ClearUP Sinus Pain Relief

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 - 2. 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<br>nerve stimulator for pain relief | Class II | 21.CFR 882.5890 | Neurology | - 5. Predicate Devices: -Pointer excel by Lhasa Oms, Inc., K060517 -Rejuvatone MD, TSTONEMD by Trophy Skin, Inc. K152199 - 6. Device Description and Principle of Operation: Page 1 of 10 Traditional 510(k) Notification Tivic Health ClearUP™ Sinus Pain Relief {4}------------------------------------------------ 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 ● ### 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<br>number | 882.5890 | 882.5890 | 882.5890 | | | 3 | OTC/prescriptio<br>n? | OTC | Prescription | OTC | | | 4 | Product code | GZJ | GZJ | NFO | | | 5 | Device name<br>and model | ClearUP Sinus Pain Relief | Pointer Excel | Rejuvatone MD, Model<br>TSTONEMD | | | 6 | Manufacturer | Tivic Health Systems Inc. | Lhasa OMS, Inc. | Trophy Skin, Inc. | | | 7 | Intended use | The Tivic ClearUP Sinus<br>Pain Relief is intended to<br>be used for the temporary<br>relief of sinus pain<br>associated with Allergic<br>Rhinitis. | The Pointer-Excel is<br>intended for use in the<br>symptomatic relief of<br>chronic intractable pain,<br>postoperative pain, and<br>acute pain. | The device is intended<br>for facial stimulation<br>and is indicated for over<br>the counter cosmetic<br>use. | | | 8 | Power source | 3.7V rechargeable battery<br>supply | 9V battery supply | 9V battery (Type:<br>6LR61) | | | | Method of line<br>current<br>isolation | N/A | N/A | N/A | | | | Patient leakage<br>current (μΑ) | 0.6uA (normal condition)<br>0.7uA (single fault<br>condition: humidity) | N/A | 60 μΑ<br>360 μΑ | The new device presents<br>reduced risk to electrical<br>shock due to patient<br>leakage current as it is<br>battery-operated and is<br>disabled when charging | | | | New Device | Predicate | Predicate | Remarks | | 9 | Average DC<br>current through<br>electrodes<br>when device is<br>on but no<br>pulses are being<br>applied (μA) | 0 μA | 0 | 0 | Device is transformer<br>output hence no DC<br>component to waveform | | 10 | Applied part<br>Number of<br>output modes | Type BF<br>1 | Type BF<br>1 | Type BF<br>1 | | | 11 | Number of<br>output channels | 1 | 1 | 1 | | | 12 | Output<br>intensity level | 3 steps, 85%, 90%, 100% | Continuously zero to full<br>power | 5 steps | | | 13 | Regulated<br>current or<br>regulated<br>voltage? | Current controlled | Current controlled | Both | No impact on risk as long<br>as either voltage or<br>current aspect of<br>stimulation energy is<br>controlled | | 14 | Software/firmw<br>are/micro-<br>processor<br>control? | Yes | Yes | Yes | | | 15 | Automatic<br>overload trip | Not required due to circuit<br>design | Unknown | Not required due to<br>circuit design | | | | | New Device | Predicate | Predicate | Remarks | | 16 | Automatic no<br>load contact<br>trip | Yes | Yes | No | The new device presents<br>reduced impact on risk of<br>delayed treatment. User<br>is prompted when no<br>contact is detected with<br>treatment site (open<br>load) | | 17 | Automatic shut<br>off | Yes | No | Yes | | | 18 | User override<br>control? | Yes<br>Power on/off on the device | Yes, Normally Open<br>stimulation activation | Yes | | | 19 | Indicator<br>display | | | | | | | -On/off status | No | No | No | No risk impact on new | | | -Low battery? | Yes | Yes | Yes | device as constant | | | -Voltage/<br>current level? | Yes | Yes | No | current output set point is | | | | No | Yes | Yes | fixed | | 20 | Timer range<br>(minutes) | 7-second treatment period | Unknown | 20 minutes | | | 21 | Weight (grams) | < 90 grams | 90 grams (main device) | 248 grams | | | 22 | Dimensions<br>(cm.) HxWxL | 76x38x17 (mm) | 225x50x38 mm (main<br>device) | 177.2x35x55mm | | | 23 | Housing<br>material and<br>construction | Housing - ABS,<br>Output contacts - Stainless<br>steel -active electrode,<br>Chrome return electrode | Housing - ABS,<br>Output contacts - ACD12<br>Chrome | Housing - ABS<br>Output contacts –<br>ACD12 Chrome | | | | | New Device | Predicate | Predicate | Remarks re new device | | 1 | 510k # | K182025 | K060517 | K152199 | | | 2 | Device name<br>and model | ClearUP Sinus Pain Relief | Pointer Excel | Rejuvatone MD, Model<br>TSTONEMD | | | 3 | Waveform | Biphasic with low duty<br>cycle | Biphasic | Pulsed monophasic | The new device presents<br>reduced risk of tissue<br>irritation due to net zero<br>transfer of charge with<br>balanced biphasic output | | 4 | Shape | AC-coupled square | Square | Modulated square | Waveform design for<br>optimal transfer of<br>current across capacitive<br>feature of skin. | | 6 | LOAD | Stimulation<br>Peak Volt / Peak mA | Stimulation<br>Peak Volt / Peak mA | Sensing<br>Peak 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 | Pulse<br>duration<br>(µsec) | 250 µsec | 260 µsec ±20% | On phase: 60 ms<br>Off phase: 60ms<br>Pulse width:120 ms | No impact on risk | | 10 | Frequency<br>(Hz) | 15Hz | 1-16 Hz | 8.33 Hz | No impact on risk | | 11 | Maximum<br>phase charge<br>(μC) 500Ω | 1.5 µC | 30 | 24.18 | The new device presents<br>reduced risk of tissue<br>damage | | | | New Device | Predicate | Predicate | Remarks re new device | | 1 | Maximum<br>current<br>density 500 Ω | $6 mA / 0.0625 cm² = 96 mA/cm²$ | $40 mA / 0.12 cm² = 330 mA/cm²$ | $0.498 mA/cm²$ (Minimum<br>electrode contact area<br>0.81 cm²) | The new device presents<br>reduced risk of tissue<br>damage | | 1 | Maximum<br>current | $2.4-2.52 mA @ 500 Ω$<br>$1.5-1.75 mA @ 2k Ω$<br>$0.6-0.7 mA @ 10k Ω$ | Blue zone 0 - 2 mA<br>Black zone 2 - 45 mA<br>± 20% at 500 ohms<br>loading | $512 μΑ @ 500 Ω$<br>$403 μA @ 2k Ω$<br>$403 μA @ 10k Ω$ | The new device presents<br>reduced risk of tissue<br>damage | | 1 | Maximum<br>average<br>power<br>density @<br>500 Ω | $42uA * 42uA * 500 /0.0625 cm² = 14uW/ cm²$ | $160uA * 160uA * 500 / 0.12 cm² = 106uW/ cm²$ | 0.03277 (Minimum<br>electrode contact area<br>0.81 cm²) | The new device presents<br>reduced risk of tissue<br>damage | | 1 | Maximum<br>power<br>density @<br>500 ohms | $6mA * 6mA * 500 /0.0625 cm² = 0.29W/ cm²$ | $40mA * 40mA *500 / 0.12 cm² = 6.6W/ cm²$ | $2.005 mW/cm² @ 10k Ω$<br>(Minimum electrode<br>contact area 0.81 cm²) | Less than the predicate<br>device. | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Output specifications: {9}------------------------------------------------ {10}------------------------------------------------ ## 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 {11}------------------------------------------------ #### 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 {12}------------------------------------------------ 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.