← Product Code [BZR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR) · K103317
# RESUSCITATION UNIT 105 (K103317)
_Atom Medical Corporation · BZR · Apr 20, 2011 · Anesthesiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K103317
## Device Facts
- **Applicant:** Atom Medical Corporation
- **Product Code:** [BZR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR.md)
- **Decision Date:** Apr 20, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5330
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology
- **Attributes:** Therapeutic, Pediatric
## Indications for Use
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
## Device Story
Resuscitation Unit 105 (models 105PV and 105EV) provides blended air/oxygen and suction for neonates/infants. Inputs: compressed air and oxygen; 105PV uses wall vacuum, 105EV uses internal venturi. Operation: manual blending of gases; pressure regulation via relief valve; monitoring via integral pressure gauge. Output: blended gas mixture to respiratory devices (tents, masks, ventilators) and suction for airway clearance. Used in NICU/delivery suites by trained clinicians. Output allows clinicians to manage oxygen concentration and airway pressure; benefits include improved respiratory support and secretion management.
## Clinical Evidence
Bench testing only. Testing included flow accuracy, pressure gauge accuracy, O2 concentration (ISO 10651-5), and suction performance (ISO 10079-3: overfill, seal, aspiration, pressure, noise). Results demonstrated device performance met all pass/fail criteria and was equivalent to predicate devices.
## Technological Characteristics
Gas-powered blender and suction unit. Features: pressure relief valve, pressure gauge, suction pressure gauge, dual outlets. 105PV: wall vacuum; 105EV: venturi vacuum. Gas sources: compressed air/oxygen (206-517 kPa). Blender range: 21-100% O2 (±3%). Flow rate: <15 lpm. Standards: ISO 10651-5 (resuscitators), ISO 10079-3 (suction). Mechanical/pneumatic operation; no software/electronics described.
## Regulatory Identification
A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
## Predicate Devices
- Atom V-505 Infant Warmer ([K060461](/device/K060461.md))
- Bio-Med Devices BMD air/oxygen blender ([K925982](/device/K925982.md))
- Precision Medical Precision Blender ([K053232](/device/K053232.md))
- GE Giraffe and Panda system ([K070210](/device/K070210.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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.K103317
## 510(k) Summary Page 1 of 8 5-Apr-11
APR 2 0 2011
| Atom Medical Corporation
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: | Resuscitation Unit 105 |
| Common/Usual Name: | Air / oxygen blender |
| Classification Name/Code: | BZR - Breathing gas mixer
CFR 868.5330 |
| Device: | Resuscitation Unit 105EV
Resuscitation Unit 105PV |
| Predicate Devices: | Bio-Med Devices_BMD_air/oxygen_blender_K925982
Precision Medical - Precision Blender - K053232
Atom Medical - V-505 Infant Warmer - K060461
GE Giraffe and Panda system - K070210 |
## Device Description:
There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.
- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV
They have the same basic design. Table 1 outlines the basic features and differences of each model.
## Indications for Use:
The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are intended to remove secretions from the neonatal / infant airways and / or to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of Use: Hospitals, delivery suites, NICU
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## 510(k) Summary Page 2 of 8 5-Apr-11
## Table 1 Resuscitation Models 105PV and 105EV
| Feature | Resuscitation Unit 105PV | Resuscitation Unit 105EV |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Suction(Piping Type) | Yes | No |
| Suction(Venturi Type) | No | Yes |
| Oxygen / Air Blender | Yes | Yes |
| Inlet Gas Sources | Oxygen compressed gas | Oxygen compressed gas |
| | Air compressed gas | Air compressed gas |
| | Suction compressed gas | |
| Pressure Relief Valve | Yes | Yes |
| Pressure Gauge | Yes | Yes |
| Suction Pressure Gauge | Yes | Yes |
| Outlet | Double outlets
(Outlet A/B) | Double outlets
(Outlet A/B) |
| | Outlet A / B is for delivery of the air/oxygen gas mixture to a
variety of devices, i.e., oxygen tent, oxygen mask, nasal cannula,
manual resuscitator or manual ventilator, in-line humidifier jar,
etc. | |
| | Airway Pressure tube and adapter can be connected at the patient
connected to measure and monitor the airway pressure which is
displayed on the integral pressure gauge as well as a pressure
regulating valve | |
As outlined in Table 1, the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are identical except for the source for vacuum. Model 105PV is from a wall vacuum source and Model 105EV is from an internal venturi.
Table 2 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates:
- Atom V-505 Infant warmer with optional oxygen / suction module (K060461) .
- . Bio-Med Devices – BMD air/oxygen blender (K925982) a blender which is incorporated into the proposed devices
- . Precision Medical – Precision Blender (K053232) which has the indications for use and product classification we are seeking.
Table 3 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates Atom V-505 Infant warmer with optional oxygen / suction module (K060461) and the GE Giraffe and Panda system (K070210) which incorporates suction function and features for the intended patient population and environment.
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510((k) Summary
S-Apr-11
# able of the Similarities and Differences to the Predicates for Air / Oxygen Blender feature
| General Attributes | Resuscitation Unit
Unit 105PV
Unit 105EV | Atom V-505 Infant
Warmer with oxygen /
suction module K060461 | Bio-Med Devices
BMD air/oxygen
blender K925982 | Precision Medical
Precision Blender
K053232 | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Indications for Use | The Resuscitation Unit
105 EV and
Resuscitation Unit 105
PV are intended to remove
secretions from the
neonatal / infant airways or
to provide blended air and
oxygen at a desired oxygen
concentration in the range
of 21-100% to a respiratory
assist device connected to
the patient such as a
ventilator (including a
manually operated one)
and an oxygen tent. | The blender and suction
modules incorporated in the
V-505 Infant Warmer are
intended to remove
secretions from the neonatal
/ infant airways or to
provide blended air and
oxygen at a desired oxygen
concentration in the range of
21-100% to a respiratory
assist device connected to
the patient such as a
ventilator (including a
manually operated one) and
an oxygen tent. | There is no indications
for sue statement in the
FDA database but the
BMD air/oxygen
blender is intended to
provide blended air and
oxygen at a desired
oxygen concentration in
the range of 21-100% | Is intended to deliver
blended air and oxygen in
a hospital setting.
Oxygen concentrations
can be dialed in from 21
to 100%. The blender is
not intended as a life
supporting device. | |
| Patient Population | Neonates and Infants | Neonates and Infants | Not specified | Not specified | |
| Environment of Use | Hospital, delivery suites,
NICU | Hospital, delivery suites,
NICU | Hospital, delivery
suites, NICU | Hospital setting | |
| Prescriptive | Yes | Yes | Yes | Yes | |
| | | Page 4 of 8
5-Apr-11 | | | |
| | Resuscitation Unit
Unit 105PV
Unit 105EV | Atom V-505 Infant
Warmer with oxygen /
suction module K0604618 | Bio-Med Devices
BMD air/oxygen
blender K925982 | Precision Medical
Precision Blender
K053232 | |
| General Attributes (continued) | Outlet connections to | Oxygen tent
Oxygen mask
Cannula
Manual ventilator
Manual resuscitator | Oxygen tent
Oxygen mask
Cannula
Manual ventilator
Manual resuscitator | Oxygen tent
Oxygen mask
Cannula
Manual ventilator
Manual resuscitator
None supplied | Oxygen tent
Oxygen mask
Cannula
Manual ventilator
Manual resuscitator
None supplied |
| | Accessories/Components | Airway pressure tube
Hoses and tubing
Humidifier jar
Suction jar | Hoses and tubing
Humidifier jar
Suction jar | | |
| Technical specifications | Oxygen / air supply module | | | | |
| | Gas sources | Air/O₂
300-500kPa | Air/O₂
206-517kPa | Air/O₂
206-517kPa | Air/O₂
206-517kPa |
| | input pressure | | | | |
| | Airway pressure
manometer
Range Accuracy | -20 to 80cmH₂O
±1% of full scale | N/A | N/A | N/A |
| | Air/O₂ blender
Range
Accuracy | | 21-100%
±3%O₂ | 21-100%
±3%O₂ | 21-100%
±3%O₂ |
| | Alarm | | Differential pressure
between oxygen and air
supply | Differential pressure
between oxygen and air
supply | Differential pressure
between oxygen and air
supply |
| | Bleed flow rate | | 2.5-3.5 lpm | N/A | N/A |
| | Gas flow rate range | < 15 lpm | < 15 lpm | ≥ 30 lpm | ≥ 30 lpm |
| | | 510(k) Summary
5 of 8
5-Apr-11 | | | |
| | Resuscitation Unit
Unit 105PV
Unit 105EV | Atom V-505 Infant
Warmer with oxygen /
suction module K060461 | Bio-Med Devices
BMD air/oxygen
blender K925982 | Precision Medical
Precision Blender
K053232 | |
| Technical specifications (continued) | | | | | |
| Relieving valve
(for preventing excessive
airway pressure) | (Default setting : 5.9kPa
(60cmH2O)) | N/A (no reliving valve) | N/A(no relieving valve) | N/A(no relieving valve) | |
| Flow outlet | Dual flow outlet to connect to
a device requiring a gas
supply
Oxygen density of both is the
same. | Single flow outlet to connect
to device requiring a gas
supply | Flow outlet for
connecting to device
requiring a gas supply | Flow outlet for connecting
to device requiring a gas
supply | |
| Standards | | | | | |
| ISO 10651-5 Gas
powered resuscitators | Yes, applicable sections | N/A | N/A | N/A | |
| ISO 10079-3 suction
equipment | Yes, applicable sections | N/A | N/A | N/A | |
| Section 514 | None | None | None | None | |
Page 52
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510(k) Summary
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510(k) Summary
## able of the Similarities and Differences to the Predicates for Suction features
| General Attributes | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for Use | Resuscitation Unit
Unit 105PV
Unit 105EV | Atom V-505 Infant Warmer with
oxygen / suction module
K060461 | GE
Giraffe and Panda
K070210 | |
| | The Resuscitation Unit 105 EV
and Resuscitation Unit 105 PV are
intended to remove secretions from
the neonatal / infant airways and to
provide blended air and oxygen at a
desired oxygen concentration in the
range of 21-100% to a respiratory
assist device connected to the patient
such as a ventilator (including a
manually operated one) and an
oxygen tent. | The blender and suction modules
incorporated in the V-505 Infant
Warmer are intended to remove
secretions from the neonatal / infant
airways and to provide blended air
and oxygen at a desired oxygen
concentration in the range of 21-
100% to a respiratory assist device
connected to the patient such as a
ventilator (including a manually
operated one) and an oxygen tent. | Provides the basic equipment
required for pulmonary
resuscitation of infants.
Pulmonary resuscitation includes
practices necessary to establish a
clear airway and provide oxygen
and air/oxygen mixtures and/or
manual ventilation to the infant.
(Includes a suction function and
feature) | |
| Patient Population | Neonates and Infants | Neonates and Infants | Infant | |
| Environment of Use | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | |
| Prescriptive | Persons trained in infant / neonate
resuscitation | Persons trained in infant / neonate
resuscitation | Persons trained in infant / neonate
resuscitation | |
| Technical specifications | | | | |
| Suction bottle capacity | Up to 1200 ml | Not specified | Not specified other than various
sizes | |
| Dimensions | 200mm(W)x180 mm(D)x370mm (H) | Built-in to warmer, not standalone | 340mm(W)x250mm(D)x250mm(H) | |
| Weight | 7kg | | 9 kg | |
| Operating and Storage
limits | -20°C to 65°C
Up to 97% RH | -20°C to 65°C
Up to 97% RH | -20°C to 60°C
Up to 95% RH | |
| 510(k) Summary
Page 7 of 8
5-Apr-11 | | | | |
| | Resuscitation Unit
Unit 105PV
Unit 105EV | Atom V-505 Infant Warmer with
oxygen / suction module K060461 | | GE
Giraffe and Panda K070210 |
| Technical specifications (continued) | | | | |
| | Vacuum source | Model 105PV - wall suction
vacuum | Model 105PV - wall suction
vacuum | Wall suction
vacuum |
| | Vacuum range | Model 105EV - venturi method
0-200 mmHg | 0-200 mmHg | 0-150 mmHg |
| | Vacuum Flow range | ~ 20 lpm | N/A | 15 lpm |
| | Standards | | | |
| | ISO 10651-5 Gas
powered resuscitators | Yes, applicable sections | N/A | Yes, applicable sections |
| | ISO 10079-3 - Suction
equipment | Yes, applicable sections | N/A | Yes, applicable sections |
| | Section 514 | None | None | None |
| Summary of substantial equivalence - Resuscitation Unit 105PV and Resuscitation Unit 105EV | | | | |
| Indications for Use - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have equivalent indications for use to the predicates. That
is as a breathing gas mixer (blender) with a suction feature. | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K103317](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K103317)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
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