(140 days)
Not Found
No
The device description focuses on mechanical components and control based on pressure and timing, with no mention of AI/ML terms or functionalities.
Yes
The device is a ventilator, which provides mechanically supported ventilation to patients in respiratory failure during hyperbaric therapy, aiming to treat or alleviate a condition.
No
The device is a ventilator used for mechanical ventilation, which is a therapeutic intervention, not a diagnostic one. It delivers oxygen and controls breathing parameters, but does not diagnose conditions.
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 and are supplied with the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mechanical ventilation to patients during hyperbaric therapy. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a ventilator that delivers oxygen to a patient's lungs. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Neptune Hyperbaric Ventilator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neptune Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.
Product codes
CBK
Device Description
The Neptune 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 and timing valves for control of inspiratory time, expiratory time, and inspiratory flow, as well as 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 valye, 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 door. 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 Neptune Hyperbaric Ventilator that 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
Not Found
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)
Performance testing was conducted that confirms that the device operates as designed. In all instances, the Neptune Hyperbaric Ventilator functioned as intended; delivery of the gas volumes, frequencies, and safety devices was verified.
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).
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K082351
P. 1 of 2
510(k) SUMMARY
JAN - 2 2009
LEVEL-5, INC.'S NEPTUNE HYPERBARIC VENTILATOR
Submitters Name, Address, Telephone Number, Contact Person and Date Prepared
Howard M. Holstein Regulatory Counsel to Level-5, Inc. Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Phone: (202) 637-5813
Facsimile: (202) 637-5910 Date Prepared: December 31, 2008
Name of Device and Name/Address of Sponsor
Neptune Hyperbaric Ventilator
Level-5, Inc. 8005 Shannon Industrial Park Lane Atchison, KS 66002
Common or Usual Name
Ventilator, Continuous (respirator)
Classification Name
Continuous Ventilator (21 C.F.R. § 868.5895)
Product Code
CBK .
Predicate Device
Sechrist Industries, Inc.'s Hyperbaric Ventilator Model 500A (K760852)
Indications for Use
The Neptune Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.
1
Technological Characteristics
The Neptune 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 and timing valves for control of inspiratory time, expiratory time, and inspiratory flow, as well as 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 valye, 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 door. 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 Neptune Hyperbaric Ventilator that are supplied with the device.
Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
Performance Data
Performance testing was conducted that confirms that the device operates as designed. In all instances, the Neptune Hyperbaric Ventilator functioned as intended; delivery of the gas volumes, frequencies, and safety devices was verified.
Substantial Equivalence
The Neptune Hyperbaric Ventilator is as safe and effective as the Sechrist Hyperbaric Ventilator Model 500A. The Neptune Hyperbaric Ventilator has the same intended uses, similar technological characteristics, and similar principles of operation as its predicate device. The minor technological differences between the Neptune and its predicate device raise no new questions of safety or effectiveness. Thus, the Neptune Hyperbaric Ventilator is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol is a stylized representation of a bird-like figure with three distinct segments, possibly representing the department's focus on health, human services, and the USA.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2009
Level-5, Incorporated C/O Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington DC 20004
Re: K082351
Trade/Device Name: Neptune Hyperbaric Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 22, 2008 Received: December 22, 2008
Dear Mr. Holstein:
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 such 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. Holstein
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Chris Evert
Chiu Lin, Ph.D. 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
0 4 2331 510(k) Number (if known) _
Device Name: Neptune Hyperbaric Ventilator
Indications for Use:
The Neptune Hyperbaric Ventilator is indicated for use with patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric 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)
_
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K082351