(59 days)
Cook® Ultraxx™ Nephrostomy Balloon Catheter
Not Found
No
The description focuses on the mechanical components and function of a balloon dilation catheter, with no mention of AI/ML features or data processing beyond radiographic visualization for placement.
Yes
The device is used for the dilation of the nephrostomy tract and placement of a working sheath, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that the Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is used for dilation of the nephrostomy tract and placement of a working sheath. This is an interventional/therapeutic purpose, not a diagnostic one. While it uses "radiographic visualization" for placement, this is a guidance mechanism for a therapeutic procedure, not for diagnosing a condition.
No
The device description clearly states it is a physical catheter with a balloon, lumens, and a radiopaque band, indicating it is a hardware medical device.
Based on the provided information, the Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the dilation of the nephrostomy tract and placement of a working sheath within the body. This is an in vivo procedure, meaning it is performed on a living organism.
- Device Description: The description details a catheter with a balloon for dilation, designed for insertion into a body tract.
- Anatomical Site: The anatomical site is the nephrostomy tract, which is a part of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples outside of the body (in vitro), such as blood, urine, or tissue samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/interventional tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.
Product codes
LJE
Device Description
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nephrostomy tract
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)
The appropriate testing to determine substantial equivalence was completed. This includes testing to accoming with Draft Guidance for the Content of This InCludes testing in deserations inal Balloon Dilation Catheters (January 24, 1992).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cook® Ultraxx™ Nephrostomy Balloon Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
K051316
Page 1 of 2
Image /page/0/Picture/2 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with black. The font is simple and geometric, with a consistent stroke width throughout each letter. The overall impression is clean and modern.
JUL 1 8 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATIC
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
SUBMITTER INFORMATION: A.
C. R. Bard. Inc. Submitter's Name: Bard Urological Division 8195 Industrial Blvd. Address: Covington, GA 30014
John C. Knorpp Contact Person: 770-784-6451 Contact Person's Telephone Number: 770-784-6419 Contact Person's Fax: May 19, 2005 Date of Preparation:
B. DEVICE NAME:
| Trade Name(s): | Bard® X-Force™ Nephrostomy Balloon Dilation
Catheter |
|-----------------------|---------------------------------------------------------|
| Common/Usual Name: | Nephrostomy Balloon Dilation Catheter |
| Classification Names: | 78 LJE - Catheter, Nephrostomy |
| CFR Reference: | N/A - Unclassified |
C. PREDICATE DEVICE NAME:
Cook® Ultraxx™ Nephrostomy Balloon Catheter Trade Names:
Device Description: D.
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.
E. Intended Use:
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.
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Ko 51316
Page 2 of 2
Technological Characteristics Summary: F.
The subject Bard® X-Force™ Nephrostomy Balloon Dilation Catheter has the The subject Dard® X-F orce - Nophrootemy Balloon in the scientific technology as the predicate device.
Performance Data Summary: G.
The appropriate testing to determine substantial equivalence was completed. This includes testing to accoming with Draft Guidance for the Content of This InCludes testing in deserations inal Balloon Dilation Catheters (January 24, 1992).
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Image /page/2/Picture/2 description: The image shows a black and white emblem or logo. The emblem features a stylized bird with three distinct lines forming its body and wings, giving it a sense of movement. The bird is positioned in the center of a circular border, with text partially visible along the border, suggesting it is part of the emblem's design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2005
Mr. John C. Knorpp Manager, Regulatory Projects Bard Urological Division C.R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014-2655
Re: K051316
Trade/Device Name: Bard® X-Force™ Nephrostomy Balloon Dilation Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LJE Dated: May 19, 2005 Received: May 20, 2005
Dear Mr. Knorpp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 110(x) prematically equivalent (for the indications for use stated in
above and have determined the device is substantially equivales commerc above and have delemined the devices is substant in interstate commerce prior to a the enclosure) to legally marketco prodical Device Amendments, or to devices that have been May 28, 1976, the enactified in the Freded For the Federal Food, Drug, and Cosmetic Act (Act) that reclassitied in accordance with the provisions of and issues of the may, therefore, market the A do not require approval of a prematics approvide approvisions of the Act. The Actualisms provisions of the Act device, subject to the general controls of the real good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Ontrols) or class III (Prematket If your device is classified (see above) mio cideols. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 89 device can be Tound in the Code of Federal Register in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualice of a substance requirements of the Act or any
FDA has made a determination that your device complex with other comply with all FDA has made a determination that your devices frail agencies. You must comply with all the Federal statutes and regulations administered of other in the first (2 CFR Part 807), labeling Act's requirements, including, but not mined to reguirements as set for in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set to prov (21 CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applica 1950 (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manseting your antial equivalence of your device to a legally premarket notification. The PDA Inding of sacsantial of the report 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), please If you desire spective advice for your dovies on our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification " (21 CFR Also, please note the regulation entitled, "Thiseration on your responsibilities under the Act from the 807.97). You may outlin other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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C.R. Bard, Inc., Bard Urological Division Bard® X-Force™ Off It Burd, The Particle Callation Catheter
Bard® X-Force™ Nephrostomy Balloon Dilation Catheter
Premarket Notification Premarket Notification [510(k)]
| 1.3 Indications for Use Statement | |
|---|---|
| 510(k) Number (if known): | K051316 |
| Device Name: | Bard® X-Force™ Nephrostomy Balloon Dilation Catheter |
| Indications for Use: |
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| (Division Sign-Off) | Nancy C Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K051316 |
(Recommended Format 11/13/2003)
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