(62 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a physical stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in the "treatment of biliary strictures produced by malignant neoplasms," which describes a therapeutic purpose.
No
The device is a stent and delivery system used for the treatment of biliary strictures, not for diagnosing conditions.
No
The device description clearly outlines physical components like a stent, delivery system, shafts, and markers, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that this device is a biliary stent and a delivery system. Its intended use is to treat biliary strictures by being implanted directly into the body. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens. It focuses on the physical properties of the stent and the mechanism for its delivery and deployment within the biliary tract.
Therefore, based on the provided information, the Biliary Wallstent® Endoprosthesis with Monorail Delivery System is a therapeutic medical device used for intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biliary Wallstent Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System consists of the following components:
- Biliary Stent
- Monorail Delivery System
The Biliary Wallstent covered in this submission is a self-expanding endoprosthesis constructed of biomedical DFT (drawn filled tubing) monofilament wires, braided in a tubular mesh configuration. It is designed to self-expand to a specified diameter following deployment into the stricture. The Biliary Wallstent is provided pre-mounted on a monorail type delivery system.
The stent will be available in unconstrained diameters of 6.0, 8.0 and 10.0 mm. The three stent diameters will be available in the following lengths.
| Stent Diameter | Stent Unconstrained Length |
|---|---|
| 6.0 mm | 22 mm |
| 8.0 mm | 21 mm, 29 mm and 36 mm |
| 10.0 mm | 24 mm, 31 mm and 37 mm |
The monorail delivery instrument consists of two coaxially arranged shafts: an inner shaft made of stainless steel proximally and thermoplast distally, and an outer sheath made of thermoplast. The central lumen within the inner shaft continues to the tip and accepts a 0.014" guide wire through the distal tip that exits the inner through two guide wire holes (inner and outer exit holes).
The stent is pre-loaded on the stent carrier located on the distal segment of the inner shaft. Two radiopaque markers on the inner shaft and one radiopaque marker on the retractable outer shaft are used to facilitate stent placement. The proximal end of the stent is firmly held on the inner shaft with a stent holder, which enables a partially deployed stent to be recaptured and repositioned, if desired. A black release marker on the proximal stainless steel shaft identifies the maximum deployment allowable for recapture of the stent.
The distal end of the outer sheath covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the outer sheath is accessed through the T-connector. All catheter models have the same overall length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary
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)
Non-clinical Test Summary:
Testing was conducted in accordance with the FDA Guidance for Metal Expandable Biliary Stents. The following functional testing was conducted.
- Stent Integrity Testing
- Mounted Stent Profile (Stent Constrained Length)
- Stent Foreshortening (Stent Unconstrained Length)
- Stent Inner Diameter
- Stent Expansion Uniformity (Implanted Length)
- Radial (Hoop) Strength
- Kink (Trackability) Testing
- Stent / Monorail Delivery Catheter System Integrity Testing
- Deployment Testing
- Tensile Testing
- Crossing Profile
- Compatibility with Accessories
Biocompatibility and 3.5 year product shelf life testing have also been conducted. All invitro test results verified that the Biliary Wallstent Endoprosthesis with Monorail Delivery System is adequate for its intended use.
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
OCT 2 4 2001
012822
Special 510(k) Notification Boston Scientific Medi-Tech, Inc. Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System
Section 6 Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
6.1 General Provisions
| Submitter's Name
and Address | Boston Scientific Scimed
One Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person | Todd Kornmann
(763) 494-2467 |
| Classification Name | Biliary Catheter and Accessories
Product Code – 78 FGE
Regulation Number 21 CFR Part 876. 5010 |
| Common or Usual Name | Biliary Stent |
| Proprietary Name | Boston Scientific Medi-Tech Transhepatic
Biliary Wallstent Endoprosthesis with
Monorail Delivery System |
| Name of Predicate Device | Boston Scientific Medi-Tech Transhepatic
Biliary Wallstent Endoprosthesis with
Unistep Plus Delivery System |
6.3 Device Description
The Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System consists of the following components:
- Biliary Stent
- Monorail Delivery System
Biliary Stent
6.2
The Biliary Wallstent covered in this submission is a self-expanding endoprosthesis constructed of biomedical DFT (drawn filled tubing) monofilament wires, braided in a tubular mesh configuration. It is designed to self-expand to a specified diameter following deployment into the stricture. The Biliary Wallstent is provided pre-mounted on a monorail type delivery system.
1
Summary of Safety and Effectiveness Section 6
The stent will be available in unconstrained diameters of 6.0, 8.0 and 10.0 mm. The three stent diameters will be available in the following lengths.
| Stent Diameter | Stent Unconstrained Length |
|---|---|
| 6.0 mm | 22 mm |
| 8.0 mm | 21 mm, 29 mm and 36 mm |
| 10.0 mm | 24 mm, 31 mm and 37 mm |
Delivery Catheter
The monorail delivery instrument consists of two coaxially arranged shafts: an inner shaft made of stainless steel proximally and thermoplast distally, and an outer sheath made of thermoplast. The central lumen within the inner shaft continues to the tip and accepts a 0.014" guide wire through the distal tip that exits the inner through two guide wire holes (inner and outer exit holes).
The stent is pre-loaded on the stent carrier located on the distal segment of the inner shaft. Two radiopaque markers on the inner shaft and one radiopaque marker on the retractable outer shaft are used to facilitate stent placement. The proximal end of the stent is firmly held on the inner shaft with a stent holder, which enables a partially deployed stent to be recaptured and repositioned, if desired. A black release marker on the proximal stainless steel shaft identifies the maximum deployment allowable for recapture of the stent.
The distal end of the outer sheath covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the outer sheath is accessed through the T-connector. All catheter models have the same overall length.
A more detailed description of the device is provided in Section 8.
6.4 Intended Use
The Biliary Wallstent Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
2
(012822
Section 6 Summary of Safety and Effectiveness
Summary of Technological Characteristics ર્ભ રિ
The Biliary Wallstent Endoprosthesis with Monorail Delivery System is manufactured in a substantially equivalent manner to the currently marketed Biliary Wallstent Endoprosthesis with Unistep Plus Delivery System (K993232). The major manufacturing differences are related to the differences in the delivery system design which will be utilized to place the stent.
6.6 Non-clinical Test Summary
Testing was conducted in accordance with the FDA Guidance for Metal Expandable Biliary Stents. The following functional testing was conducted.
- Stent Integrity Testing .
- 트 Mounted Stent Profile (Stent Constrained Length)
- 트 Stent Foreshortening (Stent Unconstrained Length)
- I Stent Inner Diameter
- 는 Stent Expansion Uniformity (Implanted Length)
- 트 Radial (Hoop) Strength
- 하 Kink (Trackability) Testing
- Stent / Monorail Delivery Catheter System Integrity Testing ●
- 미 Deployment Testing
- 트 Tensile Testing
- 로 Crossing Profile
- 트 Compatibility with Accessories
Biocompatibility and 3.5 year product shelf life testing have also been conducted. All invitro test results verified that the Biliary Wallstent Endoprosthesis with Monorail Delivery System is adequate for its intended use. The Biliary Wallstent Endoprosthesis with Monorail Delivery System is considered substantially equivalent to the currently marketed Biliary Wallstent Endoprosthesis with Unistep Plus Delivery System, based on a comparison of intended use, device design, and the results of in-vitro testing and evaluation.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Mr. Todd Kornmann Senior Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place MAPLE GROVE MN 55311
Re: K012822
Trade/Device Name: Biliary Wallstent® Endoprosthesis with Monorail Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: 78 FGE Dated: September 24, 2001 Received: September 26, 2001
Dear Mr. Kornmann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
4
Page 2 - Mr. Todd Kornmann
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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Signature
E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K012822
Device Name: Biliary Wallstent® Endoprosthesis with Monorail Delivery System
FDA's Statement of the Indications For Use for device:
The Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
Prescription Use / OR
(Per 21 CFR 801.109)
Over-The-Counter Use
Naury C. Brogdon