PNEUMOCLEAR

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 15, 2017 W.O.M. WORLD OF MEDICINE GmbH % Susanne Raab Regulatory Consultant Susanne Raab 1480 Cambridge Street Cambridge, MA 02139 Re: K170784 > Trade/Device Name: PNEUMOCLEAR™ Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV Dated: February 10, 2017 Received: March 15, 2017 Dear Susanne Raab: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170784 Device Name PNEUMOCLEAR™ Indications for Use (Describe) The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a stylized symbol above the text "WOM PNEUMOCLEAR™". Below this is the text "510(k) Premarket Notification". The symbol is a circle with a stylized shape inside, with a small triangle at the bottom. K170784 Page 1 of 7 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS # General Information: | Submitter: | W.O.M. WORLD OF MEDICINE GmbH | |------------|-------------------------------| | | Salzufer 8 | | | 10587 Berlin | | | Germany | | | Phone: +49 30 39981 594 | | | Fax: +49 30 39981 593 | Registration Number: 3001556604 | Contact Person: | Susanne Raab | |-----------------|----------------------------| | | Regulatory Consultant | | | 1480 Cambridge Street | | | Cambridge, MA 02139 | | | Phone: (617) 547-0628 | | | Fax: (617) 547-0628 | | | e-mail: sbraab@comcast.net | Date Prepared: May 12, 2017 Proposed Device: | Trade Name: | PNEUMOCLEAR™ | |----------------------|---------------------------------------------------------------------| | Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Vessel<br>Harvesting | | Classification Name: | Insufflator, Laparoscopic | | Regulation Number: | 21 CFR 884.1730 | | Regulation Name: | Laparoscopic Insufflator | | Regulatory Class: | II | | Product Code: | HIF, OSV | Predicate Devices: Primary Predicate: | Trade Name: | Insufflator 50L FM134 | |--------------------|-------------------------------| | 510(k) Number: | K153513 | | Applicant: | W.O.M. WORLD OF MEDICINE GmbH | | Regulation Number: | 21 CFR 884.1730 | | Regulatory Class: | II | | Product Code: | HIF, OSV | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized knot inside, above the text "WOM PNEUMOCLEAR™". Below this is the text "510(k) Premarket Notification". #### Secondary Predicates | Trade Name: | SurgiQuest AirSeal iFS System | |--------------------|------------------------------------------| | 510(k) Number: | K143404 | | Applicant: | SurgiQuest, Inc. | | Regulation Number: | 21 CFR 884.1730 | | Regulatory Class: | II | | Product Code: | HIF, GCJ | | Reference Devices: | | | Trade Name: | Olympus High Flow Insufflation Unit UHI- | | 510(k) Number: | K122180 | | Applicant: | Olympus Medical Systems, Corp. | | Regulation Number: | 21 CFR 884.1730 and 21 CFR 876.1500 | | Regulatory Class: | II | | Product Code: | FCX, HIF and OSV | | Trade Name: | Insuflow | | 510(k) Number: | K090456 | | Applicant: | LEXION Medical LLC | | Regulation Number: | 21 CER 884.1730 | II HIF # Device Description: Regulatory Class: Product Code: The PNEUMOCLEAR™ is a microprocessor controlled CO2 insufflator that consists of the following major components and features: (1) a casing, (2) a world power supply, (3) pressure reducers, (4) pressure sensors, (4) venting systems, (5) various safety valves. (6) a suction pump. (7) a fluid sensor and (8) a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes (i.e. Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field, and cannot be sterilized. It is to be used with specially designed single-use insufflation tube sets that are Specifically, five different tube sets may be used with the delivered sterile. proposed device: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire, and humidification media; and insufflation and smoke evacuation tube set with integrated filter. When used with a smoke evacuation tube set the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen, rectum or colon during laparoscopic {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized figure-eight shape inside, above the text "WOM PNEUMOCLEAR™". Below this is the text "510(k) Premarket Notification". and transanal minimally invasive procedures and at the end of a procedure. # Intended Use / Indication for Use: The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimally invasive surgery. # Substantial Equivalence and Comparison of Technological Characteristics: The PNEUMOCLEAR™ is substantially equivalent to the predicate devices Insufflator 50L FM134 (K153513) and SurgiQuest AirSeal iFS System (K143404). The PNEUMOCLEAR™ has features similar to those seen in the reference devices Olympus High Flow Insufflation Unit UHI-4 (K122180) and Insuflow (K090456). The proposed device, PNEUMOCLEARTM, and the predicate devices, Insufflator 50L FM134 and SurgiQuest AirSeal iFS System, as well as the reference device, Olympus High Flow Insufflation Unit UHI-4, are all CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. In addition, the PNEUMOCLEAR™ is used for the same or similar indications as the primary predicate device Insufflator 50L FM134, i.e. Standard, Bariatric, Pediatric, Vessel Harvest. With regards to the TAMIS indication the PNEUMOCLEAR™ is substantially equivalent to the secondary predicate device, SurgiQuest AirSeal iFS System, that is also indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimally invasive surgery. Furthermore, the PNEUMOCLEARTM and the primary predicate device, Insufflator 50L FM134, use the same basic operating principles and incorporate the same basic design. Both the proposed device PNEUMOCLEAR™ and the primary predicate device. Insufflator 50L FM134, are microprocessor controlled CO2 insufflators that consist of the same major components and incorporate the same major features except for the addition of a suction pump to provide for smoke evacuation in the proposed device. In addition, both the proposed device and the primary predicate device are to be used with specially designed sterile, single-use insufflation tube sets with integrated filter and optional heating function. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized "W" inside, and the text "WOM" is written below the logo. Below that, the text "PNEUMOCLEAR™" and "510(k) Premarket Notification" are written. The differences in the technological characteristics between the proposed device, PNEUMOCLEARTM, and the primary predicate device, Insufflator 50L FM134, do not raise different questions of safety or effectiveness. Specifically, with regards to the Advanced Flow Operating Mode, the proposed device is substantially equivalent to the Bariatric Operating Mode of the primary predicate device, Insufflator 50L FM134. The main technological differences between the Advanced Flow Operating Mode of the proposed device and the Bariatric Operating Mode of the primary predicate device, Insufflator 50L FM134, consist of an increased maximum gas supply pressure and a special "Intelligent Steady Insufflation" algorithm (Steady Control Feature) that is automatically activated if a large leakage is detected that cannot be compensated with the "conventional intermitted insufflation cycles" of the proposed device. With the Steady Control Feature of the Advanced Flow Operating Mode active, the length of the insufflation cycles are extended compared to the "conventional intermitted insufflation cycles". The Advanced Flow Operating Mode of the proposed device is designed with two safety features to prevent a rise in abdominal pressure above the set value during the extended insufflation cycles of the Steady Control Feature: (1) the plausibility check flow; and (2) the plausibility check pressure. Both the plausibility check flow and pressure are performed permanently while the Steady Control Feature is active, to detect any change in the abdominal pressure and if required to deactivated the Steady Control Feature during operation of the Advanced Flow Operating Mode. In addition, with regards to the TAMIS Operating Mode, the proposed device is substantially equivalent to the secondary predicate device, SurgiQuest AirSeal iFS System. In addition, the smoke evacuation function and the smoke evacuation tube sets of the proposed device can be found in the reference device, Olympus High Flow Insufflation Unit UHI-4, and secondary predicate device, SurgiQuest AirSeal iFS System. Finally, with regards to the PNEUMOCLEAR™ tube sets with integrated humidification media, these components can be found in the reference device, Insuflow. # Performance Data: # Electrical Safety and Electromagnetic Compatibility Testing: Electrical safety and electromagnetic compatibility testing was performed by independent laboratories and the test results demonstrate that the proposed device conforms to the below standards: - . IEC 60601-1 2005/(R)2012 and A1:2012. C1:2009/(R)2012 andA2:2010/(R)2012 (consolidated text); and {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for WOM, which is a stylized circle with a design inside and the letters "WOM" below it. Below the logo is the text "PNEUMOCLEAR™" and "510(k) Premarket Notification". The text is in a simple, sans-serif font and is centered below the logo. - IEC 60601-1-2 Third Edition: 2007-03. . # Software: The software was considered as major level of concern in accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software verification and validation testing of the PNEUMOCLEAR™ demonstrates that the device performs as intended. It was developed, tested and verified in accordance with the above FDA guidance document and in accordance with the following standard: - IEC 62304 First Edition 2006-05. # Biocompatibility Testing: Biocompatibility testing was performed on the insufflation tube sets of the proposed device PNEOMOCLEAR™ in accordance with: - AAMI/ANSI/ISO 10993-1 Fourth Edition 2009-10-15; ● - ISO 10993-5: 2009 (R) 2014; - . ISO 10993-10 Third Edition 2010-08-01; and - . ISO 10993-11 Second Edition 2006-08-15. # Sterilization and Package Testing: ETO sterilization validation for the sterile single use tube sets was performed in accordance with the below standards: - ISO 11135-1 Second Edition 2014; - ISO 14937 Second Edition 2009-10-15; - . ISO 10993-7 Second Edition 2008-10-15; and - AAMI TIR 28 2009/(R)2013. . Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 4 days of aeration (gas release) that remains on the tube set will not be exceeded. A sterility assurance level (SAL) < 10° is achieved. Package and product integrity of the tube sets were tested in accordance with the following standards: - ISO 11607-1 First Edition 2006-04-15; and ● - ASTM-F-1980: 2002. # Bench Testing: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized figure-eight shape inside, above the text "WOM PNEUMOCLEAR™". Below this is the text "510(k) Premarket Notification". Finally, bench testing was performed to demonstrate that the performance of the proposed device, PNEUMOCLELARTM, is substantially equivalent to that of the predicate devices: - 1. Comparative Bench Testing comparing the pressure regulation of the PNEUMOCLEARTM High Flow/Bariatric Operating Mode with the performance in the Standard Operating Mode of the primary predicate device, Insufflator 50L FM134; - 2. Comparative Bench Testing comparing the pressure regulation of the PNEUMOCLEARTM Flow/Bariatric Operating Mode with the performance in the Bariatric Operating Mode of the primary predicate device. Insufflator 50L FM134; - 3. Comparative Bench Testing, comparing the Advanced Flow Operating Mode of the PNEUMOCLEAR™ with the Bariatric Operating Mode of the INSUFFLATOR 50L FM134; - 4. Bench Testing demonstrating the safety and effectiveness of the Steady Control Feature while in the Advanced Flow Operating Mode; - 5. Comparative Bench Testing comparing the Advanced Flow Operating Mode of the PNEUMOCLEAR™ with the Bariatric Operating Mode of the INSUFFLATOR 50L FM134 in terms of large leakage compensation and maintenance of abdominal pressure with the Steady Control Feature active. - 6. Comparative Bench Testing comparing the pressure regulation performance of the PNEUMOCLEAR™ TAMIS Operating Mode with the secondary predicate device, SurgiQuest AirSeal iFS System, with and without the activation of the smoke evacuation function; - 7. Bench Testing demonstrating the effectiveness of the Stryker SDC3 HD Information Management System in controlling the PNEUMOCLEARTM and to remotely display device settings and warning messages; - Bench Testing demonstrating the effectiveness of the radio frequency 8. identification (RFID) transponder technology tube set recognition function; - 9. Comparative Bench Testing comparing the smoke evacuation function of the PNEUMOCLEAR™ with the smoke evacuation function of the reference device, Olympus High Flow Insufflation Unit UHI-4; - 10. Bench Testing demonstrating the safety and effectiveness of the desufflation function of the PNEUMOCLEARTM: {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized figure inside, above the text "WOM". Below this is the text "PNEUMOCLEAR™" and "510(k) Premarket Notification". The logo is simple and clean, with a focus on the company name and product. - 11. Comparative bench testing comparing the performance of the PNEUMOCLEARTM insufflation tube set with integrated filter and heating wire ST296 with the insufflation tube set with integrated filter and heating wire ST260 of the primary predicate device, FM134, in terms of safety and effectiveness; and - 12. Comparative bench testing was performed comparing the performance of the PNEUMOCLEAR™ insufflation tube set with integrated filter, heating wire and humidification material ST297 with the reference device, Insuflow. #### Conclusion: The PNEOMOCLEAR™ is substantially equivalent to the predicate devices: Insufflator 50L FM134, SurgiQuest AirSeal iFS System.