ActiveCare Home

• K Number: K160431
• Device Name: ActiveCare Home
• Manufacturer: MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
• Date Cleared: 2016-07-13 ( 148 days)
• Product Code: JOW , REG
• Regulation Number: 870.5800
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K151377
• Predicate For: N/A

Intended Use

The ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g. total joint (hip and knee) arthroplasty. They are in the clinical setting or home environment and can be provided directly to the patient for home use.

These devices are indicated for use in:

• · Preventing Deep Vein Thrombosis (DVT)
• · Diminishing post-operative pain and swelling
• Reducing wound healing time

· Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE))

• · Treatment of venous stasis
• · Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
• · Enhancing blood circulation
• · Treatment of chronic venous insufficiency
• · Reducing edema

The ActiveCare+SFT® and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.

Device Description

The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g. total joint(hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.

The modified ActiveCare@Home is different from the cleared device in the following:

• 1. The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
• 2. Two new Software Blocks were added to its original Software, which were designed to:
  • · Establish a communication between the ActiveCare main processor and the Bluetooth module (Bluetooth Communication)
  • · Collect and reprocess data already being measured by the device in order to detect the number of the patient's steps generated during the treatment period (hereinafter referred to in this document as "Patient's Activity Index").
• 3. Three minor modifications were added to the ActiveCare@Home device GUI:
  • · Reduction of the battery icon size in order to generate space for displaying the Activity Index graph mentioned above.
  • · Displaying under the battery icon an estimation of the remained battery life time (appears only when the ActiveCare@Home device is powered by the internal battery).
  • · Adding a 2D barcode icon to the Archives screen, this will include digital information, in addition to the same data which is displayed on the LCD screen verbally - for logistic.

AI/ML Overview

This document is a 510(k) premarket notification for the ActiveCare@Home device. While it describes the device, its intended use, and a comparison to a predicate device, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K151377) and the minor modifications made to the device in this submission (K160431). The "Performance Data" section lists general categories of testing (Risk analysis, Software validation, EMC, Performance Testing) but does not provide specific acceptance criteria or detailed results from a study that would quantify device performance against those criteria.

Therefore, I cannot populate the table or answer several of your questions directly from the provided text.

Here's what I can extract and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the document.
• Reported Device Performance: Not provided with specific measurements or metrics. The document generally states "Performance data demonstrates that the modified ActiveCare@Home is as safe and effective as the cleared ActiveCare@Home" and "Performance data and software validation has been provided, establishing that the ActiveCare@Home device performs as intended and in a manner that is substantially equivalent to the predicate." However, no raw data, statistical analysis, or specific performance metrics are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Performance testing simulated use for the patient activity index, and monitoring functionalities," which suggests laboratory testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable as the primary focus seems to be on engineering performance testing (e.g., software, EMC, simulated use) rather than a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable, as it's not a study involving human reader interpretation.

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

• No, this device is a medical compression system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant.

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

• Not applicable in the context of a "standalone algorithm" as this is a physical device with embedded software. The software verification and validation are noted, but not as a "standalone algorithm performance" study in the sense of an AI model's performance on a dataset.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Given the nature of the device (pneumatic compression) and the tests mentioned (software, EMC, simulated use), the "ground truth" would likely be engineering specifications, functional requirements, and perhaps physiological measurements in simulated environments or healthy volunteers, rather than clinical outcomes or expert consensus on medical images. No specific details are provided.

8. The sample size for the training set

• Not applicable. This is a device modification submission, not a deep learning model development where a "training set" would be used in the traditional sense for AI.

9. How the ground truth for the training set was established

• Not applicable for the reason above.

Summary of what can be gleaned from the document regarding the study:

• Study Purpose: To demonstrate substantial equivalence of the modified ActiveCare@Home device to its predicate device (K151377) and to show that the minor modifications (Bluetooth, Patient Activity Index software, GUI changes) do not raise new questions of safety or effectiveness.
• Tests Performed (Types):
  • Risk analysis per ISO 14971:2012
  • Software validation and verification (software considered "Moderate" level of concern per FDA guidance)
  • Electromagnetic compatibility (EMC) per IEC 60601-1-2
  • "Performance Testing simulated use for the patient activity index, and monitoring functionalities"
• Device Context: The device is a portable, ambulatory, sequential, intermittent pneumatic compression device (IPCD) used for preventing DVT, reducing pain/swelling, enhancing blood circulation, etc. The modifications allowed for Bluetooth communication and sensing of "Patient's Activity Index" (number of steps).

To get the detailed information you are requesting, one would typically need access to the full 510(k) submission, which includes the detailed test reports and validation data. The publicly available K summary document is a high-level overview.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2016

Medical Compression Systems (DBN) Ltd. % Orly Maor Regulatory Consultant 25 Sirkin Street Kfar Saba, 44421 Israel

Re: K160431

Trade/Device Name: ActiveCare(@)Home Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 23, 2016 Received: June 1, 2016

Dear Orly Maor:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160431

Device Name ActiveCare@Home

The ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g. total joint (hip and knee) arthroplasty. They are in the clinical setting or home environment and can be provided directly to the patient for home use.

These devices are indicated for use in:

• · Preventing Deep Vein Thrombosis (DVT)
• · Diminishing post-operative pain and swelling
• Reducing wound healing time

· Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE))

• · Treatment of venous stasis
• · Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
• · Enhancing blood circulation
• · Treatment of chronic venous insufficiency
• · Reducing edema

The ActiveCare+SFT® and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.

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/0 description: The image shows the logo for Medical Compression Systems (DBN) Ltd. The logo features a green stylized "M" next to the letters "CS" in black. Below the symbols is the text "Medical Compression Systems (DBN) Ltd" in black font.

510(k) SUMMARY Medical Compression Systems (DBN)

Active Care @ Home Device

K160431

I. SUBMITTER

Medical Compression Systems (DBN) Ltd. 12 Ha'llan Street, PO Box 75, Or Akiva 30600, Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

Contact Person:

Orly Maor Company Regulatory Consultant 25 Sirkin Street Kfar Saba 44421, Israel Office; [phone] Cell: [phone] Fax: [phone] [e-mail]

Date Prepared: May 23, 2016

II. DEVICE

Device:

Name of Device: Common or Usual Name: Classification: Product Code: Regulation No .: Class: Panel:

ActiveCare@Home ActiveCare@Home Sleeve, Limb, Compressible JOW 870.5800 II Cardiovascular

III. PREDICATE DEVICE

The predicate device is the ActiveCare@Home, cleared under K151377.

IV. DEVICE DESCRIPTION

The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient

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Image /page/4/Picture/0 description: The image contains a logo for Medical Compression Systems (DBN) Ltd. The logo features a stylized green "M" next to the letters "CS" in black. Below the letters is the text "Medical Compression Systems (DBN) Ltd" in a smaller font size.

mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g. total joint(hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.

V. INDICATIONS FOR USE

The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g total joint(hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.

These devices are indicated for use in:

• Preventing Deep Vein Thrombosis (DVT) ●
• . Diminishing post-operative pain and swelling
• Reducing wound healing time
• Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) (Venous Thromboembolism (VTE))
• Treatment of venous stasis
• Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
• Enhancing blood circulation
• Treatment of chronic venous insufficiency
• Reducing edema

The ActiveCare Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.

In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow.

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Image /page/5/Picture/0 description: The image shows the logo for Medical Compression Systems (DBN) Ltd. The logo features a green, stylized "M" next to the letters "CS" in black. Below the letters is the text "Medical Compression" in a smaller font, followed by "Systems (DBN) Ltd".

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The modified ActiveCare@Home has the same intended use and indications, principles of operation, and technological characteristics as the cleared ActiveCare@Home. The minor differences do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified ActiveCare@Home is as safe and effective as the cleared ActiveCare@Home. Thus, the ActiveCare@Home is substantially equivalent to its predicate device.

The modified ActiveCare@Home is different from the cleared device in the following:

• 1. The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
• 2. Two new Software Blocks were added to its original Software, which were designed to:
  • · Establish a communication between the ActiveCare main processor and the Bluetooth module (Bluetooth Communication)
  • · Collect and reprocess data already being measured by the device in order to detect the number of the patient's steps generated during the treatment period (hereinafter referred to in this document as "Patient's Activity Index").
• 3. Three minor modifications were added to the ActiveCare@Home device GUI:
  • · Reduction of the battery icon size in order to generate space for displaying the Activity Index graph mentioned above.
  • · Displaying under the battery icon an estimation of the remained battery life time (appears only when the ActiveCare@Home device is powered by the internal battery).
  • · Adding a 2D barcode icon to the Archives screen, this will include digital information, in addition to the same data which is displayed on the LCD screen verbally - for logistic.

VII. PERFORMANCE DATA

The following tests were performed and they are the same as those submitted in the original submissions:

• Risk analysis per ISO 14971:2012 -
• Software validation

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Image /page/6/Picture/0 description: The image shows a logo for Medical Compression Systems (DBN) Ltd. The logo features a large, stylized letter 'M' in green, next to the letters 'CS' in black. Below the letters are the words "Medical Compression Systems (DBN) Ltd" in a smaller font.

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 Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. The level of concern is Moderate if a failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also "Moderate" if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Electromagnetic compatibility (EMC) -

Electromagnetic compatibility (EMC) per IEC 60601-1-2was conducted on the ActiveCare@Home device

Performance Testing -Performance testing simulated use for the patient activity index, and monitoring functionalities

VIII. CONCLUSIONS

The modified ActiveCare@Home device has the same intended use compared to the predicate device. The principal features of the device that were described show that the minor differences in device characteristics between the subject and predicate device do not raise any new questions of safety or effectiveness.

Performance data and software validation has been provided, establishing that the ActiveCare@Home device performs as intended and in a manner that is substantially equivalent to the predicate.

Therefore, the device may be found substantially equivalent.

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).