(30 days)
Not Found
No
The description focuses on the mechanical components and function of a balloon dilation catheter, with no mention of AI or ML.
Yes
The device is used for the dilation of the nephrostomy tract, which is a therapeutic intervention to treat a medical condition.
No
Explanation: The device is a balloon dilation catheter used for mechanical dilation of the nephrostomy tract and placement of a working sheath. Its function is interventional (therapeutic/procedural), not diagnostic.
No
The device description clearly outlines physical components like a dual lumen shaft, inflation and guidewire lumens, a dilation balloon, a radiopaque band, and a high-pressure stopcock, indicating it is a hardware device.
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 dilation of the nephrostomy tract and placement of a working sheath. This is a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon designed for mechanical dilation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures directly on the body itself.
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 (comma separated list FDA assigned to the subject device)
LJE
Device Description
The Bard X-Force™ Nephrostomy 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 band which corresponds with the distal end of the balloon's working length to radiopaque 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 X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted.
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
N/A
0
PG. i uf l
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter's Information:
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 13183 Harland Dr. |
| Covington, Georgia 30014 | |
| Contact Person: | Terri Morris |
| Contact Person's Phone: | (678) 342-4922 |
| Contact Person's Fax: | (678) 342-4992 |
| Date of Preparation: | November 28, 2006 |
| JAN - 5 2007 |
- B. Device Name:
| Trade Name: | X-Force™ N30 Nephrostomy Balloon Dilation Catheter |
|---|---|
| Common / Usual Name: | Nephrostomy Balloon Dilation Catheter |
| Classification Name: | 78 LJE - Catheter, Nephrostomy |
| CFR Reference: | N/A - Unclassified |
-
C. Predicate Device Name:
X-Force™ N30 Nephrostomy Balloon Dilation Catheter # K051316 -
D. Device Description:
The Bard X-Force™ Nephrostomy 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 band which corresponds with the distal end of the balloon's working length to radiopaque 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. -
F. Technological Characteristics Summary:
The modified device has the same intended use, general design and fundamental scientific technology as the predicate device. -
G. Performance Data Summary:
The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted.
Trade Name:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Terri Morris Regulatory Affairs Specialist II Bard Urological Division C. R. Bard, Inc. 13183 Harland Drive COVINGTON GA 30014
JAN - 5 2007
Re: K063632
Trade/Device Name: X-Force™ N30 Nephrostomy Balloon Dilation Catheter Regulatory Class: Unclassified Regulation Number: None Product Code: LJE Dated: November 30, 2006 Received: December 8, 2006
Dear Ms. Morris:
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 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image shows a circular logo with the letters FDA in the center. The logo also includes the words "Centennial" and "1906-2006". There are three stars below the word Centennial. The logo is surrounded by text that reads "A Century of Consumer Protection".
ling Public
2
Page 2 -
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Bard Urological Division, C.R. Bard, Inc. X-Force™ N30 Nephrostomy Balloon Dilation Catheter Premarket Notification [510(k)]
1.3 Indications for Use Statement
K-063632 510(k) Number (if known):
Device Name:
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.
X Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
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)
David W. Wyman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __
(Recommended Format 11/13/2003)