(146 days)
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
MODES OF OPERATION
The EMV+ offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient.
Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target.
Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)
Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support.
ADDITIONAL ADJUNCTS OF OPERATION
In addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits.
Mode Breath Target Pressure Support (PS) Noninvasive Positive Pressure Ventilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes
Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.
Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target.
The document provided is a 510(k) summary for a medical device, the Uni-Vent® 731 Series Model EMV+® Portable Critical Care Ventilator. It describes modifications to an already legally marketed device (predicate device K091238), specifically adding new operating modes (SIMV and CPAP with Pressure Support and Leak Compensation).
However, the provided summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device studies (i.e., performance metrics like sensitivity, specificity, AUC, or the methodology for their calculation).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: Highlighting the new features and confirming no changes to fundamental scientific technology, materials, biocompatibility, power input, or intended use.
- Compliance with recognized standards: Stating that the device meets the same performance criteria as the predicate, which are specified by a list of national and international standards for ventilators, medical electrical equipment, pulse oximetry, and environmental factors.
- Quality system adherence: Stating that the device design and development process followed ISO 13485 and ISO 14971.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not retrievable from this specific document, as it's a 510(k) submission for a non-AI medical device update.
Here's an attempt to answer the questions based only on the provided document, acknowledging the limitations:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Claimed Equivalence/Compliance) |
|---|---|
| ASTM F1100-90 (Ventilators for Critical Care) | Meets the same performance criteria as the predicate device (K091238). |
| IEC 60601-1 (Medical Electrical Equipment - General Safety) | Meets the same performance criteria as the predicate device (K091238). |
| ISO 9919:2005 (Pulse Oximeter Equipment Safety/Performance) | Meets the same performance criteria as the predicate device (K091238). |
| Mil-Std-461F (Electromagnetic Interference) | Meets the same performance criteria as the predicate device (K091238). |
| Mil-Std-810F (Environmental Engineering Considerations) | Meets the same performance criteria as the predicate device (K091238). |
| ISO 13485 (Quality Systems - Medical Devices) | Device design and development process was in accordance with this standard. |
| ISO 14971 (Application of Risk Management to Medical Devices) | Device design and development process was in accordance with this standard. |
| Operational Modes (AC, SIMV, CPAP with PS/NPPV) | Operates as specified with the new modes and adjuncts, maintaining the operating principles of the predicate. |
| PEEP Range (0-25 cm H2O, min 3 cm H2O in CPAP-NPPV) | Maintains specified PEEP range. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable/Not provided. This 510(k) submission relies on compliance with recognized standards and substantial equivalence to a predicate device, not a distinct clinical "test set" in the context of an AI/ML algorithm evaluation.
- Data provenance: Not applicable/Not provided for performance testing. The document refers to standards compliance and design/development processes.
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 provided. Ground truth establishment for a test set like in AI/ML performance evaluation is not detailed for this type of medical device submission. The "ground truth" here is adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- Not applicable. This is not an AI-enabled device. This document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device. The "performance" refers to the device's mechanical and electronic function according to specifications and standards, not an algorithm's diagnostic or predictive output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a traditional medical device like a ventilator, the "ground truth" for its performance is typically established through direct measurement against established engineering specifications, safety standards, and physiological models/simulators, rather than expert consensus on diagnostic images or pathology. The document indicates compliance with a suite of standards which define these performance criteria.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image shows a logo for IMPACT Instrumentation Inc. The logo features the word "IMPACT" in large, bold letters, superimposed over a world map. Above the logo, there is a handwritten number, "K103318". The logo is simple and clean, with a focus on the company name and a global image.
APR - 7 2011
27 Fairfield Place, West Caldwell, NJ 07006. P.O Box 508, West Caldwell, NJ 07007-0508
510(k) Summary
This 510(k) summary consists of a table with the information required in the 510(k) Summary Checklist from the FDA Guidance document. It also includes the completed checklist with approval signature.
| Description ofRequiredInformation | Information |
|---|---|
| Owner'sName | Leslie H. Sherman (President) |
| Address | 27 Fairfield Place, West Caldwell NJ 07006 |
| Phone | 973-882-1212 |
| Fax | 973-882-4993 |
| ContactPerson | Susan McNevin Ph.D., CQA/ CQEQuality Engineer |
| Date thisSummary wasprepared | January 4, 2011 |
| Trade name ofdevice | Uni-Vent® 731 Series Model EMV+® Portable Critical Care Ventilator |
| Commonname | ventilator |
| Classificationname | Continuous Ventilator (21 CFR 868.5895, Product Codes CBK, DQA) |
| Legallymarketeddevice –EquivalenceClaim | This device has updated software from the Predicate EMV+ ventilator (K091238). This update provides SIMV (Synchronized Intermittent Mandatory Ventilation) and CPAP (Continuous Positive Airway Pressure) modes with ventilator support options of Pressure Support and Leak Compensation. |
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| Description ofRequiredInformation | Information | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Description ofthe device | MODES OF OPERATIONThe EMV+ offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient.Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target.Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support. | ||||||||||||||||
| ADDITIONAL ADJUNCTS OF OPERATIONIn addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits. | |||||||||||||||||
| Mode BreathTarget Pressure Support(PS) Noninvasive Positive PressureVentilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes | |||||||||||||||||
| Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target. |
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| Description ofRequiredInformation | Information | ||||||
|---|---|---|---|---|---|---|---|
| Intended Useof Device | The Intended Use is the same as the Predicate device (K091238):"The Model 731EMV+ (EMV+) is indicated for use in the management ofinfant through adult patients weighing ≥5 kg with acute or chronic respiratoryfailure or during resuscitation by providing continuous positive-pressureventilation. It is appropriate for use in hospitals, outside the hospital, duringtransport and in austere environments where it may be exposed to rain, dust,rough handling and extremes in temperature and humidity. With anappropriate third-party filter in place, it may be operated in environmentswhere chemical and/or biological toxins are present (see External Filter Use).It is not intended to operate in explosive environments. The EMV+ isintended for use by skilled care providers with knowledge of mechanicalventilation, emergency medical services (EMS) personnel with a basicknowledge of mechanical ventilation and by first responders under thedirection of skilled medical care providers. " | ||||||
| ComparisonTechnologicalCharacteristicsto Predicate | The changes modify the specification of the device in the following manner:EMV+ (K091238) Modified EMV+ Operating Mode: AC Operating Mode: AC, SIMV, CPAP withand without Pressure support andwith and without Noninvasive PositivePressure Ventilation (NPPV) PEEP: 0 to 25 cm H2O PEEP: 0 to 25 cm H2O (The minimumPEEP in CPAP-NPPV is 3 cm H20) There is no change to the product materials or biocompatibility. There is no change to the power input or battery usage. There is no change to Impact®'s intended use statement. There is no change to the devices' fundamental scientific technology. The operating principals remain the same. The modified EMV+ provides theoperator methods consistent with the standard of care for managing patientswith acute or chronic respiratory failure. |
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| Description ofRequiredInformation | Information | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non-ClinicalPerformancedata | This device meets the same performance criteria as the Predicate (K091238).These criteria are specified by: | ||||||||||||||
| Standard Standard Title ASTM F1100-90 Ventilators Intended for use in Critical Care IEC 60601-1 Medical Electrical Equipment - Part 1, GeneralRequirements for Safety ISO 9919:2005 Medical electrical equipment- particular requirementsfor the basic safety and essential performance of pulseoximeter equipment for medical use Additional Environmental Standards: Mil-Std-461F Requirements for the Control of ElectromagneticInterference Characteristics of Subsystems andEquipment Mil-Std-810F Environmental Engineering Considerations andLaboratory Tests | |||||||||||||||
| ClinicalPerformance | N/A. No clinical performance data is being submitted. | ||||||||||||||
| Safe andEffective asPredicate | The device design and development process is the same as the Predicate(K091238). It was in accordance with: | ||||||||||||||
| ISO 13485 Quality Systems - Medical Devices ISO 14971 Medical Devices - Application of Risk Management toMedical Devices | |||||||||||||||
| The resulting device being submitted is as safe and effective as the Predicate(K091238). | |||||||||||||||
| OtherInformationrequested byFDA | Impact Instrumentation, Inc. will provide the FDA with any additional requiredinformation. |
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Susan McNevin. Ph.D Quality Engineer Impact Instrumentation, Incorporated 27 Fairfield Place West Caldwell, New Jersey 07006
APR - 7 2011
Re: K103318
Trade/Device Name: Uni-Vent®) 731 Series Model EMV4® Portable Critical Care Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK and DQA Dated: March 30, 2011 Received: March 31, 2011
Dear Dr. McNevin:
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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Page 2 - Dr. McNevin
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Wh for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):
Device Name: Uni-Vent®) 731 Series Model EMV+® Portable Critical Care Ventilator
Indications For Use:
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
$10(k) Number: 103318
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).