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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Bard® Intra-abdominal Pressure Monitoring Device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states: "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." However, it does not provide specific acceptance criteria values, reported performance metrics, or details about the studies themselves (e.g., sample size, data provenance, ground truth, expert qualifications, adjudication methods, or specific comparative effectiveness results).

Therefore, I can only partially fulfill your request based on the information provided.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria and reported device performance values are not explicitly stated. The general statement is given under "Summary of performance data":

Acceptance Criteria (Explicitly stated)	Reported Device Performance (Explicitly stated)
Functionality is adequate for intended use	Functionality demonstrated to be adequate for intended use
Integrity is adequate for intended use	Integrity demonstrated to be adequate for intended use
Safety is adequate for intended use	Safety demonstrated to be adequate for intended use
Supports a determination of substantial equivalence	Supports a determination of substantial equivalence

Note: This table reflects the general claims made in the summary. It does not provide quantitative metrics or specific pass/fail thresholds that would typically be found in detailed study reports.

2. Sample size used for the test set and the data provenance

Not specified in the provided text. The document only mentions "bench and biocompatibility testing" without detailing the sample sizes (e.g., number of devices tested, number of measurements taken) or the provenance of any data (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The provided summary mentions "bench and biocompatibility testing." This type of testing typically involves engineering or laboratory measurements against established standards, not necessarily human expert-established ground truth in the way it might apply to diagnostic imaging or clinical assessment devices. No experts are mentioned in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. As the testing described is "bench and biocompatibility," an adjudication method for a test set (presumably clinical or image-based) is not relevant or mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a measurement tool (an intra-abdominal pressure monitoring device), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance in that context. The summary describes "bench and biocompatibility testing" for the device's physical and functional attributes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system. It is a physical medical device for measuring pressure. The performance evaluated would be the direct measurement capabilities of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "bench testing," the ground truth would typically be established by controlled experimental conditions or calibrated reference standards. For example, pressure measurements would be compared against a known, precise pressure source. For "biocompatibility testing," the ground truth would be established by standardized laboratory assays and adherence to relevant ISO standards (e.g., ISO 10993 series) to assess material safety. The document does not provide details on these specific ground truths.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML device that requires a training set and established ground truth in that context.

In summary, the provided 510(k) pertains to a physical medical device for pressure monitoring and focuses on establishing substantial equivalence through bench and biocompatibility testing. It lacks the detailed quantitative performance metrics, study designs, and human-expert-related information that would be typical for AI/ML-based diagnostic devices.

Summary

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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 DivisionC.R. Bard Inc.8195 Industrial Blvd.Covington, Georgia 30014 USAPhone: (770) 784-6722Fax: (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 pressuremonitoring device
Classification Name:	Intracompartmental Pressure MonitorProduct code: LXC, Unclassified
Predicate Device Identification:	Twin Star Compartment Monitoring and Fluid Collection SystemBard Urodynamic CatheterWolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit

Device Description:

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

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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:

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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Regulation Number and Section

N/A