(165 days)
No
The description mentions monitoring and displaying data, and using accumulated data as a benchmark, but does not describe any adaptive or learning algorithms that would classify it as AI/ML.
Yes
The device is described as treating conditions (DVT) by stimulating blood flow. It also aids in DVT prevention and acts as prophylaxis, which are therapeutic interventions.
Yes
Explanation: The device monitors patient orientation and movement and utilizes this data to identify risk factors for hospital-acquired events like DVT and pressure ulcers, which falls under the definition of providing information to aid in diagnosis or assessment of a medical condition.
No
The device description explicitly details hardware components including a MAC Strap, MAC Charging Hub, MAC Controller (housing a rechargeable battery, DC motor, gyroscope sensor, and microprocessor), and utilizes mechanical force for compression. It is a physical device with integrated software, not a software-only device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Movement and Compressions System is a mechanical device that applies compression to the leg to stimulate blood flow. It also monitors patient orientation and movement.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely external and mechanical, with data collection related to physical movement and orientation.
- Intended Use: The intended use is to prevent DVT by enhancing blood circulation and to monitor patient activity, not to diagnose or detect a condition through the analysis of biological samples.
Therefore, the device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:
- Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
Product codes
JOW
Device Description
The Movement and Compressions System (The MAC TM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.
Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients.
The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.
The strap is available in two sizes: Standard and XL. The system may be used on one or both legs. When used on both legs, the wraps operate separately.
The MAC System also monitors and displays patient orientation and movement information (see DynaSense reference device, K130752). This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the strap and controller using Radio Frequency Identification (RFID) communication and stored between them.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower leg
Indicated Patient Age Range
adult patient population
Intended User / Care Setting
healthcare professionals
home or clinical setting.
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 performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The biocompatibility evaluation for the MAC Strap was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity testing
- Closed Patch Sensitization testing
- Primary Skin Irritation testing
Based upon this testing, The MAC Strap is considered non-cytotoxic, a non-sensitizer, and produces no dermal irritation.
Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the MAC System and Charging Hub. Testing was successfully performed according to all applicable portions of:
- IEC 60601-1-2:2014/Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2005 (3rd Edition), Corr. 1:2006, Corr. 2:2007, A1:2012 (IEC 60601-1: 2012 reprint) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical electrical equipment Part 1-11, Edition 2.0 2015-01: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6 Medical electrical equipment Part 1-6, Edition 3.1 2013-10: General requirements for basic safety and essential performance - Collateral standard: Usability
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 Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern since failures, malfunction or latent design flaws are unlikely to cause any injury to the patient or operator.
Nonclinical verification and validation of performance:
Nonclinical verification and validation of performance was also performed to establish substantial equivalence to the listed predicate device. Testing was successfully performed as follows:
- Verification of strap elasticity and shear strength
- MAC Controller and Charging Hub electrical verification
- Verification of battery pack safety and performance according to applicable standards
- Compliance with established requirements applicable to radiofrequency and radiated emissions testing
- Functionality and reliability testing
- Performance testing of the subject device and predicate device to evaluate blood flow increase over baseline. Performance testing also evaluated accuracy of mobility data and strap slippage.
- Usability testing
Key results: The MAC System has the same intended use and similar performance characteristics as the predicate devices. The results of non-clinical and usability testing demonstrates that the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2021
Recovery Force, LLC % Deborah Grayeski Sr. Project Manager M Squared Associates 127 West 30th Street. 9th Floor New York, New York 10001
Re: K203052
Trade/Device Name: Movement and Compressions System (the MAC System) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 16, 2021 Received: February 17, 2021
Dear Deborah Grayeski:
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.
1
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 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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known)
Device Name
Movement and Compressions System (The MACTM System)
Indications for Use (Describe)
The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:
- · Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
- · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| -- | ------------------------------------------------------------------------------------------ |
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(K) SUMMARY
| SUBMITTER: | Recovery Force LLC |
|---|---|
| 10022 Lantern Rd., Suite 100 | |
| Fishers, IN 46037 |
CONTACT: Deborah Lavoie Grayeski M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York NY 10001 Ph. 347-307-6951/202-550-7395 Fax. 703-562-9797 Email. dgrayeski@msquaredassociates.com
DATE PREPARED:
DEVICE:
| Proprietary Name: | Movement and Compressions System (The MAC™ System) |
|---|---|
| Common Name: | Compressible Limb Sleeve |
| Classification Name: | Compressible Limb Sleeve, 21 CFR 870.5800 |
| Regulatory Class: | Class II |
| Product Code: | JOW |
March 17, 2021
PREDICATE AND REFERENCE DEVICE:
| Primary Predicate: Medical Compression Systems (DBN) Ltd's ActiveCare DVT | |
|---|---|
| System. K140755 | |
- Reference Devices: Recovery Force RF1400 Active Compression Wrap, K162481 Centauri Medical, Inc., DynaSense System, K130752
Neither the predicate nor reference devices has been subject to a recall.
DEVICE DESCRIPTION:
The Movement and Compressions System (The MACTM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single
5
patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.
Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients.
The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.
INDICATIONS FOR USE:
The Movement and Compressions System is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs:
- Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood . circulation: and,
- As a prophylaxis for DVT by persons expecting to be stationary for long periods . of time.
During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
6
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
A comparison of the technological characteristics between The MAC System to the predicate and reference devices is presented in Table 1.
7
| Table 1. Comparison of the technological characteristics between The MAC System to the predicate and reference devices. | ||||
|---|---|---|---|---|
| Company | Recovery Force | Medical Compression Systems | Recovery Force | Centauri Medical, Inc. |
| Device | The MAC System | |||
| (Subject Device) | ActiveCare DVT System | |||
| (Primary Predicate) | Recovery Force RF1400 Active | |||
| Compression Wrap | ||||
| (Reference Device) | DynaSense System | |||
| (Reference Device) | ||||
| 510(k) Number | TBD | K140755 | K162481 | K130752 |
| Classification | ||||
| Regulation | ||||
| Product Code | Class II, (21 CFR 870.5800) | |||
| Compressible Limb Sleeve | ||||
| JOW | Class II, (21 CFR 870.5800) | |||
| Compressible Limb Sleeve | ||||
| JOW | Class II, (21 CFR 870.5800) | |||
| Compressible Limb Sleeve | ||||
| JOW | Class I, (21 CFR 880.2400) | |||
| Bed-patient monitor | ||||
| KMI | ||||
| Subsequent code: KMI | ||||
| Device | ||||
| Description | The Movement and Compressions | |||
| System (The MAC™ System) is a | ||||
| prescriptive, portable, rechargeable- | ||||
| battery powered, intermittent | ||||
| compression device designed to | ||||
| stimulate blood flow in the lower | ||||
| limb. The MAC System consists of | ||||
| the MAC Strap, MAC Charging | ||||
| Hub, and MAC Controller. The | ||||
| MAC Strap is a disposable single- | ||||
| patient use strap that is wrapped | ||||
| around the patient's calf muscle. | ||||
| The MAC Controller houses a | ||||
| rechargeable battery, a small DC | ||||
| motor, a 6-axis gyroscope sensor, | ||||
| and microprocessor that is attached | ||||
| to the strap during use. The battery | ||||
| is removed from the controller for | ||||
| charging in the supplied MAC | ||||
| Charging Hub when not in use. | ||||
| Compression is applied to the calf, | ||||
| immediately below the knee, by | ||||
| intermittent application of | ||||
| mechanical force by the device | ||||
| strap. When the strap is contracted, | ||||
| compression is applied to the | The ActiveCare+DTx, | |||
| ActiveCare+SFT and ActiveCare DVT | ||||
| Systems are prescriptive, pneumatic | ||||
| compression Systems designed to | ||||
| apply sequential compression to the | ||||
| lower limb. The control units of the | ||||
| Systems provide the user with several | ||||
| treatment options: compression of the | ||||
| foot - single or double, compression of | ||||
| the calf - single or double, | ||||
| compression of the thigh - single or | ||||
| double, and combined compression of | ||||
| any combination of two sleeves. The | ||||
| foot compression program is an | ||||
| intermittent pressure pulse application | ||||
| to a single celled foot sleeve. The calf | ||||
| and thigh compression program is a | ||||
| sequential intermittent application of a | ||||
| pressure to a three-celled cuff sleeve. | The RF1400 Active Compression | |||
| Wrap is a lightweight, portable, | ||||
| rechargeable battery powered, | ||||
| prescriptive device that helps | ||||
| stimulate blood flow in the lower limb | ||||
| through the use of intermittent | ||||
| sequential compression. The wrap | ||||
| contains nickel titanium, martensite to | ||||
| austenite phase change wires, using a | ||||
| battery-powered microprocessor to | ||||
| "excite" and "relax" the wires | ||||
| resulting in compression. The battery | ||||
| and microprocessor components are | ||||
| protectively housed in a plastic | ||||
| controller case that is permanently | ||||
| attached to the wrap. A single, touch | ||||
| control button interface and a RGB | ||||
| LED light indicator provide the user | ||||
| interface, and there is a port for | ||||
| connecting the battery charger plug. | ||||
| The wrap is available in a wide range | ||||
| of sizes XS, S, M, and L, to | ||||
| accommodate varying anatomy sizes. | ||||
| The wrap is divided into three discrete | ||||
| zones which are externally applied to | ||||
| the limb. After one zone is fully | DynaSense is a patient monitoring | |||
| system that has been designed for | ||||
| use in hospitals, nursing homes, or | ||||
| other patient care facilities to aid | ||||
| standard care procedures for | ||||
| patients who are susceptible to | ||||
| pressure ulcers. The system | ||||
| monitors and reports patient | ||||
| activity and orientation as well as | ||||
| alerts the user (i.e., healthcare | ||||
| provider) when activity levels | ||||
| deviate from parameters set by | ||||
| healthcare providers. DynaSense is | ||||
| comprised of Patient Sensors, Relay | ||||
| Antennas, a USB RE Transceiver, | ||||
| Mesh Network Server Software, | ||||
| and User Interface software. Each | ||||
| Patient Sensor is associated with a | ||||
| single patient, such that the patient's | ||||
| orientation and activity can be | ||||
| monitored. Data collected by the | ||||
| Patient Sensor is automatically | ||||
| communicated wirelessly to a | ||||
| nearby Relay Antenna, which | ||||
| subsequently relays these data to be | ||||
| displayed on the User Interface and | ||||
| maintained in a database. The |
8
| patient's calf muscle. When the | activated for a period of time and turns | system's Relay Antennas that are |
|---|---|---|
| strap is retracted, compression force | off, then the next zone is activated. | plugged into electrical outlets on |
| is released from the patient's calf | This cycle continues until all three | the walls of the facility and the |
| muscle. | zones have activated and turned off. | USB RIF Transceiver that is |
| Then the sequence is repeated after a | plugged into the computer, on | |
| Since mechanical force is used to | short delay. This cycle repeats until | which the Mesh Network Server |
| provide intermittent compression, | the unit is turned off. The wrap may | Software is installed or accessed, |
| the system does not require a | be used on one or both legs. When | form a wireless network that allows |
| powered air supply, so the risk of | used on both legs, the wraps operate | data to be transmitted for display. |
| aerosolization of potential | separately. The wrap is supplied with | The Mesh Network Server |
| contaminants or germs is mitigated | a rechargeable battery, which can be | Software manages this network of |
| as there is no blowing air. There | charged when not in use. | Relay Antennas and USB REF |
| are no air connections or pneumatic | Transceiver and collects the data | |
| pumps to clean between patients. | from the Patient Sensors to allow | |
| monitoring of multiple patients on a | ||
| The strap is available in two sizes: | single screen within the User | |
| Standard and XL. The system may | Interface. | |
| be used on one or both legs. When | ||
| used on both legs, the wraps operate | ||
| separately. | ||
| The MAC System also monitors | ||
| and displays patient orientation and | ||
| movement information (see | ||
| DynaSense reference device, | ||
| K130752). This data is stored in a | ||
| RFID tag in the MAC Strap. When | ||
| the MAC Controller is connected to | ||
| the MAC Strap, and functioning, all | ||
| DVT prophylaxis compliance data, | ||
| orientation and movement data is | ||
| synced between the strap and | ||
| controller using Radio Frequency | ||
| Identification (RFID) | ||
| communication and stored between | ||
| them. | ||
9
| Intended Use | Lower limb compression | Lower limb compression | Lower limb compression | Monitor orientation and activity. |
|---|---|---|---|---|
| Indications for | ||||
| Use | The Movement and Compressions | |||
| System is intended to be a portable | ||||
| and wearable system, prescribed by | ||||
| healthcare professionals, to treat the | ||||
| following conditions by stimulating | ||||
| blood flow in the legs: | ||||
| • Aid in the prevention of DVT | ||||
| (deep vein thrombosis) by | ||||
| enhancing blood circulation; | ||||
| and, | ||||
| • As a prophylaxis for DVT by | ||||
| persons expecting to be | ||||
| stationary for long periods of | ||||
| time. |
During use, the system also
monitors patient orientation and
movement. It allows healthcare
providers and users to implement
individualized patient management
plans for DVT prophylaxis and
patient mobility protocols by
utilizing data accumulated by the
patient on the previous day as a
benchmark. The data displayed on
the device allows providers to
monitor the patient's orientation
and activity, which can be used to
identify risk factors for hospital-
acquired events linked to
immobility such as: deep vein
thrombosis, pressure ulcers,
pneumonia, atrophic muscles, and
delirium. | The ActiveCare DVT, ActiveCare+SFT
and ActiveCare+DTx Systems are
prescriptive devices that induce
Continuous Enhanced Circulation
Therapy of the lower limbs. The
Systems are intended for use in:
• Preventing Deep Vein Thrombosis
(DVT).
• Enhancing blood circulation.
• Diminishing post-operative pain and
swelling.
• Reducing wound-healing time.
• Treatment and assistance in healing:
stasis dermatitis; venous stasis
ulcers; arterial and diabetic leg
ulcers.
• Treatment of chronic venous
insufficiency.
• Reducing edema. | Intended to be a portable and wearable
system, prescribed by healthcare
professionals, to treat the following
conditions by stimulating blood flow
in the lower limbs:
• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and
swelling;
• Reduce wound healing time;
• Aid in the treatment and healing of:
stasis dermatitis, venous stasis
ulcers, arterial and diabetic leg
ulcers, chronic venous
insufficiency, chronic lymphedema,
and reduction of edema in the lower
limbs;
• As a prophylaxis for DVT by
persons expecting to be stationary
for long periods of time.
• Reduction of edema associated with
soft tissue injuries, such as burns,
postoperative or post-
immobilization edema, or ligament
sprains.
The device can be used in the home or
clinical setting. The device is
intended for use in an adult patient
population. | DynaSense monitors orientation
and activity of patients susceptible
to pressure ulcers. It allows
healthcare providers to implement
individualized turn management
plans and continuously monitor
each patient. DynaSense provides
alerts when patient orientation or
activity deviates from parameters
set by healthcare providers. The
device is intended for use in
medical, nursing and long-term care
facilities including independent
living, assisted living and
rehabilitation facilities. |
| Target
Population/
Where used | The device can be used in the home
or clinical setting. The device is
intended for use in an adult patient
population. | Home or clinical setting. | Home or clinical setting. | Medical, nursing and long-term
care facilities including
independent living, assisted living |
| | Home or clinical setting. | Home or clinical setting. | Home or clinical setting. | |
| Anatomical Site | Lower leg | Lower leg | Lower leg | Sensor attaches to patient's
sternum. |
| Principle of
Operation | Intermittent compression via DC
motor strap tightening.
Patient orientation and movement
monitored using a 6-axis gyroscope
sensor/step counter. | Sequential, intermittent, pneumatic
compression | Nickel titanium, martensite to
austenite phase change wires, resulting
in compression. | Patient orientation and activity
monitored using a patient sensor. |
| Weight | 11 oz | 1.65 lb | 1.00 lb | Unknown |
| Dimension | 6 H (at largest part) x 22.25 L
(Standard size), 0.3 thick
(Excluding Controller) inches. | 5.3 x 5.3 x 2.4 inches | 9 H x 20 L (Small size), 0.3 thick
(excluding controller) inches | Sensor 1.8" x 2.0" |
| Cycle Time | 60 seconds consisting of the
following sequence:
• Compression for ≤1 second
• Hold for 1 second
• Compression release for ≤ 2
seconds
• No compressions for ~ 56
seconds | 30 seconds consisting of the
following sequence:
• Bottom Zone inflation for 2-3
seconds
• Middle Zone inflation for 2-3
seconds
• Top Zone inflation for 2-3
seconds
Cuff deflates to a total cycle time of 30
seconds, then cycle restarts. | 30 seconds consisting of the
following sequence:
• Bottom Zone compression for
2 seconds
• Middle Zone compression for
2 seconds
• Top Zone compression for 2
seconds
• No compressions for 24
seconds | N/A, this device is solely
referenced for its use in
monitoring patient orientation
and activity. |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible |
| Bilateral
treatment
option | Yes | Yes | Yes | N/A, this device is solely
referenced for its use in monitoring
patient orientation and activity. |
10
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| Single Patient
Use | Yes (Controller and Charging Hub
that only have transient contact with
the patient are reusable) | Yes | Yes | Yes (sensor that adheres to the
patient is single use, while other
components for transmitting and
displaying the information are
reusable) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Power
Requirements
(Battery Spec's) | 3.6V; 2.9Ah; 10.44Wh Li-Ion
18650 single cell rechargeable
battery pack | 7.2 V; 1.8Ah; 12.96Wh Ni-MH battery
6 cell rechargeable battery pack | 14.4V; 2.0Ah; 28.8Wh Li-Ion 18650
four-cell rechargeable battery pack | Unknown |
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The differences between the MAC System and the predicate device does not affect the intended use and does not raise new questions of safety and effectiveness. The MAC System is equivalent to the listed predicate device in that they both use a microprocessor to provide intermittent compression to simulate muscle contractions in the lower limbs aiding the return of venous flow. Intermittent compression is the technological principle for both the subject and predicate/reference devices. Both devices have a user interface, which in addition to controlling the system, provides battery and system information (including error notification). All compression systems are encased in soft, non-latex fabrics for patient comfort and biocompatibility. All systems are prescription only and provided non-sterile. The MAC System is supplied with a rechargeable battery, which can be charged when not in use, whereas the predicate devices use a rechargeable battery or utilize a power source that must be plugged into a wall outlet. Both devices are lightweight, portable and wrap around the lower limb. Like the reference device, the MAC System can be used on one or both legs. When used on both legs, the wraps operate separately.
In addition to compression, the MAC System also monitors and reports patient orientation and movement. While the primary predicate does not provide this functionality, there are other devices that include similar functionality. Table 2 provides a comparison of the characteristics between the MAC System and the DynaSense System.
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| | Recovery Force
The MAC System | Centauri Medical, Inc.
DynaSense System
(Reference Device)
K130752, Class I device | Remarks |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Clinical Application | Sensor is located in the
MAC Controller that is
attached to the disposable
MAC Strap which is
wrapped around the
patient's lower leg. | Non-invasive adherence to
patient's skin | Similar to Reference
Device: both
sensors are placed
non-invasively, near
the surface of the
patient's skin. |
| Principle of
Operation | A gyroscope monitors
patient orientation
(horizontal versus
vertical) and movement
(steps). | Patient sensor that monitors
patient orientation and
movements (based upon
publicly available
information). | Similar to Reference
Device: both
devices monitor
patient orientation
and movement. |
| Device Output | Monitors and reports
body orientation and
movement. This
information is displayed
on a User Interface. | Monitors and reports body
orientation and movement.
This information is
communicated wirelessly
through an antenna, saved
on a server and displayed on
a User Interface. | Similar to reference
device: both
devices display the
information on a
user interface. |
Table 2. Technological comparison to bed-patient monitor reference device.
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the MAC Strap was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity testing ●
- Closed Patch Sensitization testing ●
- Primary Skin Irritation testing ●
Based upon this testing, The MAC Strap is considered non-cytotoxic, a non-sensitizer, and produces no dermal irritation.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the MAC System and Charging Hub. Testing was successfully performed according to all applicable portions of:
- . IEC 60601-1-2:2014/Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral
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Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2005 (3rd Edition), Corr. 1:2006, Corr. 2:2007, A1:2012 (IEC . 60601-1: 2012 reprint) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical electrical equipment Part 1-11, Edition 2.0 2015-01: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6 Medical electrical equipment Part 1-6, Edition 3.1 2013-10: ● General requirements for basic safety and essential performance - Collateral standard: Usability
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 Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern since failures, malfunction or latent design flaws are unlikely to cause any injury to the patient or operator.
Performance Testing
Nonclinical verification and validation of performance was also performed to establish substantial equivalence to the listed predicate device. Testing was successfully performed as follows:
- Verification of strap elasticity and shear strength
- MAC Controller and Charging Hub electrical verification
- Verification of battery pack safety and performance according to applicable standards
- Compliance with established requirements applicable to radiofrequency and radiated emissions testing
- Functionality and reliability testing
- Performance testing of the subject device and predicate device to evaluate blood ● flow increase over baseline. Performance testing also evaluated accuracy of mobility data and strap slippage.
- Usability testing
CONCLUSION
The MAC System has the same intended use and similar performance characteristics as the predicate devices. The results of non-clinical and usability testing demonstrates that
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the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.