(161 days)
Not Found
No
The summary describes a mechanical device for suction and oxygen blending, with no mention of AI, ML, or related concepts.
Yes
The device is intended to remove secretions from airways and provide blended air and oxygen to a respiratory assist device, which are therapeutic interventions.
No
The device is intended to remove secretions and provide blended air and oxygen to a respiratory assist device. It does not perform any diagnostic functions like detecting, monitoring, or predicting medical conditions.
No
The device description explicitly states it is an "air / oxygen blender with suction" and mentions two models with "basic design" and "basic features and differences," indicating a physical hardware device. The performance studies are bench tests, which are typically conducted on physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove secretions from airways and provide blended air/oxygen for respiratory support. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an air/oxygen blender with suction, which are devices used for respiratory support and airway clearance.
- Anatomical Site: The device acts on the neonatal/infant airways, which is a part of the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on providing respiratory support and airway management directly to the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neonatal / infant airways
Indicated Patient Age Range
neonatal / infant, Neonates and Infants
Intended User / Care Setting
Environment of Use: Hospitals, delivery suites, NICU
Prescriptive: Yes
Persons trained in infant / neonate resuscitation
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)
We have performed bench tests which included the list below and found that the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV met all pass /f ail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates.
We have performed the following performance testing. The results demonstrated that the device perform as intended. The tests are:
- Flow accuracy .
- Pressure gauge accuracy .
- ISO 10651-5 O2 concentration .
- ISO 10079-3 5.1.4 Suction, 3 6.1 Overfill, 6.3.1.1 Suction seal, 8.4.3 and 9.1 -. Aspiration, 6.5 - Pressure, 9.1 - External gas source, 8.1 - suction equipment, 6.11 -Noise
- ISO 11195 Alarm .
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.
K925982, K053232, K060461, K070210
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
§ 868.5330 Breathing gas mixer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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.
2
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 |