The ZI 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.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the Z1 Blower, detailing its acceptance criteria and the study that proves it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (If explicitly stated or inferred)	Reported Device Performance
Temperature at Patient Port	< 43 degrees C at Pset = 20 cmH2O	< 43 degrees C at a pressure setting of 20 cmH2O under normal and single fault conditions
Pressure Stability (Static Long-term)	Within ± 1.0 cmH2O of set pressure (Pset = 10 cmH2O) (Inferred from reported performance as the criterion)	Within ± 1.0 cmH2O of the set pressure of 10 cmH2O
Pressure Accuracy (Short-term Static)	Within ± (0.6 cmH2O + 4% * set pressure) for all pressure settings (Inferred from reported performance as the criterion)	Actual pressure was within ± (0.6 cmH2O + 4% * set pressure) of the set pressure for all pressure settings
Dynamic Pressure Stability	Less than the variation of the predicate device for all pressure and breathing rate settings	Peak to peak pressure variation was between 0.6 and 3.1 cmH2O for all pressure and breathing rate settings, and was less than the variation of the predicate device for all pressure and breathing rate settings
Maximum Flow Rate	≥ 75 Liters per minute AND ≥ the maximum flow rate of the predicate device for each pressure setting	≥ 75 Liters per minute and ≥ the maximum flow rate of the predicate device for each pressure setting
Acoustic Noise	< 36 dBA (Inferred from reported performance as the criterion)	< 36dBA
Air Leak Detection	Within ± 5 mmH2O of the specified air leak detection thresholds (Inferred from reported performance as the criterion)	Air leaks were detected within +5 mmH20 of the specified air leak detection thresholds
Volatile Organic Compounds (VOCs)	No VOCs above 5.0 ug per cubic meter in air output (Inferred from reported performance as the criterion)	No volatile organic compounds were observed in the air output of the device above 5.0 ug per cubic meter
Particulate Matter	No particulate matter above 5.0 ug per cubic meter in output air (Inferred from reported performance as the criterion)	No particulate matter was observed in the output air of the device above 5.0 ug per cubic meter
Carbon Monoxide/Dioxide Output	Added no carbon monoxide or carbon dioxide to the output air (Inferred from reported performance as the criterion)	The Z1 Blower added no carbon monoxide or carbon dioxide to the output air
Ozone Output	≤ 0.05 ppm (21 CFR 801.415 requirement)	The ozone output of the device met the 21 CFR 801.415 requirement of 0.05 ppm or less

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify sample sizes for any of the performance tests. The data provenance is also not explicitly stated, but the nature of the tests (e.g., temperature, pressure, flow rate, acoustic noise, chemical emissions) indicates these were laboratory-based engineering/performance tests rather than human clinical studies. No information about the country of origin or whether the data was retrospective or prospective is present.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable as the tests described are technical performance measurements of the device itself, not assessments of diagnostic accuracy or clinical outcomes requiring expert interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are objective technical measurements, not evaluations requiring subjective expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was generated to support a substantial equivalence determination." The studies performed were technical and engineering-based, comparing the device's physical and functional characteristics to established standards and predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of this device. The Z1 Blower is a hardware device (CPAP system) with integrated software for control and data, not an AI algorithm designed to interpret data or provide diagnostic assistance. The performance tests are for the device's physical operation.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on established engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC, 21 CFR), and the performance characteristics of predicate devices. For example:

Temperature measurement compared to a maximum safety limit.
Pressure accuracy and stability compared to defined tolerances.
Dynamic pressure stability and maximum flow rate compared to predicate device performance.
Chemical emissions compared to defined limits in regulatory standards.

8. The Sample Size for the Training Set

This information is not applicable. The Z1 Blower is a medical device, not a machine learning model that requires a distinct "training set" for its functionality in the common sense of AI development. Its performance is based on its engineering design and manufacturing, validated through the performance tests mentioned.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as in point 8. The "ground truth" for the device's design and performance validation comes from adherence to engineering principles, scientific measurements, and regulatory standards, rather than a "training set" with associated ground truth as understood in AI/ML.

Summary

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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:

FEB 2 2 2013

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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 < 43 degrees C at a pressure setting of 20 cmH20;

Pressure stability under static long-term conditions was within ± 1.0 cmH2O of the set pressure of 10 cmH2O;

Short term static pressure accuracy: the actual pressure was within ± (0.6 cmH2O + 4% * set pressure) of the set pressure for all pressure settings:

Dynamic pressure stability: the peak to peak pressure

Intended Use:

Indications for Use:

Performance Testing:

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variation was between 0.6 and 3.1 cmH2O for all pressure and breathing rate settings, and was less than the variation of the predicate device for all pressure and breathing rate settings;

Maximum flow rate was ≥ 75 Liters per minute and ≥ the maximum flow rate of the predicate device for each pressure setting.

Acoustic noise testing found that the sound pressure level was < 36dBA;

Ability of the system to detect air leaks: air leaks were detected within +5 mmH20 of the specified air leak detection thresholds;

Volatile organic compounds: no volatile organic compounds were observed in the air output of the device above 5.0 ug per cubic meter;

Particulate matter: no particulate matter was observed in the output air of the device above 5.0 ug per cubic meter;

The Z1 Blower added no carbon monoxide or carbon dioxide to the output air and the ozone output of the device met the 21 CFR 801.415 requirement of 0.05 ppm or less.

The Z1 Blower complies with the following performance and safety standards: ISO 5356-1:2004 Anesthetic and Respiratory Equipment - Conical Connectors: Part 1: Cones and Sockets. ASTM F 1246-91 standard specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits. IEC 60601-1:2005 Medical Device Equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2007 Medical Device Equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic compatibility - requirements and tests. ISO 23328-2:2002 Breathing system filters for anesthetic and respiratory use -- part 2: non filtration aspects. ISO 17510-1:2007 Sleep apnoea breathing therapy- Part 1: Sleep apnoea breathing therapy equipment.

No clinical data was generated to support a substantial equivalence determination.

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Conclusion:

The Z1 Blower is substantially equivalent to the predicate devices, as the devices share a common intended use, and technological differences between the Z1 Blower and the predicate do not raise new questions of safety or effectiveness. ,

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2013

Deshum Medical C/O Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Incorporated 5 Timber Lane NORTH READING MA 01864

Re: K121374

Trade/Device Name: ZI Blower Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 12, 2013 Received: February 13, 2013

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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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 (reporting of medical devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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Anthony D. Watson, B.S., M.S., M.B.A. 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): K 121374

Device Name: Zi Blower

Indications for Use:

The ZI 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C).

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schultheis Jr
2013.02.22 13:19:08 -05'00'

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(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number;

000058

Regulation Number and Section

§ 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).