(101 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on providing CPAP support without mentioning any intelligent or learning capabilities.
Yes
The device "provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance," which is a therapeutic function.
No
Explanation: The device description states its purpose is to "provide CPAP support for the care of spontaneously breathing individuals who require oxygen assistance." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "MACS CPAP device" and mentions using accessories like a "patient tubing circuit and positive airway pressure face mask," indicating it is a physical hardware device that delivers CPAP.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP (Continuous Positive Airway Pressure) to spontaneously breathing patients. This is a therapeutic intervention applied directly to the patient's respiratory system.
- Device Description: The device provides respiratory support and uses accessories like a patient tubing circuit and face mask to connect to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) to provide respiratory support.
N/A
Intended Use / Indications for Use
To provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.
Product codes
BTL, BYE
Device Description
The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use.
The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.
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
Training as physician, nurse, respiratory therapist, EMT / Hospital, pre-hospital (EMS) and sub-acute/alternate site facility 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)
The performance of the MACS CPAP System has been comprehensively tested. All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Emergency Resuscitator Guidance (April, 1993).
Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing. The MACS CPAP System performs as intended according to its performance specification and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024344 and K043085, K021520, K982283
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
10 80692
Image /page/0/Picture/1 description: The image shows the logo for Airon. The logo consists of a stylized circle with a line going through it, and a shape that looks like a bird inside the circle. To the right of the logo is the word "Airon" in a bold, sans-serif font.
JUN 2 0 2008
MACS CPAP System
510(k) Summary
Contact Information
G. Eric Gjerde President Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 Tel: 321-821-9433 Fax: 321-821-9443 email: egjerde@pneuton.com
Application Date
March 7, 2008
Device Trade Name
MACS CPAP System
Common Name
CPAP device
Device Classification
Powered Emergency Ventilator and Positive End Expiratory Pressure Breathing Apparatus (21 CFR 868.5925 and 868.5965, Product Code BTL and BYE)
Device Class
Class II
Classification Panel
Anesthesiology
Predicate Devices
Pneuton Transport Ventilator
PortO2Vent CPAPos
- manufactured by Emergent Respiratory Products
- · 510(k) number K021520
Whisperflow Oxygen Flow Generator
- manufactured by Caradyne Limited (now Respironics) ●
- ♣ 510(k) number K982283
Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443
1
Device Description
The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use.
The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.
Intended Use
To provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.
Substantial Equivalence
The MACS CPAP shares substantial equivalency with the Pneuton Ventilator, the PortO2Vent CPAPos device and the Whisperflow Oxygen Flow Generator across the spectrum of patient population for which each was designed.
The MACS CPAP device utilizes identical components as found in the Pneuton Ventilator, being simply the CPAP subsystem inside of the Pneuton Ventilator put into it's own enclosure.
The MACS CPAP shares common modalities with the PortOsVent CPAPos and Whisperflow Oxygen Flow Generator with significant overlap in the clinical range of function for their target population. The essential clinical function of each device is significantly similar and mimics each other in the tvpical frame of use by the health care providers. All are pneumatic controlled and applicable for the same areas of use.
| Characteristic | MACS CPAP | Pneuton
Ventilator | PortO₂Vent
CPAPos | Whisperflow
Oxygen Flow
Generator |
|-------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use -
application | Provide CPAP for
spontaneous
breathing patients
via mask or endo-
tracheal tube | Provide continuous
or intermittent
mechanical
ventilator support
for the care of
individuals who
require mechanical
ventilation. The
CPAP subsystem
provides CPAP for
spontaneous
breathing patients
via mask or endo-
tracheal tube | Provide CPAP for
spontaneous
breathing patients
via mask | Provide CPAP for
spontaneous
breathing patients
via mask or endo-
tracheal tube |
Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443
2
| Characteristic | MACS CPAP | Pneuton
Ventilator | PortO₂Vent
CPAPos | Whisperflow
Oxygen Flow
Generator |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Environments
of use | Hospital, pre-
hospital (EMS) and
sub-acute/alternate
site facility
environments | Hospital and pre-
hospital (EMS)
environments | Hospital and pre-
hospital (EMS)
environments | Hospital and pre-
hospital (EMS)
environments |
| Personnel
Requirements | Training as
physician, nurse,
respiratory
therapist, EMT | Training as
physician, nurse,
respiratory
therapist, EMT | Training as
physician, nurse,
respiratory
therapist, EMT | Training as
physician, nurse,
respiratory
therapist, EMT |
| Operating
principle | Pneumatic,
demand flow
system | Pneumatic,
demand flow
system | Pneumatic
demand flow
system | Pneumatic
continuous flow
system |
| Input gas
pressure | 40 to 70 psi | 40 to 70 psi | 40 to 70 psi | 60 psi |
| Patient circuit | Tubing with
external expiratory
valve and mask | Tubing with
external expiratory
valve and mask | Tubing with
external expiratory
valve and mask | Tubing with
external CPAP
valve and mask |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | None - venturi
device |
| Displays | Manometer | Manometer | Manometer | None |
| Safety features | Internal high
pressure release,
anti-suffocation
valve | Internal high
pressure release,
anti-suffocation
valve | Internal high
pressure release,
anti-suffocation
valve | None |
| | | | | |
| Patient support
modes | CPAP | CMV, IMV, CPAP | CPAP | CPAP |
| Peak Flow on
demand (L/min) | 140 | 140 | 100 | 140 |
| CPAP levels (cm
H2O) | 0 - 20 | 0 - 20 | 0 - 20 | 0 - 20 |
| Internal oxygen
control | 2 position, 100% or
65% | 2 position, 100% or
65% | 100% only | 28% to 100% |
| Materials in gas
pathway | Identical to
Pneuton ventilator | Cleared in
K024344 and
K043085 | Unknown | Stainless steel,
PVC |
| Accessories | Disposable patient
circuit with mask,
head strap, mobile
stand, rail / pole
mount bracket,
travel bag, oxygen
hose and oxygen
tank | Disposable patient
circuit with mask,
mobile stand, pole
mount bracket,
travel bag, oxygen
hose and oxygen
tank | Disposable patient
circuit with mask,
head strap, pole
mount bracket,
travel bag, oxygen
hose and oxygen
tank | Disposable patient
circuit with CPAP
valve, mask and
head strap |
:
Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443
:
ترا
・
3
Summary of Non-Clinical Testing and Validation
The performance of the MACS CPAP System has been comprehensively tested. All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Emergency Resuscitator Guidance (April, 1993).
The MACS CPAP Device complies with the following voluntary standards:
- . ISO 10651-5:2006 Lung ventilators for medical use — Particular requirements for basic safety and essential performance -- Part 5: Gas-powered emergency resuscitators
- . ISO 5356-1:2004 Anesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- . CGA V-5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing. The MACS CPAP System performs as intended according to its performance specification and is substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces left and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 2008
Mr. G. Eric Gjerde President and Chief Executive Officer Airon Corporation 129 West Hibiscus Boulevard, Suite S Melbourne, Florida 32901
Re: K080692 Trade/Device Name: MACS CPAP System Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL, BYE Dated: June 10, 2008 Received: June 18, 2008
Dear Mr. Gjerde:
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.
5
Page 2 - Mr. Gjerde
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Suette G. Michaud.
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
6
Indications For Use Statement
510(k) Number: K080692
Device Name: MACS CPAP System
Indications For Use: To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endotracheal tube.
Prescription Use X OR .
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Üff) (Division Sign-Chi)
Division of Anesthesiology, General Hospital
Division of Anesthesional Davison Division Control, Dental Devices
510(k) Number: K080692