(100 days)
No
The device description mentions a "microprocessor control algorithm" and "SmartDose™ technology" which senses inhalation and delivers a pulsed dose. While this involves sensing and a control algorithm, there is no mention of learning, training data, or adaptive behavior characteristic of AI/ML. The technology described appears to be a rule-based or pre-programmed system.
Yes
The device is described as a "delivery device for medial-grade oxygen" which is used to enhance oxygen delivery for patients, especially those who need to ambulate longer. This directly impacts the patient's physiological well-being by providing oxygen therapy.
No
Explanation: The device is described as a delivery device for medical-grade oxygen, designed to extend the use time of oxygen cylinders by sensing inhalation and delivering pulsed doses of oxygen. It does not mention any function for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a pressure regulator, CGA 870 style yoke, control valves, and a pressure switch. It also mentions battery power and continuous flow override, indicating a physical device with electrical and mechanical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver medical-grade oxygen from high-pressure cylinders to patients. This is a therapeutic delivery device, not a diagnostic one.
- Device Description: The description details how the device regulates and delivers oxygen based on the patient's breathing. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a medical device for oxygen delivery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
NFB
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.
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
Patients on oxygen
Intended User / Care Setting
trained clinicians in the hospital, clinical or home care 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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sunrise PD 1000 - K020329, Inspired Technologies VIAspire Model 300P LOX portable - K072011, Essex - Hi Pressure OCD - K024023
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 16-Feb-09
K.O904Al
| Inspired Technologies, Inc.
1061 Main Street - #24
N. Huntingdon, PA 15642 | Tel - 724-861-5510
Fax - 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 - K020329
Inspired Technologies VIAspire Model 300P LOX portable -
K072011
Essex - Hi Pressure OCD - K024023 |
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.
Indications for Use:
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.
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 regulator |
| Dosing device and algorithm | |
| Valves | |
| Pressure reduction from high | |
| pressure cylinders | Yes |
| Dosing algorithm | 16.0 cc/lpm x setting value ( i.e. 16x 1=16, 16 x 2 =32 etc) at |
| 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 Lpm flow settings | |
| Sport mode 1 is setting value + 16 cc | |
| Sport 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 Status |
| Patient 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 alert |
| No 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 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.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
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