(90 days)
Not Found
Not Found
No
The summary describes a mechanical stent and delivery system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms, which is a therapeutic purpose.
No
The device is a biliary stent indicated for the treatment of biliary strictures resulting from malignant neoplasms. Its purpose is to maintain patency (openness) of bile ducts, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "stenting device" and includes a "self-expanding Bard® memotherm-FLEXX™ Biliary Stent pre-loaded on a unique delivery system," indicating it is a physical medical device with hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The Bard® memotherm-FLEXX™ Biliary Stent is a physical device that is implanted into the biliary ducts to maintain their patency. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to treat biliary strictures, which is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a device used within the body for treatment, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Bard® memotherm-FLEXX™ Biliary Stent is indicated for use in the I ne Bardes monton stricture resulting from malignant neoplasms.
The Bard® memotherm-FLEXX® Biliary Stent is indicated for use in the treatment of biliary strictures resulting from malignant ncoplasms.
Product codes
78 FGE
Device Description
The Bard® memotherm-FLEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® memotherm-FLEXX™ Biliary Stent pre-loaded on a unique delivery system. This 7 Fr delivery system is compatible with a 7 Fr introducer and accepts a .035" guidewire. The Bard® memotherm-FLEXX™ Biliary Stent is available in various diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts
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)
The Bard® memotherm-FLEXX™ Biliary Stent has increased flexibility when The Bard® Memotherm® Nitinol Stent (Transhepatic Biliary Endoprosthesis) and tracks easily from the delivery system, even in a tortuous path. Expansion and compression force test results are comparable to those of the path. Expansion and compressent is resistant to corrosion by bile and compressive forces expected to be encountered within the biliary system.
The delivery system is also more flexible than that of the Bard predicate device. The delivery system bond joint tensile strengths vary depending on the bond I the denvery system of adapter, sheath to distal marker, etc. ) but are comparable to those of the Bard predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bard® Memotherm® Nitinol Stent (Transhepatic Biliary Endoprosthesis) Symphony™ Nitinol Stent Transhepatic Biliary System Medtronic AVE Bridge™ Stent System-Biliary Indication S.M.A.R.T. Stent Transhepatic Biliary Stent
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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JAN - 6 2000
K993392
Page 1 of 2
BARD
510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION
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Submitter Information: A.
C.R. Bard, Inc., Peripheral Technologies Division Submitter's Name: Submitter's Address: 13183 Harland Drive, Covington, GA 30014 Carol Vierling Contact Person: Contact Person's Telephone Number: (770) 385-2347 (770) 385-2340 Contact Person's FAX Number: Date of Preparation. October 6, 1999 -
Device Name. B
Bard® memotherm-FLEXX™ Biliary Stent -
C. Predicate Devices:
Bard® Memotherm® Nitinol Stent (Transhepatic Biliary Endoprosthesis) Symphony™ Nitinol Stent Transhepatic Biliary System Medtronic AVE Bridge™ Stent System-Biliary Indication S.M.A.R.T. Stent Transhepatic Biliary Stent -
Device Description [).
The Bard® memotherm-FLEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® memotherm-FLEXX™ Biliary Stent pre-loaded on a unique delivery system. This 7 Fr delivery system is compatible with a 7 Fr introducer and accepts a .035" guidewire. The Bard® memotherm-FLEXX™ Biliary Stent is available in various diameters and lengths.
1
Image /page/1/Picture/0 description: The image shows the handwritten text "K 993392" on the top line. The second line of text says "Page 2 of 2". The text is written in black ink on a white background.
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E. Intended Use:
The Bard® memotherm-FLEXX™ Biliary Stent is indicated for use in the I ne Bardes monton stricture resulting from malignant neoplasms. -
Technological Characteristics Summary: F
The Bard® memotherm-FLEXX™ Biliary Stent is a metal mesh stent I de Dard® inchioutions is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 6, 7, 8, 9, 10 and 12mm and in lengths from 20mm-120mm in 10mm of 0, 7, 8, 7, 10 and ivery system is available in 80cm and 120cm lengths. -
Performance Data: G.
The Bard® memotherm-FLEXX™ Biliary Stent has increased flexibility when The Bard® Memotherm® Nitinol Stent (Transhepatic Biliary Endoprosthesis) and tracks easily from the delivery system, even in a tortuous path. Expansion and compression force test results are comparable to those of the path. Expansion and compressent is resistant to corrosion by bile and compressive forces expected to be encountered within the biliary system.
The delivery system is also more flexible than that of the Bard predicate device. The delivery system bond joint tensile strengths vary depending on the bond I the denvery system of adapter, sheath to distal marker, etc. ) but are comparable to those of the Bard predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 6 2000
Ms. Carol Vierling Manager, Regulatory Affairs Bard Peripheral Technologies CR Bard, Inc. 13183 Harland Dr., N.F. Covington, GA 30014
Re: K993392
Bard® memotherm-FLEXX® Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: October 7, 1999 Received: October 8, 1999
Dear Ms. Vierling:
We have reviewed your Scction 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 proor 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.
3
Page 2 Ms Carol Vierling
It your device is classified (see above) into either class II (Special Controls) or class III Premarket Approval), it may be subject to such additional controls. Fxisting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 ictter 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" (2) CER 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number 1800) 638-2041 or (301) 443-6597 or at its Internet address ' http://www.fda.gov/cdrh/dsma/dsmamain.html"
Sincerely yours,
Daniel W-Eyler
David W. Feigal. Ir., M.D., M.P.H. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
s s
I melesure
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Page 1 of 1
510(k) Number (if known): K9933392
Device Name: Bard® memotherm-FLEXX® Biliary Stent
FI)A's Statement of the Indications For Use for device:
The Bard® memotherm-FLEXX® Biliary Stent is indicated for use in the treatment of biliary strictures resulting from malignant ncoplasms.
Presenption Use V ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) (Per 21 CFR 801.109)
Over-The-Counter Use
et
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic
510(k) Number R 87352