(191 days)
Not Found
Not Found
No
The description focuses on a mechanical system for measuring pressure and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is used for monitoring intra-abdominal pressure to aid in diagnosis, not for treating a condition.
No
The device is for monitoring intra-abdominal pressure, which can be used as an aid in diagnosis, but the device itself does not perform the diagnosis.
No
The device description explicitly states it is composed of a tubing set and a clamping device, which are physical hardware components.
Based on the provided information, the Bard® Intra-abdominal Pressure (IAP) Monitoring Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: The Bard IAP Monitoring Device measures pressure within the body (intra-abdominal pressure) via a Foley catheter. It is a device used in vivo (within a living organism).
- Intended Use: The intended use is to monitor intra-abdominal pressure, not to analyze a sample taken from the body.
Therefore, the device falls under the category of a medical device used for physiological monitoring in vivo, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
Product codes (comma separated list FDA assigned to the subject device)
LXC, PHU
Device Description
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-abdominal
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 results of bench and biocompatibility testing demonstrated that the functionality, integrity, and safety of the Bard IAP Device is adequate for its intended use and support a determination of substantial equivalence.
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.
Twin Star Compartment Monitoring and Fluid Collection System, Bard Urodynamic Catheter, Wolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit
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
510(k) SUMMARY
is 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
| Establishment Registration Number: | 1018223 | |
|---|---|---|
| Address of Manufacturer: | Bard Medical Division | |
| C.R. Bard Inc. | ||
| 8195 Industrial Blvd. | ||
| Covington, Georgia 30014 USA | ||
| Phone: (770) 784-6722 | ||
| Fax: (770) 784-6419 | AUG - 1 2007 | |
| Contact Person: | Michelle Gudith | |
| Date Prepared: | June 28, 2007 | |
| Trade or Proprietary Name: | Bard® Intra-abdominal Pressure Monitoring Device | |
| Common or Usual Name: | Cystometric tubing and infusion set; intra-abdominal pressure | |
| monitoring device | ||
| Classification Name: | Intracompartmental Pressure Monitor | |
| Product code: LXC, Unclassified | ||
| Predicate Device Identification: | Twin Star Compartment Monitoring and Fluid Collection System | |
| Bard Urodynamic Catheter | ||
| Wolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit |
Device Description:
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.
Intended use and comparison to predicate devices:
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is substantially equivalent to intracompartmental pressure monitoring systems, product code LXC, unclassified regulatory classification and urodynamics measurement systems, product code FEN, regulatory classification 21 CFR 876.1620.
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Technological characteristics and comparison to predicate devices:
The overall design of the Bard IAP Device consisting of a set of tubing with luer connections, clamping device, and saline spike provides a means of infusing fluid into the urinary bladder for measurement of bladder pressure.
y differences in technological characteristics (e.g., design, materials) among the Bard IAP Device and the predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods exist for assessing the effect of these new characteristics, such as performance (bench) and biological safety (biocompatibility) testing.
Summary of performance data:
The results of bench and biocompatibility testing demonstrated that the functionality, integrity, and safety of the Bard IAP Device is adequate for its intended use and support a determination of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
C.R. Bard Incorporated Ms. Michelle Gudith Director, Regulatory Affairs 8195 Industrial Boulevard Covington, Georgia 30014
Re: K070201
Trade/Device Name: Bard® Intra-abdominal Pressure Monitoring Device Regulatory Class: Unclassified Product Code: PHU Dated: June 28, 2007 Received: July 2, 2007
Dear Ms. Gudith:
This letter corrects our substantially equivalent letter of August 1, 2007.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Michelle Gudith
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
')(k) Number (if known): K070201
Device Name: Bard® Intra-abdominal Pressure Monitoring Device
Indications for Use:
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
Prescription Use: X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: (21 CFR 807 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 Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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