(21 days)
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of AI/ML capabilities or related performance metrics.
Yes
The device is intended for the "palliation of malignant strictures in the biliary tree" and for the "treatment of biliary strictures resulting from malignant neoplasms," which directly indicates a therapeutic purpose.
No
The device is described as a "stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "stenting device" and includes physical components like a "self-expanding Nitino! CONFORMEXX™ Stent" and a "flexible, multifunctional stent deployment system." This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the palliation and treatment of malignant strictures within the biliary tree. This involves a physical intervention inside the body to maintain the patency of ducts.
- Device Description: The device is a stent, a physical implant designed to open and support a blocked passage. It's delivered using a deployment system.
- Anatomical Site: The device is used within the biliary tree and biliary ducts, which are internal anatomical structures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health status. This device does not involve the analysis of specimens.
Therefore, the Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXXT™ Grip is intended for palliation of malignant strictures in the biliary tree.
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated for the treatment of biliary strictures resulting from malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Nitino! CONFORMEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E. ™ Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts / 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)
Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA guidance document: Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998.
All test results confirm the modified device to be substantially equivalent to the predicate devices.
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs.
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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CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug, and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:
General Information:
| Submitter Name: | Bard Peripheral Vascular, Inc. |
|---|---|
| Address: | 1625 W. Third Street |
| P.O. BOX 1740 | |
| Tempe, AZ 85280-1740 | |
| Telephone Number: | (480) 894-9515 |
| Fax Number: | (480) 449-2546 |
| Contact Person: | Dennis Salzmann, Ph.D. |
| Manager, Regulatory Affairs | |
| Device Information: | |
| Device Trade Name: | CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip |
Common/Usual Name: Biliary Stent Class II Classification:
Classification Panel: Gastroenterology/Urology
Predicate Device:
CONFORMEXX™ Biliary Stent and Delivery System (K021994, cleared January 2, 2003)
Summary of Change:
The design modifications to the CONFORMEXX™ Biliary Stent and Delivery System are addition of the PerforMAXX™ Grip, an additional delivery system length, and modification of the packaging. These changes result in a subject device that provides more deployment methods and delivery system length options for physicians. All other aspects of the subject device remain the same as the predicate devices.
Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.
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Device Description:
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Nitino! CONFORMEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E. ™ Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.
Intended Use of Device:
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXXT™ Grip is intended for palliation of malignant strictures in the biliary tree.
Technological Comparison to Predicate Device:
The technological characteristics of the Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip are substantially equivalent to those of the predicate Bard® CONFORMEXX™ Biliary Stent and Delivery System in terms of intended use, application, user population, basic design, performance, labeling, and sterilization method.
Non-Clinical Performance Data:
Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA guidance document:
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998.
All test results confirm the modified device to be substantially equivalent to the predicate devices.
Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The letter "A" is stylized with a horizontal line through the middle, resembling the Greek letter lambda.
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Conclusions:
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is substantially equivalent to the legally marketed predicate device, the Bard® CONFORMEXX™ Biliary Stent and Delivery System.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/2/Picture/7 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font is simple and geometric, with straight lines and sharp angles. The outline gives the word a three-dimensional effect.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2005
Dennis Salzmann, Ph.D. Manager, Regulatory Affairs Bard Peripheral Vascular, Inc. 1625 W. Third Street P.O. Box 1740 TEMPE AZ 85280-1740
Re: K052114 Trade/Device Name: Bard® CONFORMEXXTM Biliary Stent with the PerforMAXXTM Grip Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 2, 2005 Received: August 4, 2005
Dear Dr. Salzmann:
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 for use stated in the Merces, 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 and Cosmette Her (1 to) (1 to) provisions of the 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 The Office 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 - Dennis Salzmann, Ph.D.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling innitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA iniding of substantial equirales is your device and permits your device to proceed to the device results in a classification for your device as described in your Section market. This letter will anow you to evigation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified ($cc above) into enas regulations affecting your device can be If may be subject to additional controls. Linking majors 800 to 898. In addition, FDA may found in the Code of reactive concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dris Issualloo or our device complies with other requirements of the Act that FDA has made a decermination administered by other Federal agencies. You must of any Federal Statutes and regulations daminitives but not limited to: registration and listing (21 comply with an the Act 3 requirements, merces and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your II you desire specific information accuracy as a compliance at (240) 276-0115. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Al device (21 CFR Part 001); picuse containg by reference to premarket notification" (21) please note the regulation onlined, "Miorraneans of formation on your responsibilities under the CFK Fall 807.77). Pourmay South other gener gener gener Assistance at its Act from the Dryiblem (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K052114
Device Name: Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip
Indications For Use:
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated The Bard® CONFORETER
for the treatment of biliary strictures resulting from malignant neoplasms.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive
$10(k) Number K052114
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