The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.

Device Description

The Inspired Technologies Model 350G Gas Conserver is designed to extend the use time of oxygen cylinders. It contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. While the device is normally operated in the conserving mode, there is a continuous flow over-ride switch that allows 2 LPM of oxygen to bypass all valves for delivery to the patient. This continuous flow mode is typically used in the event of low or no battery power. In the conserving mode, the 350G Gas Conserver delivers oxygen to the patient by sensing inhalation via a pressure switch and opening one, two or both control valves for a specified period of time as determined by the microprocessor control algorithm. In the conserving mode, the device uses SmartDose™ technology to accomplish the oxygen savings. SmartDose™ senses the start of inhalation and releases a short "pulsed" dose at the very beginning of the inhalation cycle. The 350G Gas Conserver intended to be used by trained clinicians in the hospital, clinical or home care environments.

AI/ML Overview

This document describes the Inspired Technologies Model 350G Gas Conserver, a device designed to extend the use time of oxygen cylinders via a "SmartDose™" technology.

This device is not an AI/ML device, and therefore the majority of the information requested (AI/ML specific questions) cannot be answered. However, I can still provide the available information regarding its testing and acceptance within the provided text.

Based on the provided text, here's what can be extracted and what cannot be answered:

1. A table of acceptance criteria and the reported device performance

Test/Criteria	Device Performance / Compliance
Regulatory Compliance
FCC CFR 47 Parts 15B and 18	Performed and complied
Industry Canada BS EN 55011:2007	Performed and complied
IEC 60601-1	Performed and complied
Bench and Performance Testing
Low battery voltage tests	Performed
Battery Life	Performed
Battery reverse polarity	Performed
Pressure regulator verification	Performed
Storage at high and low temperatures	Performed
Operation at high and low temperatures	Performed
Cleaning verification	Performed
IPX1 - Drip proof verification	Performed
Key Features Performance (from Device Description)
Pressure reduction	Reduces cylinder pressure to 19-25 psig
Continuous flow (backup mode)	2 LPM of oxygen
Dosing algorithm	16.0 cc/lpm x setting value (1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0 Lpm)
Sport mode 1 dosing	Setting value + 16 cc
Sport Mode 2 dosing	Setting value + 32 cc/lpm
Breath sensing pressure range	0.03 to -0.200 cm H2O (vacuum)
Dosing (BPM)	Up to 35 BPM at maximum settings (5)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "the following tests" were performed, but does not specify sample sizes for any of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a hardware medical device and the tests performed are primarily engineering and compliance tests, not diagnostic or interpretive tests requiring expert "ground truth" establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the tests described are technical performance and compliance tests, not clinical evaluations requiring adjudication of subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is a hardware medical device, not an AI/ML diagnostic tool. There is no mention of an MRMC study or human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable in the context of typical AI/ML standalone performance. The device does contain a "microprocessor control algorithm" for the conserving mode, which operates in a standalone manner to deliver oxygen. However, this is a deterministic control algorithm, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the AI/ML sense. For the engineering tests, "ground truth" would be established by validated test equipment and calibration standards (e.g., pressure gauges for verifying pressure regulator, flow meters for dosing, timers for battery life), but these details are not provided.

8. The sample size for the training set

This information is not applicable. The device uses a deterministic control algorithm, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that to demonstrate the safety and efficacy of the Model 350G Gas Conserver, "the following tests according to the following standards" were performed:

Regulatory Compliance Standards:
- FCC CFR 47 Parts 15B and 18
- Industry Canada BS EN 55011:2007
- IEC 60601-1
Bench and Performance Testing:
- Low battery voltage tests
- Battery Life
- Battery reverse polarity
- Pressure regulator verification
- Storage at high and low temperatures
- Operation at high and low temperatures
- Cleaning verification
- IPX1 - Drip proof verification

The FDA's letter states that they have reviewed the premarket notification and "determined the device is substantially equivalent" to legally marketed predicate devices, implying that the submitted test results sufficiently demonstrate that the device meets safety and effectiveness requirements. The specific results of these tests (e.g., actual battery life in hours, exact pressure regulator output values, temperature ranges survived) are not detailed in this summary, but the completion of these tests according to the standards served as the proof of compliance.

Summary

{0}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 16-Feb-09

K.O904Al

Inspired Technologies, Inc.1061 Main Street - #24N. Huntingdon, PA 15642	Tel - 724-861-5510Fax - 724-861-5530
Official Contact:	Rick Confer - Director RA/QA
Proprietary or Trade Name:	Model 350G Gas Conserver
Usual Name:	Conserver, oxygen
Classification Name:	Noncontinuous ventilator (IPPB)NFB - 868.5905
Predicate Devices:	Sunrise PD 1000 - K020329Inspired Technologies VIAspire Model 300P LOX portable -K072011Essex - Hi Pressure OCD - K024023

Device Description:

Indications for Use:

Patient Population:

Patients on oxygen

Environment of Use:

Hospital, healthcare facilities, or home care environments.

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 16-Feb-09

Features	Model 350G Gas Conserver
Software driven	Yes
Components	Integral high pressure regulatorDosing device and algorithmValves
Pressure reduction from highpressure cylinders	Yes
Dosing algorithm	16.0 cc/lpm x setting value ( i.e. 16x 1=16, 16 x 2 =32 etc) at1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 Lpm flow settingsSport mode 1 is setting value + 16 ccSport Mode 2 is setting value +32 cc/lpm
Back up mode flow rate	Continuous flow in back-up mode of 2 Lpm
Powered and duration	4 "AA" batteries
Status indicators	Battery StatusPatient setting-valve activation
Breath sensing	Pressure switch range (vacuum) 0.03 to -0.200 cm H2O
Dosing	Up to 35 BPM at maximum settings (5)
Alarms	Visual battery low alertNo audible alarms
Data Storage	SD card used for storage of data

To demonstrate safety and efficacy we performed the following tests according to the following standards:

FCC CFR 47 Parts 15B and 18 Industry Canada BS EN 55011:2007 IEC 60601-1 Bench and performance testing for: Low battery voltage tests Battery Life Battery reverse polarity Pressure regulator verification Storage at high and low temperatures Operation at high and low temperatures Cleaning verification IPX1 -Drip proof verification

Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, Sunrise - PD 1000 - K020329, Inspired Technologies - VIAspire LOX Portable - K072011, and Essex - Hi Pressure OCD - K024023

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2009

Inspired Technologies, Incorporated C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K090421

Trade/Device Name: 350G Gas Conserver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: NFB Dated: May 15, 2009 Received: May 18, 2009

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.

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.

{3}------------------------------------------------

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 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 (OS) 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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Renores

Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

Page 1 of 1

510(k) Number:

Ko 1042 (To be assigned)

Device Name:

350G Gas Conserver

Indications for Use:

The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

Schuler

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090421

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).