(291 days)
Not Found
No
The summary describes a standard CPAP device with a flow generator and data interfaces. There is no mention of AI, ML, or any features that would suggest the use of such technologies for diagnosis, treatment adjustment, or data analysis beyond basic recording. The treatment settings are physician-directed.
Yes
The device "provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea," indicating a therapeutic purpose.
No
Explanation: The device is described as providing continuous positive airway pressure (CPAP) for treatment of obstructive sleep apnea, indicating it is a therapeutic device rather than a diagnostic one. Its function is to deliver air pressure, not to identify or analyze a medical condition.
No
The device description explicitly states it consists of a "flow generator" and performance studies detail testing related to physical parameters like temperature, pressure, flow rate, acoustic noise, and air composition, indicating it is a hardware device with software components.
Based on the provided information, the Z1 Blower is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure (CPAP) to support the treatment of obstructive sleep apnea. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a flow generator that provides air pressure. This aligns with a therapeutic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, the Z1 Blower is a therapeutic medical device, specifically a CPAP machine, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
Provides continuous positive airway pressure (CPAP) to support treatment of adults with obstructive sleep apnea.
The Z1 Blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
Product codes
BZD
Device Description
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
Software utilized in both primary (control of pressure) and secondary (data collection and transfer) functions of the Z1 Blower is considered a Moderate Level of Concern.
The Z1 Blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
The Z1 Blower consists of the main flow generator and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adults (over 30 kg)
Intended User / Care Setting
home use, prescription use only
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)
Deshum Medical has performed the following performance testing to support the safety and effectiveness of the Z1 Blower:
Maximum temperature at the patient connection port under normal and single fault conditions was
§ 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
K121374
510(K) SUMMARY Prepared in accordance with 21 CFR § 807.92
Date Summary Prepared: February 22, 2013
Submitter Information:
Company Name: Company Address: Deshum Medical 222 Third Street, Suite 1325 Cambridge, MA 02142
Contact Person:
Ray Bruttomesso Tel: (617) 583-1375 Fax: (617) 401-3931 ray.bruttomesso@Deshum.com
Device Information:
Trade Name:
Z1 Blower
CPAP System
Common Name:
Classification Name:
Device Class:
Predicate Devices:
Non-Continu
Non-Continuous (Respirator) Ventilator, 21 CFR & 868.5905
Class II
510(k) Number: Manufacturer: Product Name:
K100121 AEIOMed, Inc. Model 300157 CPAP System
510(k) Number: Manufacturer: Product Name:
K052597 Hoffman Laboratories, LLC Breathex Omega CPAP Device, Model 322
510(k) Number: Manufacturer: Product Name:
K013843 Resmed Corp. Autoset Spirit CPAP System
Device Description:
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is
FEB 2 2 2013
1
intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
Software utilized in both primary (control of pressure) and secondary (data collection and transfer) functions of the Z1 Blower is considered a Moderate Level of Concern.
Provides continuous positive airway pressure (CPAP) to support treatment of adults with obstructive sleep apnea.
The Z1 Blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
Technological Characteristics:
The Z1 Blower consists of the main flow generator and accessories. The Z1 Blower and the identified predicate devices have the same fundamental technological characteristic: Use of a pneumatic pump to deliver continuous positive airway pressure within a clinically indicated therapeutic pressure range. Other technological characteristics are the same or very similar. Nonetheless, minor differences are present. Importantly, these minor differences do not raise different questions of safety and effectiveness, and acceptable scientific methods for evaluation exist. Applicable standards have been utilized to ensure that the Z1 Blower is as safe and as effective as the predicate device.
Deshum Medical has performed the following performance testing to support the safety and effectiveness of the Z1 Blower:
Maximum temperature at the patient connection port under normal and single fault conditions was