SafeT T-Piece Resuscitator

{0}------------------------------------------------ November 16, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below. Ventlab, LLC Rob Yamashita Director of Regulatory Affairs 2710 Northridge Drive NW - Suite A Grand Rapids, Michigan 49544 Re: K173373 Trade/Device Name: SafeT T-Piece Resuscitator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: October 11, 2018 Received: October 17, 2018 Dear Rob Yamashita: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Amy K. Levelle -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K173373 #### Device Name Ventilator, Emergency, Powered (Resuscitator) Indications for Use (Describe) The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb). 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 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 | Date Prepared: | 10/11/2018 | |----------------------------|----------------------------------------------------| | Proprietary or Trade Name: | SafeT T-Piece Resuscitator | | Common/Usual Name: | Powered emergency ventilator | | Classification Code/Name: | BTL - Powered emergency ventilator<br>CFR 868.5925 | | Proposed Regulatory Class: | Class II | | Official Contact: | Rob Yamashita | | | Director of Regulatory Affairs | | | Ventlab, LLC | | | 2710 Northridge Dr. NW, Suite A | | | Grand Rapids, MI 49544 USA | | | Phone: (616) 259-8373 | | Predicate Devices: | Primary – Mercury Medical Neo-Tee™ – K093913 | | | Reference – Fisher & Paykel NeoPuff™ – K892885 | #### Device Description The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb). It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure. The T-Piece resuscitator can be connected to the patient via a face mask or tube. The subject device consists of several components: - T-Piece patient valve with variable PEEP dial and integrated manometer . - . Adjustable inspiratory pressure controller - . 40 cm H2O pressure relief valve - 7' Oxygen tubing with a red universal (Fits-all) connector . - 20" x 10 mm circuit tubing . - Face mask . {4}------------------------------------------------ ## Indications for Use The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb). ## Technological Characteristics The SafeT T-Piece Resuscitator is a circuit intended for emergency resuscitation of neonates and infants. Oxygen or blended gas flows through the circuit, which is composed of an inspiratory pressure controller and a T-Piece patient valve. The inspiratory pressure controller allows adjustment of Peak Inspiratory Pressure (PIP). This inspiratory pressure controller has an integral pressure relief valve, which prevents the inspiratory pressure from exceeding 40 cm H2O. The T-Piece patient valve has an integral manometer which reads and displays both Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). The T-Piece patient valve consists of a PEEP dial, which allows adjustment of Positive End-Expiratory Pressure (PEEP), and a patient port for attachment to face masks and tubes. The subject device contains a face mask. #### Substantial Equivalence Discussion The following table compares SafeT to the predicate device with respect to its physical state, structure, materials, mechanical properties, indications for use, biocompatibility and performance testing, and provides detailed information regarding the basis for the determination of substantial equivalence. The reference device is also included in this table for comparative purposes. | | SunMed SafeT | Mercury Medical<br>Neo-Tee | Fisher & Paykel<br>NeoPuff | Similarities /<br>Differences | |---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SunMed | Mercury Medical | Fisher & Paykel | - | | 510(k) | Current submission | K093913 | K892885 | - | | Device Type | Subject Device | Primary Predicate | Reference Device | - | | Classification | II | II | II | Same | | Product Code | BTL | BTL | BTL | Same | | Regulation<br>Number | 868.5925 | 868.5925 | 868.5925 | Same | | Applicable<br>Standards | ISO 10651-5, Lung<br>Ventilators for<br>Medical Use -<br>Particular<br>Requirements for<br>Basic Safety and<br>Essential<br>Performance | ISO 10651-5,<br>Lung Ventilators<br>for Medical Use -<br>Particular<br>Requirements for<br>Basic Safety and<br>Essential<br>Performance | ISO 10651-5,<br>Lung Ventilators<br>for Medical Use -<br>Particular<br>Requirements for<br>Basic Safety and<br>Essential<br>Performance | Same | | | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors<br><br>ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors<br><br>ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors<br><br>ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | | | | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors<br><br>ISO 10651-4, Lung ventilators - Part 4: Particular requirements for operator powered resuscitators | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors | | | Indications of Use | The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). | The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb.) | Manually operated, gas powered resuscitator which provides controlled and accurate resuscitation of newborn babies | The subject and predicate device have the same intended use. | | Patient Connection | Face Mask & ET Tube | Face Mask & ET Tube | Face Mask & ET Tube | Same | | Environment of Use | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU | Same | | Patient<br>Population | Infants and<br>neonates < 10 kg<br>(22 lb) | Infants and<br>neonates < 10 kg<br>(22 lb) | Infants < 10 kg (22<br>lb) | Same | | Prescriptive | Persons trained in<br>infant / neonate<br>resuscitation | Persons trained in<br>infant / neonate<br>resuscitation | Persons trained in<br>infant / neonate<br>resuscitation | Same | | Reusable | Single use,<br>disposable | Single use,<br>disposable | Single use,<br>disposable (T-<br>Piece Circuit) | Same | | Useful Life | less than 24 hours | less than 24 hours | Not specified | Same | | Shelf Life | 2 years | 2 years | Not specified | Same | | Design | Includes PIP<br>controller, tubing,<br>and patient valve<br>with manometer<br>(with PEEP<br>adjustment) | Includes PIP<br>controller, tubing,<br>and patient valve<br>with manometer<br>(with PEEP<br>adjustment) | Includes<br>resuscitator unit<br>(with integral PIP<br>controller) and<br>accessories - T-<br>Piece Circuit,<br>Masks, Gas Supply<br>Line (i.e. tubing) | The subject and<br>predicate device<br>have the same<br>design. | | Materials | ABS and<br>Polypropylene<br>(patient valve,<br>PEEP Dial,<br>Integrated<br>Manometer,<br>Patient Port, PIP<br>Dial, Inspiratory<br>Pressure<br>Controller),<br>Silicone<br>(Manometer<br>diaphragm),<br>Medical Grade<br>Stainless Steel<br>(manometer<br>spring), Phosphor<br>bronze (PEEP<br>spring), and<br>flexible PVC<br>(mask and circuit<br>tubing) | Common plastics<br>and metals | Common plastics<br>and metals | The materials used<br>in the subject and<br>predicate device<br>are similar and<br>well understood. | | Energy Source | Gas powered<br>(compressed O2 or<br>gas blend) | Gas powered<br>(compressed O2 or<br>gas blend) | Gas powered<br>(compressed O2 or<br>gas blend) | The subject and<br>predicate device<br>have the same<br>energy source. | | Gas Flow<br>Provided by | Wall gas or<br>cylinder | Wall gas or<br>cylinder | Wall gas or<br>cylinder | Same | | Cycling<br>Pressure Range | 0 to 40 cm H2O | 0 to 40 cm H2O | 0 to 40 cm H2O<br>(Max Pressure<br>Relief Factory Set<br>(a 40 cm H2O) | Same | | Ventilatory<br>Frequency | Up to 60<br>breaths/min (ISO<br>10651-5 Table 1) | Up to 60<br>breaths/min (ISO<br>10651-5 Table 1) | Up to 60<br>breaths/min (ISO<br>10651-5 Table 1) | Same | | Dead Space (no<br>accessory<br>attached) - Avg.<br>value from Gas<br>Trace Method<br>(ISO 10651-4<br>A.4.10) | 3.07 ml | 2.67 ml | Not specified | The subject and<br>predicate device<br>have similar dead<br>space. In ISO<br>10651-5 for<br>manual<br>resuscitators,<br>allowable dead<br>space is 30% of<br>the minimum<br>delivered tidal<br>volume of 18 mL<br>for a total of 5.4<br>mL. | | Dead Space (18<br>Fr endotracheal<br>tube - worst<br>case) - Avg.<br>value from Gas<br>Trace Method<br>(ISO 10651-4<br>A.4.10) | 7.4 ml | 6.9 ml | Not specified | The subject and<br>predicate device<br>have similar dead<br>space with similar<br>ET tubes and do<br>not raise questions<br>of safety and<br>effectiveness. | | Dead Space<br>(with infant<br>face mask -<br>worst case) -<br>Avg. value<br>from Gas Trace<br>Method (ISO<br>10651-4<br>A.4.10) | 29.7 ml | 29.4 ml | Not specified | The subject and<br>predicate device<br>have similar dead<br>space with similar<br>infant face mask<br>and do not raise<br>questions of safety<br>and effectiveness. | | Dead Space<br>(with neonate<br>face mask) -<br>Avg. value<br>from Gas Trace<br>Method (ISO<br>10651-4 A<br>4.10) | 22.2 ml | 19.7 ml | Not specified | The subject and<br>predicate device<br>have similar dead<br>space with similar<br>neonate face<br>masks and do not<br>raise questions of<br>safety and<br>effectiveness. | | Operational<br>Gas Flow Rate<br>(input gas flow<br>range) | 5 - 15 LPM | 5 - 15 LPM | 5 L/min (min) - 15<br>L/min (max) | Same | | Peak<br>Inspiratory<br>Flow | 15 LPM | 15 LPM | 15 LPM | Same | | Manometer<br>Range | Up to 60 cm H2O | Up to 60 cm H2O | - 10 to 80 cm H2O | The subject and<br>predicate device<br>have the same<br>manometer range. | | Manometer<br>Accuracy | Up to 15 cm H2O -<br>± 3 cm H2O<br>Greater than 15 cm<br>H2O - ± 5 cm H2O | Up to 15 cm H2O -<br>± 3 cm H2O<br>Greater than 15<br>cm H2O - ± 5 cm<br>H2O | +/- 2.0% of Full<br>Scale Deflection | The subject and<br>predicate device<br>have the same<br>manometer<br>accuracy. | | Peak<br>Inspiratory<br>Pressure (PIP) | 0 to 40 H2O @ 15<br>LPM | 0 to 40 H2O @ 15<br>LPM | @ 5 L/min - 2 to<br>70 cm H2O<br>@ 8 L/min - 3 to<br>72 cm H2O<br>@ 10 L/min - 4 to<br>73 cm H2O<br>@ 15 L/min - 8 to<br>75 cm H2O | Same | | Maximum<br>Pressure Relief<br>(high pressure<br>pop-off) | 40 cm H2O | 40 cm H2O | Max Pressure<br>Relief Factory Set<br>@ 40 cm H2O | Same | | Visual or<br>Audible<br>Indication of<br>High Pressure | Audible | Audible | Not specified | Same | | Peak End-<br>Expiratory<br>Pressure<br>(PEEP) Range | At 5 LPM, 1 to 3<br>cm H2O<br>At 8 LPM, 2 to 7<br>cm H2O<br>At 10 LPM, 4 to 12<br>cm H2O<br>At 15 LPM, 9 to 23<br>cm H2O | At 5 LPM, up to<br>approx. 2 cm H2O<br>At 8 LPM, up to<br>approx. 6 cm H2O<br>At 10 LPM, up to<br>approx. 9 cm H2O<br>At 15 LPM, up to<br>approx. 15 cm<br>H2O | At 5 L/min - 1 to 5<br>cm H2O<br>At 8 L/min - 1 to 9<br>cm H2O<br>At 10 L/min - 2 to<br>15 cm H2O<br>At 15 L/min - 3 to<br>25 cm H2O | The subject device<br>range and the<br>predicate device's<br>upper limit is<br>different, however,<br>substantially<br>equivalent. The<br>subject device<br>range falls within<br>those of the<br>reference device<br>and do not raise<br>questions of safety<br>and effectiveness. | | Delivered<br>Oxygen<br>Concentration | Up to 100% O2 | Up to 100% O2 | Up to 100%<br>depending on gas<br>supply | Same | | Oxygen<br>Concentration<br>with Optional<br>Blender | Up to 100% O2 | Up to 100% O2 | Not specified | Same | | Inspiratory<br>Resistance | 1.2 cm H2O at<br>minimum PEEP<br>setting @ 6 LPM | 1.6 cm H2O at<br>minimum PEEP<br>setting @ 6 LPM | Not specified | Similar | | Expiratory<br>Resistance | 0.8 cm H2O at<br>minimum PEEP<br>setting @ 6 LPM | 0.2 cm H2O at<br>minimum PEEP<br>setting @ 6 LPM | Not specified | Similar | | Storage<br>Temperature<br>Range | - 40° C to +60° C,<br>up to 95% RH | - 40° C to +60° C,<br>up to 95% RH | - 10 to 50 °C (+14<br>to +122 °F), up to<br>95% humidity | Same | | Operating<br>Temperature<br>Range | - 18° C to +50° C,<br>up to 95% RH | - 18° C to +50° C,<br>up to 95% RH | - 18 to 50 °C (- 0.4<br>to +122 °F), up to<br>95% humidity | Same | | Immersion<br>Resistance | Meets ISO 10651-5<br>Section 6.3.3 | Meets ISO 10651-<br>5 Section 6.3.3 | Not specified | Same | | Operating time<br>(E cylinder) | 660 L @ 15 LPM ~<br>47 min. | 660 L @ 15 LPM<br>~ 44 min. | 400 L @ 8 L/min -<br>50 minutes | Similar | | Size | Meets ISO 10651-5<br>Section 6.4.1 -<br>passes through<br>300mm X 600mm<br>opening | Meets ISO 10651-<br>5 Section 6.4.1 -<br>passes through<br>300mm X 600mm<br>opening | Height 250 mm<br>Width 200 mm | Similar | | Mass | Meets ISO 10651-5<br>Section 6.4.2 - 120<br>grams (entire<br>resuscitator). 40<br>grams (patient<br>valve) | Meets ISO 10651-<br>5 Section 6.4.2 -<br>83 grams | 1.9 kg | Similar | | Patient<br>Connection | ISO 5356-1 - 15<br>mm taper female | ISO 5356-1 - 15<br>mm taper female | ISO 5356-1 - 15<br>mm taper female | Same | | Universal<br>Supply<br>Connection | CGA 1240 Oxygen<br>DISS standard | CGA 1240<br>Oxygen DISS<br>standard | CGA 1240<br>Oxygen DISS<br>standard | Same | Substantial Equivalence Comparison Table {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Indications for Use – The subject device indications for use is the same as the predicate device. Both devices are gas-powered emergency ventilators intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. The patient populations are identical as both are specifically designed for neonate and infant use. #### Technological Characteristics – Features, Material, and Principles of Operation #### Principles of Operation and Features The principles of operation for the subject and predicate devices are identical. The setup and operation of the devices are equal. Further, the operation of the PIP dial and PEEP dial for the subject and predicate devices are also equal. {10}------------------------------------------------ For both the subject and predicate T-Piece Resuscitators. Oxygen or blended gas flows through the circuit, which is composed of an inspiratory pressure controller and a T-Piece patient valve. The subject and predicate devices have an inspiratory pressure controller that allows adjustment of Peak Inspiratory Pressure (PIP). This inspiratory pressure controller has an integral pressure relief valve, which prevents the inspiratory pressure from exceeding 40 cm H2O. The T-Piece patient valve has an integral manometer which reads and displays both Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). The T-Piece patient valve consists of a PEEP dial, which allows adjustment of Positive End-Expiratory Pressure (PEEP), and a patient port for attachment to face masks and endotracheal tubes. Both the subject and predicate devices contain a face mask. Both the subject and predicate devices are connected to a hospital flowmeter that is connected to an Oxygen or blended gas source. Gas flow is then adjusted with a flowmeter. Additionally, the subject and predicate devices are of similar size and mass. #### Material The subject device materials are ABS and Polypropylene (patient valve, PEEP Dial, Integrated Manometer, Patient Port, PIP Dial, Inspiratory Pressure Controller), Silicone (Manometer diaphragm), Medical Grade Stainless Steel (manometer spring), Phosphor bronze (PEEP spring), and flexible PVC (mask and circuit tubing). The subject device has passed all performance testing to the applicable standards. #### Operating Time The predicate device has an e-cylinder operating time of 44 minutes (@15 LPM. The subject device has an e-cylinder operating time of 47 minutes at 15 LPM. The subject device's operating time is three minutes longer than the predicate device. This difference of + 3 minutes for our subject device does not impact substantial equivalence because the purpose of the e-cylinder is to provide backup oxygen in case the pipeline supply fails. #### Face Mask Accessory The six different face masks included with the subject device are made of flexible PVC. These materials are similar to the predicate device face masks. The six different masks included with the subject device are sized for neonate and infants weighing less than 10 kg (22 lb). Likewise, the predicate device utilizes similar sizes. These sizes of masks are aligned with the subject and predicate Indications for Use Statement. #### Peak End-Expiratory Pressure (PEEP) Flow Range The PEEP flow range for the subject device is substantially equivalent to the predicate device (Mercury Medical NeoTee) and the reference device (Fisher & Paykel NeoPuff). The subject device upper PEEP delivery is 3, 7, 12, and 23 cm H2O and the predicate device upper PEEP delivery {11}------------------------------------------------ is 2, 6, 9, and 15 cm H2O at all four stated flow rates. Further, the subject device PEEP range is within the reference device PEEP range at all four stated flow rates. ## Resuscitator Dead Space The head-to-head testing, to ISO 10651-4 A.4.10 Resuscitator dead space, demonstrated the subject device is substantially equivalent to the predicate device (Mercury Medical Neo-Tee) as it relates to resuscitator dead space. #### Applicable Standards Performance Testing Standards | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date | |------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------| | 10651-5 | ISO | Lung ventilators for medical use - Particular<br>requirements for basic safety and essential<br>performance - Part 5: Gas-powered emergency<br>resuscitators | 1st Ed. | 2006 | | 10651-4 | ISO | Lung ventilators – Part 4: Particular<br>requirements for operator powered<br>resuscitators | 1st Ed. | 2002 | | 5356-1 | ISO | Anaesthetic and respiratory equipment -<br>Conical connectors - Part 1: Cones and sockets | 4th Ed. | 2004 | | 5367 | ISO | Anaesthetic and respiratory equipment -<br>breathing sets and connectors | 5th Ed. | 2014 | | 14971 | ISO | Medical Devices - Application of risk<br>management to medical devices | 2nd Ed. | 2007 | | 13544-2 | BS EN | Respiratory therapy equipment - Part 2: Tubing<br>and connectors | 2002+A1 | 2009 | # Biocompatibility Standards | Standards No. | Standards Organization | Standards Title | Version | Date | |---------------|------------------------|---------------------------------------------------------------------------------------|---------|------| | 10993-5 | ISO | Biological evaluation of medical devices - Part<br>5: Tests for in vitro cytotoxicity | 3rd Ed. | 2009 | {12}------------------------------------------------ | 10993-10 | ISO | Biological evaluation of medical devices - Part<br>10: Tests for irritation and skin sensitization | 3rd Ed. | 2010 | |----------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------| | 10993-17 | ISO | Biological evaluation of medical devices --<br>Part 17: Establishment of allowable limits for<br>leachable substances | 1st Ed. | 2002 | | 10993-18 | ISO | Biological evaluation of medical devices --<br>Part 18: Chemical characterization of materials | 1st Ed. | 2005 | | 18562-1 | ISO | Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications -- Part 1:<br>Evaluation and testing within a risk<br>management process | 1st Ed. | 2017 | | 18562-2 | ISO | Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications -- Part 2:<br>Tests for emissions of particulate matter | 1st Ed. | 2017 | | 18562-3 | ISO | Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications -- Part 3:<br>Tests for emissions of volatile organic<br>compounds (VOCs) | 1st Ed. | 2017 | | 18562-4 | ISO | Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications -- Part 4:<br>Tests for leachables in condensate | 1st Ed. | 2017 | #### Bench Performance Testing The subject and predicate devices were both subjected to the same standards. The subject device met all quantitative and qualitative requirements, as published in the applicable standards. The specifications in the Substantial Equivalency Comparison Table demonstrate that the function and performance are the same or similar between the subject and predicate devices. The subject device passed the following performance requirements per the applicable performance standards cited above: - . Delivered Oxygen Concentration - Resistance to Spontaneous Breathing Inspiratory Resistance ● - Resistance to Spontaneous Breathing Gas Input Pressure ● - Resistance to Spontaneous Breathing - Expiratory Resistance - Inadvertent PEEP ● {13}------------------------------------------------ - Delivered Volume . - Pressure Limitation . - Operation of Manual Trigger ● - Patient Valve Function after Contamination with Vomitus ● - Function after Storage Conditions . - Function During Operating Conditions after Storage Conditions ● - Function after Drop Test . - Function after Immersion in Water . - Inspection of Surfaces, Corners, and Edges ● - . Size Limitation - Resuscitation Mass - Patient Valve with Patient Connection Port Mass . - Function after Dismantling and Reassembly . - Legibility and Durability of Markings . - Flow-Direction-Sensitive Component . - Pressure Limit Under Single Fault Condition . - Resuscitator Dead Space . - . Inadvertent Continuing Expiratory Pressure - Indication of Use of Function Affecting Performance . - Indication of Pneumatic Power Rating . - Durability of Markings ● - Identification . - Controls and Indicators ● - . Indication of Pressure Limiting Device Setting - Pressure-Limitation Activation Alarm Signal ● The below performance requirements in the standards require actual values to be stated on instructions for use and does not define acceptance criteria: - Manometer Accuracy Reading . - PEEP Flow Range . - Gas Container Capacity ● - Protection Against Accidental Adjustments #### Substantial Equivalence Conclusion SafeT T-Piece Resuscitator has the same intended use, indications for use, and physical attributes as Mercury Medical Neo-Tee T-Piece Resuscitator. Any minor differences in the materials used to make the subject device when compared to the predicate device have been successfully evaluated by SunMed through extensive performance and biocompatibility testing on their device, such that the information submitted to the FDA demonstrates that the subject device is as {14}------------------------------------------------ safe and effective as the predicate device and does not raise any new questions of safety and effectiveness. SafeT T-Piece Resuscitator, as designed and manufactured by SunMed, has been determined to be substantially equivalent to Mercury Medical Neo-Tee T-Piece Resuscitator.