(214 days)
OMS 20, OMS 50
Not Found
No
The device description focuses on a mechanical system for oxygen delivery based on the patient's breathing cycle, with no mention of AI or ML.
Yes
The device delivers a bolus of oxygen to patients who require prescribed doses of supplemental gases, which directly assists in their breathing and conserves medical gas, indicating a therapeutic function.
No
The device description indicates that the Pulse Dose Series devices provide a bolus of oxygen to a patient at the start of inhalation to assist with gas conservation. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a repackaged version of existing Oxygen Management Systems (OMS 20 and 50) and describes the physical mechanism of providing a bolus of oxygen, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The description clearly states the device provides a bolus of oxygen to a patient at the start of inhalation to conserve gas. This is a device that interacts directly with the patient's respiratory system, delivering a gas.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
- Predicate Devices: The predicate devices (OMS 20 and 50) are described as "Oxygen Management Systems," which aligns with the function of delivering oxygen to a patient, not performing in vitro diagnostics.
IVD devices are used to test samples taken from the body, not to directly treat or manage a patient's physiological process like breathing.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73BZD
Device Description
The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
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)
The gas dosage methodology, oxygen delivery specifications, and performance of the devices in the Pulse Dose Series are identical to those of the OMS 20 and 50. This is evidenced in the various comparison matrices and testing reports contained in this 510(k). This equivalency is also evidenced in the non-clinical testing which reveals the same dosage delivery when comparing the predicate devices with the devices in the Pulse Dose Series. The device's performance to the end user are identical as compared to the OMS 20 and 50. Tests and analysis indicate that there is no greater risk to the end user than there is with the predicate devices. These device improvements were intended to make the devices in the Pulse Dose Series more user friendly while increasing their reliability, without altering their performance for the end user.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OMS 20, OMS 50
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
Image /page/0/Picture/3 description: The image shows the logo for Devilbiss, a division of Sunrise Medical. The logo is black and white and features a stylized graphic to the left of the text. The text is in a bold, sans-serif font, with "DEVILBISS" in large letters and "a division of SUNRISE MEDICAL" in smaller letters below.
Image /page/0/Picture/4 description: The image shows a logo for the Atlanta Paralympic Games. The logo features a large star with curved lines underneath it, and a stylized flame to the right of the star. The text "The Atlanta Paralympic Games" is arranged in a circular fashion around the star.
DeVilbiss Health Care, Inc.
1200 East Main Street
P.O. Box 635
Somerset, PA 15501-0635
U.S.A.
(814) 443-4881
Fax: (814) 443-7572
CT 21 1996
510 (k) Summary 16.0 Summary of Safety and Effectiveness
| Firms name: | DeVilbiss Health Care, Inc.
Pulsair Division
P.O. Box 2609
4106 Avenue D
Fort Pierce, Fla. 34954 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Submitter's name: | Gregory W. Good |
| Phone: | (814) 443-7466 |
| Fax: | (814) 443-7571 |
| Date of Preparation: | 9 October 1996 |
| Trade name: | Oxygen Management Systems |
| Common name: | Pulse Dose Series |
| Classification name: | Non-Continuous Ventilators 73BZD (21 CFR 868.5905 |
The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
The gas dosage methodology, oxygen delivery specifications, and performance of the devices in the Pulse Dose Series are identical to those of the OMS 20 and 50. This is evidenced in the various comparison matrices and testing reports contained in this 510(k). This equivalency is also evidenced in the non-clinical testing which reveals the same dosage delivery when comparing the predicate devices with the devices in the Pulse Dose Series. The device's performance to the end user are identical as compared to the OMS 20 and 50.
1
2004
When compared to the predicate devices, the OMS 20 and 50, the devices in the Pulse Dose Series utilize the same type of energy source, and there are no significant changes in the materials or features.
All the devices in the Pulse Dose series utilize batteries as the energy source, as do the OMS 20 and 50. The fundamental operational features are identical; however, the devices in the Pulse Dose Series include some additional features, e.g.,battery level indicator, which make the devices more user friendly.
The differences between the devices in the Pulse Dose Series and the OMS 20 and 50 can be categorized as additional patient features (battery level indicator), technological improvements (microprocessor control), or re-packaging (improved cosmetics and manufacturing /servicing assembly). Tests and analysis indicate that there is no greater risk to the end user than there is with the predicate devices. These device improvements were intended to make the devices in the Pulse Dose Series more user friendly while increasing their reliability, without altering their performance for the end user.
Therefore, based on the above mentioned similarities, especially the dosage methodology, the Pulse Dose Series devices and the OMS 20 are substantially equivalent devices.