PAJUNKS EPILONG SET PEDIATRIC

{0}------------------------------------------------ K062902 Premarket Notification Submission Image /page/0/Picture/3 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a dark background. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE". JUN - 7 2007 # 510(k) Premarket Notification Submission: ## Summary of Safety and Effectiveness Date of Preparation: May 2nd , 2007 | Submitter Information/ production site: | USA Contact: | |----------------------------------------------|--------------------------------| | Pajunk GmbH Medizintechnologie | Pajunk Medical Systems | | Karl-Hall-Strasse 01 | German American Trade Center | | 78187 Geisingen | 5126 South Royal Atlanta Drive | | Germany | 30084 Tucker, Georgia | | Fon: +49(0)7704-9291-0 | USA | | Fax: +49(0)7704-9291-610 | | | Establishment Registration Number: 9611612 | | | Contact: | Contact | | Christian Quass, Director Regulatory Affairs | Stefan Dayagi | | Fon: +49(0)7704-9291-586 | Fon: +01(0)770-493-9305 | | Fax: +49(0)7704-9291-605 | | E-Mail: stefan.dayagi@pajunk-usa.com Contract Sterilizer: Sterigenics Germany GmbH FDA-ERN: 3002807090 ## Device Information: E-Mail: christian.quass@pajunk.com Trade Names: Pajunks EpiLong Set Pediatric, EpiLong Soft Pediatric, EpiLong Pediatric Kit acc. Marhover Common Name: Pediatric Epidural Anesthesia Sets Pediatric - Classification Name: Anesthesia Conduction Kit Classification 21 CFR § 868.5140, April 1, 2005, Reference: Poposed Regulatory Class II Classification: Proposed Product CAZ, Kit, Conduction Anesthesia Classification Code: ### Panel: Anesthesiology Predicate Devices: - 1. Pajunks EpiLong Set K060311 2. Portex Pediatric Epidural and Peripheral Block Anesthesia Catheter K033080 - 3. MEDDEVICE's BIO-MATE pediatric epidural catheter K901129 - 4. BBrauns PERIFIX pediatric epidural kit K962696 -008- {1}------------------------------------------------ # Premarket Notification Submission Image /page/1/Picture/2 description: The image shows the word "PAJUNK" in large, bold, white letters. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE". The background of the image is a textured pattern of black and white. #### Device Description Pajunk's EpiLong Anesthesia Sets Pediatric are single use, sterile, non-pyrogenic and latex free medical device kits for use with pediatric patients. They are intended for continuous epidural anesthesia deliver y using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. The set is equipped with an epidural needle, for example the Tuohy. The Tuohy needle is a proven and established needle variant used in epidural anaesthesia. PAJUNK® offers the catheters for pediatric use in different lenghts and diameters. The catheter itself is equipped with ascending de pth graduations. With these depth gradua tions the position of the catheter can be exactly determined at any time. A marker at the end of the catheter indicates how deep the catheter can be introduced. Optionally the catheter can be employed with a stylet, an integrated spiral (called Epilong Soft Pediatric) or open tip. #### Predicate Devices The devices Pajunk claims substantial equivalence with is Pajunks Epilong Set cleared under K060311, BBrauns Perifix Pediatric epidural kit K962696, Portex´s Pediatric Epidural and Peripheral Block Anesthesia Catheter K033080, MEDDEVICE 's Bio-mate pediatric epidural catheter K901129. The indication for use of Pajunks EpiLong Sets already cleared for market for an unspecified patient population is enhanced for pediatric patients. The detailed discussion of substantial equivalence can be fo und in Section 12 of this submission. Because there is no change in technology or material the focus is set on the clinical literature review in section 10 of this submission. #### Sterilization #### Sterilization method: EtO The contract sterilizer and the sterilizing process are identical to the ones used for all of Pajunks devices provided sterile, especially the anesthesia conduction devices cleared for the US market in several Premarket Notification submissions. By annual validation and quarterly verification as well as by shelflife testing the sterilization procedure is claimed to be safe and effective for several years now. #### Technology Characteristics: The Pediatric epidural Anesthesia Set provides a standard epidural needle. Variant: The EpiLong Marhofer Kit. Within this Kit the needle is (NanoLine or lacqueur) coated. The catheter comes with a catheter container introductory aid for better handling and shape security, a LOR syringe, a flat filter and a Tuohy Borst adaptor. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylet. There is no change in components compared to the EpiLong sets already cleared for market. All components are available seperately. #### Conclusion: The comparison between the predicate devices and the proposed devices in section 12.0 of this submission demonstrates that the proposed devices are at least as safe and effective as, and substantially equivalent to the predicate devices. ``` AI-K062902 ``` Al-III-mod.doc {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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN -7 2007 Mr. Christian Quass Director Regulatory Affairs, Ass. Safety Official PAJUNK® GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen, GERMANY Re: K062902 Trade/Device Name: Pajunks EpiLong Sets Pediatric, Pajunk EpiLong Sets Pediatirc acc. Marhover, Pediatric Epidural Catheter, Pajunks Pediatric Epidural Needles Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 31, 2007 Received: June 04, 2007 Dear Mr. Quass: 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 such 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. {3}------------------------------------------------ Page 2 - Mr. Quass 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. CARS 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 #### Enclosure {4}------------------------------------------------ # Premarket Notification Submission Image /page/4/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a dark background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, white letters. The logo appears to be for a medical technology company. ## Indications for use | 510(k) Number: | | |----------------|--| | Device Name: | | K062902 Pajunks EpiLong Sets Pediatric #### Indications for Use: The Pajunk EpiLong Sets Pediatric are intended for delivery of continuous conduction of epidural anesthesia. The catheter has to be removed or replaced after 72 hours. They are to be used with pediatric patient population. Prescription Use (Per 21 CFR 801.109) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Signature sion Sign-Off) l Vision of Anesthesiology, General Hospital, icrection Control, Dental Devices 510(k) Number. K062902 Page 1 of 1 A1-K062902 -003- {5}------------------------------------------------ ## Premarket Notification Submission Image /page/5/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a dark background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, black letters. ## Indications for use | 510(k) Number: | | |----------------|--| | Device Name: | | K062902 Pajunks EpiLong Sets Pediatric acc. Marhover Indications for Use: The Pajunk EpiLong Sets Pediatric acc. Marhover are intended for delivery of continuous conduction of epidural anesthesia. The Marhover-Set contains a NanoLine coated cannula. The catheter has to be removed or replaced after 72 hours. They are to be used with ped iatric patient population. Prescription Use (Per 21 CFR 801.109) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) ാന Sign-Off) sion of Anesthesiology, General Hospital, Intection Control, Dental Devices 510(K) Number K062603 Page 1 of 1 Al-III-mod.doc {6}------------------------------------------------ ## Premarket Notification Submission Image /page/6/Picture/2 description: The image shows the word "PAJUNK" in large, bold, white letters against a dark background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, dark letters. The image appears to be a logo or brand name. #### Indications for use | 510(k) Number: | K062902 | |----------------|-----------------------------| | Device Name: | Pediatric epidural catheter | #### Indications for Use: The Pajunk pediatric epidural catheter is placed in the epidural space to facilitate a longer anesthetic effect. It is intended for use with pediatric patients. After the anesthesia conduction needle has be en withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours. Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ion Sign-Off) sion of Anesthesiology, General Hospital, control. Dental Devices Number K062902 -005- Al-K062902 Al-III-mod.doc {7}------------------------------------------------ ## Premarket Notification Submission Image /page/7/Picture/2 description: The image contains the word "PAJUNK" in large, bold, white letters against a dark background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, black letters. The text appears to be a logo or heading, possibly related to medical technology. #### Indications for use #### 510(k) Number: Device Name: Pajunks Pediatric Epidural needles #### Indications for Use: Pajunks pediatric epidural needles are anesthesia conduction needles e mployed to identify and to access epidural space. It is intended for use with pediatric patients. After epidural space is accessed and the catheter is inserted the anesthesia conduction needle has to be withdrawn from the patient. Prescription Use *X* (Per 21 CFR 801.109) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Qld ்பு Sign-Off) of Anesthesiology, General Hospital. Stion Control, Dental Devices 3(k) Number ... #### Page 1 of 1 -006- Al-III-mod.doc Al-K062902