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.

AI/ML Overview

The provided text describes the V12 PRO device and its FDA 510(k) clearance application. It focuses on demonstrating substantial equivalence to a predicate device (Ballancer 505 System) rather than providing detailed acceptance criteria and a study dedicated to proving those criteria for the V12 PRO as a standalone device.

However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the conducted performance tests. The study's main goal was to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with N/A where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence and Testing)	Reported Device Performance (V12 PRO)
1. Indications for Use Equivalence	The V12 PRO is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation to the treated areas in good health, simulating kneading and stroking of tissues using an inflatable garment. This is deemed similar to the predicate device's indications.
2. Technological Characteristics Equivalence	* Intermittent Pneumatic Compression: Both subject and predicate use this principle. * Electronically Controlled Air Pump with Compression Garments: Both possess this core technology. * Mode of Compression: Sequential Gradient confirmed for V12 PRO.
3. Pressure Distribution Comparability (Safety & Effectiveness)	Based on the Pressure Distribution Comparison Test, while there are a few differences between pressure curves, both products show a similar compression pressure curve in the longitudinal direction. It was concluded that both devices have the same technological characteristics, and V12 PRO has a safety and effectiveness profile similar to the predicate device.
4. Biocompatibility Standard Compliance	The device should be biocompatible for intact skin contact for less than 24 hours. The V12 PRO successfully passed: * Cytotoxicity (ISO 10993-5:2009) * Irritation (ISO 10993-10:2013) * Sensitization (ISO 10993-10:2013)
5. Electrical Safety Standard Compliance	The device should comply with relevant electrical safety standards. The V12 PRO complies with: * IEC 60601-1 * IEC 60601-1-11 (Medical electrical equipment: General requirements for basic safety and essential performance)
6. Electromagnetic Compatibility (EMC) Standard Compliance	The device should comply with relevant EMC standards. The V12 PRO complies with: * IEC 60601-1-2:2014
7. Software Verification and Validation	Software should be verified and validated as per FDA guidance. Software verification and validation testing was conducted, and documentation 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." (Specificity on exact "acceptance criteria" for software performance is not detailed in the summary, but successful V&V implies meeting defined functional and safety requirements).

Study Proving Acceptance Criteria:

The primary "study" described is a non-clinical performance evaluation and comparison to a predicate device conducted to demonstrate substantial equivalence for regulatory clearance (K210913).

Specific Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in terms of subject or patient count for clinical performance. The testing described focuses on device characteristics, not patient outcomes. The "Pressure Distribution Comparison Test" was performed on the device itself and the predicate.
- Data Provenance: The tests (biocompatibility, electrical safety, EMC, software V&V, pressure distribution) were conducted on the V12 PRO device and compared against the Ballancer 505 System (predicate device). No information on patient data (country of origin, retrospective/prospective) is provided as this was a non-clinical submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This was a non-clinical submission focusing on technical performance and equivalence. No human expert "ground truth" was established for a test set of clinical images or patient outcomes. The "ground truth" for the technical tests would be the established industry standards (IEC, ISO) and the characteristics of the predicate device.
Adjudication method for the test set:
- N/A. Not applicable as there was no expert adjudication of clinical data or images.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device (V12 PRO) is a powered inflatable tube massager, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm only" performance in the sense of an AI diagnostic. The device's performance is inherently "standalone" in its mechanical and software operation, but it requires human application and setting adjustments. The software verification and validation are essentially demonstrating its "standalone" functionality.
The type of ground truth used:
- Technical Specifications/Industry Standards: For biocompatibility, electrical safety, EMC, and software, the "ground truth" was compliance with established international standards (ISO, IEC, FDA guidance).
- Predicate Device Characteristics: For the Pressure Distribution Comparison Test, the "ground truth" was the comparable performance (pressure curve) of the legally marketed predicate device, the Ballancer 505 System.
The sample size for the training set:
- N/A. This document does not describe the development of a machine learning or artificial intelligence algorithm that would require a distinct training set. The "software" mentioned refers to the device's operational control software, which undergoes traditional software verification and validation, not machine learning model training.
How the ground truth for the training set was established:
- N/A. See point 7.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K210913

Device Name V12 PRO

Indications for Use (Describe)

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

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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

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

Device	Subject Device	Predicate	Comparison
Manufacturer	SLK Medical GmbH	Ballancer 505 System	-
510(k) Number	K210913	K150269	-
Model Name	V12 PRO	Model 1201-AC	-
Classification	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21CFR 890.5650)	Same
Indications for Use	V12 PRO is a CompressionTherapy System is intended forthe temporary relief of minormuscle aches and pains and forthe temporary increasein circulation to the treated areasin people who are in goodhealth.The V12 PRO Therapy Systemsimulates kneading and strokingof tissues by using aninflatable garment.	Ballancer 505 is apneumatic massagesystem intended toprovide gradientpressure in areas,which the inflatablegarment is applied.The Ballancer 505System is indicated for:* Simulating kneadingand stroking of thetissues by use of aninflatable garment* Temporary increasecirculation in areaswhich the garment isapplied* Temporary relief ofminor muscle achesand 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	Meetsconsensusstandards forES, EMC,Biocompatibility
Mode ofCompression	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 minutessession time.	Not publicly available	-
Max PressureMin Pressure	15-80 mmHg	Not publicly available	-
Number ofChambers	12 Chambers	Not publicly available	-
CompressionGarmentSleeve Material	Nylon with a Polyurethanelaminate	Not publicly available	-
Housing Materials	Molded ABS enclosure	Not publicly available	-
And Constructions

Patient contact	Non-conductive attachments	Not publicly available	-
PowerConsumption	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 (inflationsequences, allpreprogrammed)	Inflates chambers from bottomup but maintains pressure inlower chambers as works its wayto top. Then all chambers releasepressure at same time once allchambershave sequentially inflated.	Not publicly available	-
Modes (visualdescription)	SequentialImage: sequential mode	Not publicly available	-
"Leg" Attachment	Leg (consisting of foot, calf, knee,upper leg)	Not publicly available	-
Leg AttachmentPhotos	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, lowerback)	Not publicly available	-

Pant AttachmentPhoto		Not publicly available	-
"Arm"Attachment	Arm (consisting of entire arm, shoulder, upper chest and back)	Not publicly available	-
Arm AttachmentPhotos		Not publicly available	-
Arm AttachmentSizes	22" x 29"	Not publicly available	-
"Jacket"Attacments	Jacket (consisting of entire arms, shoulder, upper chest and back)	Not publicly available	-
Jacket AttachmentPhotos		Not publicly available	-
SW/Firmware/Microprocessorcontrol	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.

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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.

Regulation Number and Section

§ 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).