(51 days)
Not Found
No
The summary describes a mechanical device (a balloon catheter) for stone removal and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is used for the removal of biliary stones, which is a therapeutic procedure aimed at treating a medical condition.
No
The device is described as a "stone removal balloon catheter" for "removal of biliary stones." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a "triple lumen stone removal balloon catheter," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For removal of biliary stones from the common bile duct." This is a therapeutic procedure performed in vivo (within the living body).
- Device Description: The device is a "stone removal balloon catheter." This is a surgical/interventional tool used to physically remove stones.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The information provided clearly describes a medical device used for a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For removal of biliary stones from the common bile duct.
Product codes (comma separated list FDA assigned to the subject device)
78FGE
Device Description
The DURAglide3 ™ Stone Balloon is a sterile, single patient use, triple lumen stone removal balloon catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common bile duct
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)
Not Found
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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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 Division
C.R. Bard, Inc. |
|----------------------------------|----------------------------------------------------------|
| Address: | 129 Concord Road, Bldg. #3
Billerica, 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 Catheter
K920342 |
| 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): | TBD
K993892 |
|---------------------------|-------------------------------------------------------------|
| Device Name: | DURAglide 3 ™ Stone Balloon |
| Indications For Use: | For removal of biliary stones from the common bile
duct. |
. . . .
. . . . .
(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 |
---|---|
--------------- | ---------------- |
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