(24 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a paracentesis kit and needle, with no mention of AI or ML technology.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated to relieve pressure by draining fluid from the peritoneal space," and the "Device Description" states that "Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing."
Yes
The device aids in diagnosis by collecting fluid samples that "may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells" and serves a "diagnostic purpose" as "typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis."
No
The device description clearly outlines a physical kit, tray, and needle used for a medical procedure, not a software application.
Based on the provided text, the Quick-Tap® Paracentesis Kit, Tray and Needle are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to "relieve pressure by draining fluid from the peritoneal space." While the drained fluid may undergo diagnostic testing, the device itself is used for the collection of the fluid, not for performing the diagnostic test on the fluid.
- Device Description: The description focuses on the procedure of removing fluid from the body and the physical characteristics and function of the needle and cannula used for this purpose. It describes the process of inserting the device into the body to access the fluid.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside of the body to provide information for diagnosis, monitoring, or treatment. This device is used inside the body to collect the specimen.
The device is a tool for a medical procedure (paracentesis) that facilitates diagnostic testing by providing the sample. However, the device itself does not perform the diagnostic test on the fluid.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRO
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.
The Caldwell® Paracentesis Needle/Cannula
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, peritoneal cavity, peritoneal space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed on the Quick-Tap® Paracentesis Needles.
- Tensile test
- Flow rate
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Appendix F Attachment 3.0
1/2
February 28, 2003
MAR 3 1 2003
510(k) Premarket Notification Summary per 807.92(a)
| Submitter Information: | Cindy Ellis
Ballard Medical Products
12050 Lone Peak Parkway
Draper, UT 84020
Tel. 801-572-6800 extension 2452
Fax 801-572-6869 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Paracentesis Kit, Tray and Needle |
| Trade Name: | Quick-Tap® Paracentesis Kit, Tray and Needle |
| Classification Name: | Kit, Surgical - General
General and Plastic Surgery
21 CFR 878
79 LRO
Class II |
| Predicate Device: | Paracentesis Tray
K950574
Paracentesis Kit
K961863 |
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
1
$$
\xi \circ \varphi \circ \varphi \qquad \text{2/2}
$$
2
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
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).
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 Device
This submission | Predicate Device
K950574 | Predicate Device
K961863 |
|-------------------|-----------------------------------|-----------------------------|-----------------------------|
| Needle length | 2.25"
3.25"
4.75" | 3.25" | 3.25" |
| Gradient Markings | Etched gradient
markings | NA | NA |
| Needle diameter | 15 gauge
18 gauge | 17 gauge | 15 gauge
17 gauge |
2
$$
\lnot \lnot \gg \lnot \lnot \gg \lnot \gg \lnot \gg
$$
F9
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.
3
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.
4
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
5
Appendix F Attachment 2.0
FS
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