(148 days)
No
The document describes software modifications for Bluetooth communication and collecting/reprocessing data to calculate a "Patient's Activity Index" (number of steps). It does not mention any AI or ML algorithms for data analysis, decision-making, or pattern recognition beyond simple data collection and calculation. The software is classified as "Moderate" level of concern, which is less likely to involve complex AI/ML.
Yes
The device is used to prevent, diminish, treat, or enhance various medical conditions such as DVT, post-operative pain, venous stasis, and chronic venous insufficiency, which are all therapeutic purposes.
No
The device is described as an intermittent pneumatic compression device (IPCD) used to treat or enhance blood flow velocity and prevent conditions like DVT. While it can detect "hemodynamic changes in venous blood flow" and collect data on "Patient's Activity Index," its primary purpose is therapeutic (providing external compression, treating venous stasis, reducing edema, etc.), not diagnostic. The detection of changes and data collection appear to be for monitoring or adjusting treatment, rather than for diagnosing a condition.
No
The device description explicitly states it is a portable, ambulatory, sequential, intermittent pneumatic compression device (IPCD) and includes a rechargeable battery powered option and a hardware Bluetooth Module. This indicates it is a physical device with hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ActiveCare+SFT® and ActiveCare+DTx® Systems are external compression devices. They apply pressure to the limbs to enhance blood flow.
- Intended Use: The intended uses listed are all related to physical treatment and prevention of conditions like DVT, swelling, and venous insufficiency by mechanically influencing blood circulation.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It interacts with the patient's body externally.
The device description and intended use clearly indicate that this is a therapeutic device that provides external physical intervention, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for 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.
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed by health care professionals. Intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.
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)
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
- 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.
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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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: +972 (4) 6266630 Fax: +972 (4) 6266640 E-mail: mcs@mcsmed.com
Contact Person:
Orly Maor Company Regulatory Consultant 25 Sirkin Street Kfar Saba 44421, Israel Office; +972-9-745360 Cell: +972-52-8901368 Fax: +972-153-9-7453607 oram.ma@gmail.com
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:
-
- The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
-
- 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").
-
- 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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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.