K Number
K210913
Device Name
V12 PRO
Manufacturer
Date Cleared
2021-08-04

(128 days)

Product Code
Regulation Number
890.5650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body. The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord. The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.
More Information

Not Found

No
The description focuses on software-controlled air compression and sequential inflation/deflation based on timing and pressure from a sensor and microprocessor. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

Yes
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, which are therapeutic uses.

No

The V12 PRO is indicated for temporary relief of muscle aches and pains and increased circulation, and it operates by simulating kneading and stroking of tissues using inflatable garments. It is a therapeutic device that applies compression, not one that identifies or diagnoses medical conditions.

No

The device description explicitly lists hardware components such as an air pump, air pressure sensor, sleeves, air tubing, connectors, power cord, membrane keypad, and LCD screen. While software controls the device, it is an integral part of a larger hardware system.

Based on the provided information, the V12 PRO is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for temporary relief of muscle aches and pains and increasing circulation through external compression. This is a physical therapy/massage type of application, not a diagnostic test performed on biological samples.
  • Device Description: The device works by applying external pressure to the body using inflatable garments. It does not analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The V12 PRO's function falls outside of this definition.

N/A

Intended Use / Indications for Use

The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.

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

IRP

Device Description

V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord.

The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

limbs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinics, hospital, athlete training, and home environments

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)

Biocompatibility testing: The biocompatibility evaluation for the V12 PRO device was conducted in accordance with the FDA "Use of International Standards ISO-10993, #Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Irritation, Sensitization. The intended use of the product involves contact with the intact skin for a period of less than 24 hours. To evaluate the biocompatibility of the product, a cytotoxicity test as per ISO 10993-5:2009 and skin irritation and sensitization test as per ISO 10993-10:2013 were therefore considered sufficient.

Electrical Safety and Electrical Compatibility (EMC): Electrical safety and EMC testing were conducted on the V12 PRO. The system complies with the IEC 60601-1. IEC 60601-1-2:2014 standard for EMC and IEC 60601-1-11 Medical electrical equipment: General requirements for basic safety and essential performance was tested as well.

Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA´s Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."

Pressure Distribution Comparison Test: The purpose of the test was to find out if the V12 PRO has a pressure distribution comparable to that of the predicate (Ballancer 505 System) to ensure that the device is as safe and effective as a legally market device. Based on the tests it can be concluded that there are a few differences between the pressure curves but both products show a similar compression pressure cure in longitudinal direction. From this result it can be also concluded that both devices have the same technological characteristics. The V12 PRO was found to have a safety and effectiveness profile that is similar to the predicate device.

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.

K150269

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

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).

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

August 4, 2021

SLK Medical GmbH Matthew Reid Product Manager SLK Medical GmbH 298-24, Gongdan-Ro Gunpo-Si. Gyeonggido 15809 South Korea

Re: K210913

Trade/Device Name: V12 PRO Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 25, 2021 Received: June 1, 2021

Dear Matthew Reid:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K210913

Device Name V12 PRO

Indications for Use (Describe)

The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.

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)

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510(k) Summary K210913

1. SUBMITTER

SLK Medical GmbH Am Herdicksbach 18 44147 Dortmund, Germany

Tel: +49 231 9253600 Fax: +49 231 92536029

Official Contact: Matthew Reid – Product Manager Tel: +49 163 7550203

2. DEVICE

  • Name of Device: V12 PRO
  • Classification Code: CFR Classification section 890.5650

Product code: IRP

Class: 2

3. PREDICATE DEVICE

The V12 PRO is substantially equivalent to the following predicate device:

  • Ballancer 505 System, Model 1201 AC (K150269) -

4. DEVICE DESCRIPTION

V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

4

The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord.

The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.

5. INDICATIONS FOR USE

The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Intermittent pneumatic compression is the technological principle for both the subject and the predicate device. The subject and the predicate devices are based on the following same technological elements:

  • Electronically controlled Air Pump with inflatable compression garments -(arm, leg, jacket and Hip garment), which conducts a sequential compression of the patient's limbs.
    The following technological differences exist between the subject and the predicate devices:

  • -While V12 PRO uses a turning dial to set the pressure, the predicate uses push buttons for this function.

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TABLE FORMAT

DeviceSubject DevicePredicateComparison
ManufacturerSLK Medical GmbHBallancer 505 System-
510(k) NumberK210913K150269-
Model NameV12 PROModel 1201-AC-
ClassificationClass II Device, IRP (21 CFR
890.5650)Class II Device, IRP (21
CFR 890.5650)Same
Indications for UseV12 PRO is a Compression
Therapy System is intended for
the temporary relief of minor
muscle aches and pains and for
the temporary increase
in circulation to the treated areas
in people who are in good
health.
The V12 PRO Therapy System
simulates kneading and stroking
of tissues by using an
inflatable garment.Ballancer 505 is a
pneumatic massage
system intended to
provide gradient
pressure in areas,
which the inflatable
garment is applied.
The Ballancer 505
System is indicated for:
  • Simulating kneading
    and stroking of the
    tissues by use of an
    inflatable garment
  • Temporary increase
    circulation in areas
    which the garment is
    applied
  • Temporary relief of
    minor muscle aches
    and pains | Similar |
    | OTC or Rx | OTC | OTC | Same |
    | Environment of Use | Clinics, hospital, athlete training,
    and home environments | Not publicly available | - |
    | Standards | - IEC ISO 13485
  • IEC ISO 14971
  • IEC ISO 10993
  • IEC 60601-1
  • IEC 60601-1-11
  • IEC 60601-1-2
  • IEC 60601-1-6 | Not publicly available | Meets
    consensus
    standards for
    ES, EMC,
    Biocompatibility |
    | Mode of
    Compression | Sequential Gradient | Not publicly available | - |
    | Power Source | 110 -230 V 50/60 Hz | Not publicly available | - |
    | Therapy Time | User determines therapy time.
    Choose from 15 to 60 minutes
    session time. | Not publicly available | - |
    | Max Pressure
    Min Pressure | 15-80 mmHg | Not publicly available | - |
    | Number of
    Chambers | 12 Chambers | Not publicly available | - |
    | Compression
    Garment
    Sleeve Material | Nylon with a Polyurethane
    laminate | Not publicly available | - |
    | Housing Materials | Molded ABS enclosure | Not publicly available | - |
    | And Constructions | | | |
    | | | | |
    | Patient contact | Non-conductive attachments | Not publicly available | - |
    | Power
    Consumption | 20W | Not publicly available | - |
    | Cycle time | 1 min 15 sec | Not publicly available | - |
    | Photo and Size | Image: machine with dimensions 6.69" x 7.87" x 7.87" | Not publicly available | - |
    | Weight | 4.4 pounds | Not publicly available | - |
    | Modes (inflation
    sequences, all
    preprogrammed) | Inflates chambers from bottom
    up but maintains pressure in
    lower chambers as works its way
    to top. Then all chambers release
    pressure at same time once all
    chambers
    have sequentially inflated. | Not publicly available | - |
    | Modes (visual
    description) | Sequential
    Image: sequential mode | Not publicly available | - |
    | "Leg" Attachment | Leg (consisting of foot, calf, knee,
    upper leg) | Not publicly available | - |
    | Leg Attachment
    Photos | Image: leg attachment | Not publicly available | - |
    | Attachment Sizes | 32" x 30"
    Image: attachment with dimensions 32" x 30" | Not publicly available | |
    | "Pant"
    Attachment | Pant (consists of foot, calf, knee,
    upper leg, glutes, hips, lower
    back) | Not publicly available | - |
    | | | | |
    | Pant Attachment
    Photo | | Not publicly available | - |
    | "Arm"
    Attachment | Arm (consisting of entire arm, shoulder, upper chest and back) | Not publicly available | - |
    | Arm Attachment
    Photos | | Not publicly available | - |
    | Arm Attachment
    Sizes | 22" x 29" | Not publicly available | - |
    | "Jacket"
    Attacments | Jacket (consisting of entire arms, shoulder, upper chest and back) | Not publicly available | - |
    | Jacket Attachment
    Photos | | Not publicly available | - |
    | SW/Firmware/
    Microprocessor
    control | Firmware / Microprocessor | Not publicly available | - |
    | Technology | Compressor and valve system which sequentially inflates cells sequentially | Not publicly available | - |

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7. PERFORMANCE DATA

All tests were performed with the reference device VariLymph 12 Pro (V12 PRO).

There are no performance standards under the Federal Food, Drug and Cosmetic Act, for a compressible limb sleeve device. The testing included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing

The biocompatibility evaluation for the V12 PRO device was conducted in accordance with the FDA "Use of International Standards ISO-10993, #Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

  • Cytotoxicity i
  • Irritation
  • Sensitization

The intended use of the product involves contact with the intact skin for a period of less than 24 hours. To evaluate the biocompatibility of the product, a cytotoxicity test as per ISO 10993-5:2009 and skin irritation and sensitization test as per ISO 10993-10:2013 were therefore considered sufficient. Any knowledge to be gained from further biocompatibility testing with this product would not justify the unnecessarily high level of harm to experimental animals involved. As per ISO 10993-1:2009 such tests were not performed. The type and scope of the tests performed complies with the specifications as per ISO 10993-1:2009.

Electrical Safety and Electrical Compatibility (EMC)

Electrical safety and EMC testing were conducted on the V12 PRO. The system complies with the IEC 60601-1. A justification how all the applicable statutory or regulatory criteria of the EN 60601-1 are met through recognition of IEC 60601-1 was provided.

9

IEC 60601-1-2:2014 standard for EMC and IEC 60601-1-11 Medical electrical equipment: General requirements for basic safety and essential performance was tested as well.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA´s Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."

Pressure Distribution Comparison Test

The purpose of the test was to find out if the V12 PRO has a pressure distribution comparable to that of the predicate (Ballancer 505 System) to ensure that the device is as safe and effective as a legally market device.

Summary: Based on the tests it can be concluded that there are a few differences between the pressure curves but both products show a similar compression pressure cure in longitudinal direction. From this result it can be also concluded that both devices have the same technological characteristics. The V12 PRO was found to have a safety and effectiveness profile that is similar to the predicate device.

8. CONCLUSION

The conclusion drawn from the above Performance Testing and comparison to predicate device is that the V12 PRO is substantially equivalent in safety and efficacy to the predicate device listed above.

The non-clinical data support the safety of the device and the hardware and software verification und validation demonstrate that the V12 PRO should perform as intended in the specified use conditions. The data demonstrates that the V12 PRO device performs comparably to the predicate device that is currently marketed for the same intended use (temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health). V12 PRO device uses sequential inflation and deflation of cells within compression sleeves put around a limb. Inflation/Deflation, pressures, pressure distribution and sequences are similar to those of the predicate device.