(431 days)
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:
- . Infant - Less than or equal to 10 kg
- Child less than or equal to 23 kg ●
- Adult Greater than 23 kg. ●
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
This is a 510(k) premarket notification for the Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, including a PEEP valve and a disposable manometer. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" in a dedicated table for each device component with specific numerical targets. Instead, it demonstrates performance by comparing the Foremount devices to their respective predicates or by stating that the device meets relevant ISO standards.
We can infer the acceptance criteria are met if the Foremount device's specifications and performance fall within acceptable limits defined by the predicate devices and applicable ISO standards.
Inferred Acceptance Criteria and Reported Device Performance (Resuscitator)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| General | ||
| Indications for Use | Single patient use manual resuscitator for hospital, transport, emergency, and post-hospital care to temporarily ventilate in given body mass ranges. | Same as predicate: Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg (for Models A1, B1); Adult > 23 Kg (for Models A2, B2) |
| Patient Population | Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg | Same as predicate |
| Environment of Use | Hospital, transport, emergency, post-hospital care | Same as predicate |
| Duration of Use | Single patient, disposable < 24 hours | Single patient, disposable < 24 hours |
| Operational Temperature | -18°C ~ 50°C | -18°C ~ 50°C |
| Storage Temperature | -40°C ~ 60°C | -40°C ~ 60°C |
| Functional Performance (ISO 10651-4 and others) | ||
| Dimensions (Size) | Adult: 570x190 mm, Child: 510x190 mm, Infant: 430x180 mm (Predicate) | Adult: 445x190 mm, Child: 350x177 mm, Infant: 325x165 mm. Note: Differences in dimensions were assessed and did not raise new safety/effectiveness concerns. |
| Ventilation Bag Volume | Adult 1500 ml, Child 600ml, Infant 280 ml (Predicate) | Adult 1700 ml, Child 500 ml, Infant 320 ml. Note: Differences in volume were assessed and did not raise new safety/effectiveness concerns, as ISO 10651-4 specifies minimum requirements. |
| Oxygen Collection Bag Volume | Adult 1000 ml, Child 1000 ml, Infant 500 ml (Predicate) | Adult 1000 ml, Child 1000 ml, Infant 600 ml |
| Max Stroke Volume (single hand) | Adult 700 ml, Child 360 ml, Infant 150 ml (Predicate) | Adult 650 ml, Child 370 ml, Infant 180 ml. Note: Differences in volume were assessed and did not raise new safety/effectiveness concerns as ISO 10651-4 specifies minimum requirements. |
| Dead Space | 4.5 ml (measured) / 6.8 ml (labeled) for all sizes (Predicate) | ~ 3.8 ml for all sizes |
| Inspiratory Resistance | Infant: ≤ 0.5cm H2O, Child: ≤ 0.7cm H2O, Adult: ≤ 3.3cm H2O (Predicate) | Infant: 0.5cm H2O, Child: 0.5cm H2O, Adult: 3cm H2O |
| Expiratory Resistance | Infant: ≤ 0.8cm H2O, Child: ≤ 0.8cm H2O, Adult: ≤ 2.6cm H2O (Predicate) | Infant: 0.5cm H2O, Child: 0.5cm H2O, Adult: 2.8 cmH2O |
| Supplemental Oxygen % | Comparable to predicate at various flow rates and tidal volumes (e.g., Infant Vt-70ml x 20bpm: 91/97/99% at 2/5/10 lpm) | Infant Vt-70ml x 20bpm: 90/98/98% at 2/5/10 lpm (and other comparable values). |
| Pop-Off or Pressure Limiting | 40 cm H2O (Infant/Child), 60 cm H2O (Adult) | 40 cm H2O (Infant/Child), 60 cm H2O (Adult) |
| Ability to add PEEP valves | Yes, 0-20 cm H2O | Yes, 0-20 cm H2O |
| Patient connectors | 15 / 22 mm (standard) | 15 / 22 mm |
| PEEP valve fittings | 22 / 30 mm (standard) | 22 / 30 mm |
| Biocompatibility | Non-cytotoxic, non-sensitizers, non-irritants; meets ISO 10993-5, -10, -11; ISO 18562-2 for PM2.5 and inorganic gases. | Found to be non-cytotoxic, non-sensitizers, non-irritants. Tests for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Gas emission (VOC), PM2.5, Inorganic gases (Ozone, CO, CO2) were performed. |
| Materials | PVC, Polycarbonate, Silicone (Predicate) | PVC, Polycarbonate, Silicone |
| Conical connectors | Meets ISO 5356-1 | Meets ISO 5356-1 |
| Shelf-life | 3 years (Predicate) | 5 years. Note: This is a difference, but the document concludes no new safety or effectiveness concerns are raised. |
Inferred Acceptance Criteria and Reported Device Performance (PEEP Valve)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| Indications for Use | Single patient use PEEP valve for hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric. | Same as predicate |
| Pressure range | 2.5 to 10 cmH2O; 5 to 20 cmH2O (Predicate) | 0 to 10 cmH2O; 5 to 20 cmH2O. Note: Broader lower range, but within similar operational function. |
| Adjustable | Yes (Predicate also had fixed options) | Yes |
| Accuracy | +/- 2 cmH2O | +/- 2 cmH2O |
| Connectors | 22 mm / 30 mm (standard) | 22 mm / 30 mm |
| Biocompatibility | Meets biocompatibility standards for externally communicating, limited duration use. | Externally communicating, limited duration of use (<24 hours). Materials are Polycarbonate, Silicone, Stainless Steel spring; passed biocompatibility testing. |
| Materials | Polycarbonate, Silicone, Stainless Steel spring (Predicate) | Polycarbonate, Silicone, Stainless Steel spring |
| Performance Testing | Accuracy, Repeatability, Effects of Aging, Drop Test, Conical fittings | All listed tests were performed. Results implicitly met 'acceptance criteria' by demonstrating substantial equivalence, though specific numerical results beyond accuracy were not detailed in the comparison table. |
Inferred Acceptance Criteria and Reported Device Performance (Disposable Manometer)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| Indications for Use | Single patient use manometer for monitoring patient's airway pressure during ventilation, used with resuscitation systems. | Same as predicate |
| Pressure range | 0 to 60 cmH2O | 0 to 60 cmH2O |
| Markings | Increments of 10 cmH2O | Increments of 10 cmH2O |
| Accuracy | ±2 cmH2O @ 0-10 cmH2O, ±4 cmH2O @ 20 cmH2O, ±5 cmH2O @ 30-40 cmH2O, ±7 cmH2O @ 50-60 cmH2O (Predicate) | ±1 cmH2O @ 0-10 cmH2O, ±2 cmH2O @ 20-30 cmH2O, ±3 cmH2O @ 40-60 cmH2O. Note: The Foremount device reports better accuracy than the predicate. This difference is considered acceptable as it is a performance improvement. |
| Connectors | 15 / 22 mm (standard) | 15 / 22 mm |
| Biocompatibility | Meets biocompatibility standards for externally communicating, limited duration use. | Externally communicating, limited duration of use (<24 hours). Materials are Polycarbonate, Silicone, Stainless Steel Springs; passed biocompatibility testing. |
| Materials | Polycarbonate, Silicone, Stainless Steel Springs (Predicate) | Polycarbonate, Silicone, Stainless Steel Springs |
| Performance Testing | Accuracy, Repeatability, Effects of Aging, Drop Test, Conical fittings | All listed tests were performed. Results implicitly met 'acceptance criteria' by demonstrating substantial equivalence, though specific numerical results beyond accuracy were not detailed in the comparison table. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. It does not specify a "test set" in terms of patient data. The testing involves physical samples of the devices.
- Sample Size: Not explicitly stated for each individual bench test. The nature of the tests (e.g., stroke volume, resistance, oxygen concentration, drop test, aging) implies a sufficient number of devices were tested to draw statistically valid conclusions for engineering verification.
- Data Provenance: This is bench testing data, originating from the manufacturer's testing facilities (Foremount Enterprise Co., Ltd. in Taichung City, Taiwan). It is prospective in that the testing was performed specifically for this 510(k) submission. No patient data (retrospective or prospective) is mentioned as this is a physical device rather than an AI/software device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this submission concerns the hardware and functional performance of medical devices (resuscitators, PEEP valves, manometers) and involves bench testing against engineering standards and predicate device performance, not clinical studies involving expert interpretation of data or images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication typically refers to the process of resolving disagreements between experts in clinical studies or image review. Bench testing results are objective measurements against specified standards or comparative measurements against predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI or imaging software where human readers' performance with and without AI assistance is evaluated on a set of cases. This submission is for a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a physical medical device. There is no "algorithm" or standalone AI component. Performance is assessed through comprehensive bench testing of the device's physical and functional attributes.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Engineering Standards: Primarily ISO 10651-4:2002 (Lung ventilators - Particular requirements for operator-powered resuscitators) and ISO 5356-1:2004 (Anaesthetic and respiratory equipment - Conical connectors).
- Predicate Device Performance: The performance characteristics (e.g., stroke volume, resistance, oxygen concentration, accuracy for PEEP and manometer) of the legally marketed predicate devices (K082092 - GaleMed Dispo-Bag Manual Resuscitator and K122077 - Intersurgical - Airway Pressure Manometer) serve as a comparative benchmark.
- Biocompatibility Standards: ISO 10993 series and ISO 18562-2 for material safety.
8. The Sample Size for the Training Set
Not applicable. This submission is for hardware medical devices. There is no concept of a "training set" as there is no AI algorithm being developed or submitted. The devices are manufactured based on design specifications and then tested.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no "training set," the concept of establishing ground truth for it does not apply.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 11, 2018
Foremount Enterprise Co., Ltd. % Paul Dryden President ProMedic LLC. 131 Bay point Dr, NE St. Petersburg, Fl 33704
Re: K170663
Trade/Device Name: Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories Regulation Number: 21 CFR 868.5915 Regulation Name: Manual emergency ventilator Regulatory Class: Class II Product Code: BTM Dated: April 6, 2018 Received: April 9, 2018
Dear Paul Dryden:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Geeta K. Pamidimukkala -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)
K170663
Device Name
Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories
Indications for Use (Describe)
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
This 510(k) summary is being submitted by Foremount Enterprise in accordance with 21 CFR 807.92.
Date: May 8, 2018
Submitter
| Submitter's name: | Foremount Enterprise Co., Ltd. |
|---|---|
| Submitter's address: | No. 17, Alley 15, Lane 5, Shenan Street, Shengang Dist., Taichung City429, Taiwan |
| Contact person: | Tyson Hsu / President |
| Phone Number: | +886-4-2561-8788 |
| Fax Number: | +886-4-2561-8798 |
Name of the Device(s) and Predicate(s)
| Trade Name: | Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 andAccessories |
|---|---|
| Device Name: | Ventilator, Emergency, Manual (Resuscitator) |
| Product Code: | BTM |
| Regulation #: | 868.5915 |
| Device Class: | 2 |
Predicate: K082092 - GaleMed Dispo-Bag Manual Resuscitator and accessories including Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask and PEEP Valve
Disposable Manometer
Predicate: K122077 - Intersurgical - Airway Pressure Manometer
Device Description:
Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories
Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:
- . Infant - Less than or equal to 10 kg
- Child less than or equal to 23 kg ●
- Adult Greater than 23 kg. ●
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
Indications for Use:
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
{4}------------------------------------------------
Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Substantially Equivalent Information (Predicate Device)
Foremount devices are equivalent to the following predicate devices:
| Description | Foremount | Predicate |
|---|---|---|
| Disposable resuscitator | Without Pop-off valve | GaleMed – K082092 |
| With Pop-off valve | ||
| With Manometer and PEEP valve | ||
| With or without face mask and oxygen collection bag | ||
| PEEP valve | ||
| Pressure manometer | Intended to monitor airway pressure | Intersurgical – K122077Note other resuscitators havebeen cleared with the ability toadd a manometer. |
Table 1 outlines the predicate selection for each.
Table 1 - Predicate Selection
{5}------------------------------------------------
Comparison to Predicate Devices Discussion of Substantial Equivalence for the Resuscitator
| Subject Device | Predicate / K082092 | ||||
|---|---|---|---|---|---|
| Models A1 | Model A2 | Models B1 | Model B2 | GaleMed | |
| Adult, Child, | Adult | Adult, Child, | Adult | Dispo-Bag Manual | |
| and Infant | and Infant | Resuscitator | |||
| Classification | BTM | BTM | |||
| CFR 868.5915 | CFR 868.5915 | ||||
| Ventilator, Emergency, Manual (Resuscitator) | Ventilator, Emergency,Manual (Resuscitator) | ||||
| Indications for Use | Single patient use manualresuscitator for use hospital,transport, emergency, andpost hospital care totemporary ventilate a patientfor the given body massranges of: | Single patient usemanual resuscitator foruse hospital, transport,emergency, and posthospital care totemporary ventilate apatient for the givenbody mass ranges of: | Single patient use manualresuscitator for use hospital,transport, emergency, andpost hospital care totemporary ventilate a patientfor the given body massranges of: | Single patient usemanual resuscitator foruse hospital, transport,emergency, and posthospital care totemporary ventilate apatient for the givenbody mass ranges of: | Single patient use manualresuscitator for usehospital, transport,emergency, and posthospital care to temporaryventilate a patient for thegiven body mass ranges of: |
| Population | Infant $≤$ 10KgChild $≤$ 23 KgAdult > 23 Kg | Adult > 23 Kg | Infant $≤$ 10KgChild $≤$ 23 KgAdult > 23 Kg | Adult > 23 Kg | Infant $≤$ 10KgChild $≤$ 23 KgAdult > 23 Kg |
| Environment of Use | hospital, transport, emergency, andpost hospital care | hospital, transport,emergency, andpost hospital care | |||
| Contraindications | Infant > 10kgChild > 23 kgAdult < 23 kg | Adult < 23 kg | Infant > 10kgChild > 23 kgAdult < 23 kg | Adult < 23 kg | Infant > 10kgChild > 23kgAdult < 23 kg |
| Components | Self-inflating bag | Self-inflating bag | |||
| Intake valves | Intake valves | ||||
| Oxygen collection bag | Oxygen collection bag | ||||
| Oxygen tubing | Oxygen tubing | ||||
| Patient connector | Patient connector | ||||
| Face mask | Face mask | ||||
| Options - Pop-off, PEEP valve, Pressure manometer | Options - Pop-off, PEEPvalve |
| Table 2 - Comparison Disposable Resuscitator Devices | |
|---|---|
| ------------------------------------------------------ | -- |
{6}------------------------------------------------
510(k) Summary
| Subject Device | Predicate / K082092 | |||||
|---|---|---|---|---|---|---|
| Models A1Adult, Child,And Infant | Model A2Adult | Models B1Adult, Child,and Infant | Model B2Adult | GaleMedDispo-Bag ManualResuscitator | ||
| Principle of operation | The patient valve contains a duckbill valve that directs air from compression of the ventilation bag through a patient connector into the patient airway during inspiration and directs the patient expired air out to the atmosphere when the ventilation bag is released during exhalation. If the patient valve incorporates a pop off valve (40 cmH2O for infant and child and 60 cmH2O for adult), excessive pressure will be exhausted to atmosphere to prevent pressure trauma. | Similar | ||||
| Specifications | ||||||
| Duration of use | Single patient, disposable <24 hours | Single patient, disposable <24 hours | ||||
| Operationaltemperature | -18°C ~50°C | -18°C ~50°C | ||||
| Storage temperature | -40°C ~60°C | -40°C ~60°C | ||||
| Dimensions | Adult: 445x190 mmChild: 350x177 mmInfant: 325x165 mm | Adult: 445x190 mm | Adult: 445x190 mmChild: 350x177 mmInfant: 325x165 mm | Adult: 445x190 mm | Adult: 570x190 mmChild: 510x190 mmInfant: 430x180 mm | |
| Intake valves | External 2 valve designIntegrated design | 2 valvesAll in one design | ||||
| Can providesupplemental oxygen | Yes | Yes | ||||
| Ventilation Bag Volume | Adult 1700 mlChild 500 mlInfant 320 ml | Adult 1700 ml | Adult 1700 mlChild 500 mlInfant 320 ml | Adult 1700 ml | Adult 1500 mlChild 600mlInfant 280 ml | |
| Oxygen collection BagVolume | Adult 1000 mlChild 1000 mlInfant 600 ml | Adult 1000 ml | Adult 1000 mlChild 1000 mlInfant 600 ml | Adult 1000 ml | Adult 1000 mlChild 1000 mlInfant 500 ml | |
| Max Stroke Volume(single hand) | Adult 650 mlChild 370 mlInfant 180 ml | Adult 650 ml | Adult 650 mlChild 370 mlInfant 180 ml | Adult 650 ml | Adult 700 mlChild 360 mlInfant 150 ml | |
| Dead Space | ~ 3.8 ml for all sizes | 4.5 ml for all sizes astested6.8 ml from labelingNote: All values of thepredicate were measuredvalues | ||||
| Subject Device | Predicate / K082092 | |||||
| Models A1 | Model A2 | Models B1 | Model B2 | GaleMed | ||
| Adult, Child, | Adult | Adult, Child, | Adult | Dispo-Bag Manual | ||
| and Infant | and Infant | Resuscitator | ||||
| Inspiratory Resistance | Infant - 0.5cm H2O | Infant - 0.5cm H2O | ||||
| Maximum | Child - 0.5cm H2O | Child - 0.7cm H2O | ||||
| Infant@5lpm | Adult - 3cm H2O | Adult - 3.3cm H2O | ||||
| Child@5lpm | ||||||
| Adult@501pm | ||||||
| Expiratory Resistance | Infant - 0.5cm H2O | Infant -0.8cm H2O | ||||
| Maximum | Child - 0.5cm H2O | Child - 0.8cm H2O | ||||
| Adult@50 lpm | Adult - 2.8 cmH2O | Adult - 2.6 cmH2O | ||||
| Child & Infant@5 lpm | ||||||
| Supplemental Oxygen% | Infant | 2 lpm | 5 lpm | 10 lpm | 2/5/10 lpm | |
| at different flow rates | Vt - 70 ml x 20 bpm | 90% | 98% | 98% | 91/97/99% | |
| and Tidal Volumes (VT) | Vt – 70 ml x 30 bpm | 87% | 99% | 98% | 87/96/98% | |
| Supplemental Oxygen% | Child | 2 lpm | 5 lpm | 10 lpm | 2/5/10 lpm | |
| at different flow rates | Vt – 200 ml x 20 bpm | 57% | 99% | 98% | 56/99/99% | |
| and Tidal Volumes (VT) | Vt - 300 ml x 30 bpm | 39% | 66% | 98% | 42/63/99% | |
| Supplemental Oxygen% | Adult | 5 lpm | 10 lpm | 15 lpm | 5/10/15 lpm | |
| at different flow rates | Vt - 600 ml x 12 bpm | 83% | 99% | 99% | 84/98/99% | |
| and Tidal Volumes (VT) | Vt - 750 ml x 12 bpm | 57% | 99% | 99% | 76/98/99% | |
| Vt - 1000 ml x 20 bpm | 40% | 60% | 70% | 40/61/71% | ||
| Pop-Off or Pressure | 40 cm H2O | 40 cm H2O | ||||
| Limiting | 60 cm H2O | 60 cm H2O | ||||
| Ability to add PEEP | Yes | Yes | ||||
| valves | 0-20 cm H2O | 0-20 cm H2O | ||||
| Patient connectors | 15 / 22 mm | 15 / 22 mm | ||||
| PEEP valve fittings | 22 / 30 mm | 22 / 30 mm | ||||
| Face mask | #1 - Infant#2 - Child#3 - Adult | #3 - Adult | #1 - Infant#2 – Child#3 - Adult | #3 - Adult | #1 - Infant#2 - Child#3 - AdultNote: All values of thepredicate were measuredvalues | |
| Subject Device | Predicate / K082092 | |||||
| Models A1 | Model A2 | Models B1 | Model B2 | |||
| Adult, Child,and Infant | Adult | Adult, Child,and Infant | Adult | |||
| Pressure manometer | Optional | 0-60 cm H2O | 0-60 cm H2OReference IntersurgicalK122077 | |||
| Biocompatibility | Externally communicating, tissue and Surface Contact, skinLimited duration of use (<24 hours)Testing – Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Gas emission VOC, PM2.5, Inorganicgases (Ozone, CO, CO2) | Same patient exposure andduration | ||||
| Materials | PVC, Polycarbonate, Silicone | Same | ||||
| ISO 5356-1 | Conical connectors | Same | ||||
| ISO 10651-4 | Lung ventilators - operator powered | Same | ||||
| Shelf-life | 5 years | 3 years |
{7}------------------------------------------------
510(k) Summary
{8}------------------------------------------------
Discussion of Substantial Equivalence and Differences for the Resuscitator
The Foremount Disposable Resuscitators are viewed as substantially equivalent to the predicate device because:
Indications for Use -
The proposed indications for use are similar to the predicate. There are no differences in the Indications for use.
Patient Population -
The patient population is similar to the predicate. There is no difference in the population compared to the predicate.
Environment of Use -
The proposed environments of use are similar to the predicate. There are no differences in the environment of use.
Technology -
The design and principle of operation is similar to the configuration and functionality is similar The differences in specification, e.g. maximum stroke volume and ventilation bag volume do not raise new safety or effectiveness concerns related to substantial equivalence as ISO 10651-4 specifies the minimum requirements and the predicate both meet the minimum requirements as listed in the standard.
{9}------------------------------------------------
Substantial Equivalence for the PEEP Valves
The subject device includes the use of PEEP Valves as part of the optional accessories.
Table 3 provides a detailed comparison of the subject PEEP valves to the predicate PEEP valves which are part of the predicate K082092 GaleMed.
| Subject PEEP Valve | Predicate | |
|---|---|---|
| GaleMed – K082092 | ||
| Classification | BYECFR 868.5965Attachment, Breathing, Positive EndExpiratory Pressure | BYECFR 868.5965Attachment, Breathing, Positive EndExpiratory Pressure |
| Indications for Use | Single patient use positive endexpiratory pressure (PEEP) valve foruse hospital, transport, emergency,and post hospital care to evaluateend lung pressure above atmosphericat the end of exhalation in constantand intermittent gas flow conditions. | Single patient use positive endexpiratory pressure (PEEP) valve foruse hospital, transport, emergency, andpost hospital care to evaluate end lungpressure above atmospheric at the endof exhalation in constant andintermittent gas flow conditions. |
| Patient Population | Intended for patients that theclinician has determined need PEEP. | Not specified |
| Environment of Use | Hospital, transport, emergency, andpost hospital care | Hospital, transport, emergency, andpost hospital care |
| Contraindications | Contraindicated in a patient whodoes not require elevated endexpiratory pressure therapy. | Contraindicated in a patient who doesnot require elevated end expiratorypressure therapy. |
| Principle of Operation | Exhaling exerts pressure on a springwhich has tension that is calibratedto a range of pressures. Adjustmentof the spring tension changes thePEEP pressure. | Exhaling exerts pressure on a springwhich has tension that is calibrated to arange of pressures. Adjustment of thespring tension changes the PEEPpressure. |
| Pressure range | 0 to 10 cmH2O5 to 20 cmH2O | 2.5 to 10 cmH2O5 to 20 cmH2O |
| Adjustable | Yes | Yes and fixed |
| Accuracy | +/- 2 cmH2O | +/- 2 cmH2O |
| Connectors | 22 mm / 30 mm | 22 mm / 30 mm |
| Biocompatibility | Externally communicating, tissueLimited duration of use (<24 hours) | Same |
| Materials | Polycarbonate, Silicone, Stainless Steel spring | Same |
| Performance Testing | AccuracyRepeatabilityEffects of AgingDrop TestConical fittings |
Table 3 – Substantial Equivalence for PEEP Valves
{10}------------------------------------------------
510(k) Summary
Discussion of Substantial Equivalence and Differences for the PEEP Valves
The Disposable PEEP Valves are viewed as substantially equivalent to the predicate device because:
Indications for Use –
The proposed indications for use are similar to the predicate. There is no difference in the indications for use compared to the predicate.
Patient Population -
There is no specific patient population for PEEP valves. There is no difference in the population compared to the predicate.
Environment of Use –
The proposed environments of use are similar to the predicate. There is no difference in the environment of use compared to the predicate.
Technology –
The design and principle of operation is similar to the predicate. There is no difference in the technology, design or principle of operation compared to the predicate
{11}------------------------------------------------
Substantial Equivalence for the Manometer
The subject device includes the use of a disposable pressure manometer as part of the optional accessories.
Table 4 provides a detailed comparison of the subject Manometer to the Intersurgical K122077.
Table 4 – Substantial Equivalence for Manometer
| Subject | Predicate | |
|---|---|---|
| Manometer | Intersurgical – K122077 | |
| Classification | CAPCFR 868.2600Monitor, Airway Pressure | CAPCFR 868.2600Monitor, Airway Pressure |
| Indications for Use | The Disposable Manometer is a single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems. | The Disposable Manometer is a single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems. |
| Patient Population | Intended for use with a resuscitator | Intended for use with a resuscitator |
| Environment of Use | Hospital, transport, emergency, and post hospital care | Hospital, transport, emergency, and post hospital care |
| Principle of Operation | The technology is the use of a calibrated spring that when pressure rises the springs is compressed raising an indicator and showing the pressure via markings on the manometer cylinder has calibrated marking at 10 cmH2O intervals between 0 through 60 cmH2O. | Same |
| Pressure range | 0 to 60 cmH2O | 0 to 60 cmH2O |
| Markings | Increments of 10 cmH2O | Increments of 10 cmH2O |
| Accuracy | ±1 cmH2O @ 0-10 cmH2O±2 cmH2O @ 20-30 cmH2O±3 cmH2O @ 40-60 cmH2O | ±2 cmH2O @ 0-10 cmH2O±4 cmH2O @ 20 cmH2O±5 cmH2O @ 30-40 cmH2O±7 cmH2O @ 50-60 cmH2O |
| Connectors | 15 / 22 mm | 15 / 22 mm |
| Biocompatibility | Externally communicating, tissueLimited duration of use (<24 hours) | Same |
| Materials | Polycarbonate, Silicone, Stainless Steel Springs | Same |
{12}------------------------------------------------
| Performance Testing | Accuracy | |
|---|---|---|
| Repeatability | ||
| Effects of Aging | ||
| Drop Test | ||
| Conical fittings |
Discussion of Substantial Equivalence and Differences for the Manometer
The Disposable Pressure Manometer is viewed as substantially equivalent to the predicate device because:
Indications for Use -
The proposed indications for use are similar to the predicate. There is no difference in the indications for use compared to the predicate.
Patient Population -
There is no specific patient population for Manometers. There is no difference in the population compared to the predicate.
Environment of Use –
The proposed environments of use are similar to the predicate. There is no difference in the environment of use compared to the predicate.
Technology -
The design and principle of operation is similar to the predicate. There is no difference in the technology, design or principle of operation compared to the predicate.
Summary of Performance - Non-clinical for All Devices
The following tests and standards were considered in determining the safety and performance of the subject devices as compared to the predicates.
Biocompatibility of Patient Contacting Materials -
The materials of the Resuscitator bag, PEEP valve, manometer, and face mask have the following patient contact:
- . External Communicating (Indirect gas pathway)
- . Tissue / Bone / Dentin communicating
- . Duration of Use - limited (<24 hours)
The face mask are also
{13}------------------------------------------------
- Surface Contact
- Intact skin ●
- Duration of Use limited (<24 hours) ●
Discussion -
We performed the applicable tests to support biocompatibility. These tests included:
- . Cytotoxicity - ISO 10993-5 (2009) - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization and Irritation ISO 10993-10 (2010) Biological evaluation of medical devices Part 10: Tests . for irritation and skin sensitization
- Acute Systemic Toxicity ISO 10993-11 (2010) Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity
- . Gas Emission VOC testing
- PM25 ISO 18562-2:2017 Biocompatibility Evaluation of Breathing Gas Pathways Part 2: Tests for ● Emissions of Particulate Matter
- Inorganic gases - CO, CO2, and Ozone
The materials were found to be non-cytotoxic, non-sensitizers, and non-irritants.
Bench Testing
Applicable standards for bench testing:
- ISO 10651-4:2002 Lung ventilators Part 4: Particular requirements for operator-powered resuscitators. .
- . ISO 5356-1:2004 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
Tests performed included:
- . Storage condition performance
- Operating condition performance ●
- o Delivered stroke volume
- Supplementary oxygen delivered concentration at different Tidal Volumes O
- Measurement of Inspiratory and Expiratory Resistance O
- Patient Valve malfunction O
- Pressure limits of Pop-off о
- o Dead space
- Function after Contamination with Vomitus ●
- Drop Test ●
- Immersion in Water ●
- Evaluation and testing of conical fittings ●
{14}------------------------------------------------
- Effects of aging pre- and post-conditioning performance ●
- Accuracy and Repeatability .
Discussion of Differences and Substantial Equivalence Conclusion
There are no differences between the proposed device and the predicates which raise different safety or effectiveness concerns. We can conclude that the proposed device and accessory components can be considered substantially equivalent. Based upon the testing the sponsor has demonstrated the equivalence of the subject device compared to the predicate.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).