HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 23, 2017 Fisher & Paykel Healthcare Nicole Senasac Senior Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki, Auckland 2013 New Zealand Re: K162582 Trade/Device Name: HumiGard™ Surgical Humidification System Regulation Number: 21 CFR& 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: May 16, 2017 Received: May 25, 2017 Dear Nicole Senasac: 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 mav 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. {1}------------------------------------------------ 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 device-related 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, Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are well-defined, and the contrast between the text and the background is high, making it easily readable. 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) ## K162582 Device Name HumiGard™ Surgical Humidification System Indications for Use (Describe) The HumiGard Surgical Humidification System is intended to warm and humidity carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| |X Prescription 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}------------------------------------------------ # 510(k) Summary | Contact person/submitter | Nicole Senasac | | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------|--| | | Senior Regulatory Affairs Specialist | | | Date prepared | 8 May 2017 | | | Contact details | 15 Maurice Paykel Place | | | | East Tamaki | | | | Auckland 2013, New Zealand | | | | Telephone: +64 9 574 0100 | | | Trade name | HumiGard™ Surgical Humidification System | | | Common name | Laparoscopic insufflator | | | Classification name | Insufflator, laparoscopic | | | | 21 CFR, 884.1730 | | | | Product Code HIF | | | | Class II | | | Predicate device | Lexion Medical Insuflow Device, Model 6198 (K063546)<br>The predicate device has not been subject to a design<br>related recall. | | #### 1.1. Device Description The HumiGard™ Surgical Humidification System is designed to warm and humidify carbon dioxide (CQ>) gas after it leaves a commercially available insufflator (used to requlate the supply of CO2 gas into the intended body cavity) and thereafter maintain the CO2 gas in a warmed and humidified condition to the point of delivery into the patient's peritoneum via heated tubing. The HumiGard™ Surgical Humidification System is comprised of a reusable Humidifier (SH870 Humidifier), supply voltage cord (115V or 230V) and the single use, sterile Humidified Insufflation Kit (ST520). The ST520 Insufflation Kit is ETO sterilized (SAL 10th) and provides all of the necessary components needed to deliver the heated, humidified CO2 gas during laparoscopic surgical procedures, including the insufflation tube, chamber, dry-line/filter assembly, funnel, and optional barb connector. The SH870 Humidifier contains embedded software that controls the operation of the humidifier power and functions. The HumiGard™ system conditions the CO2 gas by using a water-filled chamber that is seated on a heater plate on the humidifier. Once the heater plate warms to the target temperature, the heated water in the chamber produces vapour that humidifies the gas as it passes through the chamber. The surgical humidifier also provides power to the heating element (i.e., the heaterwire) within the heated insufflation tube to maintain the desired heat and humidity of the CO2 gas as it travels from the chamber to the patient interface (trocar/cannula). #### 1.2. Intended Use The HumiGard™ Surgical Humidification System is intended to warm and humidify carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery. {4}------------------------------------------------ | Table 1-2 | | | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Indications for use and intended use | | | | | Indications for<br>use | The HumiGard™ Surgical<br>Humidification System is<br>intended to warm and<br>humidify carbon dioxide<br>gas from an insufflator<br>prior to entry into the<br>surgical cavity during<br>laparoscopic surgery. | The Lexion Medical<br>Insufiow® device is an<br>accessory to an<br>insufflator intended to<br>heat, humidify and filter a<br>gas stream used for<br>inflation during<br>laparoscopic surgery. | Identical - humidification of<br>CO2 gas used in<br>laparoscopic surgical<br>procedures | | Intended use | The HumiGard™ Surgical<br>Humidification System is<br>intended to warm and<br>humidify carbon dioxide<br>gas from an insufflator<br>prior to entry into the<br>surgical cavity during<br>laparoscopic surgery. | The Lexion Medical<br>Insufiow® device is an<br>accessory to an<br>insufflator intended to<br>heat, humidify and filter a<br>gas stream used for<br>inflation during<br>laparoscopic surgery. | Identical - humidification of<br>CO2 gas used in<br>laparoscopic surgical<br>procedures | #### Device Materials 1.3. A summary of the patient contact materials contained in ST520 insufflation kit is provided below in Table 1-2. | | | Nature of Body Contact | | | |----|--------------------------------------|--------------------------------|----------------------|----------------| | | Component | Material type | Contact | Duration | | 1 | Elbow insufflation<br>No port | HDPE | Tissue/ Bone/ Dentin | Limited | | 2 | Heaterwire<br>socket | HDPE | Tissue/ Bone/ Dentin | Limited | | 3 | Heaterwire<br>(Insulation) | HDPE | Tissue/ Bone/ Dentin | Limited | | 4 | Luer connector<br>boss | HDPE | Skin | Limited | | 5 | Luer connector<br>male | Polycarbonate | Tissue/ Bone/ Dentin | Limited | | 6 | Luer connector<br>lock ring | Polycarbonate | Skin | Limited | | 7 | Tube inner<br>smooth<br>insufflation | Polyolefin Elastomer | Tissue/ Bone/ Dentin | Limited | | 8 | Tube outer<br>insufflation | LDPE | Skin | Limited | | 9 | Band Insufflation<br>tube | Tyvek/<br>Nylon film | No contact | Not applicable | | 10 | HEPA Filter | PP | Tissue/ Bone/ Dentin | Limited | | 11 | 15Male - 8mm<br>connector | Styrene-Butadiene<br>Copolymer | Tissue/ Bone/ Dentin | Limited | {5}------------------------------------------------ | | Component | Material type | Nature of Body Contact | | |----|--------------------------------------|-------------------------------|------------------------|----------------| | | | | Contact | Duration | | 12 | 1m PVC Tubing | PVC | Tissue/ Bone/ Dentin | Limited | | 13 | 22Female - 8mm<br>connector | Styrene-Butadene<br>Copolymer | Tissue/ Bone/ Dentin | Limited | | | Glue (Note<br>2) | Medical device<br>adhesive | Tissue/ Bone/ Dentin | Limited | | 14 | Chamber<br>Moulded | Blend of K-resin & PS | Tissue/ Bone/ Dentin | Limited | | 15 | Gasket Santoprne<br>200Ser BseMk2 | TPE | Tissue/ Bone/ Dentin | Limited | | 16 | Base Sft<br>Anodised MR200<br>Series | Aluminium | Tissue/ Bone/ Dentin | Limited | | 17 | Printing | Ink | No contact | Not applicable | | 18 | Adaptor 22M/15F<br>Barb Surgical | Blend of K-resin &<br>Styron | Tissue/ Bone/ Dentin | Limited | | 19 | Tube Silicon<br>4.8mm dia | Silicon | Tissue/ Bone/ Dentin | Limited | | 20 | Funnel | PP | Tissue/ Bone/ Dentin | Limited | #### Technological Characteristics Comparison 1.4. The primary differences between the HumiGard™ system and predicate Insuflow device are the point at which the water is humidified and the method used to humidify the CO2 gas. The HumiGard™ system humidifies the CO2 gas proximal to the gas source, while the gas is humidified proximal to the patient with the Insuflow device. The HumiGard™ system conditions the gas from the control unit by using a water-filled chamber that is seated on a heating plate. Once the heater plate warms to the target temperature, the heated water in the chamber produces vapour that humidifies the CO2 gas as it passes through the chamber. The Insuflow laparoscopic gas conditioning device provides humidification directly within the disposable filter heater/humidifier tubing set. The tubing set includes a heating mechanism, a small water chamber, and a "wick" of moistened material through which the heated CO2 gas passes and is thus humidified. {6}------------------------------------------------ | Technical Specifications | | | | |------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design / technological<br>characteristic for<br>comparison | Subject device<br>(HumiGard™ Surgical<br>Humidification<br>System) | Predicate device<br>(Insuflow Device,<br>Model 6198) | Comments | | Chamber capacity | 180 mL | 10 mL | Capacity does not<br>introduce any different<br>questions of safety or<br>effectiveness as the<br>capacity is<br>commensurate with the<br>size of the respective<br>water chambers. | | Humidification<br>Element Position | Proximal to the gas<br>source | Proximal to the patient | The humidification<br>element position does<br>not introduce any<br>different questions of<br>safety or effectiveness<br>as it has no impact on<br>the humidity output<br>performance.<br>HumiGard and Insuflow<br>provide equivalent<br>relative humidity and<br>output temperature. | | Humidity Performance | At 32.1 °C | At 32.4 °C | Difference is not<br>clinically significant | | Maximum Input Flow<br>Rate | ≤ 45 L/min | 40 L/min | Equivalent | | Achieved Flow Rate | 15 L/min | 7-8 L/min | Achieved flow rate does<br>not introduce any<br>different questions of<br>safety or effectiveness<br>as both devices are<br>capable of operation<br>within the flow<br>parameters of<br>commercially available<br>insufflators | #### 1.5. Non-Clinical Performance Data Testing for the HumiGard™ system was conducted in accordance with the following standards: | Standard | Title | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005 +<br>A1:2012 (Ed 3.1) | Medical Electrical Equipment - Part 1: General requirements for basic<br>safety and essential performance | | IEC60601-1-2:2007 | Medical electrical equipment — Part 1-2: General requirements for basic<br>safety and essential performance — Collateral standard: Electromagnetic<br>compatibility — Requirements and tests | | ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testing<br>within a risk management process | | ISO 10993-10: 2010 | Biological evaluation of medical devices - Part 10: Tests for irritation and<br>skin sensitization | | ISO 10993-5:2009/(R)<br>2014 | Biological evaluation of medical devices -- Part 5: Tests for In Vitro<br>cytotoxicity | | ANSI/AAMI/ISO11607-1:<br>2006 | Packaging for terminally sterilized medical devices. Requirements for<br>materials, sterile barrier systems and packaging systems | {7}------------------------------------------------ | ANSI/AAMI/ISO11607-2:<br>2006 | Packaging for terminally sterilized medical devices -- Part 2: Validation<br>requirements for forming, sealing and assembly processes | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | | ISO 11737-2:2009 | | ISO 11135:2014 | | Test results demonstrate that the HumiGard™ system conforms to the above-referenced standards. Biocompatibility evaluation of cytotoxicity, irritation and sensitization for the ST520 kit was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 2016). The results of the biocompatibility testing were acceptable. The HumiGard™ system software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since it a failure of the device software could result in minor injury prior to mitigation of hazards, either to a patient or to a user of the device. The software validation documentation provided was complete and acceptable. Performance verification testing of the HumiGard™ system consisted of temperature output, humidity output, flow rate, leak rate, compliance, maximum delivered enthalpy, surface temperature of the tubing, condensation, and outlet connection strength. The verification testing demonstrated that the device performs as intended and met appropriate acceptance criteria. The results of the comparative bench testing demonstrate that the performance of the HumiGard™ system with respect to these key performance characteristics are comparable to the predicate Insuflow device. #### 1.6. Clinical Performance Data Substantial equivalence was did not include an assessment of clinical performance data. #### 1.7. Conclusions Based on the same intended use, different technological characteristics that do not raise different questions of safety and effectiveness and acceptable performance testing, the HumiGard™ Surgical Humidification System is as safe, as effective, and performs as well as the predicate Insuflow device.