The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by so doing, 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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the SACS PRO device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria for software or algorithm performance. The "Performance Data" section addresses non-clinical validation of physical and electrical safety, software validation, and durability, but does not include a study design or results demonstrating the stated indications for use (e.g., temporary relief of minor muscle aches, temporary increase in circulation).

Therefore, I cannot extract specific information regarding acceptance criteria, test set sample sizes, expert ground truth establishment, or human reader effectiveness from this document as it is not a study report for the device's therapeutic efficacy or an AI/ML algorithm's diagnostic performance.

However, I can extract information related to the software validation process described in the document, which implicitly means the software met its specified requirements.

Here's a breakdown of what can be extracted and what cannot:

Information Present in the Document:

Software Validation: "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)]."
Device Performance Attributes (General Statement): "...have shown that the SACS PRO device has performance characteristics consistent with the predefined requirements for the devices' intended and indications for use."
Data Provenance (Implied): The non-clinical testing was conducted for the secondary predicate device (ElastiMed SACS, K232300), which is "entirely identical in design and physical form" to the subject device (SACS PRO). The document states, "all performance data as provided for the approval of the secondary predicate device are applicable for the subject device." This suggests the data is from prior validation, likely retrospective in relation to this 510(k) submission for the SACS PRO. The country of origin of the data is not specified, but the applicant (ElastiMed Ltd.) is based in Israel.
Sample Size for Training Set: Not applicable/not provided. This device is not described as having a machine learning component that would require a "training set" in the typical sense of AI/ML. The "software validation" refers to traditional software engineering validation, not AI model training.
How Ground Truth for Training Set was Established: Not applicable/not provided for the same reason as above.
Type of Ground Truth Used: Not applicable/not provided related to human physiology or clinical outcomes. The "ground truth" for the software validation would be its adherence to specified functional and safety requirements, tested against the design specifications.

Information NOT Present in the Document:

A table of specific "acceptance criteria" and "reported device performance" for its therapeutic indications. The table provided is for "Testing" (types of tests conducted), not performance metrics for muscle ache relief or circulation increase.
Specific "sample sizes" for a clinical or performance test set related to the device's therapeutic efficacy. The non-clinical tests mentioned (electrical safety, EMC, mechanical, functional, durability) would have their own sample sizes (e.g., number of devices tested), but these are not detailed in this summary.
"Number of experts used to establish the ground truth" or their qualifications. This would be relevant for devices that rely on expert interpretation (e.g., imaging devices), which this is not.
Adjudication method for a test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human readers improved with AI assistance. This is not an AI-assisted diagnostic or therapeutic device.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (e.g., pathology, outcomes data) for clinical efficacy.

Given the nature of the device (Powered Inflatable Tube Massager) and the document provided, the "acceptance criteria" and "study" are focused on safety and functional performance as a medical device, rather than the performance of an AI/ML algorithm or a comparative clinical efficacy study.

Here's the closest one can get to answering your request based only on the provided text, focusing on the software validation aspect.

Device: SACS PRO (Powered Inflatable Tube Massager)

Acceptance Criteria (related to software and overall device function)	Reported Device Performance (Summary Statement)
Compliance with ANSI AAMI IEC 60601-1-2:2014 (EMC)	All pass/fail criteria met
Compliance with ANSI AAMI ES60601-1:2005 (Electrical Safety)	All pass/fail criteria met
Compliance with FDA's Content of Premarket Submissions for Device Software Functions (June 14, 2023)	Software validation was conducted per guidance
Compliance with ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software)	Software validation was conducted per standard
Performance characteristics consistent with intended use and indications	Device met all performance requirements
Device safety and performance after simulated distribution and aging	Validated
Withstand mechanical force during simulated use and extreme stress	Tested to withstand mechanical force
System-level verification testing of device performance with usability validation	Conducted (Functional Evaluation)
System-level functional testing after expected use life conditioning	Conducted (Device Durability)

Study Details (as inferable from the document):

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of units for electrical safety, durability, mechanical).
- Data Provenance: The data is retrospective relative to this specific 510(k) submission for the SACS PRO, as it was conducted for the "identical secondary predicate device" (ElastiMed SACS, K232300). The country of origin of the data is not specified, but the manufacturer is based in Israel.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of device and the validation described do not typically involve human experts establishing "ground truth" for performance. Ground truth for safety and performance testing would refer to engineering specifications and regulatory standards.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an imaging device or an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "software validation" performed is essentially a standalone (algorithm/software only) validation against its requirements and relevant standards.
The type of ground truth used: For software and non-clinical performance, the ground truth is defined by:
- Compliance with specific engineering design specifications of the device.
- Compliance with international and national standards (e.g., IEC 60601-1-2, ES60601-1, IEC 62304) and FDA guidance documents.
- Predefined pass/fail criteria based on the device's functions, indications, and essential performance.
The sample size for the training set: Not applicable. This device's software is validated through traditional software engineering methods, not by training a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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

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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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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.

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Intended Use / Indications for Use

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.

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	ElastiMed SACS PRO(Subject Device)	Normatec GoK221666(Primary Predicate Device)	ElastiMed SACSK232300(Secondary Predicate Device)
Intended Useand Indicationsfor Use	The ElastiMed's SACS PROdevice is a portable andlightweight device intended toprovide compression in bothsustained and intermittentsettings and by doing so, aidsin the stimulation of blood flowin the legs.The SACS PRO device isintended to temporarily relieveminor muscle aches and/orpains, and to temporarilyincrease circulation to thetreated areas. The device canbe used in Clinics, hospital,athlete training, and homeenvironments.	The Normatec Go is an airpressure massager intendedto temporarily relieve minormuscle aches and/or pains,and to temporarily increasecirculation to the treatedareas.	The ElastiMed's SACS deviceis a portable and lightweightdevice intended to providecompression in bothsustained and intermittentsettings by stimulating bloodflow in the legs.The SACS device is intendedfor:- Aid in the prevention ofDVT.- Enhance blood circulation.- Diminish post-operativepain and swelling.- Reduce wound healingtime.- Aid in the treatment andhealing of stasisdermatitis, venous stasisulcers, arterial anddiabetic leg ulcers, chronicvenous insufficiency,chronic lymphedema, andreduction of edema in thelower limbs.- As a prophylaxis for DVTby persons expecting tobe stationary for longperiods of time.- Reduction of edemaassociated with soft tissueinjuries, such as burns,postoperative or post-immobilization edema, orligament sprains.The device can be used in thehome or clinical setting.
Intended UseEnvironment	Clinics, hospital, athletetraining, and homeenvironments.	Clinics, hospital, athletetraining, and homeenvironments	Home or clinical setting
TechnologicalCharacteristics	Portable device that wrapsaround the lower limb and canbe used on one or both legs	Portable device that wrapsaround the lower limb and canbe used on one or both legs	Portable device that wrapsaround the lower limb and canbe used on one or both legs
	ElastiMed SACS PRO(Subject Device)	Normatec GoK221666(Primary Predicate Device)	ElastiMed SACSK232300(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 (<1kg)	1.2 lbs	lightweight (<1kg)
Power Source	3 AA 1.2V NIMH rechargeable batteries	Integrated rechargeable battery	3 AA 1.2V NIMH rechargeable batteries
Safety Features	LED / Buzzer indicators for battery status and general user interface indications	LED / Buzzer indicators for battery status and general user interface indications	LED / Buzzer indicators for battery status and general user interface indications
Software	Validated per applicable standards and guidance documents	Validated per applicable standards and guidance documents	Validated per applicable standards and guidance documents
Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile
Opening and closing mechanism	Hooks and Loops (Velcro)	Hooks and Loops (Velcro)	Hooks and Loops (Velcro)
Operation Mode	Sustained and intermittent	Sequential Gradient, Peristaltic and Pulsing	Sustained and intermittent
Pressure	Up to 40mmHg	40 mmHg to 220 mmHg	Up to 40mmHg
Cycle Duration	30 seconds	Stays on until the user turns it off or can be set up to turn off in a range of 15 minutes to 60 minutes	30 seconds

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Performance Data

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:

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Testing	Summary
Electrical Safety andEMC	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, andessential performance.
Software Validation	Software validation was conducted per FDA's Content of Premarket Submissions forDevice Software Functions (June 14, 2023) and ANSI AAMI IEC 62304:2006/A1:2016[Including Amendment 1 (2016)].
Packaging DesignQualification(Distribution CycleSimulation)	Device safety and performance was validated after simulated distribution cycleconditioning and 6-month accelerated aging.
Mechanical Evaluation	Pristine and aged devices were tested to withstand mechanical force both perspecification during simulated use and far exceeding requirement specifications(extreme stress testing).
Functional Evaluation	System-level verification testing of device performance with usability validation wasconducted.
Device Durability	System-level functional testing after expected use life conditioning was conducted tovalidate device durability.

Conclusions

The ElastiMed SACS PRO device has the same intended and indications for use as the primary predicate device. The results of non-clinical testing (conducted for the identical secondary predicate device) demonstrates that the device met all performance requirements. Therefore, the substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).