← Product Code PHU · K070201 # BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201) _C.R. Bard, Inc. · PHU · Aug 1, 2007 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070201 ## Device Facts - **Applicant:** C.R. Bard, Inc. - **Product Code:** PHU - **Decision Date:** Aug 1, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU ## 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). ## Device Story Bard IAP Monitoring Device is a tubing set used to measure intra-abdominal pressure. It connects to a patient's existing Foley urinary catheter sampling port. The device includes a saline spike and a clamping mechanism to occlude the urinary drainage tubing, creating a fluid column. By infusing fluid into the bladder, the device allows for the measurement of bladder pressure, which serves as a surrogate for intra-abdominal pressure. It is intended for clinical use by healthcare providers to assist in the diagnosis of intra-abdominal hypertension and abdominal compartment syndrome. The output is a pressure measurement obtained via the fluid column, which clinicians use to inform clinical decision-making regarding patient abdominal status. ## Clinical Evidence Bench testing only. Performance and biocompatibility testing demonstrated functionality, integrity, and safety adequate for the intended use. ## Technological Characteristics Tubing set with luer connections, clamping device, and saline spike. Operates via fluid column pressure measurement through a Foley catheter. Materials are biocompatible. ## Regulatory Identification Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure. ## Predicate Devices - Twin Star Compartment Monitoring and Fluid Collection System - Bard Urodynamic Catheter - Wolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) SUMMARY K070201 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. {1}------------------------------------------------ ## 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. {2}------------------------------------------------ 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 {4}------------------------------------------------ # 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_________________________________________________________________________________________________________________________________________________________________ Page 1 of 1 --- **Source:** [https://fda.innolitics.com/device/K070201](https://fda.innolitics.com/device/K070201) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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