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.

Device Description

The Z1 CPAP System provides continuous positive 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.

AI/ML Overview

The provided document describes the Z1 CPAP System and its substantial equivalence to predicate devices, focusing on performance testing rather than clinical studies with human subjects. Therefore, some of the requested information, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, or MRMC studies, are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Z1 CPAP System are primarily based on equivalence to predicate devices and adherence to established performance standards.

Acceptance Criteria Category (Derived from document)	Z1 CPAP System Performance/Compliance
General Performance Characteristics
Max Temperature at patient connection port	< 43 degrees C at 20 cmH2O (under normal and single fault conditions)
Pressure Stability (static, long-term)	Within ± 1.0 cmH2O of 10 cmH2O set pressure
Static Pressure Accuracy (short-term)	Actual pressure within specified tolerance for all pressure settings
Dynamic Pressure Stability	Average peak-to-peak pressure deviation < maximum limit established by Human Design Medical, for each pressure and breath rate setting (compared to predicate device)
Maximum Flow Rate	≥ minimum limit established by Human Design Medical for each pressure setting
Acoustic Noise Level	26 dBA sound pressure level
Air Leak Detection	Air leaks detected within +5 mmH2O of specified air leak detection thresholds
Volatile Organic Compounds (VOCs)	No VOCs observed above ambient air levels
Particulate Matter	No particulate matter observed above ambient air levels
Carbon Monoxide/Dioxide Output	No carbon monoxide or carbon dioxide added to output air
Ozone Output	Meets 21 CFR 801.415 requirement of 0.05 ppm or less
Altitude Performance	Maintained actual output pressure within specified tolerance limits throughout the entire specified altitude pressure range of operation (up to 8,000 feet)
Z-Breathe Settings Equivalence	Pressure waveforms for the three Z-Breathe settings were substantially equivalent to pressure waveforms for the predicate device.
APAP Mode Performance
Pressure Output Match (vs. iSleep20i)	Pressure output of Z1 matched iSleep20i within specified accuracy across all air flow signals within each sample time interval, meeting acceptance criterion of matching within specified accuracy.
Apnea-Hypopnea Event Detection (vs. iSleep20i)	Number of apnea-hypopnea events detected by Z1 was the same as iSleep20i, meeting acceptance criterion for an exact match.
Software-level output comparison (vs. iSleep20i)	Outputs of the software in Z1 and iSleep20i compared on a sample by sample basis and met all acceptance criteria for level of agreement.
Regulatory Compliance & Safety
ISO Standards Compliance	Complies with ISO 5356-1, ASTM F 1246-91, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ISO 23328-2, ISO 17510-1.
Biocompatibility	Patient contacting components comply with ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-12.
CPAP Tube Cleaning & Replacement	Recommended cleaning procedures and replacement interval validated.
Battery Performance	Safety, performance, and longevity of the battery accessory verified. Battery longevity: 5-8 hours depending on use conditions.

Study Proving Device Meets Acceptance Criteria:

The device's acceptance is primarily based on bench performance testing comparing the Z1 CPAP System to predicate devices, particularly the iSleep20i (K063476) for the APAP mode, and demonstrating compliance with relevant national and international performance and safety standards. No clinical data was generated to support substantial equivalence.

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

Sample Size for Test Set: Not explicitly stated as a numerical patient or case count. The testing involved "pneumatic air flow signals from a test lung" comprising a "clinically diverse data set of respiratory patterns, breathing rates, pressure settings, recovery to normal breathing and non-recovery patterns, etc." It also included "digitized flow samples" which formed another "clinically diverse data set."
Data Provenance: The data used for testing was generated from a "test lung" and "digitized flow samples." This indicates the data is synthetic/simulated rather than originating from human patients in a specific country. It is retrospective in the sense that predetermined test cases were applied to the devices, rather than ongoing data collection from patients.

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

Number of Experts: Not applicable. The ground truth for this bench testing was established by the engineering specifications and expected outputs of the predicate device (iSleep20i). The comparison was directly against the known, cleared performance of the predicate device, not against expert medical interpretations of patient data.
Qualifications of Experts: N/A as it's not an expert-driven ground truth.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The comparison was an objective, quantitative one between the output of the Z1 CPAP System and the predicate iSleep20i system, as well as against pre-defined engineering limits and standards. An "exact match" was an acceptance criterion for apnea-hypopnea event detection.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a CPAP system, not an AI-assisted diagnostic tool that involves human readers interpreting results.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the testing described appears to be a standalone (algorithm only) performance evaluation. The Z1 CPAP System's performance, particularly its APAP software, was compared directly against the iSleep20i's performance using identical input signals, without human intervention in the loop of the device's operational response.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for the APAP software equivalence testing was the known, cleared performance and output of the predicate device (iSleep20i), particularly its pressure adjustment outputs and apnea-hypopnea event detections. For other performance aspects (e.g., temperature, noise, flow rate), the ground truth was based on established engineering specifications, regulatory limits, and compliance with recognized standards.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. The document states that the Z1 CPAP System's APAP software is identical to the cleared iSleep20i software (from K063476). This means the Z1 did not involve a separate training process for its APAP algorithm itself, but rather acquired and ported existing, already-trained (or developed) software.

9. How the ground truth for the training set was established:

How Ground Truth for Training Set was Established: Not applicable, as the APAP software was acquired from a previously cleared device. The document states, "Human Design Medical ported the iSleep20i APAP software into the Z1 CPAP System without modification." Therefore, the training for the original iSleep20i software would have established its ground truth, but this information is not part of the current submission.

Summary

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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)

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 703Boston, MA 02134
Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Phone: 978-207-1245Fax: 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: K121374Manufacturer: Human Design Medical, LLCProduct Name: Z1 Blower
	510(k) Number: K063476Manufacturer: Breas Medical ABProduct Name: iSleep 20i
	510(k) Number: K100121Manufacturer: 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 useonly device. The Z1 CPAP System is a modified version ofthe Z1 Blower cleared in K121374. The modificationsinclude: addition of an optional battery, addition of anAPAP 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) tosupport treatment of adults with obstructive sleep apnea.
Indications for Use:	The Z1 CPAP System is a single patient reusable deviceThat 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 generatorand accessories. The Z1 CPAP System and the identifiedpredicate devices have the same fundamental technologicalcharacteristic: Use of a pneumatic pump to delivercontinuous positive airway pressure within a clinicallyindicated therapeutic pressure range.
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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 < 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;

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Short term static pressure accuracy: the actual pressure was within the specified tolerance of the set pressure for all pressure settings;

Dynamic pressure stability: the average peak-to-peak pressure deviation was < the maximum limit established by Human Design Medical, for each pressure and breathe rate setting and was compared to a predicate device;

Maximum flow rate was ≥ minimum limit established by Human Design Medical for each pressure setting.

Acoustic noise testing found that the sound pressure level was 26dBA:

Testing of the battery was performed to verify the safety, performance and longevity of the battery accessory.

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 what was found in the ambient air;

Particulate matter: no particulate matter was observed in the output air of the device above what was found in the ambient air;

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.

Altitude testing showed that the Z1 maintained actual output pressure within the specified tolerance limits throughout the entire specified altitude pressure range of operation.

The pressure waveforms for the three z-Breathe settings have been compared with the pressure waveforms for the predicate device and it was determined that the performance was substantially equivalent.

The Z1 Blower complies with the following performance

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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 Electrical Equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic compatibility - requirements and tests. IEC 60601-1-6: Medical Electrical Equipment-Part 1-6: General requirements for basic safety and essential performance-collateral standard: Usability. IEC 60601-1-11 Medical Electrical Equipment-Part 1-11: General requirements for basic safety and essential performancecollateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (including Technical Corridgendum 1).

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.

Biocompatibility testing was performed which showed that the patient contacting components of the system comply with ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing; ISO 10993-3:2003 Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity; ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity; ISO 10993-6:2007 Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects After Implantation: ISO 10993-10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization; and ISO 10993-12:2012 Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials.

Testing of the CPAP Tube was performed which validated the recommended cleaning procedures and replacement interval.

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The APAP software of the Z1 CPAP System is identical to the APAP software of the iSleep20i System cleared by FDA in K063476. The iSleep20i software source code, as well as the entire iSleep20i Design History File and Regulatory Master File were acquired by Human Design Medical as part of a business acquisition. Human Design Medical ported the iSleep20i APAP software into the Z1 CPAP System without modification. Therefore, the Z1 CPAP System employs the exact same software code as was cleared for the iSleep20i in K063476.

Since the APAP software has already been cleared in K063476 for the iSleep20i, it was only necessary to verify and validate that the Z1 CPAP System, when running the same software and presented with the same clinically diverse dataset on the bench, produces the same results as the iSleep20i System. Therefore Human Design Medical has conducted extensive bench testing of the Z1 CPAP System side-by-side with the iSleep20i System to verify and validate that the two devices produce the same respiratory event detections and pressure adjustment outputs for the same input air flow data. This testing is described in the following paragraph.

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. The outputs of ancillary algorithms for detecting apnea and hypopnea events were also compared. The number of apneahypopnea events detected by the two devices was the same, and met the acceptance criterion for an exact match. Additionally, software-level testing was performed in which the same digitized flow samples were presented to the iSleep20i and the Z1. The digitized flow data comprised a clinically diverse data set. The outputs of the software in each device were compared on a sample by sample basis and met all acceptance criteria for level of

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	agreement. The results of the APAP testing satisfied eachand every acceptance criterion of the V&V Plan withoutexception.
	No clinical data was generated to support a substantialequivalence determination. A determination was made thatbench performance testing was appropriate versus clinicalperformance testing because there are accepted benchperformance testing methodologies available which allow adirect comparison of the performance of the Z1 CPAPSystem compared to the predicate devices under a widevariety of operating conditions.
Conclusion:	The Z1 CPAP System is substantially equivalent to thepredicate devices, as the devices share a common intendeduse, and technological differences between the Z1 CPAPSystem and the predicate do not raise new questions ofsafety or effectiveness.

agreement. The results of the APAP testing satisfied eachand every acceptance criterion of the V&V Plan withoutexception.

No clinical data was generated to support a substantialequivalence determination. A determination was made thatbench performance testing was appropriate versus clinicalperformance testing because there are accepted benchperformance testing methodologies available which allow adirect comparison of the performance of the Z1 CPAPSystem compared to the predicate devices under a widevariety of operating conditions.

Conclusion:

The Z1 CPAP System is substantially equivalent to thepredicate devices, as the devices share a common intendeduse, and technological differences between the Z1 CPAPSystem and the predicate do not raise new questions ofsafety or effectiveness.

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).