PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a dark, textured background. Below this, the word "MEDIZINTECHNOLOGIE" is printed in smaller, sans-serif font. ## 510(k) Premarket Notification Submission: ## Summary of Safety and Effectiveness OCT 2 8 2008 ## Date of Preparation: July 21st 2008 ## Submitter Information/ production site: Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen, Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612 Contact: Christian G. H. Quass, Director Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com ## USA Contact: Pajunk Medical Systems German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA ## Contact Stefan Dayagi Fon: +01(0)770-493-9305 E-Mail: stefan.dayagi@pajunk-usa.com ## Contract Sterilizer: 1) Sterigenics Germany GmbH 2) HA2 Halberstadt ## Device Information: | Device Name: | PAJUNK®'s Generic Convenience Tray for Regional<br>Anesthesia: CSF | |---------------------------|--------------------------------------------------------------------| | Trade Names: | Several generic, e. g. Basis Set, Spinal Set, Customer Set | | Common Name: | Convenience Tray for Regional Anesthesia, contacting CSF | | Classification Name: | Kit, conduction anesthesia | | Classification Reference: | 21CFR868.5140, revised April 1st 2007 | | Establishment | | | Registration Number: | 9611612 | | Regulatory Class: | II | | Product Code: | CAZ | | Panel: | Anesthesiology | | Predicate devices | K060311 EpiLong | | | K060563 EpiSpln | | | K062900 StimuLong Tsui Method | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters against a dark background. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller letters. The text appears to be a logo or brand name. The image is black and white. ## Device Description: The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in spinal, epidural and CSEprocedures. The tray complies with FDA's guidance "Sterilized convenience kits". The devices made available for this tray are listed in section 11 of this submission. ## Predicate Devices: Predicate devices with identical or at least partial indications of use are: - 1. K060311 EpiLong; PAJUNK® - 2. K060563 EpiSpin; PAJUNK® - 3. K062900 StimuLong TSUI Method; PAJUNK® The detailed discussion of substantial eqivalence can be found in Section 12 of this submission. ## Sterilization The contract sterilizer and the sterilizing process is the same as used for all PAJUNK® manufactured and purchased devices which are already cleared for market or exempt and which may be contained in a convenience tray. Sterilization method, which ensures an SAL of 10° as well as limits for bioburden, pyroburden (i. e. LAL) and EtO-residuals and shelf life have been validated and are safe and effective. Efficacy of sterile product's lifecycle has been proven for a periode of 10 years now. Shelf life is set to 5 years. ## Blocompatibility All devices comply with ISO 10993-1, FDA-modified version also. ## Technology Characteristics: The components are listed in a table in section 11 of this submission. Shelf life and impact of sterilization and storage on the devices has been proven and found to be safe and effective n ## Conclusion: The comparison between the predicate devices and the proposed devices in section 12 of this submission as well as the validated sterilization process demonstrates that the proposed devices are substantially equivalent to the predicate devices and safe and effective. The tray components are marketed in similar combinations in Europe for more than ten years now and are safe and effective. Efficacy of manufacturing, tray assembly, sterilization, storage and shelf life has been proven. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Christian G. H. Quass Director Regulatory Affairs PAJUNK® GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen GERMANY OCT 2 8 2008 Rc: K082183 Trade/Device Name: PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Epidural Single Shot - PAJUNK® s Generic Convenience Tray for Regional Anesthesia: CSF - PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Spinal Single Shot - PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural Continuous - PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Spinal Continuous - PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Combined Spinal Epidural (CSE) - PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Common Procedure Supply Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 29, 2008 - Received: August 1, 2008 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the {kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally 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., {3}------------------------------------------------ ## Page 2 - Mr. Quass sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 docs 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. 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 the labeling regulation, please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsma/dsmamain.html. Sincerely yours, OKhmulir Lendinor for 11 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}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters. Below this word is the word "MEDIZINTECHNOLOGIE" in smaller, white letters. The background of the image is dark and grainy. The image appears to be a logo or brand name. #### Indications for use 510(k) Number: K082183 Device Name: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot Indications for Use: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot is intended for the administration of regional anaesthesia to the epidural space employing singleshot technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. 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 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 08 218 510(k) Number: Page 1 of 1 | PMN Spinal Convenience Kit K082183 | 21/ 158 | |------------------------------------|------------| | R&D | | | Regulatory | | | Resp. | SAG | | Resp. | CQ | | | 2008/10/13 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters against a dark, textured background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, sans-serif font. The text appears to be a logo or heading, possibly for a company or product related to medical technology. #### Indications for use 510(k) Number: K082183 Device Name: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF Indications for Use: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF is intended for the administration of spinal, epidural or combined spinal-epidural regional anaesthesia, single-shot or continuous technique, optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. 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) Jin Ah, M.D. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1 510(k) Number: k082153 PMN Spinal Convenience Kit K082183 R&D Resp. SAG Regulatory Resp. CQ {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters against a dark background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner letters. The text appears to be a logo or heading, possibly for a company or product related to medical technology. The image quality is somewhat grainy, but the text is still legible. ## Indications for use 510(k) Number: K082183 Device Name: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: spinal single shot Indications for Use: PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Spinal single shot is intended for the administration of regional anaesthesia to the spinal space employing single-shot technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. 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) f Aims (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Page 1 of 1 PMN Spinal Convenience Kit K082183 R&D Resp. SAG Regulatory Resp. CQ {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner, white letters. The background of the image is dark and textured. | Indications for use | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K082183 | | Device Name: | PAJUNK ^® 's Generic Convenience Tray for Regional Anesthesia: Epidural continuous | | Indications for Use: | | | | PAJUNK ^® 's Generic Convenience Tray for Regional Anesthesia: Epidural continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus. | | | Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. | | Prescription Use<br>(Per 21 CFR 801.109) | X AND/OR Over-The-Counter Use<br>(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) | | | <div align="center"><img alt="Signature" src="signature.png" width="200"/></div> | | | | (Division Sign-Off) | | | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | | 510(k) Number: | K082183 | | Page 1 of 1 | | PMN Spinal Convenience Kit K082183 R&D Regulatory Resp. SAG Resp. CQ ·· . . . . ・・・ {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters against a dark background. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, black letters. The image appears to be a logo or branding for a company or product related to medical technology. ## Indications for use 510(k) Number: K082183 PAJUNK®'s Generic Convenience Tray for Regional Device Name: Anesthesia: Spinal continuous Indications for Use: PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Spinal continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. 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) L.A. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Page 1 of 1 PMN Spinal Convenience Kit K082183 R&D Resp. SAG Regulatory Resp. CQ {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters against a dark background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters. The text appears to be a logo or brand name, possibly for a medical technology company. The image quality is somewhat grainy, but the text is still legible. ## Indications for use | 510(k) Number: | K082183 | |----------------------|--------------------------------------------------------------------------------------------| | Device Name: | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Combined Spinal Epidural (CSE) | | Indications for Use: | | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSE is intended for the administration of anaesthesia via CSE-technique, single-shot/ continuous technique, optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. | Prescription Use<br>(Per 21 CFR 801.109) | X | AND/OR | Over-The-Counter Use<br>(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)  (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | K082183 | |----------------|---------| |----------------|---------| Page 1 of 1 PMN Spinal Convenience Kit K082183 25/ 158 R&D Resp. SAG 2008/10/13 . . Regulatory Resp. CQ . : . · ......... {10}------------------------------------------------ : : Image /page/10/Picture/1 description: The image contains the word "PAJUNK" in large, bold, white letters against a dark background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters. The text appears to be a logo or brand name for a medical technology company. The background is a dark, textured pattern. | | Indications for use | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K082183 | | Device Name: | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply | | Indications for Use: | | | | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to <i>support</i> the administration of spinal, epidural and CSE-technique applied anaethesia, single-shot/ continuous technique, optional localization via electrical stimulus regional anaethesia. Neither needle nor catheter is included. | | | | | Prescription Use<br>(Per 21 CFR 801.109) | X AND/OR Over-The-Counter Use<br>(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) | | | | | | (Division Sign-Off)<br>Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | | 510(k) Number: | K082183 | | | | | | | | | Page 1 of 1 | | | | | | | | PMN Spinal Convenience Kit K082183<br>R&D<br>Regulatory | 26/ 158<br>Resp. SAG<br>2008/10/13<br>Resp. CQ | :