The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Device Description

The Normatec Elite is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for:

Starting and stopping the massage treatment; .
. Adjusting time and intensity (pressure) of the treatment;
Selection of the zone to boost the pressure .

In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called Normatec Elite. The document details the device's characteristics and compares it to a predicate device (Normatec 3). However, it does not contain the specific acceptance criteria or the full study details to prove the device meets these criteria in the way you've requested.

The document states:

"Performance testing demonstrated that the proposed device met its acceptance criteria." (Page 11)
"Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria." (Page 11)

Despite these statements, the document does not explicitly list the quantitative acceptance criteria for performance (e.g., specific pressure ranges, circulation increase percentages, muscle ache relief metrics) nor does it provide a detailed study that proves these criteria were met. It mentions "Testing of all controls," "Testing of all indicators," "Testing of battery state indicators," "Testing of performance," and "Testing of hazard mitigations" as types of bench testing performed, but no specific results or methodologies are shared.

Therefore, for your request, I can only provide the information that is present in the document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided: The document states that performance testing met acceptance criteria, but it does not list the specific quantitative acceptance criteria or the reported device performance details (e.g., what specific values were achieved for pressure, time, etc., against defined thresholds). It only broadly mentions general areas of testing.

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

Cannot be provided: The document mentions "Performance testing" and "Bench testing" but does not specify any sample sizes for a test set or the provenance of any data used for testing (e.g., patient data, country of origin, retrospective or prospective). This device is a massager, and the testing described appears to be bench testing for device functionality rather than clinical studies on human subjects with specific sample sizes.

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

Cannot be provided: This information is not present. The document focuses on the engineering and regulatory comparison of the device to a predicate, not on a study involving human experts establishing ground truth for a diagnostic or interpretive task.

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

Cannot be provided: This information is not present in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided: This information is not present. The device is a powered inflatable tube massager, not a diagnostic imaging device typically requiring MRMC studies. There is no mention of AI assistance in relation to human readers.

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

Cannot be provided: While the device uses a "Microprocessor" and "Bluetooth communication ability" to control inflation sequences, the document does not describe "standalone algorithm performance" in the context of diagnostic AI or a human-in-the-loop comparison. The "performance testing" mentioned is for the device's operational functionality (controls, indicators, battery, hazard mitigations).

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

Cannot be provided: The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable to the descriptions of testing in this document. The testing described is functional verification against pre-defined engineering and safety specifications, not "ground truth" derived from clinical outcomes or expert labels.

8. The sample size for the training set

Cannot be provided: The document does not describe any machine learning/AI models that would require a "training set" in the conventional sense. The "Microprocessor Control" mentioned refers to the device's embedded firmware, not a trainable AI model with a distinct training set.

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

Cannot be provided: As no training set is described, this information is not applicable.

Summary

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March 21, 2024

NormaTec Industries, LP % Matt Dryden Director ProMedic. LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K240122

Trade/Device Name: Normatec Elite Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: March 18, 2024 Received: March 18, 2024

Dear Matt Dryden:

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 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"

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(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 OS 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.

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 mediation-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.

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Expiration Date: 07/31/2026 See PRA Statement below.

Form Approved: OMB No. 0910-0120

Submission Number (if known)

K240122

Device Name

Normatec Elite

Indications for Use (Describe)

The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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NormaTec Industries, LP

Date of Preparation:	January 15, 2024
480 Pleasant StreetSuite A200Watertown MA 02472	Tel - 800.355.0960Fax - 866.279.2579
Official Contact:	Steve Henderson, Director of Quality & Regulatory Systems
Proprietary or TradeName:	Normatec Elite
Proposed Device:	Normatec Elite
Common/Usual Name:	Massager, Powered Inflatable Tube
Classification Name	Powered inflatable tube massager
Regulation Number:	21 CFR 890.5650
Product Code:	IRP
Regulation MedicalSpeciality:	Physical Medicine
Predicate Device:	K220217 – Normatec 3
Reference Device:	K221666 – Normatec Go
Classification Name	Powered inflatable tube massager
Common/Usual Name	Massager, Powered Inflatable Tube
Regulation Number:	21 CFR 890.5650
Product Code	IRP
Regulation MedicalSpeciality:	Physical Medicine

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Device Description

The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for:

Starting and stopping the massage treatment; .
. Adjusting time and intensity (pressure) of the treatment;
Selection of the zone to boost the pressure .

Intended User

OTC

Patient Population

Adults

Indications for Use

The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

Intended Use Environment:

Clinics, hospital, athlete training, and home environments.

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510(k) Summary Page 3 of 9

Table 1 – Table of Device Comparisons and Differences

	Proposed DeviceNormatec Elite	Predicate DeviceNormatec 3 – K220217	Reference DeviceNormatec Go – K221666	Comment
Manufacturer	NormaTec Industries, LP	NormaTec Industries, LP	NormaTec Industries, LP
Prescriptive	OTC	OTC	OTC	Identical
Indications for use	The Normatec Elite is an airpressure massager intended totemporarily relieve minor muscleaches and/or pains, and totemporarily increase circulation tothe treated areas.	The Normatec 3 is an airpressure massager intended totemporarily relieve minormuscle aches and/or pains, andto temporarily increasecirculation to the treated areas.	The Normatec Go is an airpressure massager intended totemporarily relieve minormuscle aches and/or pains, andto temporarily increasecirculation to the treated areas.	Identical
AnatomicalCoverage	Control unit mounted to inflatablesegment with integral hoses.Image: Normatec Elite device	Control unit connected toinflatable segments via a hose.Image: Normatec 3 device	Control unit mounted toinflatable segment with integralhoses.Image: Normatec Go device	The proposed device has a smallercontrol unit version of predicatedevice, which eliminates the hoseand mounting the control unitdirectly on the inflatable patientpart.The reference device is includedonly to demonstrate that FDA haspreviously cleared a NormaTecdevice with a similar control unitmounted directly to the deviceitself.
Intended UseEnvironment	Clinics, hospital, athlete training,and home environments	Clinics, hospital, athlete training,and home environments	Clinics, hospital, athlete training,and home environments	Identical
	Proposed DeviceNormatec Elite	Predicate DeviceNormatec 3 - K220217	Reference DeviceNormatec Go – K221666	Comment
Power Source(s)	12 VDC via an IEC 60601-1compliant power supply (100-240 VAC input)Integrated rechargeable battery	15 VDC via an IEC 60601-1compliant power supply (100-240 VAC input)Integrated rechargeable battery	Charging via 5 VDCcompliant power supply (100-240 VAC input)Powered by integratedrechargeable battery	SimilarNormatec Elite and Normatec 3are operational when plugged intothe power supply, though Elite hasa different power supply.
Software /FirmwareMicro-processorControl	Microprocessor	Microprocessor	Microprocessor	Identical
Technology	Compressor and valve system thatsequentially inflates cells.Bluetooth communication ability.	Compressor and valve systemthat sequentially inflates cells.Bluetooth communicationability.	Compressor and valve systemthat sequentially inflates cells.Bluetooth communicationability.	Identical
Device Pressurerange	0 - 110 mm Hg	0 - 110 mm Hg	0 – 220 mm Hg	Identical
Pressure Levels	Level 1: 40 mm HgLevel 2: 50 - 60 mm HgLevel 3: 60 - 70 mm HgLevel 4: 70 - 80 mm HgLevel 5: 80 mm HgLevel 6: 80 - 90 mm HgLevel 7: 100 mm Hg	Level 1: 40 mm HgLevel 2: 50 - 60 mm HgLevel 3: 60 - 70 mm HgLevel 4: 70 - 80 mm HgLevel 5: 80 mm HgLevel 6: 80 - 90 mm HgLevel 7: 100 mm Hg	Level 1: 40 - 70 mm HgLevel 2: 60 - 90 mm HgLevel 3: 80 - 110 mm HgLevel 4: 100 - 140 mm HgLevel 5: 130 - 170 mm HgLevel 6: 150 - 200 mm HgLevel 7: 180 - 220 mm Hg	Identical
Treatment Time	Stays on until the user turns it offor can be set up to turn off in arange of 15 minutes to 60 minutes	Stays on until the user turns itoff or can be set up to turn off ina range of 15 minutes to 60minutes	Stays on until the user turns itoff or can be set up to turn off ina range of 15 minutes to 60minutes	Identical
	Proposed DeviceNormatec Elite	Predicate DeviceNormatec 3 – K220217	Reference DeviceNormatec Go – K221666	Comment
Inflation/DeflationCycle Type	Sequential Gradient, Peristalticand Pulsing	Sequential Gradient, Peristalticand Pulsing	Sequential Gradient, Peristalticand Pulsing	Identical
Contact SurfaceMaterial	200 denier nylon with apolyurethane laminate/extrusion	200 denier nylon with apolyurethane laminate/extrusion	200 denier nylon with apolyurethane laminate/extrusion	Identical
Number ofInflatable segments	5 segments for leg attachment	5 segments for leg attachment2 segments for hip attachment5 segments for arm attachment	3	IdenticalNormatec Elite does not contain ahip or arm attachments.
Weight	3.0 lbs	3.6 lbs	1.2 lbs	Similar
Control UnitDimensions(W x H x D)	3.5" x 1.75" x 7.0"	4.17" x 3.66" x 8.25"	4.94" x 1.27" x 2.76"	Similar
Housing Materialsand Construction	Molded ABS enclosure (94V0)	Molded ABS enclosure (94V0)	Molded ABS enclosure (94V0)	Identical
Patient contact	Non-conductive wrapSurface DeviceIntact SkinLimited Duration (<24 hours)	Non-conductive wrapSurface DeviceIntact SkinLimited Duration (<24 hours)	Non-conductive wrapSurface DeviceIntact SkinLimited Duration (<24 hours)	Identical

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Normatec Elite

510(k) Summary Page 4 of 9

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Normatec Elite

510(k) Summary Page 5 of 9

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510(k) Summary

Page 6 of 9

Differences Between Models

An "X" indicates the feature is present in the device.

Characteristic	Normatec Elite	Normatec 3
Power On - The system has settings for:
Adjustable Treatment time (15 min to 60 min)	X	X
Inflatable Leg Boot	X	X
7 Pressure Levels	X	X
5 zone Inflatable leg boot	X	X
Adjustable Rest time	N/A	X
Time
User can Add time
Before treatment	X	X
During treatment
User can Decrease time
Before treatment	X	X
During treatment
Provides a Counter	X	X
Count down - 1 second increments	X	X
Compliance – Trip meter	X	X
Chronometer Odometer - cannot be reset by User	X	X
Pressure
User can Increase level
Before treatment	X	X
During treatment
User can Decrease level
Before treatment	X	X
During treatment

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510(k) Summary Page 7 of 9

Characteristic	Normatec Elite	Normatec 3
Treatment Mode
NormaTec Patented Pulse Algorithm	X	X
Treatment
Starting via button press	X	X
Pause via button press	X	X
Un-pause via button press	X	X
End - If timer reaches 0:00⁰⁰, treatment willcontinue until Rest period is reached.	X	X
Remote operation via Bluetooth app	X	X
Battery Charging
Control unit interface displays battery level	X	X
Control unit interface displays when battery ischarging	X	X
Power On/Off Button
Off mode - No treatment in process	X	X
On mode - Treatment is process when start buttonalso pressed.	X	X
Appliance type
Selection of appliance - Inflatable boot, arm orhipNOTE: If hip appliance is selected, treatmentmode defaults to 2-zone treatmentNote: Normatec Elite is only an inflatableboot.	Boot only	BootArmHip

Differences between Proposed and Predicate Device Discussion

The proposed device differs in the following ways from the predicate:

The proposed device Normatec Elite does not contain hip or arm attachments like the proposed device -● Normatec 3 - K220217. The proposed device only offers leg attachments.
Physical size of control unit was reduced while maintaining the same technology.
The power supply for Normatec Elite is different than Normatec 3 K220217. ●
External air hose was integrated into the air inflatable.

Discussion of Differences

The differences between the proposed and predicate device do not raise any new concerns regarding the safety and effectiveness as demonstrated by performance testing.

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510(k) Summary Page 8 of 9

Substantial Equivalence Discussion

The table above compares the key features of the proposed device with the identified predicate - Normatec 3 -K220217. The comparison demonstrates that the proposed device can be found to be substantially equivalent to the predicate device.

Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate device. Discussion - The indications for use are identical.

Technology and construction -

The technology and principle of operation is identical for the proposed device when compared to the predicate device.

Discussion - Both the proposed and predicate device have identical principles of operation.

Environment of Use -

The environments of use are similar to predicate, which are clinics, hospital, athlete training, and home environments.

Discussion - The environments of use are the identical.

Patient Population -

The patient population is adults. Discussion - The proposed and predicate device patient populations are identical.

Non-Clinical Testing Summary -

Bench testing -

Performance testing demonstrated that the proposed device met its acceptance criteria. Testing included:

Testing of all controls ●
Testing of all indicators ●
Testing of battery state indicators ●
Testing of performance ●
Testing of hazard mitigations

Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria.

Biocompatibility -

The materials utilized in the proposed device are identical to the listed predicate as they were approved in their respective 510(k)s and their relationship to the patient for the proposed device are identical in formation, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.)

Discussion - The proposed device was found to meet the applicable requirements for biocompatibility safety for the intended population.

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Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

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).