Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

Device Description

SLK Varilymph 12 Pro Compression Therapy Device utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus, treat the symptoms of a variety of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main control contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and a rotating dis controlling air outflow. The regulated compressed air is transferred via an air distributor through a series of hoses to a sleeve garment. Each garment contains 12 pressure cells. The sleeve fits on the affected limb and can easily adjusted to any limb size within the sleeve tolerance. The devices are powered from a system supply voltage (230V / 110V).

The SLK VariLymph 12 Pro (SLK 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 SLK VariLymph 12 Pro is a Membrane Keypad with dome switches. The settings are shown on a 3,2" LCD Screen.

The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

AI/ML Overview

The SLK VariLymph 12 Pro is a compressible limb sleeve device. The provided text indicates that its predicate device is the LYMPHA PRESS OPTIMAL MODEL 1201AP COMPRESSIBLE LIMB SLEEVE DEVICE (K082149). The justification for substantial equivalence relies on non-clinical performance data and a comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics. Instead, it describes various tests and concludes that the device performs similarly to the predicate. The overall acceptance criterion is demonstrating substantial equivalence in safety and efficacy to the predicate device.

Here's a summary of the performance claims based on the non-clinical data:

Test/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Technological Principle	Same as predicate (Intermittent pneumatic compression).	Both subject and predicate devices use intermittent pneumatic compression.
Biocompatibility	Complies with ISO 10993-1, 10993-5, 10993-10 for contact with intact skin (<24 hours).	Cytotoxicity, Irritation, and Sensitization tests conducted. The type and scope of tests comply with ISO 10993-1:2009 specifications.
Electrical Safety	Complies with IEC 60601-1, IEC 60601-2:2014, and IEC 60601-1-11.	The system complies with IEC 60601-1. Justification for meeting EN 60601-1 was provided. IEC 60601-2:2014 (EMC) and IEC 60601-1-11 were tested as well.
Software Verification & Validation	Complies with FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" for "minor" level of concern.	Software verification and validation testing were conducted, and documentation was provided. The software was considered a "minor" level of concern.
Usability	Complies with IEC 60601-1-6 / IEC 62366.	Usability Test Protocol IEC 60601-1-6 / IEC 62366 was followed.
Mechanical & Acoustic Testing	Complies with IEC 60601-1-11 and IEC 60068-2-27 (Shock test), and IEC 60601-1-11 and IEC 60068-2-64 (Vibration test).	Shock and vibration tests were performed according to the specified IEC standards.
Pressure Distribution Comparison	Pressure distribution is comparable to the predicate device, ensuring similar safety and effectiveness.	An Expert Report by Berlin Cert GmbH concluded that there are a few differences but both products show a similar compression pressure curve in longitudinal direction. This indicates similar technological characteristics, safety, and effectiveness.
Overall Safety & Efficacy	Substantially equivalent to the predicate device.	The SLK VariLymph 12 Pro was found to have a safety and effectiveness profile similar to the predicate device. The device performs comparably to the predicate for the same intended use.

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

The document describes non-clinical performance data and a comparison to a predicate device. There is no mention of a "test set" in the context of patient data or clinical trials for the SLK VariLymph 12 Pro. The primary "test" to show equivalence was a "Pressure distribution Comparison Test."

Sample Size for Pressure Distribution Test: Not explicitly stated as a number of devices or measurements. It refers to "the test" and "pressure curves," implying a comparison of the pressure output of the SLK VariLymph 12 Pro against the Lympha Press Optimal predicate device.
Data Provenance: The "Expert Report by Berlin Cert GmbH" suggests the testing was conducted by an external German certification body. The document does not specify a country of origin for any "data" beyond this. The data is based on device performance, not patient data, so "retrospective or prospective" is not applicable in the typical clinical sense.

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

Number of Experts: One "Expert Report by Berlin Cert GmbH" is mentioned. It's unclear if this refers to a single expert or a team/committee from Berlin Cert GmbH.
Qualifications of Experts: Not explicitly stated beyond being an "Expert Report by Berlin Cert GmbH." Berlin Cert GmbH is a recognized certification body, implying their expertise in medical device testing and conformity assessment.

4. Adjudication Method for the Test Set:

Not applicable. The "Pressure distribution Comparison Test" involved comparing technical pressure curves, not expert adjudication of clinical outcomes or images.

5. 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:

Not applicable. This device is a compressible limb sleeve, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. The device is a physical therapeutic device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance comparison was the performance characteristics (specifically pressure distribution) of the legally marketed predicate device (Lympha Press Optimal Model 1201AP). The SLK VariLymph 12 Pro's pressure curves were compared to those of the predicate.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of an algorithm or AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 19, 2020

SLK Medical GmbH Matthew Reid Product Manager Oberste-Wilms-Str. 15a Dortmund, 44309 De

Re: K193476

Trade/Device Name: SLK VariLymph 12 Pro Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 25, 2019 Received: December 16, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular 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) K193476

Device Name SLK VariLymph 12 Pro (SLK V12 Pro)

Indications for Use (Describe) Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for SLK Medical. The logo features the letters "SLK" in large, bold, dark blue font with a red outline. Below the letters, the word "medical" is written in a smaller, red, sans-serif font. The logo has a clean and professional design.

Medical Gmb Lindenhorster Straße 38-40 44147 Dortmund Tel. 0800 - 755 00-55 Fax 0800 - 755 00-66

March, 05th 2020

www.slk-medical.de

510(k) Summary

l. SUBMITTER
SLK Medical GmbH

Lindenhorster Str. 38-40

44147 Dortmund, Germany

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

Official Contact: Matthew Reid – Product Manager

Tel: +49 163 7550203

II. DEVICE
Name of Device: SLK VariLymph 12 Pro

Common / Usual Name: SLK V12 Pro

Classification Code: CFR Classification section 870.5800 Compression limb sleeve

Product code: JOW

Classification: Class II medical Device

III. PREDICATE DEVICE

The SLK VaryLymph 12 Pro Compression Therapy Device is substantially equivalent to the following predicate device:

LYMPHA PRESS OPTIMAL MODEL 1201AP COMPRESSIBLE LIMB SLEEVE DEVICE, K082149

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Image /page/4/Picture/0 description: The image shows the logo for SLK Medical GmbH. The logo features the letters "SLK" in a stylized, bold font, with the word "medical" written in a smaller font underneath. Below the logo is the company's address: Lindenhorster Straße 38-40, 44147 Dortmund.

www.slk-medical.de

Tel. 0800 - 755 00 - 55 Fax 0800 - 755 00-66

IV. DEVICE DESCRIPTION

The user interface on the SLK VariLymph 12 Pro is a Membrane Keypad with dome switches. The settings are shown on a 3,2" LCD Screen.

The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

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Image /page/5/Picture/0 description: The image shows the logo and contact information for SLK Medical GmbH. The logo features the letters "SLK" in a stylized font, with the word "medical" underneath in a smaller font. Below the logo is the company name, address (Lindenhorster Straße 38-40, 44147 Dortmund), telephone number (0800-755 00-55), and fax number (0800-755 00-66).

www.slk-medical.de

V. INDICATIONS FOR USE AND CONTRAINDICATIONS

The SLK VariLymph 12 Pro is intended for the following indications for use:

Primary lymphedema (for example, congenital lymphedema/ milroy's disease)
Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema)
Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers)
. Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

The device is intended to be used by the patient (adults=8 or older) at home, as well as by physicians at clinics or hospitals.

The SLK VariLymph 12 Pro should not be used in the following cases:

-Recent myocardial infarct
-Cardiac and renal caused edema
-Acute erysipelas
-Acute soft-part-trauma of extremities
-Occlusive processes in the lymphatic drainage area
-Extensive thrombophlebitis, thrombosis or suspected thrombosis
-Pulmonary edema
-Decompensated cardiac insufficiency
Severe unestablished hypertension -
neuropathy

These indications and contraindications are identical to the predicate.

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Image /page/6/Picture/0 description: The image shows the logo and contact information for SLK Medical GmbH. The logo features the letters "SLK" in a bold, blue font above the word "medical" in a smaller, red font. Below the logo is the company name, address (Lindenhorster Straße 38-40, 44147 Dortmund), telephone number (0800-755 00-55), and fax number (0800-755 00-66).

www.slk-medical.de

VI. 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 trouser garment), which conducts a sequential compression of the patient's limbs
The following technological differences exist between the subject and the predicate devices:
-While Varilymph 12 Pro uses a turning dial to set the predicate uses push buttons for this function

VII. PERFORMANCE DATA

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 SLK VariLymph 12 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

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Image /page/7/Picture/0 description: The image shows the logo for SLK Medical. The logo is in blue and red, with the letters "SLK" in large, bold font. The word "medical" is written in smaller letters below the letters "SLK". There is a registered trademark symbol to the right of the letter "K".

SLK Medical Gmb Lindenhorster Straße 38-40 44147 Dortmund Tel. 0800 - 755 00-55 Fax 0800 - 755 00-66

www.slk-medical.de

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 an epicutan 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 SLK VariLymph 12Pro. 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.

IEC 60601-2:2014 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." The software was considered "minor" level of concern, since all answers to the questions in Table 1 and 2 in the Guidance are no.

Usability

Usability Test Protocol IEC 60601-1-6 / IEC 62366

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Mechanical and acoustic testing

Shock test according to IEC 60601-1-11 and IEC 60068-2-27 Vibration test according to IEC 60601-1-11and IEC 60068-2-64

*all test reports provided by SLK Prüf- und Zertifizierungs GmbH follow the IECEE CB scheme - IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components

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Image /page/9/Picture/0 description: The image shows the logo for SLK. The logo is in a stylized font, with the letters "SLK" in a dark blue color with a red outline. The letters are large and bold, and they are slightly overlapping each other. The registered trademark symbol is in the bottom right corner of the logo.

SLK Medical GmbH Lindenhorster Stra5e 38-40 44 147 Dortmund Tel. 0800 - 755 00-55 Fax 0800 - 755 00-66

www.slk medical.de

Animal Study

Anyknowledge to be gained from testing with this product would not justify the unnecessarily high level of harm to experimental animalsinvolved.

Pressure distribution Comparison Test

The purpose of the test was to find out if the SLK VariLymph 12 Pro has a pressure distribution comparable to that of the predicate (Lympha Press Optimal of Mego Afek) to ensure that the device is as safe and effective as a legally market device.

Summary: Based on the Expert Report by Berlin Cert GmbHit can beconcluded 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 SLK VariLymph 12 Pro was found to have a safety and effectiveness profile that is similar to the predicate device.

VIII. CONCLUSION

Since the predicate device was cleared based in part on the results of clinical studies, performance data was required to support substantial equivalence. The conclusion drawn from the above Performance Testing and comparison topredicate device is that the SLK VariLymph 12 Procompression therapy device 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 SLK VariLymph 12 Prodevice should perform as intended in the specified use conditions. The clinical data demonstrate that the SLK VariLymph 12 Pro device performs comparably to the predicate device that is currently marketed for the same intended use (treatment of venous and lymphatic disorders and dysfunction of the muscle pump). The device uses sequential inflation and deflation of cells within compression sleeves put around a limb. Inflation/Deflation, pressures, pressure distribution andsequences are similar to those of the predicate device.

Sincerely,

Martin Herberg
Chief Executive Manager

SLK Medical GmbH

SLK Medical GmbH Sitz der Gesellschaft: Dortmund Amtsgericht Dortmund HRB 26 223

Geschaftsfiihrer: Oliver Otte, Marhn Herberg U5t. ID-Nummer: DE 81390633Q Steuer-Nr. 317/5979/1865

VR-Bank Westmunsterland eG BLZ 428 613 87 Konto-Nr. 64B 816 600 IBAN: DE23 4286 1387 0648 8166 DO SWIFT: GENODEM1BOB

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).