The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Device Description

Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection.

Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis.

Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc.

Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock.

There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula.

Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

AI/ML Overview

The provided text describes the 510(k) Premarket Notification Summary for the Quick-Tap® Paracentesis Kit, Tray and Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic would.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new device's performance. Instead, it asserts substantial equivalence to predicate devices based on design, composition, technology, function, and a limited set of non-clinical tests.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Quick-Tap®)
Functional Equivalence	Able to drain fluid from the abdominal cavity for therapeutic relief and diagnostic purposes.	Intended to drain fluid from the abdominal cavity (Paracentesis procedure).
Technological Characteristics	Similar needle length, diameter, and presence/absence of gradient markings to predicate devices.	Needle Length: 2.25", 3.25", 4.75" (Predicate K950574: 3.25"; Predicate K961863: 3.25")Gradient Markings: Etched gradient markings (Predicate K950574: NA; Predicate K961863: NA)Needle Diameter: 15 gauge, 18 gauge (Predicate K950574: 17 gauge; Predicate K961863: 15 gauge, 17 gauge)
Performance Testing	Safe and effective for intended use, as demonstrated by non-clinical tests (tensile, flow rate, visual).	Passed non-clinical tests: Tensile test, Flow rate, Visual. "Safe and effective for the intended use."

Note: The acceptance criteria are largely implied by the substantial equivalence framework, meaning the device should perform similarly to its predicates regarding safety and efficacy for the stated intended use. Specific quantitative thresholds for tensile strength, flow rate, or visual inspection are not provided in this summary.

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

The document describes non-clinical data through direct performance testing of the device components (needles), rather than a "test set" of patient data.

Sample Size: Not specified for the Tensile test, Flow rate, or Visual inspection. It's common for such tests to use a statistically representative sample size, but the exact number isn't mentioned in this summary.
Data Provenance: Non-clinical (laboratory testing of the device itself), not human or animal data.

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

N/A. This is a medical device for a procedure, and its safety and efficacy are evaluated through functional and material testing, and comparison to legally marketed predicate devices, not through a diagnostic assessment requiring expert ground truth on a test set.

4. Adjudication Method for the Test Set

N/A. As there's no clinical "test set" requiring expert ground truth or diagnostic assessment, no adjudication method is applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a 510(k) submission for a medical device (paracentesis kit, tray, and needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human readers with or without AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This is a physical medical device. The concept of an "algorithm only" or "standalone" performance without human interaction does not apply.

7. The Type of Ground Truth Used

The "ground truth" here is the functional integrity and material properties of the device components, relative to established engineering standards and the performance of predicate devices. This is established through:

Engineering/Material Testing: Tensile strength, flow rate, visual inspection.
Comparison to Predicate Devices: Demonstrating similar design, composition, technology, and function to previously cleared devices.

8. The Sample Size for the Training Set

N/A. There is no machine learning "training set" involved as this is a physical medical device.

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

N/A. Same as above, no machine learning training set applies.

Summary

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Appendix F Attachment 3.0

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February 28, 2003

MAR 3 1 2003

510(k) Premarket Notification Summary per 807.92(a)

Submitter Information:	Cindy EllisBallard Medical Products12050 Lone Peak ParkwayDraper, UT 84020Tel. 801-572-6800 extension 2452Fax 801-572-6869
Common/Usual Name:	Paracentesis Kit, Tray and Needle
Trade Name:	Quick-Tap® Paracentesis Kit, Tray and Needle
Classification Name:	Kit, Surgical - GeneralGeneral and Plastic Surgery21 CFR 87879 LROClass II
Predicate Device:	Paracentesis TrayK950574Paracentesis KitK961863

Device Description:

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ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc.

Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock.

Image /page/1/Figure/3 description: This image shows a diagram of a Caldwell Paracentesis Needle. The diagram labels the length, gauge, inner needle, and outer cannula of the needle. The diagram is labeled as Figure A-1.

The Caldwell® Paracentesis Needle/Cannula

Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

Intended Use:

Intended to drain fluid from the abdominal cavity (Paracentesis procedure).

Technological Characteristics (equivalence to predicate device) per 807.92(a)(6):

Characteristic	Subject DeviceThis submission	Predicate DeviceK950574	Predicate DeviceK961863
Needle length	2.25"3.25"4.75"	3.25"	3.25"
Gradient Markings	Etched gradientmarkings	NA	NA
Needle diameter	15 gauge18 gauge	17 gauge	15 gauge17 gauge

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Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1);

The following tests were performed on the Quick-Tap® Paracentesis Needles.

1.	Tensile test
2.	Flow rate
3.	Visual

Conclusions from non-clinical data per 807.92(b)(3):

Based on the indications for use, technological characteristics, and performance testing, the Ballard Quick-Tap® Paracentesis Kit, Tray and Needles are safe and effective for the intended use described above.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines extending from the bottom of the faces. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

Ms. Cindy Ellis Regulatory Affairs Specialist Ballard Medical Products 12050 Lone Peak Parkway Draper, Utah 84020

Re: K030721

Trade/Device Name: Quick-Tap® Paracentesis Tray, Kit and Needle Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories Regulatory Class: II Product Code: LRO Dated: February 28, 2003 Received: March 7, 2003

Dear Ms. Ellis:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Cindy Ellis

In addition, we have determined that your device kit contains lidocaine which is subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

Co Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix F Attachment 2.0

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): unknown K030731

Device Name: Quick-Tap® Paracentesis Tray, Kit and Needle

Indications for Use: The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE______________________________________________________________________________________________________________________________________________________________

OVER-THE-COUNTER USE_ OR

Meriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030721

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.