in vivo, not for testing samples in vitro.
- The device description focuses on mechanical function. The description details the delivery system, balloon, and stent, all of which are components for physically interacting with and supporting the biliary tree. There is no mention of reagents, assays, or any other components typically associated with diagnostic testing.
- The performance studies are related to mechanical properties. The summary of performance studies mentions "First article and shaft and bond burst testing," which are tests related to the structural integrity and function of the device itself, not its ability to diagnose a condition.
Therefore, based on the provided information, the Express SD Biliary Monorail Premounted Stent System is a therapeutic device, not an in vitro diagnostic device.
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
The Express® SD Biliary Monorail® Premounted Stent System (Express SD Biliary) is a traditional Monorail catheter with a balloon near the distal tip. Express SD Biliary consists of a delivery system and a stent that is balloon expandable intended to maintain patency of biliary strictures produced by malignant neoplasms.
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)
First article and shaft and bond burst testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device with the modified corewire have 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three faces layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2016
Boston Scientific Corporation Ka Zoua Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K162404
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: August 26, 2016 Received: August 29, 2016
Dear Ka Zoua Xiong:
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 (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,
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
2
Indications for Use
510(k) Number (if known)
K162404
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- |
| 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 Per 21 CFR §807.92
| Common or Usual Name | Biliary Stent and Balloon Dilatation Catheter |
|---|---|
| Trade Name(s) | Express® SD Biliary Monorail® Premounted Stent System |
| Product Code | FGE -Catheter, Biliary, Diagnostic |
| Classification of Device | Class II - 21 CFR 876.5010 |
| Submitter's Name and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and Information | Ka Zoua Xiong |
| Regulatory Affairs Specialist | |
| Phone: 763-494-2970 | |
| Fax: 763-494-2222 | |
| Email: Kazoua.Xiong@bsci.com | |
| Date Prepared | 11 October 2016 |
| 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:
BSC Coventry
8 Industrial Drive
Coventry, RI 02816
USA
Synergy Health (Tullamore)
IDA Business & Technology Park
Tullamore
County Offaly
Ireland |
4
| Predicate
Devices | K152607 - Express® SD Biliary Monorail® Premounted Stent
System, cleared 27 October 2015 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Express® SD Biliary Monorail® Premounted Stent System
(Express SD Biliary) is a traditional Monorail catheter with a
balloon near the distal tip. Express SD Biliary consists of a
delivery system and a stent that is balloon expandable
intended to maintain patency of biliary strictures produced by
malignant neoplasms. |
| 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 is substantially equivalent to
the existing Express SD Biliary cleared by FDA under
premarket notification K152607 (27Oct2015). Express SD
Biliary has the same intended use, scientific technology,
design (with the exception of the corewire design), materials,
sterilization method, and packaging materials as the
applicable predicate device. |
| Summary of
Non-Clinical Test
Summary | First article and shaft and bond burst testing were performed
to support a determination of substantial equivalence. The
results of these tests provide reasonable assurance that the
proposed device with the modified corewire have 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 with the modified corewire has been shown to be
appropriate for its intended use and is considered to be
substantially equivalent to its predicate (K152607). |