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.

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

AI/ML Overview

The VBOX Trooper Oxygen Concentrator's acceptance criteria and the study proving it meets these criteria are outlined below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device specifications and the comparison to predicate devices, demonstrating substantial equivalence. The reported device performance is taken directly from the "Trooper Device Specifications" and the "Summary Comparison to Predicate Devices" tables.

Parameter	Acceptance Criteria (Implied from Predicate/Standard)	Reported Device Performance (VBOX Trooper)
Dimensions (LxWxH)	Relevant to portability and size comparison	6 x 2.5 x 6.25 inches
Weight	Relevant to portability and size comparison	3.2 lbs (includes battery)
Sieve Bed Material	Synthetic zeolite	Synthetic zeolite
Nasal Cannula Material	PVC (standard cannula supplied by Salter Labs)	PVC (standard cannula supplied by Salter Labs)
Battery Type	Li-Ion	Li-Ion
Method of Oxygen Concentration	Molecular sieve (mechanical)	Molecular sieve (mechanical)
Oxygen Release Process	Differential pressure swing adsorption	Differential pressure swing adsorption
Flow Rate (settings)	5 settings: 1 to 5 LPM	5 settings: 1 to 5 (equivalent to 1 LPM to 5 LPM)
Duration of Flow	Pulsed	Pulsed
Trigger Sensitivity	≤ 0.12 cm water (Inogen One) or ≤ 0.16 cm water (EverGo)	≤ 0.13 cm water (≤ 12.7 Pa)
Oxygen Concentration	87-93% (Inogen One) or 86-92% (EverGo)	87-94% at all settings
Software/Hardware	Analog and digital electronics with microprocessor	Analog and digital electronics with microprocessor
Rechargeable Battery	Yes	Yes
Power Options	Battery, AC	Battery, AC
Output Gas Composition	Free of VOCs, particulate matter, ozone/carbon monoxide/carbon dioxide issues	Tested for conformance
User Display & LED Functions	Functional and compliant	Tested for conformance
Electromagnetic Compatibility	Compliant with EN 60601-1-2:2007, EN 55011:2007, FCC Part 15 Subpart B	Tested for conformance
Electrical Safety	Compliant with IEC 60601-1:2003	Tested for conformance
Functional Performance	Compliant with standards (e.g., trigger sensitivity, pulse volume, duration) and comparable to predicate devices	Tested for conformance and side-by-side comparison
Output Gas Temperature	Within acceptable limits	Tested for conformance
Biocompatibility	Compliant with ISO 10993-1:2009	Tested for conformance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a specific "sample size" for the test set in terms of a number of devices. However, the testing involved:

Bench testing of the VBOX Trooper Oxygen Concentrator unit(s).
Functional side-by-side comparison testing using the proposed device (VBOX Trooper) and each of the predicate devices (Inogen One Oxygen Concentrator and EverGo Portable Oxygen Concentrator).

Data Provenance: The testing was conducted by VBOX, Inc. (the device manufacturer) under applicable standards (ASTM, ISO, EN, FCC, IEC). This indicates the data is from prospective bench and comparison testing performed in a controlled environment, likely in the United States (where VBOX, Inc. is located).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the summary. The study is a technical/engineering assessment of a medical device's performance, not a diagnostic study relying on expert interpretation of data or images. Ground truth, in this context, would be established by technical specifications, established measurement standards, and the performance of predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as the testing described is technical performance evaluation, not a subjective assessment requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers evaluate cases with and without AI assistance. The VBOX Trooper is an oxygen concentrator, and its effectiveness is determined by its functional performance and safety, not by human reader interpretation.

Effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable in the context of an oxygen concentrator. The "device" itself is the algorithm (control system) in conjunction with the physical components. The performance described (Oxygen concentration, Trigger Sensitivity, Flow Rate, etc.) is the standalone performance of the device without a "human-in-the-loop" directly affecting its primary function of oxygen delivery. The human interacts with the device by setting flow rates and inhaling, but these are inputs to the device's autonomous operation.

7. The Type of Ground Truth Used

The ground truth for the performance parameters was established by:

Established technical standards: e.g., ASTM F1464-93:2005, ISO 8359:1996, EN 60601-1-2:2007, IEC 60601-1:2003 for various aspects of safety and performance.
Comparison to legally marketed predicate devices: The "substantial equivalence" claim relies on demonstrating that the VBOX Trooper's performance is comparable to or better than the predicate devices (Inogen One and EverGo) across key performance indicators like oxygen concentration, trigger sensitivity, and flow rates.
Internal device specifications and design requirements: Bench testing verified that the device met its own designed performance metrics.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The VBOX Trooper Oxygen Concentrator is a mechanical and electronic device, not an AI/machine learning algorithm that requires a data-driven training set. Its design and development would have involved engineering principles and iterative testing, not machine learning model training.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there was no training set for an AI/machine learning model. The 'ground truth' for the development of the device would be based on engineering specifications, medical requirements for oxygen delivery, and adherence to relevant industry standards.

Summary

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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

· Inogen One Oxygen Concentrator (K032818)
· EverGo Portable Oxygen Concentrator (K043615)

Device Description:

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 .

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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 suppliedby Salter Labs)
Battery	Li-Ion
Performance Specifications
Method of oxygenconcentration	Molecular sieve (mechanical)
Process by which Oxygen isreleased	Differential pressure swingadsorption
Flow Rate	5 settings: 1 to 5 (flow ratesequivalent 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 electronicswith microprocessor
Rechargeable Battery	Yes
Power Options	Battery, AC

Intended Use:

Summary Comparison to Predicate Devices:

	VBOX TrooperOxygen Concentrator(Subject Device)	Inogen One OxygenConcentrator(Predicate Device)	EverGo PortableOxygen Concentrator(Predicate Device)
Manufacturer	VBOX, Inc.	Inogen	Philips Respironics
Classification	Class II	Class II	Class II
Product Code	CAW	CAW	CAW
Indications forUse	The VBOX Trooper oxygen concentratordevice is used on aprescriptive basis bypatients requiringsupplemental oxygen. Itsupplies a highconcentration of oxygenand is used with a nasalcannula to channeloxygen from theconcentrator to thepatient. The VBOXTrooper may be used inhome, institution,vehicle and variousmobile environments.	The Inogen OneOxygen Concentrator isused on a prescriptivebasis by patientsrequiring supplementaloxygen. It supplies ahigh concentration ofoxygen and is usedwith a nasal cannula tochannel oxygen fromthe concentrator to thepatient. The InogenOne may be used inhome, institution,vehicle and variousmobile environments.	The EverGo PortableOxygen Concentrator isintended for prescriptionuse by patients requiringhigh concentrations ofoxygen on asupplemental basis. It issmall, portable and iscapable of continuoususe in home,institutional, and travel /mobile environments.
PrescriptionRequired	Yes	Yes	Yes
PatientInterface	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 cannulasupplied by Salter Labs)	PVC (standard cannulasupplied by SalterLabs)	Not supplied with thedevice
Battery	Li-Ion	Li-Ion	Li-Ion
Performance Specifications
Method ofoxygenconcentration	Molecular sieve(mechanical)	Molecular sieve(mechanical)	Molecular sieve(mechanical)
Process bywhich Oxygen isreleased	Differential pressureswing adsorption	Differential pressureswing adsorption	Differential pressureswing adsorption
Flow Rate	5 settings: 1 to 5 (flowrates equivalent to 1LPM to 5 LPM)	5 settings: 1 to 5 (flowrates equivalent to 1LPM to 5 LPM) andone setting of"Satellite"	6 settings: 1 to 6 (flowrates equivalent to 1LPM to 6 LPM)
Duration offlow	Pulsed	Pulsed	Pulsed
TriggerSensitivity	≤ 0.13 cm water(≤ 12.7 Pa)	0.12 cm water (12 Pa)	0.16 cm water (16 Pa)
Oxygenconcentration	87-94% at all settings	87-93% at all settings	86-92% at all settings
Software/Hardware	Analog and digitalelectronics withmicroprocessor	Analog and digitalelectronics withmicroprocessor	Analog and digitalelectronics withmicroprocessor
RechargeableBattery	Yes	Yes	Yes
Power Options	Battery, AC	Battery, AC	Battery, AC

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Pre-Market Notification for the VBOX Trooper Oxygen Concentrator

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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)

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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.

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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.

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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

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4.0 Indications for Use Statement

Device Name: VBOX Trooper Oxygen Concentrator

Indications for Use:

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

Regulation Number and Section

§ 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).