K Number

Device Name

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

Manufacturer

Foremount Enterprise Co., Ltd.

Date Cleared

2018-05-11

(431 days)

Product Code

BTM BYE CAP

Regulation Number

868.5915

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082092, K122077

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a manual resuscitator, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as a "manual resuscitator" used to "temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure," which directly addresses a medical condition to improve patient health.

Diagnostic

Yes

The device includes a Disposable Manometer, which is explicitly stated to be "intended to be used for monitoring the patient's airway pressure during ventilation," and a PEEP Valve used "to evaluate end lung pressure." Monitoring and evaluating are diagnostic functions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as a Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional PEEP Valve and Manometer. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "temporarily ventilate a patient" and "augment ventilation in patients during ventilatory insufficiency or ventilatory failure." This describes a device used on a patient to support a physiological function (breathing).
Device Description: The description details components like ventilation bags, valves, masks, and tubing, all of which are used in the mechanical process of delivering air to a patient's lungs.
Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or analysis of biological materials.

The device described is a manual resuscitator, which is a life-support device used to assist breathing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

BTM

Device Description

. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg.

Intended User / Care Setting

hospital, transport, emergency, and post hospital care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance studies were conducted.
Bench studies performed included:

Storage condition performance
Operating condition performance: Delivered stroke volume, Supplementary oxygen delivered concentration at different Tidal Volumes, Measurement of Inspiratory and Expiratory Resistance, Patient Valve malfunction, Pressure limits of Pop-off, Dead space
Function after Contamination with Vomitus
Drop Test
Immersion in Water
Evaluation and testing of conical fittings
Effects of aging pre- and post-conditioning performance
Accuracy and Repeatability

Biocompatibility tests included:

Cytotoxicity - ISO 10993-5 (2009)
Sensitization and Irritation ISO 10993-10 (2010)
Acute Systemic Toxicity ISO 10993-11 (2010)
Gas Emission VOC testing
PM25 ISO 18562-2:2017
Inorganic gases - CO, CO2, and Ozone

Key results: The materials were found to be non-cytotoxic, non-sensitizers, and non-irritants.
The tests and standards were considered in determining the safety and performance of the subject devices as compared to the predicates.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082092, K122077

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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);

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

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)

This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.

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
429, 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 and
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

. Infant - Less than or equal to 10 kg
Child less than or equal to 23 kg ●
Adult Greater than 23 kg. ●

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:

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
Note other resuscitators have
been cleared with the ability to
add a manometer.

Table 1 outlines the predicate selection for each.

Table 1 - Predicate Selection

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 manual
resuscitator for use hospital,
transport, emergency, and
post hospital care to
temporary ventilate a patient
for the given body mass
ranges of:	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:	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:	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:	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:
Population	Infant $≤$ 10Kg
Child $≤$ 23 Kg
Adult > 23 Kg	Adult > 23 Kg	Infant $≤$ 10Kg
Child $≤$ 23 Kg
Adult > 23 Kg	Adult > 23 Kg	Infant $≤$ 10Kg
Child $≤$ 23 Kg
Adult > 23 Kg
Environment of Use	hospital, transport, emergency, and
post hospital care				hospital, transport,
emergency, and
post hospital care
Contraindications	Infant > 10kg
Child > 23 kg
Adult 10kg
Child > 23 kg
Adult 10kg
Child > 23kg
Adult