The Tivic Health ClearUP(TM) Sinus Pain Relief device is intended to be used for the temporary relief of sinus pain associated with Allergic Rhinitis.

Device Description

Clear UP™ Sinus Pain Relief is a handheld microcurent stimulation device used for the temporary relief of sinus pain associated with allergic rhinitis. The unit applies a low level electrical current to the facial sinus passages.

The ClearUP Sinus Pain Relief unit provides a customized treatment with the following features:

Microcurrent waveforms to relieve sinus pain associated with allergic rhinitis
Patent-pending algorithm to locate the optimal treatment points
Simple-to-use system of lights and vibrations to guide the user
Small handheld shape for easy holding and comfort

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with specific thresholds for performance metrics. Instead, the document describes the successful completion of various tests and then presents clinical study results.

Implicit Acceptance Criteria (Inferred from sections 9, 10, and 11):

Acceptance Criteria Category	Reported Device Performance
Bench Testing	Passed predefined acceptance criteria.
Software Verification	All device functions perform as intended.
Compliance with Standards	Passed criteria as specified in various ISO, ANSI AAMI, USP, IEC, and ASTM standards (listed in Section 9), covering biological evaluation, software lifecycle, usability, basic safety, essential performance, home healthcare, electromagnetic disturbances, and material specifications.
Labeling Usability/Comprehension (OTC)	93% agreed that the device is easy to understand. 94% agreed that the instructions are easy to follow. 97% agreed that performing treatment was easy. 88% agreed that performing treatment was fast. (Implied acceptance is a high percentage of agreement for each statement, which was met.)
Clinical Effectiveness (Pain Relief)	74% of microcurrent device users experienced a reduction in sinus pain. 24% of microcurrent device users experienced sinus pain reduction of 3 points or more on the visual analog pain scale (0 no pain to 10 severe pain). Statistically significant greater mean reduction in pain for active-treated subjects compared to sham after a single treatment. (Implied acceptance is a significant portion of users experiencing pain relief and statistically significant superiority over sham, which was met).
Clinical Safety	Only one subject experienced minor reddening of the skin which disappeared within minutes. (Implied acceptance is a low incidence of adverse events and minor, transient nature of any events, which was met).
Preference	82% preferred ClearUP Sinus Pain Relief device to their current sinus treatment(s). (This is a preference metric, not a strict effectiveness criterion, but indicates positive user reception).
Substantial Equivalence	The device has the same fundamental scientific technology, intended use, and similar output parameters compared to predicate devices. Differences do not raise new safety and effectiveness issues.

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

Labeling Validation Study (Usability/Label Comprehension):
- Sample Size: 71 participants.
- Data Provenance: Not explicitly stated, but typically these studies are prospective and often conducted within the country of the regulatory submission (USA in this case, implicitly).
Clinical Validation Study:
- Sample Size: 81 subjects (27 chronic rhinosinusitis + 49 allergic rhinitis + 5 other sinus conditions). The study compares "active subjects" (microcurrent device) to "sham subjects." The mean age for sham subjects was 44 and for active subjects 45, both groups had approximately 2:1 ratio of females to males.
- Data Provenance: Conducted at the Stanford Sinus Center. This implies prospective clinical data from the USA.

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

For the Labeling Validation Study: No "experts" in the sense of medical professionals establishing a ground truth for a diagnosis. The ground truth here is user comprehension and ease of use, established directly from the feedback of the 71 participants who are representative of the intended over-the-counter (OTC) user population.
For the Clinical Validation Study: The "ground truth" for sinus pain and allergic rhinitis would have been established by the clinicians at the Stanford Sinus Center who enrolled the patients. While the exact number and qualifications are not specified in this document, it's implied that these would be medical professionals specializing in rhinology/ENT. The study assessed the patients' self-reported pain levels using a Visual Analog Pain Scale, so the ground truth for pain reduction is the patient's subjective experience, quantified by this recognized scale during the course of the study by clinical staff.

4. Adjudication Method for the Test Set

Labeling Validation Study: No formal "adjudication" in the medical sense for this study. Participant feedback on comprehension and ease of use was directly collected.
Clinical Validation Study: This was a double-blinded randomized controlled clinical validation study. This means:
- Double-blinded: Neither the participants nor the clinical staff administering the treatment (or potentially assessing results) knew whether the device was active or sham. This helps minimize bias.
- Randomized Controlled: Participants were randomly assigned to either the active device group or the sham/placebo device group, allowing for a controlled comparison.
- Adjudication on outcome: The primary outcome (reduction in sinus pain on the visual analog scale) was a patient-reported outcome. While not explicitly stated, the data collection from the visual analog scale would have been directly recorded by the study staff without further 'adjudication' on the pain score itself. The statistical analysis of these scores would determine the significance of the results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where multiple readers interpret cases with and without AI assistance. The ClearUP device is a therapeutic device for pain relief, and its clinical validation focused on direct patient outcomes (pain reduction) compared to a sham device.

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

Yes, in essence, the clinical validation study represents a standalone evaluation of the device's therapeutic effect. The "algorithm" here refers to the device's operating principles (microcurrent waveforms to relieve sinus pain and a patent-pending algorithm to locate optimal treatment points). The study evaluated the device's performance on its own (when used as directed by patients) in reducing pain, compared to a sham device, without a human-in-the-loop in terms of diagnostic interpretation or decision-making. The interaction is solely between the user and the device for treatment application.

7. The Type of Ground Truth Used

For Labeling Validation: User feedback/comprehension.
For Clinical Validation: Subjective patient-reported outcomes using a validated scale (Visual Analog Pain Scale for sinus pain reduction). The diagnosis of "sinus pain associated with Allergic Rhinitis" for patient inclusion would have been clinical diagnosis by medical professionals.

8. The Sample Size for the Training Set

The provided text does not specify a training set sample size. This is common as the device is a direct treatment device, not a machine learning model that requires a discrete training phase on labeled data in the same way a diagnostic AI would. The "patent-pending algorithm to locate the optimal treatment points" likely refers to an embedded logic or heuristic, not a deep learning model trained on a large dataset. The development and refinement of such an algorithm would typically fall under engineering and design verification, not a separate "training set" in the context of clinical validation.

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

Since no explicit training set for a machine learning algorithm is detailed, the concept of "ground truth for the training set" as it applies to AI/ML development is not directly applicable here. The device's underlying "algorithm" (likely a rule-based or heuristic system) would have been developed based on scientific principles of microcurrent stimulation and anatomy related to sinus pain, and refined through engineering testing and possibly user feedback during product development, rather than a labeled training dataset.

Summary

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January 2, 2019

Tivic Health Systems Inc. % Nina Peled Consultant Medical Device Regulatory Consultant 550 Davis St. Unit 27 San Francisco, California 94111

Re: K182025

Trade/Device Name: ClearUP™ Sinus Pain Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: November 25, 2018 Received: December 3, 2018

Dear Nina Peled:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Pamela D. Scott -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182025

Device Name ClearUP(TM) Sinus Pain Relief

Indications for Use (Describe)

The Tivic Health ClearUP(TM) Sinus Pain Relief device is intended to be used for the temporary relief of sinus pain associated with Allergic Rhinitis.

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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1. Submitter Information

Company: Tivic Health Systems Inc. 750 Menlo Ave, #200 Menlo Park, CA 94025
Contact Person: Nina Peled Regulatory Consultant 550 Davis St. Unit 27 San Francisco, CA 94111 npeled@yahoo.com 650 454 0322
1. Date Prepared: December 26.2018
ClearUP™ Sinus Pain Relief 3. Device Name:

4. Product Code, Class, Regulation Number and Panel

Product Code	Class	Regulation Number	Panel
GZJ, Transcutaneous electricalnerve stimulator for pain relief	Class II	21.CFR 882.5890	Neurology

1. Predicate Devices: -Pointer excel by Lhasa Oms, Inc., K060517 -Rejuvatone MD, TSTONEMD by Trophy Skin, Inc. K152199
1. Device Description and Principle of Operation:

Page 1 of 10 Traditional 510(k) Notification Tivic Health ClearUP™ Sinus Pain Relief

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The ClearUP Sinus Pain Relief unit provides a customized treatment with the following features:

Microcurrent waveforms to relieve sinus pain associated with allergic rhinitis ●
Patent-pending algorithm to locate the optimal treatment points ●
Simple-to-use system of lights and vibrations to guide the user ●
Small handheld shape for easy holding and comfort ●

7. Indications for Use:

The Tivic Health ClearUP Sinus Pain Relief device is intended to be used for the temporary relief of sinus pain associated with Allergic Rhinitis.

Over-the Counter (OTC) use:

The labeling, instructions, and user operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. Proposed labeling for the device passed a Flesch-Kincaid reading below 80 grade. Clinical trial users were able to operate the device without any further training or help from the clinical staff.

8. Technological Characteristics and Predicate Device Comparison

The subject device and the predicate devices use the same fundamental technology. A comparison of the subject device technology and any differences to the predicate devices is provided in the table below.

Substantial Equivalence Comparison Table

	New Device	Predicate	Predicate	Remarks
1	510k #	K182025	K060517	K152199
		New Device	Predicate	Predicate	Remarks
2	Regulationnumber	882.5890	882.5890	882.5890
3	OTC/prescription?	OTC	Prescription	OTC
4	Product code	GZJ	GZJ	NFO
5	Device nameand model	ClearUP Sinus Pain Relief	Pointer Excel	Rejuvatone MD, ModelTSTONEMD
6	Manufacturer	Tivic Health Systems Inc.	Lhasa OMS, Inc.	Trophy Skin, Inc.
7	Intended use	The Tivic ClearUP SinusPain Relief is intended tobe used for the temporaryrelief of sinus painassociated with AllergicRhinitis.	The Pointer-Excel isintended for use in thesymptomatic relief ofchronic intractable pain,postoperative pain, andacute pain.	The device is intendedfor facial stimulationand is indicated for overthe counter cosmeticuse.
8	Power source	3.7V rechargeable batterysupply	9V battery supply	9V battery (Type:6LR61)
	Method of linecurrentisolation	N/A	N/A	N/A
	Patient leakagecurrent (μΑ)	0.6uA (normal condition)0.7uA (single faultcondition: humidity)	N/A	60 μΑ360 μΑ	The new device presentsreduced risk to electricalshock due to patientleakage current as it isbattery-operated and isdisabled when charging
		New Device	Predicate	Predicate	Remarks
9	Average DCcurrent throughelectrodeswhen device ison but nopulses are beingapplied (μA)	0 μA	0	0	Device is transformeroutput hence no DCcomponent to waveform
10	Applied partNumber ofoutput modes	Type BF1	Type BF1	Type BF1
11	Number ofoutput channels	1	1	1
12	Outputintensity level	3 steps, 85%, 90%, 100%	Continuously zero to fullpower	5 steps
13	Regulatedcurrent orregulatedvoltage?	Current controlled	Current controlled	Both	No impact on risk as longas either voltage orcurrent aspect ofstimulation energy iscontrolled
14	Software/firmware/micro-processorcontrol?	Yes	Yes	Yes
15	Automaticoverload trip	Not required due to circuitdesign	Unknown	Not required due tocircuit design
		New Device	Predicate	Predicate	Remarks
16	Automatic noload contacttrip	Yes	Yes	No	The new device presentsreduced impact on risk ofdelayed treatment. Useris prompted when nocontact is detected withtreatment site (openload)
17	Automatic shutoff	Yes	No	Yes
18	User overridecontrol?	YesPower on/off on the device	Yes, Normally Openstimulation activation	Yes
19	Indicatordisplay
	-On/off status	No	No	No	No risk impact on new
	-Low battery?	Yes	Yes	Yes	device as constant
	-Voltage/current level?	Yes	Yes	No	current output set point is
		No	Yes	Yes	fixed
20	Timer range(minutes)	7-second treatment period	Unknown	20 minutes
21	Weight (grams)	< 90 grams	90 grams (main device)	248 grams
22	Dimensions(cm.) HxWxL	76x38x17 (mm)	225x50x38 mm (maindevice)	177.2x35x55mm
23	Housingmaterial andconstruction	Housing - ABS,Output contacts - Stainlesssteel -active electrode,Chrome return electrode	Housing - ABS,Output contacts - ACD12Chrome	Housing - ABSOutput contacts –ACD12 Chrome
		New Device	Predicate	Predicate	Remarks re new device
1	510k #	K182025	K060517	K152199
2	Device nameand model	ClearUP Sinus Pain Relief	Pointer Excel	Rejuvatone MD, ModelTSTONEMD
3	Waveform	Biphasic with low dutycycle	Biphasic	Pulsed monophasic	The new device presentsreduced risk of tissueirritation due to net zerotransfer of charge withbalanced biphasic output
4	Shape	AC-coupled square	Square	Modulated square	Waveform design foroptimal transfer ofcurrent across capacitivefeature of skin.
6	LOAD	StimulationPeak Volt / Peak mA	StimulationPeak Volt / Peak mA	SensingPeak Volt / Peak mA
	500Ω	+/- 3V / 6mA	20V / 40mA	256mV / 0.5mA
	2kΩ	+/- 10V / 5mA	46V / 23mA	806mV/ 0.4mA
	10kΩ	+/- 20V / 2mA	85V / 8.5mA	4.02V / 0.4mA	No impact on risk
9	Pulseduration(µsec)	250 µsec	260 µsec ±20%	On phase: 60 msOff phase: 60msPulse width:120 ms	No impact on risk
10	Frequency(Hz)	15Hz	1-16 Hz	8.33 Hz	No impact on risk
11	Maximumphase charge(μC) 500Ω	1.5 µC	30	24.18	The new device presentsreduced risk of tissuedamage
		New Device	Predicate	Predicate	Remarks re new device
1	Maximumcurrentdensity 500 Ω	$6 mA / 0.0625 cm² = 96 mA/cm²$	$40 mA / 0.12 cm² = 330 mA/cm²$	$0.498 mA/cm²$ (Minimumelectrode contact area0.81 cm²)	The new device presentsreduced risk of tissuedamage
1	Maximumcurrent	$2.4-2.52 mA @ 500 Ω$$1.5-1.75 mA @ 2k Ω$$0.6-0.7 mA @ 10k Ω$	Blue zone 0 - 2 mABlack zone 2 - 45 mA± 20% at 500 ohmsloading	$512 μΑ @ 500 Ω$$403 μA @ 2k Ω$$403 μA @ 10k Ω$	The new device presentsreduced risk of tissuedamage
1	Maximumaveragepowerdensity @500 Ω	$42uA * 42uA * 500 /0.0625 cm² = 14uW/ cm²$	$160uA * 160uA * 500 / 0.12 cm² = 106uW/ cm²$	0.03277 (Minimumelectrode contact area0.81 cm²)	The new device presentsreduced risk of tissuedamage
1	Maximumpowerdensity @500 ohms	$6mA * 6mA * 500 /0.0625 cm² = 0.29W/ cm²$	$40mA * 40mA *500 / 0.12 cm² = 6.6W/ cm²$	$2.005 mW/cm² @ 10k Ω$(Minimum electrodecontact area 0.81 cm²)	Less than the predicatedevice.

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Output specifications:

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9. Summary of Verification and Validation activities

Bench testing passed predefined acceptance criteria. Software verification testing was carried out to ensure all device functions perform as intended. Testing was conducted and passed criteria as specified in the following standards:

트 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)], ISO, 10993-1 Edition 4: 2009-10, FDA Recognition Number: 2-220
트 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, ANSI AAMI ISO, 10993-5 2009/(R)2014, FDA Recognition Number: 2-245
. <87> Biological Reactivity Test, In Vitro -- Elution Test, USP, 40-NF35: 2017, FDA Recognition Number: 2-252
트 Medical device software - Software life cycle processes, IEC, 62304 Edition 1.1: 2015-06, FDA Recognition Number: 13-79
. Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, IEC, 60601-1-6 Edition 3.1: 2013-10, FDA Recognition Number: 5-89
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators, IEC, 60601-2-10 Edition 2.1: 2016-04, FDA Recognition Number: 17-16
. Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, IEC, 60601-1-11 Edition 2: 2015-01, FDA Recognition Number: 19-14
. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests, IEC, 60601-1-2 Edition 4: 2014-02, FDA Recognition Number: 19-8
. Medical Devices - Part 1: Application of usability engineering to medical devices, IEC, 62366-1, Edition 1: 2015-02, FDA Recognition Number: 5-114
C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), ES60601-1, FDA Recognition Number 19-4
Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications |Including: Corrigendum 1 (2013)], IEC 62133 Edition 2.0 2012-12, FDA Recognition Number 19-13
Standard Specification for Wrought Stainless Steels for Surgical Instruments, ASTM F899-12b, FDA Recognition Number 8-343

Page 8 of 10 Traditional 510(k) Notification Tivic Health ClearUP™ Sinus Pain Relief

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10. Labeling Validation

A Usability/Label Comprehension Validation Study was conducted with 71 participants in order to validate the OTC appropriateness of the device labeling. The study group found that:

93% agreed that the device is easy to understand.
트 94% agreed that the instructions are easy to follow.
97% agreed that performing treatment was easy.
트 88% agreed that performing treatment was fast

11. Clinical Validation

A double-blinded randomized controlled clinical validation study was conducted at the Stanford Sinus Center to demonstrate the ability of subjects suffering from sinus pain to self-treat with the ClearUP Sinus Pain Relief device and to obtain pain relief compared to a sham/placebo device. Included were 27 sinus pain subjects with chronic rhinosinusitis, 49 patients suffering from allergic rhinitis and 5 subjects with other sinus conditions. The mean age for sham subjects was 44 and for active subjects 45 both groups had approximately 2:1 ratio of females to males.

Results from the clinical study were:

-74% who used the microcurrent device experienced a reduction in sinus pain
-24% who used the microcurrent device experienced sinus pain reduction of 3 points or more on the visual analog pain scale (0 no pain to 10 severe pain)
-82% preferred ClearUP Sinus Pain Relief device to their current sinus treatment(s)
-Only one subject experienced minor reddening of the skin which disappeared within minutes.

The statistically significant results demonstrated that the ClearUp device is a safe and effective treatment for sinus pain associated with allergic rhinitis. After a single treatment, active-treated subjects exhibited a statistically significant greater mean reduction in pain than subjects using the sham device.

12. Conclusion

The ClearUP Sinus Pain Relief device has the same fundamental scientific technology, intended use, and similar output parameters I comparison to predicate devices. . The differences between the proposed device and the predicate devices do not raise new

Page 9 of 10 Traditional 510(k) Notification Tivic Health ClearUP™ Sinus Pain Relief

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issues of safety and effectiveness and the proposed indication for sinus pain associated with allergic rhinitis was supported by clinical performance data as described above. In conclusion, the Tivic Health ClearUP Sinus Pain Relief device is substantially equivalent to the identified predicate devices.

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).