(385 days)
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).
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.
The provided text is a 510(k) summary for the Ventlab, LLC SafeT T-Piece Resuscitator, a medical device for emergency respiratory support. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA clearance.
Crucially, this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. It focuses on the substantial equivalence of a physical medical device (a resuscitator) based on its technological characteristics and performance testing against established standards, not on an algorithm's performance in interpreting medical images or data.
Therefore, many of the requested points, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, are not applicable to the context of this document.
However, I can extract the closest analogous information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific "acceptance criteria" table in the way one might for an AI device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the compliance with applicable performance standards and the comparative data to predicate devices. The "reported device performance" is demonstrated by stating that the subject device "met all quantitative and qualitative requirements" of these standards and by the head-to-head comparison data presented in the "Substantial Equivalence Comparison Table" and subsequent discussion.
The most direct representation of "acceptance criteria" and "reported device performance" is found within the "Substantial Equivalence Comparison Table" itself, where critical performance metrics of the SafeT T-Piece Resuscitator are compared against those of the predicate device (Mercury Medical Neo-Tee) and a reference device (Fisher & Paykel NeoPuff).
Here is a partial table, extracted and reformatted from the "Substantial Equivalence Comparison Table" that acts as the primary evidence of meeting "acceptance criteria" (i.e., being substantially equivalent to the predicate device):
| Characteristic / Performance Metric | SafeT T-Piece Resuscitator (Reported Performance) | Mercury Medical Neo-Tee (Predicate Device) | Acceptance Criteria/Comparison Outcome (from document) |
|---|---|---|---|
| Indications of Use | Emergency respiratory support for neonates/infants < 10kg. | Emergency respiratory support for neonates/infants < 10kg. | Same (Acceptable for Substantial Equivalence) |
| Patient Population | Infants and neonates < 10 kg (22 lb) | Infants and neonates < 10 kg (22 lb) | Same (Acceptable for Substantial Equivalence) |
| Cycling Pressure Range | 0 to 40 cm H2O | 0 to 40 cm H2O | Same (Acceptable for Substantial Equivalence) |
| Ventilatory Frequency | Up to 60 breaths/min (ISO 10651-5 Table 1) | Up to 60 breaths/min (ISO 10651-5 Table 1) | Same (Acceptable for Substantial Equivalence) |
| Manometer Range | Up to 60 cm H2O | Up to 60 cm H2O | Same (Acceptable for Substantial Equivalence) |
| Manometer Accuracy | Up to 15 cm H2O - ± 3 cm H2O, Greater than 15 cm H2O - ± 5 cm H2O | Up to 15 cm H2O - ± 3 cm H2O, Greater than 15 cm H2O - ± 5 cm H2O | Same (Acceptable for Substantial Equivalence) |
| Peak Inspiratory Pressure (PIP) | 0 to 40 H2O @ 15 LPM | 0 to 40 H2O @ 15 LPM | Same (Acceptable for Substantial Equivalence) |
| Maximum Pressure Relief (high pressure pop-off) | 40 cm H2O | 40 cm H2O | Same (Acceptable for Substantial Equivalence) |
| Visual or Audible Indication of High Pressure | Audible | Audible | Same (Acceptable for Substantial Equivalence) |
| PEEP Flow Range (Example at 15 LPM) | 9 to 23 cm H2O | Up to approx. 15 cm H2O | Subject device range and predicate device's upper limit is different, however, substantially equivalent. Subject device range falls within those of the reference device and do not raise questions of safety and effectiveness. (Deemed Acceptable) |
| Delivered Oxygen Concentration | Up to 100% O2 | Up to 100% O2 | Same (Acceptable for Substantial Equivalence) |
| Resuscitator Dead Space (no accessory attached) | 3.07 ml | 2.67 ml | The subject and predicate device have similar dead space. In ISO 10651-5 for manual resuscitators, allowable dead space is 30% of the minimum delivered tidal volume of 18 mL for a total of 5.4 mL. (Deemed Acceptable) |
| Resuscitator Dead Space (with infant face mask - worst case) | 29.7 ml | 29.4 ml | The subject and predicate device have similar dead space with similar infant face mask and do not raise questions of safety and effectiveness. (Deemed Acceptable) |
| Operating time (E cylinder) | 660 L @ 15 LPM ~ 47 min. | 660 L @ 15 LPM ~ 44 min. | Similar; +3 min for subject device does not impact substantial equivalence as purpose is backup oxygen. (Deemed Acceptable) |
The study that proves the device meets the acceptance criteria is primarily the "Bench Performance Testing" described on page 12-13, assessed against the "Applicable Standards" listed on page 11-12.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is a bench performance test for a physical device, not an AI model. The "tests" refer to evaluations of the manufacturing design and performance characteristics, often involving one or a few units under controlled conditions (e.g., measuring pressure, flow, resistance). The phrase "head-to-head testing" is mentioned for resuscitator dead space but does not specify a "sample size" in the statistical sense for a data set.
- Data Provenance: Not applicable. The "data" comes from the physical testing of the device itself by the manufacturer (Ventlab, LLC/SunMed) to demonstrate compliance with standards. There's no country of origin of patient data, nor is it retrospective or prospective in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device that requires expert-established ground truth from medical images or clinical observations. The "ground truth" for this device's performance is objective measurement against established engineering and safety standards (e.g., ISO 10651-5 for lung ventilators). The experts involved would be engineers and quality control personnel performing the bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human interpretation or adjudication of outputs is described, as this is a physical device subject to objective performance measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is explicitly stated as not being an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical resuscitator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by engineering standards and specifications (e.g., ISO 10651-5, ISO 5356-1) which define acceptable ranges for physical parameters (pressure, flow, dead space, etc.). Compliance is determined by direct physical measurement during bench testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
{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 ventilatorCFR 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 MedicalNeo-Tee | Fisher & PaykelNeoPuff | Similarities /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 |
| RegulationNumber | 868.5925 | 868.5925 | 868.5925 | Same |
| ApplicableStandards | ISO 10651-5, LungVentilators forMedical Use -ParticularRequirements forBasic Safety andEssentialPerformance | ISO 10651-5,Lung Ventilatorsfor Medical Use -ParticularRequirements forBasic Safety andEssentialPerformance | ISO 10651-5,Lung Ventilatorsfor Medical Use -ParticularRequirements forBasic Safety andEssentialPerformance | Same |
| ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical ConnectorsISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical ConnectorsISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical ConnectorsISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ||
| BS EN 13544-2, Respiratory Therapy Equipment, Tubing and ConnectorsISO 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 |
| PatientPopulation | Infants andneonates < 10 kg(22 lb) | Infants andneonates < 10 kg(22 lb) | Infants < 10 kg (22lb) | Same |
| Prescriptive | Persons trained ininfant / neonateresuscitation | Persons trained ininfant / neonateresuscitation | Persons trained ininfant / neonateresuscitation | Same |
| Reusable | Single use,disposable | Single use,disposable | Single use,disposable (T-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 PIPcontroller, tubing,and patient valvewith manometer(with PEEPadjustment) | Includes PIPcontroller, tubing,and patient valvewith manometer(with PEEPadjustment) | Includesresuscitator unit(with integral PIPcontroller) andaccessories - T-Piece Circuit,Masks, Gas SupplyLine (i.e. tubing) | The subject andpredicate devicehave the samedesign. |
| Materials | ABS andPolypropylene(patient valve,PEEP Dial,IntegratedManometer,Patient Port, PIPDial, InspiratoryPressureController),Silicone(Manometerdiaphragm),Medical GradeStainless Steel(manometerspring), Phosphorbronze (PEEPspring), andflexible PVC(mask and circuittubing) | Common plasticsand metals | Common plasticsand metals | The materials usedin the subject andpredicate deviceare similar andwell understood. |
| Energy Source | Gas powered(compressed O2 orgas blend) | Gas powered(compressed O2 orgas blend) | Gas powered(compressed O2 orgas blend) | The subject andpredicate devicehave the sameenergy source. |
| Gas FlowProvided by | Wall gas orcylinder | Wall gas orcylinder | Wall gas orcylinder | Same |
| CyclingPressure Range | 0 to 40 cm H2O | 0 to 40 cm H2O | 0 to 40 cm H2O(Max PressureRelief Factory Set(a 40 cm H2O) | Same |
| VentilatoryFrequency | Up to 60breaths/min (ISO10651-5 Table 1) | Up to 60breaths/min (ISO10651-5 Table 1) | Up to 60breaths/min (ISO10651-5 Table 1) | Same |
| Dead Space (noaccessoryattached) - Avg.value from GasTrace Method(ISO 10651-4A.4.10) | 3.07 ml | 2.67 ml | Not specified | The subject andpredicate devicehave similar deadspace. In ISO10651-5 formanualresuscitators,allowable deadspace is 30% ofthe minimumdelivered tidalvolume of 18 mLfor a total of 5.4mL. |
| Dead Space (18Fr endotrachealtube - worstcase) - Avg.value from GasTrace Method(ISO 10651-4A.4.10) | 7.4 ml | 6.9 ml | Not specified | The subject andpredicate devicehave similar deadspace with similarET tubes and donot raise questionsof safety andeffectiveness. |
| Dead Space(with infantface mask -worst case) -Avg. valuefrom Gas TraceMethod (ISO10651-4A.4.10) | 29.7 ml | 29.4 ml | Not specified | The subject andpredicate devicehave similar deadspace with similarinfant face maskand do not raisequestions of safetyand effectiveness. |
| Dead Space(with neonateface mask) -Avg. valuefrom Gas TraceMethod (ISO10651-4 A4.10) | 22.2 ml | 19.7 ml | Not specified | The subject andpredicate devicehave similar deadspace with similarneonate facemasks and do notraise questions ofsafety andeffectiveness. |
| OperationalGas Flow Rate(input gas flowrange) | 5 - 15 LPM | 5 - 15 LPM | 5 L/min (min) - 15L/min (max) | Same |
| PeakInspiratoryFlow | 15 LPM | 15 LPM | 15 LPM | Same |
| ManometerRange | Up to 60 cm H2O | Up to 60 cm H2O | - 10 to 80 cm H2O | The subject andpredicate devicehave the samemanometer range. |
| ManometerAccuracy | Up to 15 cm H2O -± 3 cm H2OGreater than 15 cmH2O - ± 5 cm H2O | Up to 15 cm H2O -± 3 cm H2OGreater than 15cm H2O - ± 5 cmH2O | +/- 2.0% of FullScale Deflection | The subject andpredicate devicehave the samemanometeraccuracy. |
| PeakInspiratoryPressure (PIP) | 0 to 40 H2O @ 15LPM | 0 to 40 H2O @ 15LPM | @ 5 L/min - 2 to70 cm H2O@ 8 L/min - 3 to72 cm H2O@ 10 L/min - 4 to73 cm H2O@ 15 L/min - 8 to75 cm H2O | Same |
| MaximumPressure Relief(high pressurepop-off) | 40 cm H2O | 40 cm H2O | Max PressureRelief Factory Set@ 40 cm H2O | Same |
| Visual orAudibleIndication ofHigh Pressure | Audible | Audible | Not specified | Same |
| Peak End-ExpiratoryPressure(PEEP) Range | At 5 LPM, 1 to 3cm H2OAt 8 LPM, 2 to 7cm H2OAt 10 LPM, 4 to 12cm H2OAt 15 LPM, 9 to 23cm H2O | At 5 LPM, up toapprox. 2 cm H2OAt 8 LPM, up toapprox. 6 cm H2OAt 10 LPM, up toapprox. 9 cm H2OAt 15 LPM, up toapprox. 15 cmH2O | At 5 L/min - 1 to 5cm H2OAt 8 L/min - 1 to 9cm H2OAt 10 L/min - 2 to15 cm H2OAt 15 L/min - 3 to25 cm H2O | The subject devicerange and thepredicate device'supper limit isdifferent, however,substantiallyequivalent. Thesubject devicerange falls withinthose of thereference deviceand do not raisequestions of safetyand effectiveness. |
| DeliveredOxygenConcentration | Up to 100% O2 | Up to 100% O2 | Up to 100%depending on gassupply | Same |
| OxygenConcentrationwith OptionalBlender | Up to 100% O2 | Up to 100% O2 | Not specified | Same |
| InspiratoryResistance | 1.2 cm H2O atminimum PEEPsetting @ 6 LPM | 1.6 cm H2O atminimum PEEPsetting @ 6 LPM | Not specified | Similar |
| ExpiratoryResistance | 0.8 cm H2O atminimum PEEPsetting @ 6 LPM | 0.2 cm H2O atminimum PEEPsetting @ 6 LPM | Not specified | Similar |
| StorageTemperatureRange | - 40° C to +60° C,up to 95% RH | - 40° C to +60° C,up to 95% RH | - 10 to 50 °C (+14to +122 °F), up to95% humidity | Same |
| OperatingTemperatureRange | - 18° C to +50° C,up to 95% RH | - 18° C to +50° C,up to 95% RH | - 18 to 50 °C (- 0.4to +122 °F), up to95% humidity | Same |
| ImmersionResistance | Meets ISO 10651-5Section 6.3.3 | Meets ISO 10651-5 Section 6.3.3 | Not specified | Same |
| Operating time(E cylinder) | 660 L @ 15 LPM ~47 min. | 660 L @ 15 LPM~ 44 min. | 400 L @ 8 L/min -50 minutes | Similar |
| Size | Meets ISO 10651-5Section 6.4.1 -passes through300mm X 600mmopening | Meets ISO 10651-5 Section 6.4.1 -passes through300mm X 600mmopening | Height 250 mmWidth 200 mm | Similar |
| Mass | Meets ISO 10651-5Section 6.4.2 - 120grams (entireresuscitator). 40grams (patientvalve) | Meets ISO 10651-5 Section 6.4.2 -83 grams | 1.9 kg | Similar |
| PatientConnection | ISO 5356-1 - 15mm taper female | ISO 5356-1 - 15mm taper female | ISO 5356-1 - 15mm taper female | Same |
| UniversalSupplyConnection | CGA 1240 OxygenDISS standard | CGA 1240Oxygen DISSstandard | CGA 1240Oxygen DISSstandard | 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
| StandardsNo. | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|
| 10651-5 | ISO | Lung ventilators for medical use - Particularrequirements for basic safety and essentialperformance - Part 5: Gas-powered emergencyresuscitators | 1st Ed. | 2006 |
| 10651-4 | ISO | Lung ventilators – Part 4: Particularrequirements for operator poweredresuscitators | 1st Ed. | 2002 |
| 5356-1 | ISO | Anaesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets | 4th Ed. | 2004 |
| 5367 | ISO | Anaesthetic and respiratory equipment -breathing sets and connectors | 5th Ed. | 2014 |
| 14971 | ISO | Medical Devices - Application of riskmanagement to medical devices | 2nd Ed. | 2007 |
| 13544-2 | BS EN | Respiratory therapy equipment - Part 2: Tubingand connectors | 2002+A1 | 2009 |
Biocompatibility Standards
| Standards No. | Standards Organization | Standards Title | Version | Date |
|---|---|---|---|---|
| 10993-5 | ISO | Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity | 3rd Ed. | 2009 |
{12}------------------------------------------------
| 10993-10 | ISO | Biological evaluation of medical devices - Part10: Tests for irritation and skin sensitization | 3rd Ed. | 2010 |
|---|---|---|---|---|
| 10993-17 | ISO | Biological evaluation of medical devices --Part 17: Establishment of allowable limits forleachable substances | 1st Ed. | 2002 |
| 10993-18 | ISO | Biological evaluation of medical devices --Part 18: Chemical characterization of materials | 1st Ed. | 2005 |
| 18562-1 | ISO | Biocompatibility evaluation of breathing gaspathways in healthcare applications -- Part 1:Evaluation and testing within a riskmanagement process | 1st Ed. | 2017 |
| 18562-2 | ISO | Biocompatibility evaluation of breathing gaspathways in healthcare applications -- Part 2:Tests for emissions of particulate matter | 1st Ed. | 2017 |
| 18562-3 | ISO | Biocompatibility evaluation of breathing gaspathways in healthcare applications -- Part 3:Tests for emissions of volatile organiccompounds (VOCs) | 1st Ed. | 2017 |
| 18562-4 | ISO | Biocompatibility evaluation of breathing gaspathways in healthcare applications -- Part 4: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.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).