(198 days)
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® CONFORMEXX™ Biliary Stent pre-loaded on a unique delivery system. The stent is available in a variety of diameters and lengths. The 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a 0.018" to 0.035" guidewire. The delivery systems is 135cm in length. The Bard® CONFORMEXX™ Biliary Stent is a metal mesh stent constructed of nitinol. The nitinol tube is laser cut into a series of rhombi.
The provided document is a 510(k) summary for a medical device (Bard® CONFORMEXX™ Biliary Stent and Delivery System) and outlines its intended use and performance data compared to predicate devices. However, it does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as typically expected for a detailed AI/ML study description.
This document is from 2003, predating widespread AI/ML integration into medical device approvals in the way described in your request. The "Performance Data" section primarily focuses on physical and functional characteristics of the stent and its delivery system, rather than diagnostic accuracy or effectiveness metrics that would be relevant to studies involving AI assistance or standalone performance evaluation against a ground truth.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to answer based only on the provided text, with clear indications where information is missing:
Acceptance Criteria and Device Performance Study
The provided document describes a 510(k) premarket notification for the Bard® CONFORMEXX™ Biliary Stent and Delivery System. The performance data presented focuses on the physical and functional characteristics of the stent and delivery system itself, rather than a diagnostic or predictive algorithm. Therefore, the "acceptance criteria" discussed are related to the stent's mechanical properties and ease of use, assessed by comparison to predicate devices, not statistical performance metrics against a ground truth as would be typical for an AI/ML-driven device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (from "Performance Data" section) |
|---|---|---|
| Physical/Functional | Ease of tracking | Tracks easily from the delivery system, even in a tortuous path. |
| Accuracy of placement | Comparable to those of the predicate devices. | |
| Expansion force | Comparable to those of the predicate devices. | |
| Compression force | Comparable to those of the predicate devices. | |
| Material Properties | Corrosion resistance (by bile) | Resistant to corrosion by bile. |
| Delivery System | Bond joint tensile strengths | Vary depending on the bond location but are comparable to those of the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "test results" and "data" but does not quantify the number of stents, delivery systems, or test conditions used in the performance evaluations.
- Data provenance: Not specified. The studies appear to be laboratory or bench-top tests focused on the device's mechanical and material properties. There is no mention of human subject data, country of origin, or retrospective/prospective clinical studies for the performance data presented here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. The "ground truth" for the performance data (e.g., whether a stent tracks easily, its expansion force, or corrosion resistance) would be determined by objective physical measurements and engineering standards, not expert consensus or clinical interpretation.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This type of physical performance testing does not typically involve adjudication in the sense of resolving discrepancies between expert interpretations.
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
- MRMC study: No. The device is a physical medical implant (biliary stent) and its delivery system, not an AI-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This device is not an algorithm. Its performance is evaluated based on its physical characteristics and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: The "ground truth" for the described performance data is based on objective engineering and material science standards and measurements. For example, the expansion force would be measured against a specific target, and corrosion resistance would be evaluated against material science standards for bile compatibility. It is not based on expert consensus, pathology, or outcomes data, as these are not relevant to the described performance tests.
8. The sample size for the training set
- Sample size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.
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KO21994
IMPRA A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe. AZ 85280-1740 TEL: 800-321-4254 480-894-9515 FAX: 480-966-7062
JAN 0 2 2003
IMPA
510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION
Submitter Information: A.
Impra, Inc. Submitter's Name: Submitter's Address: 1625 West 3rd Street Tempe, AZ 85281 Contact Person: Aymee Berry Contact Person's Telephone Number: (480) 303-2752 (480) 449-2546 Contact Person's FAX Number: Date of Preparation: June 12, 2002
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Device Name: B.
Bard® CONFORMEXX™ Biliary Stent and Delivery System -
C. Predicate Device:
Bard® memotherm-FLEXX™ Biliary Stent Bard® memotherm Transhepatic Biliary Endoprosthesis Bard® LUMINEXX™ 6 Fr Delivery System -
D. Device Description:
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® CONFORMEXX™ Biliary Stent pre-loaded on a unique delivery system. The stent is available in a variety of diameters and lengths.
The 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a 0.018" to 0.035" guidewire. The delivery systems is 135cm in length.
Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is slightly distorted, with some of the letters appearing to be slightly tilted or skewed. The overall effect is a somewhat rough or textured appearance.
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E. Intended Use:
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms. -
Technological Characteristics Summary: F.
The Bard® CONFORMEXX™ Biliary Stent is a metal mesh stent constructed of nitinol. The nitinol tube is laser cut into a series of rhombi.
The flexibility of the Bard® CONFORMEXX™ Delivery System allows for smooth trackability and accurate stent placement.
- Performance Data: G.
The Bard® CONFORMEXX™ Biliary Stent tracks easily from the delivery system, even in a tortuous path. Accuracy of placement, expansion and compression force test results are comparable to those of the predicate devices. The stent is resistant to corrosion by bile.
The delivery system bond joint tensile strengths vary depending on the bond location but are comparable to those of the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The words are stacked on top of each other. The text is in a simple, sans-serif font.
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved shapes, resembling a bird or abstract symbol. The image is in black and white.
JAN 2 - 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Aymee R. Berry Senior Regulatory Affairs Specialist C.R. Bard, Inc., Division of IMPRA, Inc 1625 West 3rd Street TEMPE AZ 85281
Re: K021994
Trade/Device Name: Bard® CONFORMEXX™ Biliary Stent and Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: October 2, 2002 Received: October 3, 2002
Dear Ms. Berry:
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.
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Page. 2 - Ms. Avmee R. Berry
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 (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.
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 Section 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 Part 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 Part 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.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David C. Sabol, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known): K021994
Device Name: Bard® CONFORMEXX™ Biliary Stent and Delivery System
FDA's Statement of the Indications For Use for device:
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
Prescription Use ✓ OR (Per 21 CFR 801.109)
Over-The-Counter Use_
Nancy C Brogdon
510(k) Num
§ 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.