The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the user's lower back.

Device Description

The device is a battery powered over the counter transcutaneous electrical nerve stimulator with a wireless remote control feature. The general purpose of the device is to apply an electrical stimulus to integral electrodes that are applied to a user's lower back to relieve pain. The device includes a current generator and permanently-affixed electrodes with user replaceable single patient use hydrogel pads (gel-pads) that may be reused for a limited number of reuses. The number of reuses of the gel-pads varv person-to-person dependent upon skin type, oils and pH levels. One side of the adhesive gel-pad adheres to the electrode, and the other the device to the healthy intact skin of the user's lower back to provide an analgesic electrical stimulus to the painful area. The user controls are located on a hand-held wireless remote control commonly referred to as a Key-fob. The user controls are simple straightforward power on/off and electrical stimulus intensity up/down.

AI/ML Overview

This document describes a 510(k) premarket notification for "The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™," a transcutaneous electrical nerve stimulator (TENS) device. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its efficacy through extensive clinical studies and acceptance criteria as might be seen for novel devices.

Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety standards, rather than presenting a performance study with acceptance criteria in the typical sense for algorithm performance.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as performance metrics for an algorithm or device efficacy study. Instead, it demonstrates compliance with recognized safety standards and substantial equivalence to predicate devices based on technical specifications. The "performance" is implicitly tied to meeting these standards and being comparable to legally marketed TENS devices.

Metric / Standard	Device Performance / Compliance
Safety Standards
FDA Recognized Number 5-4, IEC 60601-1 (General)	Complies
FDA Recognized Number 5-60, IEC 60601-1-2 (Electromagnetic compatibility)	Complies
FDA Recognized Number 5-41, IEC 60601-1-4 (Programmable electrical medical systems)	Complies
FDA Recognized Number 17-5, IEC 60601-2-10 (Safety of nerve and muscle stimulators)	Complies
FDA Recognition Number 2-156, AAMI/AMSI/ ISO 10993-1 (Biological evaluation – risk management)	Complies
FDA Recognition Number 2-153, ISO 10993-5 (Biocompatibility – In Vitro cytotoxicity)	Complies
FDA Recognition Number 2-173, AAMI / ANSI / ISO 10993-10 (Biocompatibility – irritation and skin sensitization)	Complies
Compliance with U.S. FDA Title 21 CFR 898 Electrode Lead Wire Performance Standard	Yes
Technical Specifications (Comparison to Predicates)
Maximum average power density of electrodes with gel-pads	Less than 0.25 watts per square centimeter (consistent with predicates to reduce thermal burn risk)
TENS Device Power Source	Battery 1.5VDC (2-Alkaline AAA)
Number of Output Modes	4
Number of Output Channels	1 Channel, Asynchronous - Biphasic
Software/Firmware/Microprocessor Control?	Yes
Automatic Shut Off?	Yes
User Override Control?	Yes
Indicator Display (On/Off Status, Low Battery, Voltage/Current Level)	On/Off: Yes, Low Battery: Yes, Voltage/Current: No
Timer Range	Nonadjustable 30 minutes
Phase Duration	120μs - 480μs
Maximum Current Density	0.12mA @500Ω
Maximum Average Current	1.6mA @500 Ω
Maximum Average Power Density (using 500Ω)	0.69mW/cm² @500Ω

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

This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to existing predicate devices through technical comparisons and adherence to recognized standards. It does not present a clinical study with a "test set" and "data provenance" in the context of evaluating algorithm performance or clinical efficacy against specific acceptance criteria. The "study" here is predominantly a technical and regulatory comparison.

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

Not applicable. As noted above, there's no clinical "test set" with ground truth established by experts for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

Not applicable. This device is a TENS unit, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported.

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

Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

Not applicable. There is no "ground truth" as would be established for an AI algorithm or diagnostic test. The device's "truth" is its compliance with safety standards and its substantial equivalence to other legally marketed TENS devices.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. No training set is involved.

Summary of the "Study" that Proves the Device Meets the Criteria:

The "study" presented in this 510(k) submission is a demonstration of substantial equivalence to legally marketed predicate devices, along with evidence of compliance with relevant FDA-recognized safety and performance standards.

Methodology: The submission extensively compares the new device (The Pain Pilot™ / WiTouch™) to three predicate TENS devices (PM3030™, Painmaster™ MCT Patch, and T1040™). This comparison covers:
- Indications for Use (showing equivalence for lower back pain relief).
- Intended Use (showing equivalence in providing analgesic electrical stimulus).
- Technical specifications (e.g., power source, output modes/channels, control mechanisms, timer, dimensions, electrical characteristics like current density and power density).
- The submission argues that differences (like integral electrodes and wireless remote control) are "insignificant as it relates to safety and effectiveness, and is not critical to the intended use."
Evidence: The primary evidence provided is the detailed table comparing the various specifications of the new device against the predicate devices (page 3 of 4). Additionally, declarations of conformity to numerous FDA-recognized international and national standards (IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) are provided (page 4 of 4).
Conclusion: The FDA's letter (pages 5-6 of 6) states that they have "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the regulatory "acceptance criteria" for marketing under the 510(k) pathway.

In essence, for a 510(k) submission like this for a TENS device, the acceptance criteria are satisfied by proving the new device is as safe and effective as a device already on the market through detailed technical comparison and adherence to recognized standards, rather than through a clinical trial with performance metrics.

Summary

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510(k) # K120500

Page 1 of 4

510(k) SUBMITTER:	Hollywog, LLC2830 Amnicola HighwayChattanooga, TN 37406
ESTABLISHMENT REGISTRATION:	3008585473
CONTACT:	Michael W. TreasChief Compliance Officer
DATE PREPARED:	August 16, 2012
PROPRIETARY NAME:	The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™
PANEL:	Neurology
REGULATION NUMBER:	CFR Title 21, 882.5890
CLASSIFICATION:	Class II
PRODUCT CODE:	NUH
COMMON NAME:	Transcutaneous electrical nerve stimulator for painrelief intended for over the counter use

Description:

Indication for Use:

The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Intended Use:

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510(k) # K120500

Page 2 of 4

Accessories:

The device utilizes hydrogel pads) for achieving the indications for use and intended use. The composition of the gel-pads is common materials found in the electrode industry. The uniqueness of the gel-pads is in the shape. The maximum average power density of the electrodes with the gel-pads applied is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns which is consistent with the referenced predicate devices.

PredicateDevices	510(k)#	Proprietary Name	Device Classification Name(s), Regulation Number(s),Classification(s) and Product Code(s).
#1	K110068	PM3030TM	CFR Title 21, Sec. 882.5890, Class II, NUH
#2	K090042	PainmasterTM MCT Patch	CFR Title 21, Sec. 882.5890, Class II, NUH
#3	K060846	T1040TM	CFR Title 21, Sec. 882.5890, Class II, NUH, NGX

Substantially Equivalent Predicate Devices

The predicate devices PM3030" and T1040" utilize flexible wires between the electrodes and the electrical stimulus generator; thus, increases the indications for use to the lower back and to body surfaces with greater ranges of motion (e.g., knee, shoulder, elbow, and hip). The indications for use for the predicate device Painmaster™ MCT Patch is solely for application to the lower back; same as The Pain Pilot™ / WiTouch™ device.

The intended design of The Pain Pilot™ / WiTouch" device limits the application for use to the anatomical site of the back. The design includes carbon rubber electrodes that are intended for reuse and are permanently-affixed to a rigid surface of the electrical stimulus generator. The unique connection makes the electrodes integral to the generator. The connection and shape of the electrodes limit application of the device to the contours of the back. These unique characteristic of the integral electrodes are insignificant as it relates to safety and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices.

The referenced predicate devices utilize affixed buttons as the sole method to control the electrical stimulus generator on/off and intensity up/down. The Pain Pilot" / WiTouch " device utilizes a wireless remote control radio frequency transceiver to control the electrical stimulus generator on/off and intensity up/down. The transceiver operates in the ISM radio frequency band for wireless medical technology. This uniqueness of controlling the electrical stimulus generator by utilizing a radio frequency transceiver is insignificant as it relates to safety and is not critical to the intended use between the device and the referenced predicate devices.

The characteristics of the analgesic electrical stimulus between the device and the referenced predicate devices are substantially equivalent as it relates to safety and effectiveness.

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510(k) Summary per 21 CFR 807.92(c)

510(k) # K120500

Page 3 of 4

Substantial Equivalence
510(k) Number	K120500	K110068	K090042	K060846
Device Name and Model	The Pain Pilot™	PM3030™	Painmaster MCT Patch	T1040™
Manufacturer	Hollywog, LLC	Omron Healthcare, Inc.	Newmark, Inc.	Endurance Therapeutics
TENS Device Power Source (DC battery)	Battery 1.5VDC(2-Alkaline AAA)	Battery 1.5VDC(3-Alkaline AAA)	No replaceable bonded battery tomicro circuit chip	Battery 1.5VDC(2-Alkaline AAA)
Number of Output Modes	4	3	1	10
Number of Output Channels:	1 Channel, Asynchronous - Biphasic	1 Channel, Asynchronous - Biphasic	1 Channel, Monophasic Microcurrent	1 Channel, Asynchronous - Biphasic
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes
Automatic Shut Off?	Yes	Yes	Yes	Yes
User Override Control?	Yes	Yes	Yes	Yes
Indicator Display:	On/Off Status?	Yes	Yes	Yes
	Low Battery?	Yes	Yes	No	Yes
	Voltage/Current Level?	No	Yes	No	Yes
Timer Range (minutes)	Nonadjustable30 minutes	Nonadjustable30 minutes	NonadjustableContinuous up to4 - 5 days	Nonadjustable15 minutes
Weight (lbs., oz.)	4.8 oz.w/ batteriesincluded	2.1 oz.w/ batteriesincluded	2.0 oz.w/ batteryincluded	3.1 oz.
Dimensions (in.) [W x H x D].	7.5"(W) x 3.5(H)" x0.7"(D)	2.17" x 3.74" x0.74	unspecified	5.91" x 2.68" x1.02"
Housing Material and Construction	ABS plastic	ABS plastic	unspecified	unspecified
Compliance with U.S. FDA Title 21 CFR898 Electrode Lead Wire PerformanceStandard?	Yes	Yes	Yes	Yes
For multiphasic	Symmetrical phases?	No	No	Yes	No
	Phase Duration(include units), (staterange, if applicable),(both phases, ifasymmetrical)	120μs - 480μs	unspecified	unspecified	4.1μs - 500μs
Maximum Current Density, (mA/cm², r.m.s.)	0.12mA @500Ω	0.095mA @500Ω	unspecified	2.71mA @500Ω
Maximum Average Current (average absolute value), mA	1.6mA @500 Ω	3.5mA @500 Ω	unspecified	2.71mA @500Ω
Maximum Average Power Density, (W/cm²),(using	0.69mW/cm²@500Ω	89mW/cm²@500Ω	unspecified	5.35mW/cm²@500Ω

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510(k) # K120500

Page 4 of 4

Declarations of Conformity

The device complies with the following FDA recognized standards:

FDA Recognized Number 5-4, IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988 Amendment 1, 1991-11, Amendment 2, 1995. (General)

FDA Recognized Number 5-60, IEC 60601-1-2 Int. 1 Third Edition/I-SH 01:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet. (General)

FDA Recognized Number 5-41. Medical electrical equipment - Part 1-4: General requirements for safety- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)

FDA Recognized Number 17-5, IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. (Neurology)

FDA Recognition Number 2-156: AAMI/AMSI/ ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. (Biocompatibility)

FDA Recognition Number 2-153 (Electrodes) ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)

FDA Recognized Standard 2-173 (Electrodes) Recognition Number 2-173: AAMI / ANSI / ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. (Biocompatibility)

Truthful and Accurate Statement

A statement was included in the Premarket Notification attesting to the truthfulness and accuracy of the information provided.

Further Information

In the event that additional information is required, please contact:

Michael W. Treas Chief Compliance Officer Hollywog, LLC 2830 Amnicola Highway Chattanooga, TN 37406

Telephone: (423) 305-7778 ext. 108 Fax: (423) 305-7867 E-mail: mike.treas@hollywog.com

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

AUG 20 2012

Hollywog, LLC c/o Mr. Michael Treas Chief Compliance Officer 2830 Amnicola Highway Chattanooga, TN 37406

Re: K120500

Trade/Device Name: The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 31, 2012 Received: August 1, 2012

Dear Mr. Treas:

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. 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 fray of cable of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Michael Treas

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kisia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K120500

Device Names: The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™

Indications for Use:

The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use √(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Callaway

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120500

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).