RESUSCI FLOW; RESUSCI FLOW 104

• K Number: K102542
• Device Name: RESUSCI FLOW; RESUSCI FLOW 104
• Manufacturer: ATOM MEDICAL CORPORATION
• Date Cleared: 2011-04-06 ( 215 days)
• Product Code: BTL
• Regulation Number: 868.5925

Intended Use

The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP). The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure. All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.

Device Description

There are four (4) models of the Resusci Flow resuscitator. - Resusci Flow ● - Resusci Flow with blender ● - Resusci Flow 104PV . - Resusci Flow 104EV . They all have the same basic design. Table 1 outlines the basic features and differences of each model.

Predicate Devices

K070210, K892885

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a manually operated ventilator with no mention of AI or ML capabilities, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

Yes
The device is described as a manually operated ventilator intended to assist in resuscitating infants by providing positive end-expiratory pressure (PEEP) and peak inspiratory pressure (PIP), removing secretions, and ventilating neonates suffering from apnea or other respiratory failure. These functions directly treat or alleviate a medical condition, qualifying it as a therapeutic device.

Diagnostic

No

The device is described as a manually operated ventilator intended to assist in resuscitating infants by providing positive end-expiratory pressure (PEEP) and peak inspiratory pressure (PIP), and to remove secretions or ventilate neonates with respiratory failure. Its primary function is therapeutic support, not the identification or diagnosis of medical conditions.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate this is a hardware device (manually operated ventilator) with physical components and performance characteristics related to gas flow, pressure, and mechanical resistance. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The Resusci Flow series is a manually operated ventilator and suction device. Its function is to provide respiratory support and clear airways in infants. It directly interacts with the patient's respiratory system, not with specimens taken from the body.
• Intended Use: The intended use clearly states assisting in resuscitating infants by providing pressure and removing secretions. This is a therapeutic and supportive function, not a diagnostic one based on analyzing biological samples.

The description and intended use clearly indicate this is a medical device used for direct patient care and intervention, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).

The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.

All are intended for neonates and infants (le 10kg or 22 lbs) in a delivery room and a NICU.

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

BTL

Device Description

There are four (4) models of the Resusci Flow resuscitator.

• Resusci Flow
• Resusci Flow with blender
• Resusci Flow 104PV
• Resusci Flow 104EV

They all have the same basic design. Table 1 outlines the basic features and differences of each model.

Table 1 Resusci Flow Series

Feature	Resusci Flow	Resusci Flow with Blender	Resusci Flow 104PV	Resusci Flow 104EV
PIP (Peak Inspiratory. Pressure)	Yes	Yes	Yes	Yes
Suction(Piping Type)	No	No	Yes	No
Suction(Venturi Type)	No	No	No	Yes
Oxygen / Air Mixture	No	Yes	Yes	Yes
Inlet Gas Sources	Mixture of oxygen and air	Oxygen compression gas Air compression gas	Oxygen compression gas Air compression gas Suction compression gas	Oxygen compression gas Air compression gas
Pressure Relief Valve	Yes	Yes	Yes	Yes
Pressure Gauge	Yes	Yes	Yes	Yes
Suction Pressure Gauge	No	No	Yes	Yes
Outlet	Single outlet This outlet is for resuscitation using aerosol tube and "T" Flow Valve. It may be connected a face mask or tracheal tube.	Single outlet	Double outlets (Outlet A/B) Outlet A is for resuscitation using aerosol tube and "T" Flow Valve. It may be connected a face mask or tracheal tube. Outlet B can be connected to oxygen tent, oxygen mask, oxygen cannula and humidifier jar etc.	Double outlets (Outlet A/B)

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

neonates and infants (le 10kg or 22 lbs)

Intended User / Care Setting

Environment of Use: Hospitals, delivery suites, NICU

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)

Bench tests were performed to evaluate the Resusci Flow series resuscitators against pass/fail criteria and cited standards requirements, or for equivalence to predicates. The tests performed included:

• ISO 10651-5 clause 5.1.10 Display accuracy of the airway pressure gauge.
• Gas discharge flow rate from the patient circuit.
• ISO 10651-5 Clause 7.7.1 Delivered concentration accuracy of oxygen.
• ISO 10651-5 clause 7.1.2.2 Inspiratory resistance.
• ISO 10651-5 clause 7.2.4 pressure limitation.
• ISO 10651-5 clause 7.2.4 and 5.1.10 Pressure characteristics of peak inspiratory pressure (PIP inspiratory resistance).
• Confirm the maximum open pressure (Pmax).
• ISO 10651-5 clause 7.2.4 and 5.1.10 positive end-expiratory pressure (PEEP).
• Environment Performance.
• Vibration Testing.
• Drop Testing.
• Test pressure loss alarm.
• ISO 11195 Gas mixers alarm for loss of pressure.
• ISO 10079-3 for suction equipment.
• Safety requirements.
• Vomitus Resistance.
• Expiratory Resistance.

Key results: The Resusci Flow series resuscitators met all pass/fail criteria, cited standards requirements, or were found to be equivalent in comparison 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.

K070210, K892885

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

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).

Summary

0

K102542

510(k) Summary Page 1 of 5 27-Mar-11

APR -- 6 2011

Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku

| 3-18-15, Hongo, Bunkyo-ku
Tokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632
Fax - 011-81-3-3812-3199 |
|----------------------------------------------------|----------------------------------------------------------------------------------------|
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Resusci Flow series resuscitator |
| Common/Usual Name: | Infant Resuscitator |
| Classification Name/Code: | BTL - powered emergency ventilator
CFR 868.5925 |
| Device: | Resusci Flow
Resusci Flow and blender
Resusci Flow 104 EV
Resusci Flow 104 PV |
| Predicate Devices: | GE - Giraffe and Panda – K070210
Fisher & Paykel - NeoPuff – K892885 |

Device Description:

There are four (4) models of the Resusci Flow resuscitator.

• Resusci Flow ●
• Resusci Flow with blender ●
• Resusci Flow 104PV .
• Resusci Flow 104EV .

They all have the same basic design. Table 1 outlines the basic features and differences of each model.

• )

1

510(k) Summary Page 2 of 5 27-Mar-11

Table 1 Resusci Flow Series

| Feature | Resusci Flow | Resusci Flow
with Blender | Resusci Flow
104PV | Resusci Flow
104EV |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| PIP (Peak Inspiratory.
Pressure) | Yes | Yes | Yes | Yes |
| Suction(Piping Type) | No | No | Yes | No |
| Suction(Venturi Type) | No | No | No | Yes |
| Oxygen / Air Mixture | No | Yes | Yes | Yes |
| Inlet Gas Sources | Mixture of oxygen
and air | Oxygen
compression
gas
Air
compression
gas | Oxygen compression
gas
Air compression gas
Suction compression
gas | Oxygen
compression gas
Air compression
gas |
| Pressure Relief Valve | Yes | Yes | Yes | Yes |
| Pressure Gauge | Yes | Yes | Yes | Yes |
| Suction Pressure Gauge | No | No | Yes | Yes |
| Outlet | Single outlet | Single outlet | Double outlets
(Outlet A/B) | Double outlets
(Outlet A/B) |
| | This outlet is for resuscitation using
aerosol tube and "T" Flow Valve.
It may be connected a face mask or
tracheal tube. | | Outlet A is for resuscitation using
aerosol tube and "T" Flow Valve.
It may be connected a face mask or
tracheal tube.
Outlet B can be connected to oxygen
tent, oxygen mask, oxygen cannula and
humidifier jar etc. | |
| Predicates | Fisher & Paykel
RD1000 NEOPUFF
INFANT
RESUSCITATOR | Giraffe and Panda T-piece Resuscitation System
(K070210) | | |

Indications for Use:

The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).

The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.

All are intended for neonates and infants (