QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

{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<br>Ballard Medical Products<br>12050 Lone Peak Parkway<br>Draper, UT 84020<br>Tel. 801-572-6800 extension 2452<br>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<br>General and Plastic Surgery<br>21 CFR 878<br>79 LRO<br>Class II | | Predicate Device: | Paracentesis Tray<br>K950574<br><br>Paracentesis Kit<br>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 The inner needle is withdrawn and disposed of leaving the outer cannula in place.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<br>This submission | Predicate Device<br>K950574 | Predicate Device<br>K961863 | |-------------------|-----------------------------------|-----------------------------|-----------------------------| | Needle length | 2.25"<br>3.25"<br>4.75" | 3.25" | 3.25" | | Gradient Markings | Etched gradient<br>markings | NA | NA | | Needle diameter | 15 gauge<br>18 gauge | 17 gauge | 15 gauge<br>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