(276 days)
o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.
The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.
The provided text describes the O-Two Medical Technologies' e700, e600, and e500 Electronic Transport Ventilators and their substantial equivalence to predicate devices, but it does not contain the specific information requested in the prompt regarding acceptance criteria, performance tables, sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) premarket notification for device clearance, which focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing detailed acceptance criteria and performance study outcomes in the format you've requested.
Here's what can be extracted based on the document, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
-
Not explicitly provided in the requested format with specific numerical acceptance criteria and performance metrics for an AI/algorithm-based device.
-
The document primarily presents a comparative table showing the characteristics and specifications of the proposed devices against the predicate devices (Oxylog 3000 and CAREvent PAR) to demonstrate "Substantial Equivalence." Instead of acceptance criteria, it lists features and parameters and asserts "Yes" for substantial equivalence or notes specific differences.
- Example from the document (partial):
| Characteristic | Proposed o_two e700, o_two e600 and o_two e500 | Predicate K062267 Oxylog 3000 or K081330 CAREvent PAR | Substantial Equivalence |
|---|---|---|---|
| Ventilation modes | CMV, ACV, SIMV, SIMV / PS, BiLVL, BiLVL /PS, CPAP, CPAP /PS | CMV, CMVassist (ACV), SIMV, SIMV /PS, BIPAP(BiLVL), BIPAP (BiLVL)/PS, CPAP, CPAP /PS | Equivalent to Oxylog 3000 |
| Tidal Volume (L) | 50 ml to 2.0 L | 50 ml to 2.0 L | Equivalent to Oxylog 3000 |
| Battery Operating time | 18 hrs | 4 hrs | Better than Oxylog 3000 |
| Safety relief valve | Opens at 80 cmH2O | Opens at 80 cmH2O | Equivalent to Oxylog 3000 |
| Alarms Audible/Visual & indications | Pmax, Pmin, MVHigh, MVLow, Low Battery (20% increments), BCI, Supply pressure Low or No, APNEA | Pmax, Pmin, MVHigh, MVLow, Low Battery (25% increments), Leakage, Supply pressure, APNEA | Equivalent to Oxylog 3000 |
- The "Summary of Performance Testing" section lists qualitative findings from a comparative bench test:
- "Both ventilators delivered equivalent volume-time, pressure-time and flow-time wave forms under the same ventilation mode;"
- "Both ventilators were responsive to spontaneous breathing trigger;"
- "Ventilation Vt, frequency and I:E ratio or Ti of both units were close to target or preset parameters;"
- "Both units delivered similar pressure supports."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document mentions "comparative side-by-side bench testing" but does not specify sample sizes (e.g., number of test cases, simulated patient scenarios, or real patient data) or data provenance. It's bench testing, implying simulated rather than patient 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 / Not available. This is a ventilator device, and the testing described is bench testing against established performance metrics and comparison to predicate devices, not an AI/imaging diagnostic device requiring human expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.
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 was not done. This is not relevant for an electronic transport ventilator. The study focused on proving substantial equivalence through bench testing and comparison of specifications to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a ventilator, a physical system with embedded software, not a standalone algorithm for diagnostic or interpretative tasks. The "Summary of Performance Testing" refers to bench testing of the device's operational performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench testing, the "ground truth" would be the expected physical performance parameters and waveforms based on established engineering and medical device standards (e.g., IEC 60601 series, EN 794-3, ISO 10651-3, ISO 80601-2-12) and the known performance of the predicate devices. The device's output (volume-time, pressure-time, flow-time waveforms, Vt, frequency, I:E ratio, etc.) was compared against these established targets.
8. The sample size for the training set
- Not applicable / Not available. This is not an AI/machine learning device that uses a "training set" in the conventional sense. The device's software logic is developed based on engineering principles and validated through testing.
9. How the ground truth for the training set was established
- Not applicable / Not available. As this is not an AI/machine learning device requiring a training set, the concept of establishing ground truth for a training set does not apply.
In summary: The provided FDA document is a 510(k) clearance letter and summary for a medical device (electronic transport ventilator). It demonstrates "substantial equivalence" to predicate devices through comparative bench testing and specifications. It does not contain the specific information about AI/algorithm performance, detailed acceptance criteria tables, sample sizes for AI model development/testing, or expert-based ground truth evaluations as typically found in submissions for AI-enabled diagnostic or interpretive devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2015
O-Two Medical Technologies Inc. Mr. David Zhang Ouality Assurance Manager 7575 Kimbel Street Mississauga, Ontario CANADA
Re: K141595
Trade/Device Name: o two e700, e600 and e500 Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 12, 2015 Received: February 18, 2015
Dear Mr. Zhang:
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.
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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 (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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141595
Device Name
o two e700, e600, e500 Electronic Transport Ventilators
Indications for Use (Describe)
o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
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| Submitter's Name & Address: | O-Two Medical Technologies7575 Kimbel St.Mississauga, Ontario L5S1C8CanadaTel - 905-677-9410 |
|---|---|
| Official Contact: | David Zhang |
| Application Date: | 2014-04-25 |
| Proprietary or Trade Name: | o_two e700, o_two e600, o_two e500 |
| Common/Usual Name: | Electronic Transport Ventilators |
| Classification Name: | Ventilator, emergency, powered (resuscitator)(21 CFR 868.5925, product code: BTL) |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
Oxylog 3000
Carevent PAR
510k Summary
Device Description:
Predicate Devices:
The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators.
• 510(k) number K062267
• 510(k) number K081330
· Manufactured Draeger medical GmbH
· Manufactured by O-Two Medical Technologies Inc.
They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack.
The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.
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Indications for Use:
o_two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support.
Patient Population:
Adult, child and infant patients with a tidal volume from 50 ml (100 ml for o_two e500) upwards.
Contraindications: NA
Environment of Use:
They are intended for use in the prehospital, intrahospital and ground transport settings.
| Intendeduse | Proposedo_two e700, o_two e600, o_two e500 | PredicateK062267 Oxylog 3000® | SubstantialEquivalence |
|---|---|---|---|
| Operatingprinciple | time-cycled, volume-constant andpressure-controlled (only o_twoe700) emergency and transportventilators | time-cycled, volume-constant andpressure controlledemergency and transport ventilator | Yes |
| Patientpopulation | intended for adult, child and infantpatients with a tidal volume from 50ml* upwards who are in respiratoryand/or cardiac arrest or respiratorydistress and who require ventilatorysupport.* o_two e500: from 100 ml upwards | intended for patients with a tidal volumefrom 50 ml upwards. | Yes |
| Environmentof use | pre-hospital, intra-hospital, inter-hospital and ground transport settings | Mobile use for emergency medical care orprimary care of emergency patients:- During transport in emergency rescuevehicles or aircrafts including helicopters(pre-hospital, transport);- In accident and emergency departments,in the recovery room. (intra-hospital)Mobile use for secondary transfers:- During transfer by road or air(inter-hospital, transport)- When moving ventilated patients aroundin the hospital. (intra-hospital) | Yes (airtransportexcluded) |
| Operatingprinciple | Proposedo_two e700, o_two e600, o_two e500 | PredicateK062267 Oxylog 3000® | SubstantialEquivalence |
| Control logic | time-cycled, volume-constant andpressure-controlled emergency andtransport ventilators | time-cycled, volume-constant andpressure controlled emergency andtransport ventilator | Yes |
| Flow & frequencycontrol | Solenoid Valves activated by themicroprocessor at the controlledintervals to deliver the desired flow Gas blender controlled by themicroprocessor to deliver thevariable flow rates as per theventilation mode Yes | ||
| During inhalation, the pressure controlvalve (VCA) controls the breathingvalve (Anti-Lock up valve) blockingthe exhaust path resulting in all gasdelivered to patient | During inspiration, the pressurecontrol (V6) controls the BreathingValve (V10) to seal off againstatmosphere air | Yes | |
| Expiration | During expiration , the VCA controlsthe breathing valve (Anti-Lock upvalve) to open the patient airwayexhaust path and releasing all exhaledgas to ambient. | During expiration, the V6 controlsBreathing Valve (V10) to adjust therequired patient pressure bycontrolling the pressure in theinspiration hose. | Yes |
| Pressure Control | the pressure control valve (VCA)provide pressure ventilation andsupport by controlling Airwaypressure to desired values | the pressure control (V6) reduces thepressure in the inspiration hose tocontrol pressure support or Pmaxwhen the target values are reached | Yes |
| Safety | In the event of a fault, the pressurecontrol valve (VCA) opens toatmosphere to vent excess pressure;A safety valve limits patient airwaypressure to 80 cm H2O in the presenceof an excesses pressure | In the event of a fault, the pressurecontrol (V6) opens to atmosphere tovent excess pressure;The relieve SV (set to 80 cmH2O)opens in the presence of an excessespressure | Yes |
| Monitoring | The flow and airway pressure signalsmeasured on the patient side aretransmitted to the pressure sensors forflow and airway pressure curvedisplay as well as the measured tidalvolume and Pmax, Pmean. | The flow and airway pressure signalsmeasured on the patient side aretransmitted to the pressure sensors forflow and airway pressure curvedisplay as well as the measured tidalvolume and Pmax, Pmean. | Yes |
| Characteristic | Proposedo_two e700, o_two e600 ando_two e500 | PredicateK062267 Oxylog 3000 orK081330 CAREvent PAR | SubstantialEquivalence |
| Product code | BTL | BTL | Equivalent toCAREvent PAR |
| Ventilation modes | CMV, ACV,SIMV, SIMV / PSBiLVL, BiLVL /PS,CPAP, CPAP /PS | CMV, CMVassist (ACV)SIMV, SIMV /PSBIPAP(BiLVL), BIPAP (BiLVL)/PSCPAP, CPAP /PS | Equivalent toOxylog 3000 |
| CPR mode | CPR mode synchronized withaudible prompts and visualanimated display | CPR mode synchronized withaudible prompts and visualanimated display | Equivalent toCAREvent PAR |
| Chestcompression | 30 compression within 18 secaudible prompts and visualanimation | 30 compression within 18 secaudible prompts and visualanimation | |
| Ventilation | Two 1 sec mandatory breaths ;Breath interval: 2 secCompression/ ventilation rate: 30:2visual animation | Two 1 sec mandatory breaths;Breath interval: 2 secCompression/ ventilation rate: 30:2visual animation | |
| Pmax:60 cmH2O-adult,40 cmH2Ol-child & infant | Pmax:60 cmH2O-adult only | ||
| Waveforms | volume-time, pressure-time andflow- time | volume-time, pressure-time andflow- time | Equivalent toOxylog 3000 |
| Trigger Sensitivity | 1 to 15 L/min | 3 to 15 L/min | Equivalent toOxylog 3000 |
| Input pressure | Compressed O245 PSI to 87 PSI | Compressed O243.5 PSI to 87 PSI | Equivalent toOxylog 3000 |
| PSV (pressuresupport ventilation) | 0, 4- 35 cmH2O (e700) | 0- 35 cmH2O | Equivalent toOxylog 3000 |
| VentilationFrequency | 5 to 60 breath/min | 2 to 60 breath/min (SIMV, BIPAP)5 to 60 breath/min (CMV, ACV) | Equivalent toOxylog 3000 |
| Tidal Volume (L) | 50 ml to 2.0 L | 50 ml to 2.0 L | Equivalent toOxylog 3000 |
| Manual ventilation/Inspiration hold | Yes | Yes | Equivalent toOxylog 3000 |
| Inspiration time toexpiration time ratio | 3: 1 to 1: 4 | 3:1 to 1: 4 | Equivalent toOxylog 3000 |
| Inspiration time Ti(sec.) | 0.3 - 9 sec | 0.2 to 10 sec | Equivalent toOxylog 3000 |
| PEEP/ CPAP(cm H2O) | 0 - 20 cm H2O | 0 - 20 cm H2O | Equivalent toOxylog 3000 |
| F;O2 (%) | 60% & 100% | 60% & 100% | Equivalent toOxylog 3000 |
| Pmax | 10- 80 cmH2O | 20- 60 cmH2O | Equivalent toOxylog 3000 |
| Safety relief valve | Opens at 80 cmH2O | Opens at 80 cmH2O | Equivalent toOxylog 3000 |
| Inhalation pressure(cm H2O) | 4 - 50 | 3 - 55 | Equivalent toOxylog 3000 |
| Apnea back up time | 10 to 60 sec | 15 to 60 sec | Equivalent toOxylog 3000 |
| Battery Operatingtime | 18 hrs | 4 hrs | Better thanOxylog 3000 |
| Live monitoring | Mve, Vte,Paw(AV), Paw(Peak),Fbpm | Mve, Vte,Paw(AV), Paw(Peak), Pplat, PEEPFbpm, FiO2 (%) | Equivalent toOxylog 3000 |
| Wave formdisplayed | Pressure and flow | Pressure and flow | Equivalent toOxylog 3000 |
| AlarmsAudible/Visual &indications | Pmax, Pmin,MVHigh, MVLow,Low Battery (20% increments)BCI,Supply pressure Low or No,APNEA | Pmax, Pmin,MVHigh, MVLow,Low Battery (25% increments)Leakage,Supply pressure,APNEA | Equivalent toOxylog 3000 |
| Accessories | - AC/DC power supply- Lithium ion battery pack- Patient ventilation circuit- Oxygen supply hose | - AC/DC power supply Input:- Lithium ion battery pack- Patient ventilation circuit- Oxygen supply hose | Equivalent toOxylog 3000 |
Comparative table- Intended use
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Comparative table- Operating principle
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Comparative table- Technological characteristics/specifications of performance
{7}------------------------------------------------
Substantially equivalence to the predicate devices:
The proposed devices (o two e700, o two e600 and o two e500) have the equivalent intended use, Patient populations, environment of use, contra-indications and intended user to predicate devices.
The proposed devices and the Oxylog 3000/K062267 provide the similar ventilation modes including CMV, SIMV, ACV, BiLevel, CPAP and Pressure Control and Pressure Support. Furthermore, o two e700, o two e600 and o two e500 use the similar operating principle as the Oxylog 3000. Specific features and range of performance specifications of the o two e700, o two e600 and o two e500 are also found equivalent to those on the Oxylog 3000/K062267.
As there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices regarding the intended patient population, use environment/setting, contraindications, end users, as well as the technological characteristics (operating principles, waveforms, start-up mode, breath triggering and range of performance specifications), the proposed o_two e600 and o_two e500 are viewed as substantially equivalent to the predicate devices - Oxylog 3000/K062267 with the exception of CPR mode.
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In addition, o_two e700, o_two e600 and o_two e500 incorporate an extra CPR mode which use the same CPR function as the predicate CARevent PAR/K081330. As a result, they are considered as substantially equivalent regarding their intended use, use environment/setting, contraindications, end users and technological characteristics.
Summary of Performance Testing:
A comparative side-by-side bench testing was performed on o_two e700 and Oxylog 3000 to demonstrate substantial equivalence of the proposed to the predicate Oxylog 3000.
The summary of the test results follows:
- -Both ventilators delivered equivalent volume-time, pressure-time and flow- time wave forms under the same ventilation mode;
- Both ventilators were responsive to spontaneous breathing trigger; -
- -Ventilation Vt, frequency and I:E ratio or Ti of both units were close to target or preset parameters;
- -Both units delivered similar pressure supports
We have also performed the following safety/essential performance bench testing as per to IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical, software, usability and biocompatibility.
| Safety & Essentialperformance testing | Testing standards/ Comparative testing | TestResult |
|---|---|---|
| Safety & Essentialperformance | IEC 60601-1:2005 | Comply |
| EN794-3:1998/A2 :2009, ISO10651-3:1997, Product specifications,ISO 80601-2-12 :2011 | Comply | |
| EMC | IEC 60601-1-2:2007 w/ increased levels:ESD: ±8kV contact & ±15kV AirRadiated Immunity: 30V/mPower Freq Magnetic: 30A/m | Comply |
| Vibration/ Bump | Vibration (sinusoidal) per IEC60068-2-6 FcRandom vibration per IEC60068-2-36 Fdb, IEC60068-2-64 FhBump per IEC60068-2-29 Eb, IEC60068-2-27 Type 1Crash (10 g) per EN 1789 :2007 Clause 4.5.9 6.2, 6.3.5 | Comply |
| Environmental | ISO10651-3:1997 Clause 10.2.1, EN 794-3:1998/ A1: 2005 Sec.10.2.1 R | Comply |
| Altitude | EN794-3:1998/A2 :2009 10.2.1 c) | Comply |
| Software | IEC 60601-1:2005 Sec.14, ANSI/AMMI/IEC 62304:2006 | Comply |
| Usability | IEC 60601-1-6 :2010, IEC62366 :2007, Human Factor/Usability Validation | Comply |
| Safety - Battery | IEC62133:2002, EN60950-1:2006/ A11:2009/ A1:2010/A12:2011 | Comply |
| Transportation- battery | UN 38.3 test | Comply |
| Bio-compatibility | ISO 10993-1: 2009, ISO 10993-5:2009, ISO 10993-10: 2010 | Comply |
| Function/ Validation test | O-Two Validation Protocol-e700/e600 and Validation Protocol-e500 | Comply |
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Conclusion:
The results of the above comparative performance and specification as well as bench testing demonstrate that the proposed o_two e700, o_two e600 and o_two e500 are as safe, as effective and perform as well as the legally marketed predicate devices - Oxylog 3000 (K062267) and CARevent PAR (K081330).
§ 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).