The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Valved Safety Centesis Catheter." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information required to answer your specific questions related to acceptance criteria, a study proving performance against acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

This document focuses on demonstrating substantial equivalence through performance testing (functional and biocompatibility) and comparing technical characteristics to a predicate device, rather than a clinical study establishing performance against predefined acceptance criteria for AI or diagnostic purposes.

Here's why the requested information isn't present in this document:

Device Type: This is a physical medical device (a catheter), not a software or AI-driven diagnostic tool. The questions you've asked (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are typically relevant for AI/ML-driven diagnostic devices or software that provides interpretations.
Regulatory Focus: The 510(k) process for this type of device primarily aims to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is often achieved through bench testing (functional and biocompatibility) and comparing design features, not clinical trials requiring human reader analysis or complex ground truth establishment for diagnostic accuracy.
Lack of AI/Diagnostic Component: There is no mention of any AI component, image analysis, or diagnostic output from this catheter that would necessitate the kind of rigorous validation against human expert performance or established ground truth that your questions imply.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as the provided document does not contain this type of information for a device like the Valved Safety Centesis Catheter.

The document does mention "Performance Testing" which includes flow rate, tensile strength, pressure testing, and safety feature verification. These are functional performance criteria for a physical device, not diagnostic performance criteria.

To be absolutely clear, here's what the document does say about testing:

Performance Testing Areas: Visual Inspection, Radio-detectability, Echogenicity, Flow rate, Occlusion, Tensile strength, Pressure testing, Penetration force, Safety feature verification.
Biocompatibility Testing: Completed considering ISO 10993-1 recommendations.
Clinical Testing: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

This explicitly states that no clinical studies were performed, which further confirms why information on human readers, ground truth establishment by experts, or MRMC studies would not be present.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

B. Braun Medical Incorporated Ms. Nancy Skocypec Regulatory Affairs Manager 901 Marcon Boulevard Allentown, Pennsylvania 18109

November 12, 2015

Re: K150800

Trade/Device Name: Valved Safety Centesis Catheter Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: Class I Product Code: GCB Dated: October 14, 2015 Received: October 20, 2015

Dear Ms. Skocypec:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21 CFR 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.

Joshua C. Nipper -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

510(k) Number (if known) K150800

Device Name Valved Safety Centesis Catheter

Indications for Use (Describe)

The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) SUMMARY

Date:	November 10, 2015
Submitter:	B. Braun Medical Inc.
Address:	901 Marcon BoulevardAllentown, PA 18109-9341
Phone number:	610-266-0500
Contact:	Nancy Skocypec
Phone:	(610) 596-2796
Fax:	(610) 266-4962
E-mail:	nancy.skocypec@bbraun.com
Trade name:	Valved Safety Centesis Catheter
Common name:	Centesis Catheter
Product Code:	GCB, Needle, Catheter
Regulation:	21 CFR 878.4200, Drainage Catheter, Class II
Predicate Device:	Paracentesis Catheter, Allegiance Healthcare Corporation,K974146
Reference device:	Introcan Safety 3. B. Braun Medical Inc., K111236

Description:

A drainage catheter under 21 CFR 878.4200 is normally classified as Class I exempt; however, this device has a sharps injury prevention feature. According to the FDA Guidance, "Medical Devices with Sharps Injury Prevention Features", devices with sharps injury prevention features are Class II devices subject to 21 CFR Part 820 Quality System Regulation. Therefore, under 21 CFR 878.9, a premarket notification is required before introducing this catheter into interstate commerce for commercial distribution.

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Indications for Use:

The Valved Safety Centesis Catheter is indicated for the therapeutic or diagnostic aspiration of fluids from body cavities.

Substantial Equivalence:

Technical Characteristics

The Valved Safety Centesis Catheter has the following similarities to the predicate device:

Intended use
Indications for use ●
Catheter-over-the-needle design ●
Principle of operation ●
Self sealing valve .
Radiopaque catheter ●

The differences between the predicate and subject device include a sharps injury prevention feature, catheter material composition and attached components.

Performance Testing

The proposed Valved Safety Centesis Catheter was subjected to functional and performance testing to demonstrate that the device performs as intended.

The following testing was performed:

Visual Inspection .
Radio-detectability
Echogenicity ●
Flow rate ●
Occlusion
Tensile strength
Pressure testing ●
Penetration force
Safety feature verification ●

Biocompatibility Testing

Biocompatibility testing and chemical characterization was completed considering the recommendations defined in ISO 10993-1. The biocompatibility testing verified that no new issues of biocompatibility have been introduced with the proposed devices and therefore support the biological safety of the materials of composition.

Results of performance and biocompatibility testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

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Conclusion:

Results of testing conducted on the proposed device demonstrate that the Valved Safety Centesis Catheter is safe and effective when used in accordance with its intended use. The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness. The Valved Safety Centesis Catheter is therefore substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.