ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM

{0}------------------------------------------------ Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 256 586 1580 Fax 256 586 8529 K 041158 JUN 1 7 2004 Image /page/0/Picture/3 description: The image shows the logo for Atrion Medical. The logo is in black and features a stylized "A" with a swoosh extending from the left side. The word "Atrion" is written in bold, sans-serif font. Below the word "Atrion" is the word "Medical" in a smaller font. #### 11. 510(k) SUMMARY | Date of Preparation: | April 30, 2003 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Atrion Epidural Anesthesia Kit with NeedleVISE™ sharps<br>securing system | | Common Name: | Anesthesia Conduction Kit | | Classification Name: | Anesthetic Conduction Kit 21 CFR 868.5140, ProCode 73 CAZ<br>Accessory to single lumen hypodermic needle<br>21 CFR 880.5570, ProCode 80 FMI | | Manufacturer: | Atrion Medical Products, Inc.<br>1426 Curt Francis Road<br>Arab, AL 35016 | | Contact: | Mr. Dan Clark,<br>Atrion Medical Products, Inc.<br>1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: (256) 586-1580, Fax: (256) 586-8529 | | Predicate: | Cambridge Marketing, Inc. Needle Barn Stik Stopper® (K010038)<br>Devon Industries, Inc. Point-Lok® Needle Protection Device<br>(K946289)<br>B. Braun Epidural Kit with Soft Tip Catheter (K971233)<br>Portex Continuous Epidural Anesthesia Tray (K802065) | #### Device Description: The Atrion Epidural Anesthesia Kit with NeedleVISE™ Sharps Securing System consists of components necessary for conducting repeated administration of anesthetic agents in the epidural space. The kit also contains the NeedleVISE™ sharps securing system which is a opidural opade, single patient procedure use, disposable device used for securing the specialized needles found in sterile anesthesiology procedural trays. As provided to the user, the NeedleV/SE™ sharps securing system is retained in an upright position in the sterile procedure tray to allow for stability and one-hand insertion of sharps during a procedure. The healthcare professional using only one hand can render the sharps harmless while remaining with the patient in the sterile field. The purpose of the NeedleVISE™ sharps while rounsvitem is to provide a means to make engineered sharps control protection available within the sterile field, for all instances in which introduction of contaminated sharps containers is not acceptable. {1}------------------------------------------------ Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 256 586 1580 Fax 256 586 8529 Image /page/1/Picture/1 description: The image shows the logo for Atrion Medical. The logo consists of the word "Atrion" in a bold, sans-serif font, with a stylized line extending from the left side of the "A" to the upper left corner of the image. Below the word "Atrion" is the word "Medical" in a smaller, italicized font. ### Intended Use: The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents into the epidural space. It is recommended that the epidural catheter be removed or replaced every 72 hours. The NeedleVISE™ sharps securing system is intended for use in sterile anesthesiology procedure trays as a sharps securing device for the contaminated specialized needles that do not have integral engineered sharps safety devices. ### Technological Characteristics: All the components used in the Atrion Epidural Anesthesia Kit with NeedleVISE™ Sharps Securing System are legally marketed devices. The inclusion of these components in the kit will have the same implications as their current usage. The NeedleVISE™ sharps securing system has similar materials as the predicate products, but acts by locking the used sharp into a metal retaining clip contained within the plastic housing. ### Summary of Testing: As the only new component to the kit, testing was conducted on the NeedleVISE™ sharps securing system. The tests included mechanical property testing to assess impact, stability, puncture and leak resistance. The results showed the NeedleVISE™ device to be substantially equivalent to the predicate sharps securing devices. Clinical utility was evaluated in field trials designed to assess ease of 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 7 2004 Mr. Dan Clark Vice President Regulatory and Quality Atrion Medical Products, Incorporated 1426 Curt Francis Road Arab, Alabama 35016 Re: K041158 R041156 Atrion Epidural Anesthesia Kit with NeedleVISE™ sharps securing system Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: 73 CAZ Dated: April 30, 2004 Received: May 3, 2004 Dear Mr. Clark: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarement the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments or to conninerec prof to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market the device, subject to the general and Cosmette Feel (und Free), a same , you are responsible to determine that the medical devices controls provisions of rions of rion been determined as substantially equivalent under you use as contiponents in the mess (Section 510(k) of the act), or were on the market prior to the premarket non from on proves of the Medical Device Amendments. Please note: If you May 26, 1770, the onaoment and on bells (i.e., unfinished) and further process (e.g., sterilize) purchase your de ree componenee are including these components in your kit. The general you must submit a new by Act include requirements for annual registration, listing of devices, Controls provisions of the Ired 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 your device is elassifica nal 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 I lease oe advised that I Dr other mation that your device complies with other requirements of the Act that I DI has intatutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 11et 61ed by and 801); good manufacturing practice requirements as set CTN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality 355cms (Sections 531-542 of the Act); 21 CFR 1000-1050. In addition, we have determined that your device kit contains Povidone Solution which is subject to regulation as a drug. Our substantially equivalent determination does not apply to the drug component of your device. Our substantially equivalent determinenter for Drug Evaluation and Research before marketing we recommend your first commonent. 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) I this icher will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific advise for your do, please note the regulation entitled, "Misbranding by of Comphanee 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, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ## 12. INDICATIONS FOR USE STATEMENT # Indications for Use 510(k) Number (if known): Ko YUSS ___ Device Name: Atrion Epidural Anesthesia Kit with Atrion NeedleVISE™ sharps securing system Indications For Use: The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthelic agents of The Athon Epidural Anesthesia Nr is intendoulter as the as a looks as a removed or replace every 72 hours. The NeedleVISE™ sharps securing system is intended for use in sterile anesthesiology The NeedleVISE™ Sharps Securing System is mondonation device for the contaminated procedure thays within the Stenle "hold" as "a sheered sharps safety devices. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Lilia M. Pinto on Sign-Off vision of Anesthesiology, General Hospit. Infection Control, Dental 510(k) Number: Page 1 of