(51 days)
For removal of biliary stones from the common bile duct.
The DURAglide3 ™ Stone Balloon is a sterile, single patient use, triple lumen stone removal balloon catheter.
The provided text is a 510(k) summary for the DURAglide3™ Stone Balloon, a biliary catheter used for the removal of biliary stones. It is important to note that this document is for a medical device and not a software/AI device. Therefore, many of the typical questions for AI/software devices (such as sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be answered from this type of regulatory submission.
Here's an analysis based on the provided text, focusing on what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All results obtained during design verification activities met our predetermined acceptance criteria." However, the specific acceptance criteria (e.g., tensile strength, burst pressure, flow rates, maneuverability specifications) and the detailed results of the performance testing are not disclosed in this 510(k) summary. These details are typically internal to the manufacturer's design control documentation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in summary | All results met predetermined acceptance criteria |
The study that proves the device meets the acceptance criteria is referred to as "design verification activities."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not applicable in the context of a physical medical device. The "test set" would refer to the samples of the device itself undergoing various physical and functional tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. For a physical device like a catheter, "ground truth" is established through engineering and manufacturing specifications, material testing, and functional performance assessments, not expert consensus on data interpretation.
- Qualifications of Experts: Not applicable. Testing would be performed by engineers, technicians, and quality control personnel.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for ambiguous data interpretation, typically in diagnostic imaging or clinical trials. For a physical device, performance is measured against objective specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- MRMC Study: No. This is a physical medical device, not an AI or diagnostic imaging device.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For a physical medical device, the "ground truth" for performance evaluation consists of established engineering specifications, material properties, biocompatibility standards, and functional requirements. For example, a catheter must have a certain burst pressure, flow rate, and flexibility, and these are objective measurements.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is not an AI/software device that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
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Bard Interventional Products Division
C.R. Bard, Inc. 129 Concord Road, Bldg #3 P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
JAN - 6 2000
BARD
510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990, codified 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 follows.
- A. Submitter Information
| Submitter's Name: | Bard Interventional Products DivisionC.R. Bard, Inc. |
|---|---|
| Address: | 129 Concord Road, Bldg. #3Billerica, MA 01821 |
| Phone: | 978 – 262 – 4867 |
| Fax: | 978 – 262 – 4878 |
| Contact Person: | Marion Gordon, R.A.C. |
| Date of Preparation: | November 15, 1999 |
| B. Device Name | |
| Trade Name: | DURAglide3™ Stone Balloon |
| Common/Usual Name: | Biliary Catheter |
| Classification Name: | Class II, 21 CFR 876.5010, 78FGE |
| C. Predicate Device Name: | |
| Stone Removal Balloon CatheterK920342 | |
| Trade Name: | DURAglide™ Stone Balloon |
D. Description:
The DURAglide3 ™ Stone Balloon is a sterile, single patient use, triple lumen stone removal balloon catheter.
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-
E. Intended Use:
The proposed stone balloon is intended for removal of biliary stones from the common bile duct. -
F. Technological Characteristics Summary:
The DURAglide3™ is a three-lumen line extension to our two-lumen stone removal balloon. The proposed device has the same intended use and fundamental scientific technology. -
G. Performance Standards
The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards for the proposed device. All materials used in the Duraglide3™ Stone Balloon are biocompatible.
Design control, risk analysis and design verification activities for the proposed device have been conducted in accordance with internal procedures and inclusive of the elements stipulated by 21 CFR 820.30, as applicable to this device. All results obtained during design verification activities met our predetermined acceptance criteria.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2000
Ms. Marion Gordon, R.A.C. Senior Requiatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg #3 P.O. Box 7031 Billerica, MA 01821-7031
Re: K993892 DURAglide3™ Stone Removal Balloon Catheter (three-lumen) Dated: December 9, 1999 Received: December 10, 1999 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE
Dear Ms. Gordon:
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. 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.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | TBDK993892 |
|---|---|
| Device Name: | DURAglide 3 ™ Stone Balloon |
| Indications For Use: | For removal of biliary stones from the common bileduct. |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use ______(Optional Format 1-2-96) |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | --------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K993892 / S⁰⁰¹ |
|---|---|
| --------------- | ---------------- |
1
§ 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.