(90 days)
The Bard® memotherm-FLEXX™ Biliary Stent is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
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.
The provided document is a 510(k) summary for the Bard® memotherm-FLEXX™ Biliary Stent. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT include a "study that proves the device meets the acceptance criteria" in the way one would describe a clinical performance study for an AI/ML device.
Instead, it describes bench testing for physical characteristics, comparing the new device to its predicate. The acceptance criteria for such a device are typically internal engineering specifications derived from the predicate device's performance, industry standards, and clinical needs. The "reported device performance" in this context refers to the results of these bench tests being comparable to the predicate.
Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer as best as possible based on the provided text, while explicitly stating what is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flexibility | Comparable to Bard® Memotherm® Nitinol Stent and allow easy tracking in tortuous paths. | "The Bard® memotherm-FLEXX™ Biliary Stent has increased flexibility...and tracks easily from the delivery system, even in a tortuous path." (Implies meeting/exceeding criteria) |
| Expansion and Compression Force | Comparable to Bard® Memotherm® Nitinol Stent and resistant to corrosion by bile and compressive forces expected in biliary system. | "Expansion and compression force test results are comparable to those of the predicate device...stent is resistant to corrosion by bile and compressive forces expected to be encountered within the biliary system." |
| Delivery System Flexibility | Comparable to the Bard predicate device's delivery system. | "The delivery system is also more flexible than that of the Bard predicate device." (Implies meeting/exceeding criteria) |
| Delivery System Bond Joint Tensile Strengths | Comparable to the Bard predicate device's bond joint tensile strengths. | "The delivery system bond joint tensile strengths...are comparable to those of the Bard predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing described is bench testing, not a clinical trial with human data.
- Data Provenance: Not applicable. The data is from internal bench testing of the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for physical properties (flexibility, force, tensile strength, corrosion resistance) is established through engineering and material science standards and testing, not expert medical opinion on a dataset.
4. Adjudication method for the test set
- No adjudication method described as this is not a study involving human readers or interpretation.
5. 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
- No. This is a medical device (stent) 510(k) submission, not an AI/ML device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (stent) 510(k) submission, not an AI/ML device.
7. The type of ground truth used
- The "ground truth" for the performance claims relates to the physical and mechanical properties of the stent and its delivery system, typically established through validated engineering test methods and material specifications. For example, force measurements, tensile strength testing, and material compatibility tests (e.g., corrosion resistance). The comparison is against the established performance of a predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The device itself (the stent) is the "product," not a software algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is involved.
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JAN - 6 2000
K993392
Page 1 of 2
BARD
510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION
-
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.
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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.
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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.
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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
§ 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.