(142 days)
Not Found
No
The device description focuses on mechanical components and control mechanisms (pressure regulators, timing valves, gauges) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a ventilator used in conjunction with a hyperbaric chamber for prescribed therapy, meaning it supports a therapeutic process rather than being a therapeutic device itself.
No
The device description indicates it is a ventilator used to deliver oxygen to patients in a hyperbaric chamber, not to diagnose a condition.
No
The device description clearly outlines physical hardware components (Control Module, Patient Breathing Circuit, pressure regulators, valves, gauges, hoses) that are integral to the device's function. It is 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 describes the device as a ventilator used to support breathing in patients within a hyperbaric chamber. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details components for controlling and delivering oxygen to a patient's airway. It focuses on mechanical and pressure-based functions related to breathing support. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device is clearly a medical device used for patient treatment and support, specifically in the context of hyperbaric therapy.
N/A
Intended Use / Indications for Use
The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.
Product codes
CBK
Device Description
The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device.
Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
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
pediatric and adult patients
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Helen Redd President Providence Global Medical, Incorporated 4659 South, 2300 East #203 Salt Lake City, Utah 84117
DEC 1 7 2009
Re: K092264
Trade/Device Name: Atlantis Hyperbaric Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 19, 2009 Received: November 25, 2009
Dear Ms. Redd:
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.
1
Page 2- Ms. Redd
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
2
Indications for Use Statement
510(k) Number (if known) K092264
Device Name: Atlantis Hyperbaric Ventilator
Indications for Use:
The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-the counter Use (21 C.F.R. Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultt
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092264
0000 Ved
3
510(k) SUMMARY
PROVIDENCE GLOBAL MEDICAL, INC.'s, ATLANTIS HYPERBARIC VENTILATOR
Submitters Name, Address, Telephone Number, Contact Person and Date Prepared
Submitters Name: Helen Redd, President Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117 Telephone: 800 292 8765 Contact Person: Helen Redd, President Date Prepared: July 15, 2009
Name of Device and Name/Address of Sponsor
Atlantis Hyperbaric Ventilator
Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117
Common or Usual Name
Ventilator, Continuous, Facility Use
Classification Name
Continuous Ventilator (21 C.F.R. § 868.5895)
Product Code
CBK
Predicate Device
Level-S, Inc.'s Neptune Hyperbaric Ventilator (K082351)
Indications for Use
The Atlantis Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.
4
Technological Characteristics
The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device.
Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
Substantial Equivalence
The Atlantis Hyperbaric Ventilator is as safe and effective and is an exact duplicate of the predicate, designed and built by the same person as the predicate Neptune Hyperbaric Ventilator, who is now Vice-President of the Company.
The Atlantis Hyperbaric Ventilator has the same intended uses, exactly the same technological characteristics, and exactly the same principles of operations as its predicate device. Any minor technological differences between the Atlantis and its predicated device raise no new issues of safety or effectiveness. Thus, the Atlantis Hyperbaric Ventilator is substantially equivalent.