New Wave System

K260455 · Zeto, Inc. · GWQ · Mar 13, 2026 · Neurology

Device Facts

• Record ID: K260455
• Device Name: New Wave System
• Applicant: Zeto, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended to measure, record, and display electrical activity of the brain for clinical evaluation and diagnosis of neurological conditions.

Device Story

New Wave System is a wearable, full-montage EEG device for outpatient or home use. It utilizes a flexible, semi-rigid headset with 19 active dry Ag/AgCl electrodes (10-20 system) and auxiliary inputs to capture brain electrical activity. The system includes a head unit, display unit, and extension unit. Data is transmitted to the Zeto Cloud Platform (ZCP) for storage and review. A clinician operates the system to initiate recordings; the client application displays real-time waveforms and allows for standard signal transformations (filters, montage). The device includes an orientation sensor for motion artifact detection. Output is used by healthcare providers for clinical evaluation and diagnosis of neurological conditions. The system benefits patients by enabling short-term EEG monitoring outside of traditional hospital settings.

Clinical Evidence

No clinical performance testing was conducted. The device maintains the same technological characteristics, signal acquisition performance, and clinical functionality as the predicate device. Bench testing only.

Technological Characteristics

19-channel EEG system with active dry Ag/AgCl electrodes (flat/bristle). 500Hz sampling rate, 24-bit A/D conversion, >90 dB CMRR, 1 TΩ input impedance. Flexible polymer headset (PA12, polyetherimide, polypropylene, polyimide, polydimethylsiloxane). Wireless connectivity (Wi-Fi/LTE). Powered by 5000 mAh Li-Ion battery. Software includes firmware, cloud-based data center application, and client application for waveform display/filtering.

Indications for Use

Indicated for prescription use in outpatient healthcare facilities or home use to acquire, transmit, display, and store EEG and auxiliary signals (ECG, EOG, EMG, orientation, photic, external trigger, video) for adults and children, excluding newborns. Intended for short-term recordings up to 2.5 hours.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Flexset System (K233403)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 13, 2026

Zeto, Inc.
% Ameera Roubi
Regulatory Consultant
Innolitics, LLC
1101 W. 34th St. #550
Austin, Texas 78705

Re: K260455
Trade/Device Name: New Wave System
Regulation Number: 21 CFR 882.1400
Regulation Name: Electroencephalograph
Regulatory Class: Class II
Product Code: GWQ, GXY
Dated: February 11, 2026
Received: February 11, 2026

Dear Ms. Roubi:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for
Jay Gupta
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260455 | ? |
| Please provide the device trade name(s). | | ? |
| New Wave System | | |
| Please provide your Indications for Use below. | | ? |
| The New Wave system is intended for prescription use in an outpatient healthcare facility or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The New Wave system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals, and video. The system is only intended to be used for short-term recordings up to 2.5 hours. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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ZETO
510(k) Summary
New Wave System
Page 1 of 12

Date Summary Prepared: February 11, 2026

## Contact Information

| Company Name | Zeto, Inc. |
| --- | --- |
| Address | 5565 Centerview Dr STE 105
Raleigh, NC 27606 |
| Phone Number | 1-833-938-6334 |
| Company Representative | Florian Strelzyk, Ph.D. |
| Title | Chief Executive Officer |
| Email | [e-mail] |
| Official Correspondent | Ameera Roubi |
| Title | Regulatory Consultant |
| Company Name | Innolitics, LLC |
| Phone Number | +1.832.672.1070 |
| Email | [e-mail] |

## Device Information

| Element | Information |
| --- | --- |
| Submission Type | Special 510(k) – Device Modification |
| Proprietary Name | New Wave System |
| Common Name | Full-montage standard electroencephalograph |
| Classification Name | Electroencephalograph |
| Regulation Number | 21 CFR 882.1400 |
| Regulatory Class | Class II |
| Product Code | GWQ, GXY |
| Review Panel | Neurology |

## Predicate Device Information

| Element | Information |
| --- | --- |
| Predicate Device Name | Flexset System |
| Predicate 510(k) Number | K233403 |

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510(k) Summary
New Wave System
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| Element | Information |
| --- | --- |
| Product Code | GWQ, GXY |
| Classification Regulation | 21 CFR 882.1400 |
| Regulatory Class | Class II |
| Relationship to Subject Device | Same intended use, same technological characteristics except for minor modifications suitable for a Special 510(k) |

## Device Description

The New Wave System is intended to acquire, analyze, transmit, display and store primarily EEG and optionally auxiliary signals. The New Wave is designed to perform EEG using 19 signal electrodes and 1 dedicated active ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system.

The device consists of the following components:

- Head Unit
- Electrodes
- Charger
- Display Unit
- Extension Unit
- Lead wires
- Software and Zeto Cloud Platform (ZCP)
- Firmware and Display Unit software
- Data center application
- Client application

## Intended Use

The device is intended to measure, record, and display electrical activity of the brain for clinical evaluation and diagnosis of neurological conditions.

## Indications for Use

The New Wave system is intended for prescription use in an outpatient healthcare facility, or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The New Wave system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals, and video. The system is only intended to be used for short-term recordings up to 2.5 hours.

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ZETO® 510(k) Summary New Wave System Page 3 of 12

# Contraindications for Use

The New Wave System is not intended for use in the following situations:

- Not intended for use in newborns
- Not intended for use in inpatient or hospital
- Not intended for recordings longer than 2.5 hours
- Not intended as a replacement for comprehensive neurological evaluation or diagnosis

# Substantial Equivalence Discussion

## Indications for Use Equivalence Discussion

The subject device, New Wave, retains the same overall intended use as the predicate Flexset system. Both devices are intended for prescription use to acquire, transmit, display, and store EEG and auxiliary physiological signals for adults and children, excluding newborns. The clinical purpose, patient population, and physiological measurements remain unchanged.

The differences between the indications relate only to the use environment and duration of recording. The New Wave is tailored for home, and outpatient healthcare facilities and short-term recordings up to 2.5 hours, whereas the predicate is cleared for use in a broader range of environments including healthcare facilities and transport. Flexset also supports longer monitoring durations to support the needs of the other use environments. These changes narrow the contexts in which the device may be used but do not expand the clinical purpose, user population, or diagnostic application.

Limiting the use environment and duration does not alter the underlying clinical use or introduce new clinical functions. Instead, these restrictions represent a subset of the predicate's broader indications and therefore do not constitute a new intended use. Because the New Wave performs the same physiological measurements for the same population and clinical purpose as the predicate, and because its more limited indications remain fully encompassed within the predicate's cleared intended use, the differences do not raise new questions of safety or effectiveness.

## Technological Characteristics Comparison

The Flexset System and the New Wave share the same fundamental technological characteristics across all core EEG acquisition and data management functions. Both devices use an identical 19-channel EEG electrode configuration with up to 8 auxiliary inputs, employ active dry $\mathrm{Ag / AgCl}$ electrodes (flat or bristle), and provide the same signal acquisition performance, including a $500\mathrm{Hz}$ sampling rate, 24-bit A/D conversion, and approximately $1\mu \mathrm{V}$ RMS noise. Each system uses the same flexible, semi-rigid headset architecture designed to conform to

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510(k) Summary
New Wave System
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various head sizes while maintaining fixed electrode positioning consistent with the 10–20 EEG system. Wireless communication (Wi-Fi and LTE) and the firmware/software used for data acquisition, display, and analysis are also unchanged between the two devices.

The technological differences are minor and do not alter the device’s operating principles, performance, or data outputs. The New Wave’s narrower use environment does not affect the technological characteristics of the system and does not introduce new questions of safety or effectiveness.

# Device Comparison Tables

# Comparison- Overview

The following table provides a comparison of overview of the technological characteristics between the New Wave System and the Flexset System:

| Feature/Function | New Wave | Flexset System (k233403) | Comments |
| --- | --- | --- | --- |
| System Components | - Headset
- Electrodes
- Charger with cable
- Display Unit
- Extension Unit
- Lead wires
- Software:
- Firmware and Display Unit Software
- Data center application (same as K233403)
- Client application (same as K233403) | - Flexset (Headset)
- Electrodes
- Charger with cable
- Display Unit
- Extension Unit
- Lead wires
- Software:
- Firmware and Display Unit Software
- Data center application
- Client application | Same |
| Signals Acquired | - Scalp EEG
- Orientation Sensor (accelerometer)
- Optional non-EEG signals:
- ECG
- EOG
- EMG | - Scalp EEG
- Orientation Sensor (accelerometer)
- Optional non-EEG signals:
- ECG
- EOG
- EMG | Same |

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510(k) Summary
New Wave System
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| | - Photic Trigger Detection
- External Trigger Input
- Video | - Photic Trigger Detection
- External Trigger Input
- Video | |
| --- | --- | --- | --- |
| Power Supply | 1 × 5000 mAh 3.85V Lithium-Ion battery | 1 × 3950 mAh 3.85V Lithium-Ion battery | The subject device has a slightly higher battery capacity, which supports its intended 2.5-hour operating time but does not change the underlying power supply technology or raise new questions of safety or effectiveness. |
| Battery Charging | Commercial grade wall charger | Medical grade wall charger | The subject device uses a commercial grade wall charger instead of a medical grade wall charger. Both charger types are designed to safely charge lithium-ion batteries and meet applicable electrical safety standards. The use of a commercial grade charger is appropriate for the subject device that implements medical device safety requirements as per IEC 60601-1 internally, without relying on the safety features of an external medical grade charger. This change does not |

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510(k) Summary
New Wave System
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| | | | raise new questions of safety or effectiveness. |
| --- | --- | --- | --- |
| Typical Charging Time | 0.5-3.5 hours | 0.5-6.0 hours | The New Wave has a shorter typical charging time, consistent with its shorter operating time and intended use for short-term recordings. |
| Operating Time | 2.5 hours | 6-7 hours | The New Wave system has a shorter operating time of up to 2.5 hours compared to the predicate’s 6–7 hours, reflecting its intended use in outpatient settings where only short-term recordings are required. This reduced duration aligns with the device’s narrower indications for use and does not introduce new questions of safety or effectiveness. |
| Typical Use Duration | 20 mins to 2.5 hours | 20 mins to several hours | See discussion for operating time above. |
| Dimensions | Head Unit: a hemisphere with an approximate radius of 8 cm (3.1 in)
Display Unit: 22 cm × 9 cm × 2.2 cm (8.8 in × 3.5 in × 0.86 in) | Head Unit: a hemisphere with an approximate radius of 8 cm (3.1 in)
Display Unit: 22 cm × 9 cm × 2.2 cm (8.8 in × 3.5 in × 0.86 in) | Same |

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510(k) Summary
New Wave System
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| Weight | Head Unit: approx. 406 grams (14.3 ounces) | Head Unit: approx. 406 grams (14.3 ounces) | Same |
| --- | --- | --- | --- |
| | Display Unit: approx. 380 grams (13.4 ounces) | Display Unit: approx. 380 grams (13.4 ounces) | |
| Cleaning | Cleaned and disinfected by rubbing or immersion in isopropyl alcohol | Cleaned and disinfected by rubbing or immersion in isopropyl alcohol | Same |

# Comparison- Data Transfer & Storage

The following table provides a comparison of data transfer and storage characteristics between the New Wave System and the Flexset System:

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Internal Data Storage | Up to 25 hours of EEG recordings | Up to 250 hours of EEG recordings | Subject device stores 10 EEG recordings up to 2.5 hours and the predicate device stores 10 EEG recordings of longer duration, which is appropriate based on the updated intended use application. |
| Wireless Data Transfer | Wi-Fi 802.11 a/b/g/n/ac 5G Hz LTE | Wi-Fi 802.11 a/b/g/n/ac 4G Hz LTE | The subject device supports 5G Hz LTE wireless data transfer, representing an upgrade from the predicate's 4G Hz LTE capability. This enhancement improves data transfer speed and reliability while maintaining the same fundamental wireless communication technology. The upgrade does not change the device's core functionality or raise new questions of safety or effectiveness. |

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510(k) Summary
New Wave System
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| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Maximum Wireless Transfer Distance | Display unit includes commercially available, FCC-certified, Wi-Fi device that works for standard transfer distance from WiFi Router, typically up to 30 meters. | Display unit includes commercially available, FCC-certified, Wi-Fi device that works for standard transfer distance from WiFi Router, typically up to 30 meters. | Same |

# Comparison- EEG Measurements

The following table provides a comparison of EEG measurement characteristics between the New Wave System and the Flexset System:

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Definition | 19 EEG electrodes + Up to 8 auxiliary electrode lead wire ports (2 on the sides of the Head Unit and 6 on the Extension Unit) | 19 EEG electrodes + Up to 8 auxiliary electrode lead wire ports (2 on the sides of the Flexset Unit and 6 on the Extension Unit) | Same |
| Signal Processing Techniques | Sampling Rate: 500 s/s
No hardware
LPF/HPF/Notch filters.
Software Filtering:
Following are optional:
LPF and HPF (Cutoff frequency selectable by operator), 50Hz, 60Hz notch | Sampling Rate: 500 s/s
No hardware
LPF/HPF/Notch filters.
Software Filtering:
Following are optional:
LPF and HPF (Cutoff frequency selectable by operator), 50Hz, 60Hz notch | Same |
| Accuracy Performance | Sampling rate: 500 Hz
Dynamic range: ± 375 mV
Resolution: 44.7 nV
Peak-to-peak noise: 6 μV
Common-mode rejection ratio: > 90 dB
Input impedance: 1 TΩ | Sampling rate: 500 Hz
Dynamic range: ± 375 mV
Resolution: 44.7 nV
Peak-to-peak noise: 6 μV
Common-mode rejection ratio: > 90 dB
Input impedance: 1 TΩ | Same |

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510(k) Summary
New Wave System
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| | Noise: 1 μV RMS A/D Conversion: 24 Bit | Noise: 1 μV RMS A/D Conversion: 24 Bit | |
| --- | --- | --- | --- |
| Headset Material | Semi-rigid and flexible polymer material (e.g., Polyamide PA12, polyetherimide, polypropylene, polyimide, polydimethylsiloxane) | Semi-rigid and flexible polymer material (e.g., Polyamide PA12, polyetherimide, polypropylene, polyimide, polydimethylsiloxane) | Same |
| Electrode Type | Active, dry | Active, dry | Same |
| Contact quality/ Impedance measurement | Contact quality monitoring performed real time throughout the test. Additionally, impedance measurement mode available, typically performed by operator before the start of EEG test. | Contact quality monitoring performed real time throughout the test. Additionally, impedance measurement mode available, typically performed by operator before the start of EEG test. | Same |
| Contact Quality Indicators | LED indicators (tuned on optionally) for contact quality of each electrode on the headset. Same as shown on the client application of predicate | LED indicators (tuned on optionally) for contact quality of each electrode on the headset. | Same |

## Comparison- Orientation Sensor

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Scope of Use | Used primarily as an aid for motion detection and hence finding EEG artifacts | Used primarily as an aid for motion detection and hence finding EEG artifacts | Same |
| Channels | Dynamic Range: -180° to 180° Three channels (X, Y, Z) used by software to measure movement and position | Dynamic Range: -180° to 180° Three channels (X, Y, Z) used by software to measure movement and position | Same |

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510(k) Summary
New Wave System
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# Comparison- Software Characteristics

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Firmware | Head unit is controlled by firmware. | Flexset headset is controlled by firmware. | Same |
| Data Center Application | Display Unit sends data to the data center application (same as K233403) in the cloud. | Flexset Display Unit sends data to the data center application in the cloud. | Same |
| Client Application | Client application (same as K233403) presents waveforms, controls EEG session, and offers standard EEG transformations such as low-pass, high-pass and notch filters and montage transformations.
Client application (same as K233403) records and retrieves EEG waveforms. | Client application presents waveforms, controls EEG session, and offers standard EEG transformations such as low-pass, high-pass and notch filters and montage transformations.
Client application records and retrieves EEG waveforms. | Same |

# Comparison- Technological Comparison

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Electrode Material | Ag/AgCl coated with optional gel tip | Ag/AgCl coated with optional gel tip | Same |
| Type of Electrodes | Active, dry | Active, dry | Same |
| Electrode Shapes | Flat and bristle type electrodes | Flat and bristle type electrodes | Same |
| Fitting to the Head | Flexible, wearable headset that can be stretched and put on the head. | Flexible, wearable headset that can be stretched and put on the head. | Same |
| Electrode Mounting Mechanism | Electrode positions are fixed and stretch based on head size. Flexible electrode legs. | Electrode positions are fixed and stretch based on head size. Flexible electrode legs. | Same |

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ZETO® 510(k) Summary New Wave System Page 11 of 12

| Feature/Function | New Wave | Flexset System (K233403) | Comments |
| --- | --- | --- | --- |
| Typical Usage Setting | Intended for use for home and healthcare settings per the 10-20 EEG system | Intended for use for healthcare, home and transport settings per the 10-20 EEG system | The New Wave is limited to home and healthcare settings (outpatient healthcare facilities), while the predicate device is intended for broader use environments. This narrower intended use environment falls within the scope of the predicate and does not raise new questions of safety or effectiveness. |

# Performance Data

## Software Verification and Validation Testing

No software verification and validation testing was conducted because the New Wave uses the same software as the predicate device, Flexset System (K233403). The firmware and client application remain materially unchanged between the two devices.

As the software is the same as the software on the predicate device, additional software verification and validation testing is not necessary.

## Clinical Performance Testing

No clinical performance testing was required because the New Wave maintains the same technological characteristics, signal acquisition performance, and clinical functionality as the predicate device. The only differences are a narrower use environment and a reduced maximum recording duration, neither of which affect the device's ability to acquire EEG or auxiliary signals. As the device operates within the same validated performance parameters as the predicate and no changes impact clinical performance, clinical testing is not warranted.

## Conclusion

The New Wave is substantially equivalent to the predicate device, Flexset System (K233403). The devices share near identical technological characteristics, intended use, and functionality with the predicate device.

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510(k) Summary
New Wave System
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The New Wave differs only in having a narrower intended use environment (home and outpatient healthcare facilities only) and reduced operating time (2.5 hours versus 6-7 hours). These differences represent a subset of the predicate's approved scope and do not raise new questions of safety or effectiveness.