The ZIIP+ Device is a hand-held, battery-powered device used with conductive gel to stimulate the face superficially through application of transcutaneous electrical currents. The device is powered by a Lithium-lon rechargeable battery, and it is shipped with a portable battery charger.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification Summary for the ZIIP+ Device. The document details the device's characteristics, its comparison to predicate devices, and nonclinical testing performed to establish substantial equivalence.

However, the nature of this document (a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator for Pain Relief, used here for facial and neck stimulation for cosmetic use) means that its acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to existing devices through non-clinical performance data, rather than clinical efficacy studies with specific performance metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot populate a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, because such studies are not typically required or performed for devices demonstrating substantial equivalence through non-clinical data, especially for cosmetic indications under this regulatory pathway.

The “study that proves the device meets the acceptance criteria” here refers to the nonclinical performance testing that demonstrates the ZIIP+ Device is as safe and effective as its predicate devices.

Here's a breakdown of the requested information based on the provided document, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The "acceptance criteria" for a 510(k) submission like this are generally demonstrating compliance with safety standards and functional equivalence to predicates, rather than specific performance metrics for diagnostic accuracy.)

Acceptance Criteria Category	Specific Acceptance Criteria (Implied from Nonclinical Testing)	Reported Device Performance (Compliance)
Electrical Safety	Compliance with IEC 60601-1 (General requirements for basic safety and essential performance)	Compliant with IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (Electromagnetic disturbances – requirements and tests for radiated and power line conducted emissions)	Compliant with IEC 60601-1-2.
Home Healthcare Environment Safety	Compliance with IEC 60601-1-11 (Requirements for medical electrical systems used in the home healthcare environment)	Compliant with IEC 60601-1-11.
Software Functionality	Software Verification and Validation to confirm the device meets and complies with applicable software requirements specifications.	Results confirmed that the ZIIP+ Device meets and complies with the applicable software requirements specifications.
Biocompatibility	Skin-contacting materials are biocompatible, or identical to a device already determined to be biocompatible.	The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible. Therefore, the ZIIP+ Device is biocompatible and substantially equivalent.
Wireless Coexistence	Compliance with applicable standards for wireless coexistence (implied by inclusion in summary of safety and performance testing results).	Compliant with applicable standards for wireless coexistence.
Bench Testing Performance Requirements	Meets bench testing performance requirements (general statement of successful completion of testing).	Meets bench testing performance requirements.
Output Characteristics Equivalence	The output characteristics of the ZIIP+ Device are substantially equivalent to the predicate ZIIP device (specifically mentioned for: Power Source, Patient Leakage Current, Number of Output Modules/Channels, Regulated Current/Voltage, Software Control, Automatic Overload/No-Load Trip, Automatic Shut Off, Patient Override Control, Indicator Display).	The ZIIP+ Device has identical output characteristics to the predicate ZIIP device for most listed parameters (e.g., patient leakage current, number of channels, software control, automatic shut-off). Differences with the NuFace Trinity Plus (e.g., waveform, burst mode) are acknowledged but asserted not to raise new questions of safety or effectiveness.
Fundamental Technological Characteristics	Demonstrated substantial equivalence in principles of operation, design, and overall technological characteristics.	The ZIIP+ has the identical output characteristics, principles of operation, and treatment method as the predicate ZIIP Device, and essentially the same intended use and technological characteristics as the NuFACE Trinity Plus Device (including BLE). The document concludes that the device is substantially equivalent based on these comparisons and nonclinical testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable or not specified in this type of submission. The "test set" here refers to hardware/software units tested against engineering standards, not a patient cohort or imaging dataset.
Data Provenance: Not applicable. The data provenances are results from laboratory testing (e.g., electrical safety tests, software validation).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the context of this 510(k), is defined by established engineering and medical device safety standards (e.g., IEC standards) and the functional specifications of the device. There are no patient-specific "ground truths" being adjudicated by clinical experts for performance metrics like diagnostic accuracy.
Qualifications of Experts: Not applicable. Testing would be performed by qualified engineers and technicians in specialized labs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is not a clinical study involving human readers or interpretations. Test results are compared against predefined technical specifications and regulatory standards.

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 study was not done. This device is a Transcutaneous Electrical Nerve Stimulator for cosmetic use, not an AI-powered diagnostic imaging device that assists human readers.

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

Standalone Performance: Not applicable. The device's "performance" is its ability to deliver specified electrical currents safely and reliably according to its design and standards, not an algorithm's diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for this submission are the established international and national standards for medical device safety and performance (e.g., IEC 60601 series, software validation requirements) and the technical specifications of the predicate devices. The claim is substantial equivalence based on meeting these technical benchmarks.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set of data.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI/ML model.

Summary

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September 23, 2021

ZIIP, Inc. % Heather Tanner Principle Consultant Hill Regulatory Consulting, LLC 1910 15th Ave E Seattle, Washington 98112

Re: K212342

Trade/Device Name: ZIIP+ Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: July 23, 2021 Received: July 28, 2021

Dear Heather Tanner:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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

510(k) Number (if known) K212342

Device Name ZIIP+ Device

Indications for Use (Describe)

The ZIIP+ Device is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

510(k) Notification K212342

1. GENERAL INFORMATION

Applicant: ZIIP Inc. 1425 Leimert Blvd Suite 203 Oakland, CA 94602

Contact Person: David Mason President, ZIIP, Inc. Contact information: david@ziipbeauty.com

Date Prepared: July 23, 2021

2. DEVICE INFORMATION

Trade Name: ZIIP+ Device

Generic/Common Name: Facial Toning Device

Classification: Transcutaneous Electrical Nerve Stimulatory - CFR 882.5890

Product Code: NFO

3. PREDICATE DEVICE(S)

K161484 ZIIP Skincare Device ●
K201782 NūFACE® Trinity Plus ●

4. INDICATIONS FOR USE

The ZIIP+ Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

5. DEVICE DESCRIPTION

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6. SUBSTANTIAL EQUIVALENCE

The ZIIP+ is substantially equivalent to the legally marketed ZIIP device (K161484) and the NuFACE Trinity Plus Device (K201782). The ZIIP+ Device has the identical output characteristics, principles of operation, and treatment method, and it has a similar indication for use as the predicate ZIIP Device. In addition, the ZIIP+ Device has the same intended use and indication for use [facial and neck toning] as the NuFACE Trinity Plus Device, as well as substantially equivalent technological characteristics and principles as operation, including Bluetooth Low Energy (BLE) capability.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

General Device Characteristics
	ZIIP+ Subject Device	ZIIP PredicateDevice	NuFace Trinity Plus PredicateDevice
Manufacturer	ZIIP Inc.	ZIIP Inc.	NuFace
K Number	K212342	K161484	K201782
Device Name	ZIIP+	ZIIP	NuFace Trinity Plus
OTC/Rx	OTC	OTC	OTC
Med Dev Class	Class II	Class II	Class II
Product Code	NFO	NFO	NFO
Common Name	Transcutaneous ElectricalNerve Stimulator	TranscutaneousElectrical NerveStimulator	Transcutaneous Electrical NerveStimulator
Mechanism of Action	Microcurrent electricaltherapy to deliver skinstimulation through cellularresponse	Microcurrentelectrical therapy todeliver skinstimulation throughcellular response	Microcurrent electrical therapy todeliver skin stimulation throughcellular response
Device Type	21 CFR, Part 882.5890	21 CFR, Part882.5890	21 CFR, Part 882.5890
Indications for Use/Intended Use	The ZIIP+ Device isintended for facial and neckstimulation and is indicatedfor over-the-counter use.	The ZIIP Device isintended for facialstimulation and isindicated for over-the-counter use.	The NuFace Trinity Plus Device isintended for facial and neckstimulation and is indicated for over-the-counter use.
Material/ Biocompatibility	Biocompatible materialstypically used in medicaldevices and identical topredicate ZIIP device	Biocompatiblematerials typicallyused in medicaldevices.	Biocompatible materials typicallyused in medical devices.
Power source	Internal RechargeableLithium Ion Battery	InternalRechargeable LithiumIon Battery	Internal Rechargeable Lithium IonBattery
Performance standard	No known requiredperformance standards	No known requiredperformancestandards	No known required performancestandards
Sterility	Not applicable - this deviceis not sold sterile	Not applicable - thisdevice is not soldsterile	Not applicable - this device is notsold sterile

General Device Characteristics

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Human Factors	Ergonomic handheld design	Ergonomic handheld design	Ergonomic handheld design
Electrical Safety	Compliant with IEC 60601-1, 60601-1-2, 60601-1-11	Compliant with IEC 60601-1, 60601-1-2	IEC 60601-1, 60601-1-2, 60601-1-11
Type of Energy	Electrical current	Electrical current	Electrical current
Charging Method	External wall adaptor	External wall adaptor	Wireless charging
Charging Circuitry	Internal to device	Internal to device	Internal to device
Special Requirements	Conductive gel	Conductive gel	Conductive gel primer
Wireless Capability	Bluetooth Low Energy (BLE)	N/A	Bluetooth Low Energy (BLE)

Detailed Output Characteristics

Detailed OutputSpecifications	ZIIP Subject Device	ZIIP Predicate Device	NuFace Trinity Plus
Power Source(s)
a) Method of LineCurrent Isolation	One rechargeable Lithium-Ion Battery and ExternalCharger Isolation	One rechargeable Lithium-Ion Battery and ExternalCharger Isolation	One rechargeable Lithium-Ion Battery and ExternalCharger Isolation
b) Patient LeakageCurrent	External Charger Included	External Charger Included	External Charger Included
1. NormalCondition	$46 \mu A$	$46 \mu A$	N/A - Battery Operated
2. Fault Condition	$46 \mu A$	$46 \mu A$	N/A - Battery Operated
Number of OutputModules	1	1	1
Number of OutputChannels	1	1	1
a) Synchronous orAlternating	N/A - 1 Output Channel	N/A - 1 Output Channel	N/A - 1 Output Channel
b) Method ofChannelIsolation	N/A - 1 Output Channel	N/A - 1 Output Channel	N/A - 1 Output Channel
Regulated Current orRegulated Voltage	Both	Both	Both
Software/Firmware/MicroprocessorControlled	Yes	Yes	Yes
Automatic Overload Trip	Not required because ofcircuit design (Current andVoltage Limited by CircuitDesign and Firmware)	Not required because ofcircuit design (Current andVoltage Limited by CircuitDesign and Firmware)	Not required because ofcircuit design
Automatic No-Load Trip	Yes (Reversion to FixedVoltage Output)	Yes (Reversion to FixedVoltage Output)	Yes
Automatic Shut Off	Yes	Yes	Yes
Patient Override Control	Yes	Yes	Yes
Indicator Display
a) On/Off Status	Yes (LED Illumination onConduction)	Yes (LED Illumination onConduction)	Yes
b) Low Battery	Yes	Yes	Yes
c) Voltage/CurrentLevel	Yes (LED Illumination onTarget Current Levels)	Yes (LED Illumination onTarget Current Levels)	Yes

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Output Specifications	ZIIP Subject Device	ZIIP Predicate Device	NuFace Trinity Plus
Waveform	Pulsed Biphasic	Pulsed Biphasic	Pulsed Monophasic
Shape	Modulated Square Wave	Modulated Square Wave	Modulated Square Wave
Maximum Output Voltage	154mV@500Ω465mV@52KΩ2.2V@10KΩ	154mV@500Ω465mV@52KΩ2.2V@10KΩ	Not publicly available
Maximum Output Current	309μA@500Ω232μΑ@2ΚΩ202μΑ@10ΚΩ	309μA@500Ω232μΑ@2ΚΩ202μΑ@10ΚΩ	Not publicly available
Burst Mode (i.e. pulsetrains)	N/A - no burst mode	N/A - no burst mode	20 (10 positive and 10 negative)
Pulses per second			8.3 (@ 8.3 Hz)
Burst duration (seconds)			2.4s (@ 8.3 Hz)
Duty Cycle [Line (b) xLine (c)] (on time perburst)			Duty Cycle: 50%On time per burst: 20.2s
On time (seconds)	Constant	Constant	60 ms (@8.3 Hz)
Off time (seconds)	None	None	60 ms (@8.3 Hz)
Maximum Phase Charge(μC)	6.16 µC@500Ω	6.16 µC@500Ω	23.06 μC@500Ω
Maximum CurrentDensity (mA/cm2)	0.34 mA/cm2 @500Ω	0.34 mA/cm2 @500Ω	0.78 mA/cm2 @500Ω
Maximum Power Density(µW/cm2)	3.44 W/cm2@500Ω	3.44 W/cm2@500Ω	3.22 µW/cm2@500Ω

8. NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Comprehensive performance testing was performed to support the substantial equivalence determination for the ZIIP+ Device, including the following:

. Electrical Safety Testing, including EMC. Specifically, the ZIIP+ Device was tested and found to be in compliance with:
- o IEC 60601- 1 -2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – requirements and tests) for radiated and power line conducted emissions
- IEC 60601-1 (Medical electrical equipment: Part 1: General requirements for basic o safety and essential performance) for Electrical Safety
- o IEC 60601-1-11 (Medical Electrical Equipment: Part 1-11: Requirements for medical electrical systems used in the home healthcare environment) for home healthcare devices
Software Verification and Validation Testing
- The results of software verification and validation confirmed that the ZIIP+ Device meets and complies with the applicable software requirements specifications.
Biocompatibility Evaluation
- The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible; therefore, the ZIIP+ Device is biocompatible and substantially equivalent to the predicate device.

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In summary, the safety and performance testing results for EMC, Electrical Safety, Wireless Coexistence, and Verification & Validation concluded that the ZIIP+ Device complies with the applicable standards and meets bench testing performance requirements.

9. CONCLUSION

The submitted documentation and performance testing demonstrates that the ZIIP+ device is substantially equivalent to the cited predicate devices in its intended use, principles of operation, design, and overall technological characteristics.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).