(84 days)
Not Found
No
The summary describes a device that uses sequential compression via electro-active polymer straps controlled by a microprocessor. There is no mention of AI, ML, or any related concepts like training data, test data, or complex algorithms for decision-making or pattern recognition. The control appears to be based on pre-programmed sequential actions.
Yes
The device is intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation, which are therapeutic claims.
No
The primary stated uses of the device are to provide compression to stimulate blood flow, temporarily relieve muscle aches and pains, and increase circulation. These are therapeutic functions, not diagnostic ones. The device description also focuses on its mechanical action (sequential compression), not on capabilities for detecting or analyzing medical conditions.
No
The device description explicitly details hardware components such as Electro Active Polymer (EAP) straps, a rechargeable battery, a microprocessor, a control box with a buzzer, LED light indicator, micro speaker, and a micro-USB port. This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the ElastiMed SACS PRO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing compression to stimulate blood flow, relieve muscle aches/pains, and increase circulation. These are all physical effects on the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a physical compression device using EAP straps. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The SACS PRO device is a therapeutic device that applies physical compression to the body.
N/A
Intended Use / Indications for Use
The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by doing so, aids in the stimulation of blood flow in the legs.
The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The ElastiMed SACS PRO is a lightweight, portable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression.
The SACS PRO device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in Clinics, hospital, athlete training, and home environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs, lower limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments.
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)
Non-clinical validation, including electrical safety, EMC, software validation, environmental / shipping, life cycle (durability and shelf-life), and performance testing verformance attributes, pressure delivery, geometrical attributes, and system durability, have shown that the SACS PRO device has performance characteristics consistent with the predefined requirements for the devices' intended and indications for use. Since the subject device and the secondary predicate device share identical specifications, i.e., identical device master records, all performance data as provided for the approval of the secondary predicate device are applicable for the subject device.
The following table summarizes the evaluations conducted:
Testing: Electrical Safety and EMC
Summary: EMC was tested according to ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]. Electrical Safety was tested according to ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]. All pass/fail criteria were based on the device's functions, indications, intended use, and essential performance.
Testing: Software Validation
Summary: Software validation was conducted per FDA's Content of Premarket Submissions for Device Software Functions (June 14, 2023) and ANSI AAMI IEC 62304:2006/A1:2016 [Including Amendment 1 (2016)].
Testing: Packaging Design Qualification (Distribution Cycle Simulation)
Summary: Device safety and performance was validated after simulated distribution cycle conditioning and 6-month accelerated aging.
Testing: Mechanical Evaluation
Summary: Pristine and aged devices were tested to withstand mechanical force both per specification during simulated use and far exceeding requirement specifications (extreme stress testing).
Testing: Functional Evaluation
Summary: System-level verification testing of device performance with usability validation was conducted.
Testing: Device Durability
Summary: System-level functional testing after expected use life conditioning was conducted to validate device durability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
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December 23, 2024
ElastiMed Ltd. % John J. Smith Partner Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, District of Columbia 20004
Re: K243177 Trade/Device Name: SACS PRO Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 30, 2024 Received: September 30, 2024
Dear John J. Smith:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Device Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243177
Device Name SACS PRO
Indications for Use (Describe)
The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by doing so, aids in the stimulation of blood flow in the legs.
The SACS PRO device is intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.
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) | ☑ |
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4
510(k) SUMMARY ElastiMed's SACS PRO Device
Submitter
ElastiMed Ltd.
HaKidma 7 Yokneam Ilit. 2069236 Israel Tel: +972-74-7036220 Fax: +972-74-7036218 E-mail: omer@elastimed.com
Date Prepared: December 10, 2024
Name of Device: SACS PRO
Common or Usual Name: Compression Device
Classification Name: Powered inflatable tube massager
Regulatory Class: II
Product Code: IRP
C.F.R. Section no .: 21 C.F.R. § 890.5650
Predicate Devices:
- -Primary Predicate: NormaTec Industries, LP, Normatec Go (K221666)
- -Secondary Predicate: ElastiMed Ltd., SACS , (K232300)
Device Description
The ElastiMed SACS PRO is a lightweight, portable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression.
The SACS PRO device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in Clinics, hospital, athlete training, and home environments.
5
Intended Use / Indications for Use
The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by doing so, aids in the stimulation of blood flow in the legs.
The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.
Summary of Technological Characteristics
The SACS PRO device is substantially equivalent to both listed predicate devices in that all devices use a microprocessor to provide intermittent compression to simulate muscle contractions in the return of venous flow.
Like the predicate devices, the SACS PRO device is lightweight, portable, and wraps around the lower limb. Identical to the secondary predicate device, the SACS PRO may be used on one or both legs, the wraps operate separately.
The predicates and subject devices all have the same intended use; specifically, the subject and the primary predicate (Normatec Go) have identical Over the-Counter (OTC) indications for use. Both the secondary predicate device have three discrete compression zones with similar on-body pressure and cycle times (2-3 seconds of compression, with approximately 24 seconds of rest period before the cycle repeats, i.e., 2 cycles per minute), providing sequential compression, which cannot be changed. In all devices, compression is controlled by a microprocessor-controlled system having a user interface, which in addition the system, provides battery and system information (including error notification). All compression systems are encased in soft, non-latex fabrics for patient comfort. The SACS PRO, like the secondary predicate device, is supplied with a rechargeable battery, which can be charged when not in use.
The subject device and the secondary predicate device (SACS) are entirely identical in design and physical form. The sole difference between the subject device and the secondary predicate device is the fact that the secondary predicate device is for prescription use only while the subject device (like the primary predicate device) may be supplied as an OTC device. All systems are provided non-sterile and are intended for single patient use.
6
| | ElastiMed SACS PRO
(Subject Device) | Normatec Go
K221666
(Primary Predicate Device) | ElastiMed SACS
K232300
(Secondary Predicate Device) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
and Indications
for Use | The ElastiMed's SACS PRO
device is a portable and
lightweight device intended to
provide compression in both
sustained and intermittent
settings and by doing so, aids
in the stimulation of blood flow
in the legs.
The SACS PRO device is
intended to temporarily relieve
minor muscle aches and/or
pains, and to temporarily
increase circulation to the
treated areas. The device can
be used in Clinics, hospital,
athlete training, and home
environments. | The Normatec Go is an air
pressure massager intended
to temporarily relieve minor
muscle aches and/or pains,
and to temporarily increase
circulation to the treated
areas. | The ElastiMed's SACS device
is a portable and lightweight
device intended to provide
compression in both
sustained and intermittent
settings by stimulating blood
flow in the legs.
The SACS device is intended
for:
- 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. |
| Intended Use
Environment | Clinics, hospital, athlete
training, and home
environments. | Clinics, hospital, athlete
training, and home
environments | Home or clinical setting |
| Technological
Characteristics | Portable device that wraps
around the lower limb and can
be used on one or both legs | Portable device that wraps
around the lower limb and can
be used on one or both legs | Portable device that wraps
around the lower limb and can
be used on one or both legs |
| | ElastiMed SACS PRO
(Subject Device) | Normatec Go
K221666
(Primary Predicate Device) | ElastiMed SACS
K232300
(Secondary Predicate Device) |
| Main components | Three compression / relaxation enabling straps cased within a fabric casing | Control unit mounted to inflatable segment with compressor and valve system that sequentially inflates cells | Three compression / relaxation enabling straps cased within a fabric casing |
| Weight | lightweight (