Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard electrotherapy and ultrasound functionalities with user-configurable programs and a therapy menu for assigning indications to programs. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.

Therapeutic

Yes
The device description and intended use clearly state that it is used for "Ultrasound therapy" and "Electrotherapy" for the "relief of pain, muscle spasms and joint contractures" and other medical conditions, which are therapeutic applications.

Diagnostic

No

The device description and intended use clearly state that it is a therapy device used for pain relief, muscle stimulation, and other therapeutic applications, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components including a screen, touch control, ultrasound module, stimulation current therapy module, ultrasound heads, and the ability to combine these hardware functions. It is described as a "device family" with different hardware configurations.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The indications for use clearly describe therapeutic applications (pain relief, muscle spasm reduction, increasing range of motion, etc.) using ultrasound and electrotherapy. These are treatments applied to the body, not tests performed on samples taken from the body.
Device Description: The description details a device that delivers ultrasound and electrical stimulation. It talks about waveforms, frequencies, duty cycles, and different heads for application to the body. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.

The device is clearly described as a therapeutic device used by healthcare providers to treat patients.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The indications for use of the proposed device are the same as those for the predicate devices Ultrasound therapy:

Relief of pain, muscle spasms and joint contractures
Relief of pain, muscle spasms and joint contractures that may be associated with: "
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
Relief of pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular scarring

Electrotherapy:

Relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain

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

IPF, IMI, IMG, GZJ

Device Description

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.

Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.

The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).

The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.

At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:

Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated

The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.

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)

Non-clinical Tests Performed
Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided to demonstrate that Soleo Stim and Soleo SonoStim are safe and effective in its intended use.

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.

K031077, K954411, K952536

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

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo for "zimmer MedizinSysteme". The word "zimmer" is in a bold, sans-serif font, with the "i" having a square dot. Below "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo appears to be a scan or photocopy, as the text has a slightly rough or pixelated appearance.

(12/059 AGE | OF ID

Zimmer Medizinsysteme GmbH Junkersstraße 9 D-89231 Neu-Uim

Tel. 073179761-0

info@zimmer.de Fax 0731 / 9761-118

www.zimmer.de

AUG

5. 510(k) Summary

The following information is provided as required in 21CFR807.87 and the Guidance Document "Guidance Document for Powered Muscle Stimulators 510(k)s"

a.) General

| 510(k) Submitter: | Zimmer MedizinSysteme GmbH
Junkersstrasse 9
D-89231 Neu-Ulm
Germany |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Mr. Armin Pétraschka
Project Manager
Phone: +49-731-9761-140
Fax: +49-731-9761-4475
E-mail: a.petraschka@zimmer.de |
| Establishment Registration: | 8010720 |
| Submission Date: | January 13th, 2012 |
| Device Names: | |
| Device family name: | Soleoline |
| Trade Names: | Soleo Stim
Soleo Sono
Soleo SonoStim |
| Common Names: | Ultrasound and muscle stimulator
Powered muscle stimulator
Transcutaneous electrical nerve stimulator for pain relief
Ultrasonic diathermy |
| Regulation Numbers and Classification Names: | 21 CFR 890.5850 - Stimulator, Muscle, Powered
21 CFR 890.5300 - Ultrasonic diathermy
21 CFR 890.5860 - Ultrasound and muscle stimulator
21 CFR 882.5890 - Transcutaneous electrical nerve stimulator for pain relief |
| Classification: | Class II |
| Product Codes: | IPF, IMI, IMG, GZJ |
| Panel: | 89 - Physical Medicine
84 - Neurology |

1

K121059 PAGE 2 OF IO

b.) Predicate Devices

| 1-
Device:
Manufacturer:
510(k) number: | Vectra Genisys
CHATTANOOGA GROUP (Encore Medical)
4717 adams rd. P.O. Box 489
Hixson, Tennessee 37343-0489
K031077 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | |
| 2.
Device:
Manufacturer: | Galva 5 M
Zimmer MedizinSysteme GmbH (former Zimmer Elektromedizin GmbH) |
| | Junkersstrasse 9
89231 Neu-Ulm
Germany |
| 510(k) number: | K954411 |
| 3. | |
| Device: | Sono 5 |
| Manufacturer: | Zimmer MedizinSysteme GmbH |
| | Junkersstrasse 9 |
| | 89231 Neu-Ulm |
| 510(k) number: | Germany
K952536 |
| | |
| | |

c.) Device Description

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.

Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.

The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).

The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.

At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:

Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated

The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

2

K121059
PAGE 3 OF 10

d.) Statement of indications for use

The indications for use of the proposed device are the same as those for the predicate devices Ultrasound therapy:

Relief of pain, muscle spasms and joint contractures 1.
- Relief of pain, muscle spasms and joint contractures that may be associated with: "
  - · Adhesive capsulitis
  - Bursitis with slight calcification o
  - · Myositis
  - Soft tissue injuries o
  - Shortened tendons due to past injuries and scar tissues o
1. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring

Electrotherapy:

1. Relaxation of muscle spasm
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
ର. Maintaining or increasing range of motion
1. Symptomatic relief or management of chronic, intractable pain
1. Post-traumatic acute pain
ு. Post-surgical acute pain

e.) Comparison of Technological Characteristics

General:

| Feature | Zimmer Soleoline
(Soleo Sono,
Soleo Stim,
Soleo SonoStim) | Chattanooga Vectra
Genisys w/o EMG | Zimmer Galva 5 | Zimmer Sono 5 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Number of channels | 2 | 2/4 | 2 | - |
| Number of connections | 2 | 2 | 1 | - |
| Touch screen interface | + | - | - | - |
| Color LCD screen | + | + | - | - |
| Intended use | Ultrasound diathermy,
Powered muscle
stimulator,
Ultrasound and
muscle stimulator | Ultrasound and muscle
stimulator | Powered muscle
stimulator, | Ultrasound diathermy |
| Indications
electrotherapy | Relaxation of
muscle spasm
Prevention or
retardation of
disuse atrophy
Increasing local
blood circulation
Muscle re-
education
Immediate post-
surgical
stimulation of calf | Relaxation of
muscle spasm
Prevention or
retardation of
disuse atrophy
Increasing local
blood circulation
Muscle re-
education
Immediate post-
surgical
stimulation of calf | Relaxation of muscle
spasm
Prevention or
retardation of disuse
atrophy
Increasing local
blood circulation
Muscle re-education
Immediate post-
surgical stimulation
of calf muscles to
prevent thrombosis | - |

3

K121059

PASE 4 OF D

	muscles to	muscles to	Maintaining or
	prevent	prevent	increasing range of
	thrombosis	thrombosis	motion
	Maintaining or	Maintaining or

	increasing range	increasing range
	of motion	of motion
	Symptomatic	Symptomatic
	relief or	relief or
	management of	management of

	chronic,	chronic,
	intractable pain	intractable pain
	Post-traumatic	Post-traumatic
	acute pain	acute pain
	Post-surgical	Post-surgical

	acute pain	acute pain
Indications ultrasound	Relief of pain,

                          | Relief of pain,
                                 |                                                                        | Relief of pain     |    |    |    |    |    |