(191 days)
Not Found
No
The summary does not mention AI or ML, and the description of the device and testing focuses on standard CPAP functionality and comparisons to predicate devices without indicating advanced learning algorithms.
Yes
The device is described as providing "continuous positive airway pressure (CPAP) to support treatment of adults ... with obstructive sleep apnea," which explicitly states its therapeutic purpose.
No
The device is a CPAP system used for treatment of obstructive sleep apnea, not for diagnosis. While it does detect apnea and hypopnea events, this is part of its treatment function to adjust pressure, not for primary diagnosis of the condition.
No
The device description explicitly states it is a "CPAP System" and mentions hardware components like a "blower" and an "optional battery." It also describes performance studies involving physical parameters like pressure, flow rate, temperature, and acoustic noise, which are characteristic of a hardware device. While it includes software components (firmware, mobile app), it is not solely software.
Based on the provided information, the Z1 CPAP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device "provides continuous positive airway pressure (CPAP) to support treatment of adults... with obstructive sleep apnea." This describes a therapeutic device that delivers air pressure to a patient's airway.
- Device Description: The description reinforces this by stating it "provides continuous positive airway pressure to support the treatment of adults... with obstructive sleep apnea."
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Z1 CPAP System does not interact with or analyze such specimens. It directly interacts with the patient's airway.
The device is a therapeutic device used to treat a medical condition by delivering air pressure.
N/A
Intended Use / Indications for Use
The Z1 CPAP System is a single patient reusable device That provides continuous positive airway pressure (CPAP) To support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Z1 CPAP System provides continuous positive airway pressure to support the treatment of adults over 66 lbs (30 kg) with obstructive sleep apnea. The device is a non-critical care, reusable, single patient device for use in the home setting, and it is intended to be a prescription use only device. The Z1 CPAP System is a modified version of the Z1 Blower cleared in K121374. The modifications include: addition of an optional battery, addition of an APAP mode, addition of Bluetooth and a mobile app, addition of new user settings, and changes to firmware.
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
adults
Intended User / Care Setting
prescription use only device for use in the home setting.
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
The same pneumatic air flow signals from a test lung were presented to the iSleep20i and the Z1. The test lung air flow signals comprised a clinically diverse data set of respiratory patterns, breathing rates, pressure settings, recovery to normal breathing and non-recovery patterns, etc. The therapy pressures generated by each device over time were compared. The pressure output of the Z1 matched the pressure output of the iSleep20i within the specified accuracy across all air flow signals within each sample time interval and met the acceptance criterion of matching within the specified accuracy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human Design Medical has performed the following Performance Testing to support the safety and effectiveness of the Z1 CPAP System:
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Human Design Medical, LLC C/O Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K140929
Trade/Device Name: Z1 CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous Regulatory Class: II Product Code: BZD Dated: September 16, 2014 Received: September 17, 2014
Dear Ms. O'Connell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Ms. O'Connell
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140929
Device Name Z1 CPAP System
Indications for Use (Describe)
The Z1 CPAP System is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
Prepared in accordance with 21 CFR § 807.92
| Date Summary Prepared: | September 16, 2014 |
|---|---|
| Submitter Information: | |
| Company Name: | Human Design Medical, LLC |
| Company Address: | 119 Braintree Street, Unit 703 |
| Boston, MA 02134 | |
| Contact Person: | Maureen O'Connell |
| O'Connell Regulatory Consultants, Inc. | |
| 5 Timber Lane | |
| North Reading, MA 01864 | |
| Phone: 978-207-1245 | |
| Fax: 978-824-2541 | |
| Device Information: | |
| Trade Name: | Z1 CPAP System |
| Common Name: | CPAP System |
| Classification Name: | Non-Continuous (Respirator) Ventilator, 21 CFR § 868.5905 |
| Device Class: | Class II |
| Predicate Devices: | 510(k) Number: K121374 |
| Manufacturer: Human Design Medical, LLC | |
| Product Name: Z1 Blower | |
| 510(k) Number: K063476 | |
| Manufacturer: Breas Medical AB | |
| Product Name: iSleep 20i | |
| 510(k) Number: K100121 | |
| Manufacturer: AeioMed, Inc. | |
| Product Name: Model 300157 | |
| Device Description: | The Z1 CPAP System provides continuous positive airway pressure to support the treatment of adults over 66 lbs (30 kg) with obstructive sleep apnea. The device is a non-critical care, reusable, single patient device for use in the |
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| | home setting, and it is intended to be a prescription use
only device. The Z1 CPAP System is a modified version of
the Z1 Blower cleared in K121374. The modifications
include: addition of an optional battery, addition of an
APAP mode, addition of Bluetooth and a mobile app,
addition of new user settings, and changes to firmware. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Provides continuous positive airway pressure (CPAP) to
support treatment of adults with obstructive sleep apnea. |
| Indications for Use: | The Z1 CPAP System is a single patient reusable device
That provides continuous positive airway pressure (CPAP)
To support treatment of adults weighing over 66 lbs (30 kg)
with obstructive sleep apnea. |
Technological Characteristics
| Compared to Predicate: | The Z1 CPAP System consists of the main flow generator
and accessories. The Z1 CPAP System 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. |
| ------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
All four of the systems include a flow generator and a power adaptor. The Z1 CPAP System, the Breas iSleep 20i System and the AeioMed Model 300157 also include an air tube and battery while the Z1 Blower cleared in K121374 can only be operated using the power adaptor and the air tube must be purchased separately. All four of the systems have buttons and a status display that allow the user to control the system. Additionally, the Z1 CPAP System allows the user to interact with the system via a mobile application. This is an optional user convenience component that does not impact the safety or effectiveness of the treatment delivered.
All four of the systems include a CPAP treatment mode with a ramp feature. The Z1 CPAP System, the Z1 Blower and the AeioMed Model 300157 include a ramp period up to 45 minutes while the Breas iSleep 20i System has a ramp period up to 60 minutes. This minor difference between the Z1 CPAP System and the Breas iSleep 20i System does not impact the substantial equivalence. All ramp features are identical between the Z1 Blower and the Z1 CPAP System.
The Z1 CPAP System and the Breas iSleep 20i System
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both include an APAP mode with an auto pressure setting algorithm. The Z1 employs the exact same software code for the APAP mode auto pressure setting algorithm as was cleared for the iSleep20i in K063476. Performance data is provided which shows that the performance of the Z1 CPAP System in the APAP mode is substantially equivalent to the predicate device.
All four of the systems include dynamic pressure control. The predicate systems have one fixed setting. The Z1 CPAP System has three user selectable settings (called Z-Breathe 1, 2 and 3). Performance data is provided which shows that all Z-Breathe settings are equivalent between the Z1 CPAP System and one of the identified predicate devices.
The pressure range for all four of the systems is 4-20 cmH20 in 0.5 cm H2O increments. The Z1 CPAP System, the Z1 Blower and the AeioMed Model 300157 include an automatic altitude adjustment for conditions up to 8,000 feet. The operating range and storage range for the Z1 CPAP System and the Z1 Blower are identical. All four systems allow data management functionality through an SD data card or memory card or through a USB port.
Both the Z1 CPAP System and one of the identified predicate devices use a lithium ion battery pack with 4 cells and a voltage of 14.4 volts. The battery longevity was measured to be 5-8 hours for the Z1 CPAP System depending upon the exact use conditions while it was measured to be 5-7 hours for the predicate. The environment of use for all four systems is the home while the Breas iSleep 20i System can also be used in a clinical setting.
Human Design Medical has performed the following Performance Testing: performance testing to support the safety and effectiveness of the Z1 CPAP System:
Maximum temperature at the patient connection port under normal and single fault conditions was