K Number

Device Name

HPM-6000UF

Manufacturer

BTL Industries, Inc.

Date Cleared

2018-11-14

(160 days)

Product Code

KPI

Regulation Number

876.5320

Intended Use

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.

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

K162010, K134020

Reference Devices

K162010, K134020

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a device that uses electromagnetic stimulation and a user interface for setting parameters. There is no mention of AI, ML, or any related concepts like data analysis, learning, or adaptive algorithms based on patient data. The "computer" mentioned is likely for controlling the electromagnetic field generation and the user interface, not for AI/ML processing.

Therapeutic

Yes
The 'Device Description' explicitly states, "The HPM-6000UF is a non-invasive therapeutic device." Additionally, the 'Intended Use / Indications for Use' describes its purpose as the "rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence," which is a therapeutic aim.

Diagnostic

No
The device is described as a non-invasive therapeutic device for electromagnetic stimulation to rehabilitate weak pelvic muscles, not for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components such as electromagnetic field generators, a system console, an applicator chair with a coil, a touch screen, buttons, and a knob. It is a physical therapeutic device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the HPM-6000UF device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
HPM-6000UF Function: The HPM-6000UF is a therapeutic device that uses electromagnetic stimulation applied externally to the body (non-invasive) to treat a condition (urinary incontinence). It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "non-invasive electromagnetic stimulation... for the purpose of rehabilitation... and restoration of neuromuscular control for the treatment of male and female urinary incontinence." This describes a therapeutic intervention, not a diagnostic test.
Device Description: The description focuses on the device's mechanism of action (electromagnetic field stimulation) and its components for delivering this therapy. There is no mention of sample collection, analysis, or diagnostic results.

Therefore, the HPM-6000UF falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

KPI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic floor musculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

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.

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.

K162010, K134020

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

§ 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).

Summary

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

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.

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

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)
---------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Type of Use (Select one or both, as applicable)

Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares on the left side of the image. The text "BTL Industries" is on the right side of the image.

510(k) Summary

General Information

| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
Date: | 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)

Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL". The squares are arranged in a triangular pattern. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.

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.

Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is simple and modern, and the colors are muted.

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 Code
and Regulation	Gastroenterology-
Urology Devices
21 CFR 876.5320
KPI - Stimulator,
Electrical, Non-
Implantable, For
Incontinence	Gastroenterology-
Urology Devices
21 CFR 876.5320
KPI - Stimulator,
Electrical, Non-
Implantable, For
Incontinence	Gastroenterology-
Urology Devices
21 CFR 876.5320
KPI - Stimulator,
Electrical, Non-
Implantable, For
Incontinence
Intended Use	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.	HPM-6000U 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
urinary incontinence in
women.	InToneMV is intended
to provide electrical
stimulation and/or visual
biofeedback (via
manometry) for
treatment of male and
female urinary and fecal
incontinence.

Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.

| | | K181497
Page 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 of
physician
Applicable
Patients	Male and Female	Woman	Male and Female
Primary Function	Muscle stimulation	Muscle stimulation	Muscle stimulation
Principle of Action	Initiating action potential
of nerves results in
muscle contraction	Initiating action potential
of nerves results in
muscle contraction	Initiating action potential
of nerves results in
muscle contraction
Type of Energy	Magnetic field	Magnetic field	Electrical
Energy Source	100 - 240 V AC, 50 - 60
Hz, max 14 A	100 - 240 V AC, 50 -
60 Hz, max 14 A	4/5 AA nickel metal
hydride battery
Number of output
channels	1	1	1
Magnetic Field
Intensity	0.7 – 2.5 T	0.7 – 2.5 T	N/A
Pulse Repetition
Rate	1 – 150 Hz	1 — 150 Hz	0 - 50 Hz
Pulse Width	280 $ μ $ s (± 20%)	280 $ μ $ s (± 20%)	200 $ μ $ s
Shape of
Stimulation Pulse	Dual phase, rectangular
pulses	Dual phase, rectangular
pulses	Dual phase, rectangular
pulses
Therapy Time	Up to 30 min	Up to 30 min	Up to 30 min
Interface	Touch-screen	Touch-screen	Buttons accompanied
by simple screen
Firmware
controlled	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 of
Concern	Moderate	Moderate	Moderate
Environmental
Specifications	For indoor use only	For indoor use only	For indoor use only
Feedback	By Patient	By Patient	Manometric air pressure
Operating
Temperature	+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

Image /page/7/Picture/1 description: The image contains the logo for BTL Industries. The logo consists of three overlapping blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a dark gray sans-serif font. The logo is simple and modern, and the text is clear and easy to read.

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.