Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

K170663 · Foremount Enterprise Co., Ltd. · BTM · May 11, 2018 · Anesthesiology

Device Facts

• Record ID: K170663
• Device Name: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
• Applicant: Foremount Enterprise Co., Ltd.
• Product Code: BTM · Anesthesiology
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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: 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.

Device Story

Manual, self-inflating resuscitator for temporary ventilation; used in hospital, transport, emergency, and post-hospital care by clinicians. Input: manual compression of ventilation bag by operator. Principle: patient valve with duckbill mechanism directs air to patient during inspiration and vents expired air to atmosphere during release; optional pop-off valve limits pressure (40 cmH2O for infant/child, 60 cmH2O for adult). Output: delivered tidal volume and airway pressure monitoring via optional manometer. PEEP valve (optional) maintains end-lung pressure. Benefits: provides emergency ventilatory support during failure or insufficiency. Healthcare providers use output (visual pressure monitoring) to adjust manual ventilation technique.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 10651-4 and ISO 5356-1. Testing included delivered stroke volume, oxygen concentration, inspiratory/expiratory resistance, pop-off valve pressure limits, dead space, function after contamination, drop testing, and immersion. Biocompatibility testing per ISO 10993-5, -10, -11, and ISO 18562-2 confirmed non-cytotoxic, non-sensitizing, and non-irritating materials.

Technological Characteristics

Materials: PVC, Polycarbonate, Silicone, Stainless Steel. Principle: Manual, operator-powered, self-inflating bag. Energy: Manual. Dimensions: Adult (445x190mm), Child (350x177mm), Infant (325x165mm). Connectivity: None. Sterilization: Not specified (single patient use). Software: None. Conical connectors per ISO 5356-1.

Indications for Use

Indicated for temporary ventilation of patients in hospital, transport, emergency, and post-hospital settings. Patient populations: Infants (≤10 kg), Children (≤23 kg), and Adults (>23 kg). PEEP valve indicated for patients requiring elevated end-expiratory pressure. Manometer indicated for monitoring airway pressure during ventilation. Contraindications: PEEP valve contraindicated in patients not requiring elevated end-expiratory pressure therapy.

Regulatory Classification

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.

Predicate Devices

• GaleMed Dispo-Bag Manual Resuscitator (K082092)
• Intersurgical Airway Pressure Manometer (K122077)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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

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# 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)

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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 City<br>429, Taiwan |
| Contact person: | Tyson Hsu / President |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

### Name of the Device(s) and Predicate(s)

| Trade Name: | Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and<br>Accessories |
|---------------|-------------------------------------------------------------------------------|
| 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:

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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 – K122077<br>Note other resuscitators have<br>been cleared with the ability to<br>add a manometer. |

Table 1 outlines the predicate selection for each.

Table 1 - Predicate Selection

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# 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,<br>Manual (Resuscitator) |
| Indications for Use | Single patient use manual<br>resuscitator for use hospital,<br>transport, emergency, and<br>post hospital care to<br>temporary ventilate a patient<br>for the given body mass<br>ranges of: | Single patient use<br>manual resuscitator for<br>use hospital, transport,<br>emergency, and post<br>hospital care to<br>temporary ventilate a<br>patient for the given<br>body mass ranges of: | Single patient use manual<br>resuscitator for use hospital,<br>transport, emergency, and<br>post hospital care to<br>temporary ventilate a patient<br>for the given body mass<br>ranges of: | Single patient use<br>manual resuscitator for<br>use hospital, transport,<br>emergency, and post<br>hospital care to<br>temporary ventilate a<br>patient for the given<br>body mass ranges of: | Single patient use manual<br>resuscitator for use<br>hospital, transport,<br>emergency, and post<br>hospital care to temporary<br>ventilate a patient for the<br>given body mass ranges of: |
| Population | Infant $≤$ 10Kg<br>Child $≤$ 23 Kg<br>Adult > 23 Kg | Adult > 23 Kg | Infant $≤$ 10Kg<br>Child $≤$ 23 Kg<br>Adult > 23 Kg | Adult > 23 Kg | Infant $≤$ 10Kg<br>Child $≤$ 23 Kg<br>Adult > 23 Kg |
| Environment of Use | hospital, transport, emergency, and<br>post hospital care | | | | hospital, transport,<br>emergency, and<br>post hospital care |
| Contraindications | Infant > 10kg<br>Child > 23 kg<br>Adult < 23 kg | Adult < 23 kg | Infant > 10kg<br>Child > 23 kg<br>Adult < 23 kg | Adult < 23 kg | Infant > 10kg<br>Child > 23kg<br>Adult < 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, PEEP<br>valve |

| Table 2 - Comparison Disposable Resuscitator Devices | |
|------------------------------------------------------|--|
|------------------------------------------------------|--|

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# 510(k) Summary

| | Subject Device | | | | Predicate / K082092 | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | Models A1<br>Adult, Child,<br>And Infant | Model A2<br>Adult | Models B1<br>Adult, Child,<br>and Infant | Model B2<br>Adult | GaleMed<br>Dispo-Bag Manual<br>Resuscitator | |
| 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 | |
| Operational<br>temperature | -18°C ~50°C | | | | -18°C ~50°C | |
| Storage temperature | -40°C ~60°C | | | | -40°C ~60°C | |
| Dimensions | Adult: 445x190 mm<br>Child: 350x177 mm<br>Infant: 325x165 mm | Adult: 445x190 mm | Adult: 445x190 mm<br>Child: 350x177 mm<br>Infant: 325x165 mm | Adult: 445x190 mm | Adult: 570x190 mm<br>Child: 510x190 mm<br>Infant: 430x180 mm | |
| Intake valves | External 2 valve design<br>Integrated design | | | | 2 valves<br>All in one design | |
| Can provide<br>supplemental oxygen | Yes | | | | Yes | |
| Ventilation Bag Volume | Adult 1700 ml<br>Child 500 ml<br>Infant 320 ml | Adult 1700 ml | Adult 1700 ml<br>Child 500 ml<br>Infant 320 ml | Adult 1700 ml | Adult 1500 ml<br>Child 600ml<br>Infant 280 ml | |
| Oxygen collection Bag<br>Volume | Adult 1000 ml<br>Child 1000 ml<br>Infant 600 ml | Adult 1000 ml | Adult 1000 ml<br>Child 1000 ml<br>Infant 600 ml | Adult 1000 ml | Adult 1000 ml<br>Child 1000 ml<br>Infant 500 ml | |
| Max Stroke Volume<br>(single hand) | Adult 650 ml<br>Child 370 ml<br>Infant 180 ml | Adult 650 ml | Adult 650 ml<br>Child 370 ml<br>Infant 180 ml | Adult 650 ml | Adult 700 ml<br>Child 360 ml<br>Infant 150 ml | |
| Dead Space | ~ 3.8 ml for all sizes | | | | 4.5 ml for all sizes as<br>tested<br>6.8 ml from labeling<br>Note: All values of the<br>predicate were measured<br>values | |
| | 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<br>#2 - Child<br>#3 - Adult | #3 - Adult | #1 - Infant<br>#2 – Child<br>#3 - Adult | #3 - Adult | #1 - Infant<br>#2 - Child<br>#3 - Adult<br>Note: All values of the<br>predicate were measured<br>values | |
| | | Subject Device | | | | Predicate / K082092 |
| | | Models A1 | Model A2 | Models B1 | Model B2 | |
| | | Adult, Child,<br>and Infant…