(148 days)
Not Found
No
The description focuses on standard oxygen concentration technology (molecular sieve, pressure swing adsorption) and basic sensing (pressure change for triggering). There is no mention of AI, ML, or any learning/adaptive algorithms in the device description, testing, or performance summaries.
Yes
The device is an oxygen concentrator used by patients requiring supplemental oxygen, which directly addresses a medical condition to improve health.
No
Explanation: The VBOX Trooper oxygen concentrator is used to supply supplemental oxygen to patients. It does not perform any diagnostic functions like detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly outlines hardware components such as a molecular sieve, pressure swing adsorption system, front panel controls and indicators (LEDs, buttons, displays), an oxygen outlet, batteries, power supply, charger, carrying case, and nasal cannula. The testing described also focuses on the performance of these physical components and the overall system, not solely on software functionality.
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 VBOX Trooper oxygen concentrator is a device that delivers oxygen directly to a patient to supplement their breathing. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "patients requiring supplemental oxygen" and is used with a nasal cannula to channel oxygen to the patient. This is a therapeutic function, not a diagnostic one.
The description and testing performed are all related to the device's ability to produce and deliver oxygen effectively and safely, not to analyze biological samples.
N/A
Intended Use / Indications for Use
The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Trooper oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94 % in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it.
The front panel of the Trooper contains controls and indicators such as, device status indicator LEDs, an ON/OFF button, oxygen flow rate controls, and flow rate and battery status displays. The oxygen outlet is also located on the front panel of the device.
The VBOX Trooper oxygen concentrator system will be provided under a single model number, A-1000, which includes the following items:
- One (1) Trooper Oxygen Concentrator Unit
- Two (2) Li-Ion Batteries (only one connected to the device at a time)
- One (1) Auxiliary AC Power Supply
- One (1) Battery Charger
- One (1) Carrying case
- One (1) nasal cannula
- User manual
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
Not Found
Intended User / Care Setting
Used in home, institution, vehicle and various mobile environments.
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)
Functional and Safety Testing:
Applicable portions of the following standards were applied during development and testing of the Trooper Oxygen Concentrator:
- ASTM F1464-93:2005 Oxygen Concentrators for Domiciliary Use
- ISO 8359:1996 Oxygen Concentrators for medical use - Safety Requirements
- EN 60601-1-2:2007 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- EN 55011:2007 (including Amendment A2:2007) - Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment
- Federal Communications Commission (FCC) Part 15 Subpart B
- IEC 60601-1:2003 Medical Electrical Equipment Part 1: General Requirements for Safety
- ISO 10993-1:2009 Biological evaluation of medical devices
Bench testing was performed to provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
- Output gas composition (e.g. VOCs, particulate matter, ozone/carbon monoxide/carbon dioxide content)
- User display and LED functions
- Oxygen flow rate and concentration
- Electromagnetic compatibility and electrical safety
- Functional performance (e.g. trigger sensitivity and delay, pulse volume and duration)
- Output gas temperature
In addition, functional side-by-side comparison testing was performed to demonstrate substantial equivalence of the proposed device to each of the predicate devices. The following parameters were evaluated across all breath rates:
- Trigger Sensitivity
- Oxygen Pulse Timing
- Pulse Time
- Pulse Delay
- Total Time to Deliver Pulse
- Pulse Volume
- Oxygen Purity
- Relative Fraction of Inspired Oxygen (FIO2)
The pulse delivery waveforms (liters per minute flow over time) were also assessed for the proposed device and each of the predicate devices.
Conclusion: The similarities between the Trooper (proposed device) and the predicate devices referenced above with respect to the principles of operation, technology, materials, indications for use, and functional performance clearly support a conclusion of substantial equivalence.
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.
Inogen One Oxygen Concentrator (K032818), EverGo Portable Oxygen Concentrator (K043615)
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
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
510(k) Summary 12/260 : 5.0
VBOX. Inc.
Submitter:
WH
TI
Contact Person:
2340 East County Road J White Bear Lake, MN 55110 Theodore Jagger Director, Regulatory & Test
Telephone: 651-407-6206 Fax: 651-407-6206 Email: jagger@vboxinc.com
Trooper Oxygen Concentrator
Portable Oxygen Concentrator
September 19, 2012
Date Prepared: Trade Name: Common Name: Classification: Product Code:
Class II, 21 CFR 868.5440 CAW
Predicate Devices:
The subject device is substantially equivalent to the following devices:
SEP 2 1 2012
Device Description:
The Trooper oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94 % in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it.
The front panel of the Trooper contains controls and indicators such as, device status indicator LEDs, an ON/OFF button, oxygen flow rate controls, and flow rate and battery status displays. The oxygen outlet is also located on the front panel of the device.
The VBOX Trooper oxygen concentrator system will be provided under a single model number, A-1000, which includes the following items:
- One (1) Trooper Oxygen Concentrator Unit .
- Two (2) Li-Ion Batteries (only one connected to the device . at a time)
- One (1) Auxiliary AC Power Supply .
- One (1) Battery Charger ●
- One (1) Carrying case .
- One (1) nasal cannula .
1
- User manual .
per Device Specifications:
| Trooper Device Specifications: | |
|---|---|
| Dimensions (LxWxH) | 6 x 2.5 x 6.25 inches |
| Weight | 3.2 lbs (includes battery) |
| Materials | |
| Sieve Bed | Synthetic zeolite |
| Nasal Cannula | PVC (standard cannula supplied |
| by Salter Labs) | |
| Battery | Li-Ion |
| Performance Specifications | |
| Method of oxygen | |
| concentration | Molecular sieve (mechanical) |
| Process by which Oxygen is | |
| released | Differential pressure swing |
| adsorption | |
| Flow Rate | 5 settings: 1 to 5 (flow rates |
| equivalent to 1 LPM to 5 LPM) | |
| Duration of flow | Pulsed |
| Trigger Sensitivity | $ \leq $ 0.13 cm water ( $\leq$ 12.7 Pa) |
| Oxygen concentration | 87-94% at all settings |
| Software/ Hardware | Analog and digital electronics |
| with microprocessor | |
| Rechargeable Battery | Yes |
| Power Options | Battery, AC |
Intended Use:
The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
Summary Comparison to Predicate Devices:
| | VBOX Trooper
Oxygen Concentrator
(Subject Device) | Inogen One Oxygen
Concentrator
(Predicate Device) | EverGo Portable
Oxygen Concentrator
(Predicate Device) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | VBOX, Inc. | Inogen | Philips Respironics |
| Classification | Class II | Class II | Class II |
| Product Code | CAW | CAW | CAW |
| Indications for
Use | The VBOX Trooper oxygen concentrator
device is used on a
prescriptive basis by
patients requiring
supplemental oxygen. It
supplies a high
concentration of oxygen
and is used with a nasal
cannula to channel
oxygen from the
concentrator to the
patient. The VBOX
Trooper may be used in
home, institution,
vehicle and various
mobile environments. | The Inogen One
Oxygen Concentrator is
used on a prescriptive
basis by patients
requiring supplemental
oxygen. It supplies a
high concentration of
oxygen and is used
with a nasal cannula to
channel oxygen from
the concentrator to the
patient. The Inogen
One may be used in
home, institution,
vehicle and various
mobile environments. | The EverGo Portable
Oxygen Concentrator is
intended for prescription
use by patients requiring
high concentrations of
oxygen on a
supplemental basis. It is
small, portable and is
capable of continuous
use in home,
institutional, and travel /
mobile environments. |
| Prescription
Required | Yes | Yes | Yes |
| Patient
Interface | Standard nasal cannula | Standard nasal cannula | Standard nasal cannula |
| Dimensions
(LxWxH) | 6 x 2.5 x 6.25 inches | 11.6 x 6.0 x 10.7 inches | 12 x 6 x 8.5 inches |
| Weight | 3.2 lbs
(includes battery) | 9.8 lbs
(includes battery) | 10 lbs
(includes batteries) |
| Materials | | | |
| Sieve Bed | Synthetic zeolite | Synthetic zeolite | Synthetic zeolite |
| Nasal Cannula | PVC (standard cannula
supplied by Salter Labs) | PVC (standard cannula
supplied by Salter
Labs) | Not supplied with the
device |
| Battery | Li-Ion | Li-Ion | Li-Ion |
| Performance Specifications | | | |
| Method of
oxygen
concentration | Molecular sieve
(mechanical) | Molecular sieve
(mechanical) | Molecular sieve
(mechanical) |
| Process by
which Oxygen is
released | Differential pressure
swing adsorption | Differential pressure
swing adsorption | Differential pressure
swing adsorption |
| Flow Rate | 5 settings: 1 to 5 (flow
rates equivalent to 1
LPM to 5 LPM) | 5 settings: 1 to 5 (flow
rates equivalent to 1
LPM to 5 LPM) and
one setting of
"Satellite" | 6 settings: 1 to 6 (flow
rates equivalent to 1
LPM to 6 LPM) |
| Duration of
flow | Pulsed | Pulsed | Pulsed |
| Trigger
Sensitivity | ≤ 0.13 cm water
(≤ 12.7 Pa) | 0.12 cm water (12 Pa) | 0.16 cm water (16 Pa) |
| Oxygen
concentration | 87-94% at all settings | 87-93% at all settings | 86-92% at all settings |
| Software/
Hardware | Analog and digital
electronics with
microprocessor | Analog and digital
electronics with
microprocessor | Analog and digital
electronics with
microprocessor |
| Rechargeable
Battery | Yes | Yes | Yes |
| Power Options | Battery, AC | Battery, AC | Battery, AC |
2
Pre-Market Notification for the VBOX Trooper Oxygen Concentrator
3
Functional and Safety Testing:
Applicable portions of the following standards were applied during development and testing of the Trooper Oxygen Concentrator:
- ASTM F1464-93:2005 Oxygen Concentrators for . Domiciliary Use
- ISO 8359:1996 Oxygen Concentrators for medical use -. Safety Requirements
- EN 60601-1-2:2007 Medical Electrical Equipment-Part 1-. 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- . EN 55011:2007 (including Amendment A2:2007) - Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment
- Federal Communications Commission (FCC) Part 15 . Subpart B
- IEC 60601-1:2003 Medical Electrical Equipment Part 1: . General Requirements for Safety
- ISO 10993-1:2009 Biological evaluation of medical devices .
Bench testing was performed to provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
- Output gas composition (e.g. VOCs, particulate matter, � ozone/carbon monoxide/carbon dioxide content)
- User display and LED functions .
- Oxygen flow rate and concentration ●
- Electromagnetic compatibility and electrical safety ●
- Functional performance (e.g. trigger sensitivity and delay, . pulse volume and duration)
4
-
Output gas temperature .
In addition, functional side-by-side comparison testing was performed to demonstrate substantial equivalence of the proposed device to each of the predicate devices. The following parameters were evaluated across all breath rates: -
Trigger Sensitivity .
-
. Oxygen Pulse Timing
- o Pulse Time
- o Pulse Delay
- o Total Time to Deliver Pulse
-
Pulse Volume �
.
- · Oxygen Purity
- Relative Fraction of Inspired Oxygen (FIO2) .
The pulse delivery waveforms (liters per minute flow over time) were also assessed for the proposed device and each of the predicate devices.
The similarities between the Trooper (proposed device) and the Conclusion: predicate devices referenced above with respect to the principles of operation, technology, materials, indications for use, and functional performance clearly support a conclusion of substantial equivalence.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Vbox, Incorporated C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 53313
SEP
2 1 2012
Re: K121260
Trade/Device Name: Trooper Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: September 6, 2012 Received: September 7, 2012
Dear Mr. Job:
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.
6
Page 2- Mr. Job
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 (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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. 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
7
4.0 Indications for Use Statement
Device Name: VBOX Trooper Oxygen Concentrator
Indications for Use:
The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultze
(Division Division of Anesthesiology, General Hospitai Intection Control, Dental Device
510(k) Number;
K L L B
VBOX, Inc.
Pre-Market Notification for the VBOX Trooper Oxygen Concentrator Page 14 of 57