HPM-6000UF is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

Device Description

The HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.

The HPM-6000UF is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The HPM-6000UF device and its predicates are comprised of a system console and applicator. The system consists of the electromagnetic field generators, computer, and the touch-screen control panel. Applicator Chair is designed for non-invasive therapy of urinal incontinence. The coil is located in the middle of the seat and air cooled. Running therapy is indicated by illuminated segments in armrests. For precise patient positioning prior to the therapy, the seat height can be electronically adjusted by a remote control.

AI/ML Overview

This document, K181497, is a 510(k) summary for the HPM-6000UF device, a non-invasive electromagnetic stimulator for pelvic floor muscles, intended for the treatment of male and female urinary incontinence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial that defines and meets specific acceptance criteria for performance. The "clinical testing" mentioned is specifically to address temperature safety in males for an expanded indication, and not for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) clearance process for this device (HPM-6000UF) is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance criteria (like sensitivity, specificity, accuracy for a diagnostic device) through a comparative study against a ground truth.

Therefore, a table of acceptance criteria and reported device performance in the context of clinical efficacy is not directly provided or the primary focus of this submission. The "performance" demonstrated for clearance is primarily about safety and equivalent technological characteristics and intended use compared to the predicates.

The closest thing to a "performance" metric related to a study is the thermal safety for male subjects:

Acceptance Criteria (Implied for expanded indication)	Reported Device Performance
Safety regarding scrotal surface temperature in males	No meaningful rise in scrotal surface temperature during treatment (Page 5)

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

Test Set Sample Size: The document states: "In order to demonstrate safety of the HPM-6000UF in the treatment of males (specifically, thermal safety to the testes), a clinical study has been conducted." However, the sample size for this clinical study is NOT specified in the provided text.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a "clinical study conducted" for safety, it would typically be a prospective study.

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

This information is not applicable in the traditional sense for this 510(k) submission. The clinical study mentioned was for thermal safety demonstration, not for establishing a ground truth for efficacy using expert consensus. The "ground truth" for safety would be measured physiological parameters (temperature).

4. Adjudication Method for the Test Set

This information is not applicable as the clinical study described is for thermal safety, not for evaluating device performance against an adjudicated ground truth for efficacy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done according to the provided information. This type of study is more common for diagnostic imaging devices where human readers interpret images with and without AI assistance. The HPM-6000UF is a therapeutic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not applicable to the HPM-6000UF. This device is a physical instrument for therapeutic use, not a diagnostic algorithm. Its "performance" is its ability to deliver the electromagnetic field and achieve neuromuscular stimulation for the stated indication. The closest "standalone" performance would be its technical specifications and safety profile, which are covered by non-clinical testing and the thermal safety study.

7. Type of Ground Truth Used

The "ground truth" for the single clinical study mentioned was physiological measurement (scrotal surface temperature) to demonstrate thermal safety.
For the overall substantial equivalence claim, the "ground truth" is effectively the performance and safety profile of the legally marketed predicate devices. The new device (HPM-6000UF) is asserted to be "identical in design" to its primary predicate (HPM-6000U) with the only difference being an expanded indication for use to include males, which prompted the specific thermal safety study.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The "HPM-6000UF is identical in design to the HPM-6000U predicate." The design and engineering would be based on established principles and the prior device's development, not a data-driven training set.

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

Not applicable as there is no "training set" for an AI/ML algorithm in this context.

Summary of Device Performance and Equivalence Claim:

The HPM-6000UF's acceptance for market is based on its substantial equivalence to the HPM-6000U and InToneMV predicate devices. The key arguments for equivalence are:

Identical Design to Primary Predicate: The HPM-6000UF is stated to be "identical in design to the HPM-6000U predicate."
Expanded Indications Addressed: The only difference from the HPM-6000U is the expansion of the indication to include males.
Clinical Study for Safety (Males): A specific clinical study was conducted only to address the safety concern of thermal effects on male testes when expanding the indication. This study concluded there was "no meaningful rise in scrotal surface temperature."
Similar Principle of Action: While the HPM-6000UF uses a magnetic field and InToneMV uses direct current, both lead to "induction of electrical stimulus in the neuromuscular tissue resulting in the muscle contraction."
No New Safety/Effectiveness Questions: The technological differences are asserted not to "raise any new types of safety or effectiveness questions."

In essence, the device's "performance" for regulatory purposes in this 510(k) is primarily its demonstrated safety for the expanded indication and its technological and intended use similarity to already cleared devices. It is not presenting novel efficacy data in a comparative trial setting against a clinical "ground truth."

Summary

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November 14, 2018

BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, MA 01752

Re: K181497

Trade/Device Name: HPM-6000UF Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: September 21, 2018 Received: September 26, 2018

Dear David Chmel:

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 mav, 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 avare 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.

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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,

Glenn B. Bell -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181497

Device Name HPM-6000UF

Indications for Use (Describe)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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510(k) Summary

General Information

Sponsor:	BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502
Applicant:	BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502
Contact Person:	David ChmelBTL Industries, Inc.chmel@btlnet.com
Summary PreparationDate:	November 13, 2018

Device Name

Trade/Proprietary Name:	HPM-6000UF
Primary Classification Name:	Nonimplanted electrical continence device
Common Name:	Pelvic floor muscle stimulator
Classification Regulation:	21 CFR 876.5320, Class II
Classification Product Code:	KPI

Legally Marketed Predicate Devices

The HPM-6000UF is a non-invasive therapeutic device, and is substantially equivalent to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:

Primary predicate - HPM-6000U (K162010) Secondary predicate - InToneMV (K134020)

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Product Description

Intended Use

Side Effects

The intended use may be accompanied by various side effects such as muscular pain, temporary muscle spasm, temporary joint or tendon pain, temporary increase of local circulation, increased sensitivity during intercourse, and local erythema or skin redness.

Non-clinical Testing

The HPM-6000UF is identical in design to the HPM-6000U predicate. Therefore, no nonclinical testing was needed.

Clinical testing

In order to demonstrate safety of the HPM-6000UF in the treatment of males (specifically, thermal safety to the testes), a clinical study has been conducted. The clinical study documented no meaningful rise in scrotal surface temperature during treatment, and that the HPM-6000UF device is safe in the male population.

Technological Characteristics

The HPM-6000UF is identical in design to the HPM-6000U predicate device. The only difference relative to this predicate device is to expand the indications for use statement.

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therapy is indicated by illuminated segments in armrests. For precise patient positioning prior to the therapy, the seat height can be electronically adjusted by a remote control.

The HPM-6000UF device is using a maqnetic field in order to induce neuromuscular tissue stimulation. The InToneMV predicate device is stimulating neuromuscular tissue via the direct current flow. In both cases there is an induction of electrical stimulus in the neuromuscular tissue resulting in the muscle contraction.

The HPM-6000UF device is intended for professional use as a prescription use only, while the InToneMV predicate device is intended also for a home use. The energy source of the HPM-6000UF device is electric power grid instead of battery source by the InToneMV predicate device. Further, the HPM-6000UF is equipped with larger colorful touch-screen control panel to increase user comfort.

The technological differences between the HPM-6000UF device and the predicate devices do not raise any new types of safety or effectiveness questions.

510(k) number	Not Assigned	K162010	K134020
Device name	HPM-6000UF	HPM-6000U	InToneMV
Company name	BTL Industries, Inc.	BTL Industries, Inc.	InControl Medical,LLC
Product Codeand Regulation	Gastroenterology-Urology Devices21 CFR 876.5320KPI - Stimulator,Electrical, Non-Implantable, ForIncontinence	Gastroenterology-Urology Devices21 CFR 876.5320KPI - Stimulator,Electrical, Non-Implantable, ForIncontinence	Gastroenterology-Urology Devices21 CFR 876.5320KPI - Stimulator,Electrical, Non-Implantable, ForIncontinence
Intended Use	HPM-6000UF isintended to provideentirely non-invasiveelectromagneticstimulation of pelvic floormusculature for thepurpose of rehabilitationof weak pelvic musclesand restoration ofneuromuscular controlfor the treatment of maleand female urinaryincontinence.	HPM-6000U is intendedto provide entirely non-invasiveelectromagneticstimulation of pelvicfloor musculature for thepurpose of rehabilitationof weak pelvic musclesand restoration ofneuromuscular controlfor the treatment ofurinary incontinence inwomen.	InToneMV is intendedto provide electricalstimulation and/or visualbiofeedback (viamanometry) fortreatment of male andfemale urinary and fecalincontinence.

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		K181497Page 4 of 5
	510(K) SUMMARY

	K134020
	InToneMV
J	InControl Medical,LLC
ies, Inc.

510(k) number	Not Assigned	K162010	K134020
Device name	HPM-6000UF	HPM-6000U	InToneMV
Company name	BTL Industries, Inc.	BTL Industries, Inc.	InControl Medical,LLC
Clinical Use	Prescription Use	Prescription Use	Clinic or home use,under direction ofphysician
ApplicablePatients	Male and Female	Woman	Male and Female
Primary Function	Muscle stimulation	Muscle stimulation	Muscle stimulation
Principle of Action	Initiating action potentialof nerves results inmuscle contraction	Initiating action potentialof nerves results inmuscle contraction	Initiating action potentialof nerves results inmuscle contraction
Type of Energy	Magnetic field	Magnetic field	Electrical
Energy Source	100 - 240 V AC, 50 - 60Hz, max 14 A	100 - 240 V AC, 50 -60 Hz, max 14 A	4/5 AA nickel metalhydride battery
Number of outputchannels	1	1	1
Magnetic FieldIntensity	0.7 – 2.5 T	0.7 – 2.5 T	N/A
Pulse RepetitionRate	1 – 150 Hz	1 — 150 Hz	0 - 50 Hz
Pulse Width	280 $ μ $ s (± 20%)	280 $ μ $ s (± 20%)	200 $ μ $ s
Shape ofStimulation Pulse	Dual phase, rectangularpulses	Dual phase, rectangularpulses	Dual phase, rectangularpulses
Therapy Time	Up to 30 min	Up to 30 min	Up to 30 min
Interface	Touch-screen	Touch-screen	Buttons accompaniedby simple screen
Firmwarecontrolled	Yes	Yes	Yes
510(k) number	Not Assigned	K162010	K134020

Device name	HPM-6000UF	HPM-6000U	InToneMV

Company name	BTL Industries, Inc.	BTL Industries, Inc.	InControl Medical,LLC
Software Level ofConcern	Moderate	Moderate	Moderate
EnvironmentalSpecifications	For indoor use only	For indoor use only	For indoor use only
Feedback	By Patient	By Patient	Manometric air pressure
OperatingTemperature	+10 to +30 °C(50 - 86 °F)	+10 to +30 °C(50 – 86 °F)	Unknown
Main Unit	500 × 970 × 580 mm	500 × 970 × 580 mm	122 x 61 x 30 mm
Dimensions
(W×H×D)	(20 × 38 × 23 in)	(20 × 38 × 23 in)	(4.8 x 2.4 x 1.1 in)
Applicator	730 x 730 x 730 mm	730 x 730 x 730 mm	196 x 58 x 99 mm
Dimensions(W×H×D)	(29 x 29 x 29 in)	(29 x 29 x 29 in)	(7.7 x 2.3 x 3.9 in)
System Weight	46 kg (101 lb)	46 kg (101 lb)	Unknown

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510(K) SUMMARY

Substantial Equivalence

Based upon the intended use and known technical information provided in this pre-market notification, the HPM-6000UF device has been shown to be substantially equivalent to currently marketed predicate devices.

Conclusion

Based on the aforementioned information, the HPM-6000UF is safe and effective and substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).