The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.

AI/ML Overview

This document is a 510(k) summary for a Paracentesis Catheter and does not contain detailed information about specific acceptance criteria or an efficacy study in the manner typically expected for AI/ML device submissions. Instead, it focuses on substantial equivalence to a predicate device and biocompatibility testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Intended Use	Same as predicate device (therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity).	The proposed device's intended use is the same as the currently marketed Allegiance Paracentesis Catheter.
Performance Attributes	Same as predicate device.	The proposed device's performance attributes are the same as the currently marketed Allegiance Paracentesis Catheter.
Biocompatibility	Meet testing requirements for cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), and hemocompatibility for materials used.	All materials used were evaluated through biological qualification safety tests and met the testing requirements. They were found to be acceptable for the intended use.
Substantial Equivalence	Demonstrated by identical intended use and performance attributes to the predicate device (K870704).	Substantial equivalence was claimed and accepted by the FDA based on identical intended use and performance attributes.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe an efficacy or performance study with a "test set" in the context of an AI/ML device.
For biocompatibility, the "sample size" is implied to be of the materials used in the device. The provenance is internal to Allegiance Healthcare Corporation (manufacturer). The testing is described as "biological qualification safety tests," which are typically laboratory-based tests on material samples, not a clinical study on a patient population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as there is no "test set" and "ground truth" establishment in the context of clinical interpretation by experts for this type of device submission. The evaluation focused on material safety and equivalence to an existing device.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This submission is for a physical medical device (catheter) and not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

For biocompatibility: The "ground truth" was established by standardized laboratory tests and recognized safety criteria for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility, as applied to the device materials.
For substantial equivalence: The "ground truth" was the characteristics (intended use, performance attributes) of the predicate device (K870704).

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of AI/ML for this device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was involved.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" or rather, the evidence provided to prove the device meets acceptance criteria, focuses on two main aspects:

Substantial Equivalence Demonstration: The manufacturer asserted that the proposed Paracentesis Catheter is substantially equivalent to a legally marketed predicate device (K870704, also owned by Allegiance Healthcare Corporation). This was "proved" by demonstrating that its intended use and performance attributes are the same as the predicate device. This is a foundational regulatory pathway for many medical devices.
Biocompatibility Testing: The materials used in the fabrication of the paracentesis device underwent a battery of biological qualification safety tests. These tests covered:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Systemic toxicity (acute)
- Hemocompatibility
  The document states that these materials met the testing requirements and were found to be acceptable for the intended use. This indicates internal lab testing against established biocompatibility standards.

In essence, the "study" for this 510(k) submission primarily consisted of a comparison to a predicate device and laboratory-based material safety testing, rather than a clinical performance study with human subjects, which is common for physical devices demonstrating substantial equivalence.

Summary

{0}------------------------------------------------

K974146

Allegian

JAN 2 8 1998

Allegiance Healthcare Corporation 500 Waukegan Road AcGaw Park, Illinois 60085-6787 47.473.1500 FAX: 847.785.2461

SMDA REQUIREMENTS XII.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER

Manufacturer:

Allegiance Healthcare Corporation 400 East Foster Road Mannford, OK 74044

Regulatory Affairs Contact:

Sharon Robbins Allegiance Healthcare Corporation 1500 Waukegan Road MP-WM McGaw Park, IL 60085

Telephone:

Common Name:

Classification:

Description:

Predicate Device:

Date Summary Prepared: October, 1997

Paracentesis Catheter

(847) 785-3311

Class II per 21CFR § 878.4200, Needle, Catheter

Paracentesis Catheter device, K870704 owned by Allegiance Healthcare Corporation

The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.

{1}------------------------------------------------

XII. SMDA REQUIREMENTS (continued)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER

Intended Use: The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity. Substantial

Equivalence:

The proposed Allegiance Paracentesis Catheter is substantially equivalent to the currently marketed Allegiance Paracentesis Catheter in that:

intended use is the same
performance attributes are the same

All materials used in the fabrication of this paracentesis Summary of testing: device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute) and hemocompatibility as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.

{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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circumference.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1998

Ms. Sharon Robbins 'Manager of Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787

Re : K974146 Paracentesis Catheter Device Trade Name: Requlatory Class: II Product Code: GCB Dated: October 30, 1997 Received: November 3, 1997

Dear Ms. Robbins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Sharon Robbins

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K974146

Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

Indications for Use

510(k) Number (if known):

Device Name:

Paracentesis Catheter

Indications For Use:

The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
------------------------------------------	--

Over-The Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	2974146

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.