RESUSCI FLOW; RESUSCI FLOW 104
Device Facts
| Record ID | K102542 |
|---|---|
| Device Name | RESUSCI FLOW; RESUSCI FLOW 104 |
| Applicant | Atom Medical Corporation |
| Product Code | BTL · Anesthesiology |
| Decision Date | Apr 6, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5925 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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 (≤ 10kg or 22 lbs) in a delivery room and a NICU.
Device Story
Resusci Flow series are manually operated gas-powered resuscitators for neonates/infants. Inputs: oxygen and air compression gas sources. Operation: clinician-controlled T-piece system provides PEEP and PIP; models 104PV/104EV include suction capabilities (piping or Venturi-based). Outputs: controlled airway pressure for ventilation; suction for secretion removal. Used in delivery rooms and NICUs by physicians/clinicians. Device provides pressure monitoring via integrated gauges and pressure relief valves to ensure safe delivery of respiratory support. Benefits: assists breathing in infants with respiratory failure or apnea; facilitates airway clearance.
Clinical Evidence
Bench testing only. Performance verified against ISO 10651-5 and ISO 10079-3 standards. Tests included display accuracy of airway pressure gauge, gas discharge flow rate, oxygen concentration accuracy, inspiratory/expiratory resistance, pressure limitation, PEEP/PIP characteristics, vibration, drop testing, and alarm functionality (pressure loss/gas mixer). All models met pass/fail criteria.
Technological Characteristics
Gas-powered manual resuscitator; T-piece design. Features include pressure relief valves, pressure gauges, and optional oxygen/air blenders. Models 104PV/104EV include suction (piping or Venturi). Connectivity: gas inlet sources. Standards: ISO 10651-5 (resuscitators), ISO 10079-3 (suction). No software/electronics.
Indications for Use
Indicated for neonates and infants ≤ 10kg (22 lbs) in delivery rooms and NICUs requiring resuscitation, secretion removal, or ventilation support for apnea or respiratory failure.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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<br>Tokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632<br>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<br>CFR 868.5925 |
| Device: | Resusci Flow<br>Resusci Flow and blender<br>Resusci Flow 104 EV<br>Resusci Flow 104 PV |
| Predicate Devices: | GE - Giraffe and Panda – K070210<br>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.
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## 510(k) Summary Page 2 of 5 27-Mar-11
#### Table 1 Resusci Flow Series
| Feature | Resusci Flow | Resusci Flow<br>with Blender | Resusci Flow<br>104PV | Resusci Flow<br>104EV |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| PIP (Peak Inspiratory.<br>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<br>and air | Oxygen<br>compression<br>gas<br>Air<br>compression<br>gas | Oxygen compression<br>gas<br>Air compression gas<br>Suction compression<br>gas | Oxygen<br>compression gas<br>Air compression<br>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<br>(Outlet A/B) | Double outlets<br>(Outlet A/B) |
| | This outlet is for resuscitation using<br>aerosol tube and "T" Flow Valve.<br>It may be connected a face mask or<br>tracheal tube. | | Outlet A is for resuscitation using<br>aerosol tube and "T" Flow Valve.<br>It may be connected a face mask or<br>tracheal tube.<br>Outlet B can be connected to oxygen<br>tent, oxygen mask, oxygen cannula and<br>humidifier jar etc. | |
| Predicates | Fisher & Paykel<br>RD1000 NEOPUFF<br>INFANT<br>RESUSCITATOR | Giraffe and Panda T-piece Resuscitation System<br>(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 (< 10kg or 22 lbs) in a delivery room and a NICU.
Environment of Use: Hospitals, delivery suites, NICU
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## 510(k) Summary Page 3 of 5 27-Mar-11
### Summary of substantial equivalence
### Resusci Flow
The Resusci Flow model was compared to the predicate Fisher & Paykel NeoPuff (K892885) and found to be substantially equivalent based upon:
Indications for Use - The Resusci Flow has equivalent indications for use to the predicate.
The details of the NeoPuff indications are not available, except in their labeling due to the age of the clearance, 1989. Nonetheless the indications for use are equivalent.
Patient Population - The Resusci Flow has the equivalent patient population neonates and infants. We have been more specific than the predicate NeoPuff and included a limitation of patient weight.
Environment for use - The Resusci Flow has the identical environments for use as the predicate.
Prescriptive - The Resusci Flow is identical to the predicate.
Design and Technology - The Resusci Flow has an equivalent design and features as the predicate and has the identical technology as the predicate.
Performance and Specifications - The Resusci Flow has equivalent specifications of performance as the predicate.
Compliance with standards - Both devices declare compliance with the internal standard ISO 10651-5 for powered resuscitators.
#### Conclusion
The Resusci Flow is substantially equivalent to the predicate NeoPuff (K892885) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards
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# 510(k) Summary Page 4 of 5 27-Mar-11
# Resusci Flow with Blender, Resusci Flow 104 PV and Resusci Flow 104 EV
The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV were compared to the predicate GE Giraffe and Panda T-piece resuscitator (K070210). As well as the Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV were compared to the predicate GE Giraffe and Panda (K070210) for equivalence.
Indications for Use - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have equivalent indications for use to the predicate.
Patient Population - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have the equivalent patient population neonates and infants.
Environment for use - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have the identical environments for use as the predicate.
Prescriptive - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV are identical to the predicate.
Design and Technology - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have an equivalent design and features as the predicate and has the identical technology as the predicate.
Performance and Specifications - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have equivalent specifications of performance as the predicate.
Compliance with standards - Both devices declare compliance with the internal standard ISO 10651-5 for gas powered resuscitators and ISO 10079-3 for suction equipment.
#### Conclusion
The Resusci Flow with Blender. Resusci Flow 104PV, and Resusci Flow 104EV is substantially equivalent to the predicate GE Giraffe and Panda (K070210) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.
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## 510(k) Summary Page 5 of 5 27-Mar-11
## Performance Testing
We have performed bench tests which included the list below and found that the Resusci Flow series (Resusci Flow, Resusci Flow with blender, Resusci Flow 104 PV, and Resusci Flow 104 EV) resuscitators met all pass /fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates.
- 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 .
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing segments and a flowing tail.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atom Medical Corporation C/O Mr. Paul Dryden ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
APR -- 6 2011
Re: K102542
Trade/Device Name: Resusci Flow Series, Resusci Flow, Resusci Flow with Blender, Resusci Flow 104 PV and Resusci Flow 104 EV Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 27, 2011 Received: March 29, 2011
Dear Mr. 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.
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Page 2 - Mr. Dryden
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 requirem. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its offective number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
in fer
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use Statement
510(k) Number:
K102542
Device Name:
Resusci Flow series Resusci Flow Resusci Flow with blender Resusci Flow 104 PV Resusci Flow 104 EV
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 (≤ 10kg or 22 lbs) in a delivery room and a NICU.
Prescription Use XX (Part 21 CFR 801 Subpart D) or '
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f. Schulthess
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K.V. 542
