K Number

Device Name

ClearUP Sinus Pain Relief

Manufacturer

Tivic Health Systems Inc.

Date Cleared

2019-01-02

(156 days)

Product Code

GZJ

Regulation Number

882.5890

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060517, K152199

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The device description mentions a "patent-pending algorithm to locate the optimal treatment points," but it does not provide enough detail to determine if this algorithm utilizes AI or ML techniques. The summary explicitly states "Mentions AI, DNN, or ML: Not Found."

Therapeutic

Yes
The device is intended for the temporary relief of sinus pain associated with Allergic Rhinitis, which is a medical purpose aimed at alleviating symptoms and improving health conditions.

Diagnostic

The device is intended for the temporary relief of sinus pain, a therapeutic purpose, not for diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "handheld microcurrent stimulation device" and applies "a low level electrical current," indicating it is a hardware device that delivers electrical stimulation.

IVD (In Vitro Diagnostic)

Based on the provided information, the Tivic Health ClearUP(TM) Sinus Pain Relief device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
ClearUP's Function: The ClearUP device is a handheld microcurrent stimulation device that applies electrical current to the facial sinus passages. It is used for the temporary relief of sinus pain.
Mechanism of Action: Its mechanism involves electrical stimulation applied externally to the body, not the analysis of biological samples.
Intended Use: The intended use is for pain relief, not for diagnosing a condition based on analyzing a sample.

Therefore, the ClearUP device falls under the category of a therapeutic or pain relief device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GZJ

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

facial sinus passages

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060517, K152199

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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 electrical
nerve 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

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	Regulation
number	882.5890	882.5890	882.5890
3	OTC/prescriptio
n?	OTC	Prescription	OTC
4	Product code	GZJ	GZJ	NFO
5	Device name
and model	ClearUP Sinus Pain Relief	Pointer Excel	Rejuvatone MD, Model
TSTONEMD
6	Manufacturer	Tivic Health Systems Inc.	Lhasa OMS, Inc.	Trophy Skin, Inc.
7	Intended use	The Tivic ClearUP Sinus
Pain Relief is intended to
be used for the temporary
relief of sinus pain
associated with Allergic
Rhinitis.	The Pointer-Excel is
intended for use in the
symptomatic relief of
chronic intractable pain,
postoperative pain, and
acute pain.	The device is intended
for facial stimulation
and is indicated for over
the counter cosmetic
use.
8	Power source	3.7V rechargeable battery
supply	9V battery supply	9V battery (Type:
6LR61)
	Method of line
current
isolation	N/A	N/A	N/A
	Patient leakage
current (μΑ)	0.6uA (normal condition)
0.7uA (single fault
condition: humidity)	N/A	60 μΑ
360 μΑ	The new device presents
reduced risk to electrical
shock due to patient
leakage current as it is
battery-operated and is
disabled when charging
		New Device	Predicate	Predicate	Remarks
9	Average DC
current through
electrodes
when device is
on but no
pulses are being
applied (μA)	0 μA	0	0	Device is transformer
output hence no DC
component to waveform
10	Applied part
Number of
output modes	Type BF
1	Type BF
1	Type BF
1
11	Number of
output channels	1	1	1
12	Output
intensity level	3 steps, 85%, 90%, 100%	Continuously zero to full
power	5 steps
13	Regulated
current or
regulated
voltage?	Current controlled	Current controlled	Both	No impact on risk as long
as either voltage or
current aspect of
stimulation energy is
controlled
14	Software/firmw
are/micro-
processor
control?	Yes	Yes	Yes
15	Automatic
overload trip	Not required due to circuit
design	Unknown	Not required due to
circuit design
		New Device	Predicate	Predicate	Remarks
16	Automatic no
load contact
trip	Yes	Yes	No	The new device presents
reduced impact on risk of
delayed treatment. User
is prompted when no
contact is detected with
treatment site (open
load)
17	Automatic shut
off	Yes	No	Yes
18	User override
control?	Yes
Power on/off on the device	Yes, Normally Open
stimulation activation	Yes
19	Indicator
display
	-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)	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

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

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.

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

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.