(259 days)
Not Found
No
The summary describes a software-controlled device for cold and compression therapy with pumps and electronics, but there is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain, which falls under the definition of a therapeutic device.
No
The device is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain by providing cold and compression therapy. It does not perform any diagnostic functions.
No
The device description clearly outlines multiple hardware components including a pump, electronics, reservoir, tubing, and a joint wrap, in addition to the software control.
Based on the provided information, the Armory Motion device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating postsurgical and acute injuries to reduce edema, swelling, and pain. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a device that provides physical therapies (cold and compression) applied externally to the body. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
In summary, the Armory Motion is a therapeutic device used for physical rehabilitation and pain management, not a device used to diagnose diseases or conditions by examining samples outside the body.
N/A
Intended Use / Indications for Use
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.
Product codes (comma separated list FDA assigned to the subject device)
ILO, IRP
Device Description
Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.
The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.
The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.
The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.
The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back, elbow, shoulder, foot, ankle, and knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care professional in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
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)
No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission.
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
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2022
Pain Management Technologies, Inc. Joshua Lefkovitz President 1760 Wadsworth Rd. Akron, Ohio 44320
Re: K213097
Trade/Device Name: Armory Motion Regulation Number: 21 CFR 890.5720; 21 CFR 890.5650 Regulation Name: Water Circulating Hot Or Cold Pack; Powered inflatable tube massager Regulatory Class: Class II Product Code: ILO, IRP Dated: May 10, 2022 Received: May 18, 2022
Dear Joshua Lefkovitz:
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.
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
1
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 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,
Heather Dean, PhD Assistant Director, Acute Injury Devices 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
2
Indications for Use
510(k) Number (if known) K213097
Device Name Armory Motion
Indications for Use (Describe)
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| 7 Prescription Use (Part 21 CED 801 Subnart D) | Over The Counter I lea (21 CED 201 Submort C) |
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3
510(k) Summary
K213097
Date of Submission prepared: 16 August 2021
Submitter l
| Address: | 1760 Wadsworth Rd. Akron, OH 44320, USA |
|---|---|
| Tel: | 614-937-8236 |
| Fax: | 888-304-5454 |
| E-Mail: | josh@paintechnology.com |
| FDA Establishment Registration No: | 1528161 |
| Contact person: | Joshua A. Lefkovitz / President |
Address of the manufacturing facility:
| Manufacturer: | EasyMed Instruments Co Ltd |
|---|---|
| Address: | 3/F, 5F-6F, Block A, GupoGongmao Building, |
| Fengxin Road, Fengxiang Industrial District, | |
| Daliang, 528300 Shunde, Foshan, Guangdong | |
| China, | |
| FDA Establishment |
Registration No: 3004049909
ll Submitted Device:
| Trade name: | Armory Motion |
|---|---|
| Common name: | Cold and Compression Therapy |
| Classification Name: | Powered Inflatable Tube Massager; |
| Water circulating hot or cold pack | |
| Classification Number: | Title 21 CFR 890.5650; |
| Title 21, CFR 890.5720 | |
| Product Code: | IRP, ILO |
| Classification Panel: | Neurological and Physical Medicine |
| Regulatory Class: | Class II |
Predicate Device: ���
| Trade/Device Name: | Cold and Compression Therapy |
|---|---|
| Model Number: | Polar Care Wave™ |
| Submitter: | Breg, Inc. |
| 510(k) Number: | K183702 |
| Product Code: | IRP, ILO |
| Type of Use: | Prescription |
4
Classification: Class II
IV DEVICE DESCRIPTION
Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.
The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.
The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.
The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.
The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.
Indications for Use of the device >
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
VI Equivalence Comparison to the Predicate Devices:
The technical characteristics of the applicant device (Model: Armory Motion) are similar to those of the predicate device in design, intended use and function. The predicate device Breg Polar Care Wave (K183702), and the new device Armory Motion is a device that
5
utilize a pneumatically controlled compression wrap providing intermittent pressure to joints and the lower extremities of a patient.
The Breg Polar Care Wave (K183702) provides both intermittent pneumatically controlled compression and cold thermal therapy.
The table below summarizes the shared and unique technological elements between the Armory Motion and the predicate device. The technology, engineering, and performance for Armory Motion are substantially equivalent to the predicate device.
From the view of safety and effectiveness, the new device Armory Motion uses preset programs that are substantially equivalently to the predicated device. The output characteristics of Armory Motion are similar to those of predicated device, see Table below.
The new device Armory Motion is designed to comply with relevant safety applicable recognized consensus standards; the output pressure is controlled well within the safety and effectiveness ranges specified by relevant FDA guidance. Detailed and strictly controlled testing has been carried out.
Furthermore, Test results, Risk Analysis, and FMEA analysis show that the new device Armory Motion is safe with no hazard.
As such:
-
the new device (Model: Armory Motion) has the same technological characteristics and intended uses as the predicate devices, and
-
the information submitted to the FDA for the new device (Model: Armory Motion) does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
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Table 1 Substantial Equivalence Comparison Table
| 510(K)No.: | (to be assigned) | Primary Predicate Device
K183702 | Conclusion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device name: | Armory Motion and
Armory Force | Polar Care Wave | |
| Submitter: | Pain Management Technologies | Breg, Inc. | |
| Indications for use: | The Armory Motion is a prescription device
that combines cold and compression
therapy and is intended to treat
post-surgical and acute injuries to reduce
edema, swelling, and pain for which cold
and compression are indicated.
Armory Motion is intended to be used by
licensed health care professional
rehabilitation facilities, outpatient clinics,
athletic training settings, and home settings. | The Breg is a prescription device
intended to treat post-surgical and acute
injuries to reduce edema, swelling, and
pain where cold and compression are
indicated. It is intended to be used by or
on the order of licensed healthcare
professionals in hospitals, outpatient
clinics, athletic training settings, or home
settings. | Substantially equivalent |
| OTC use | Prescription | Prescription | Substantially Equivalent. |
| Classification
Number | 21 CFR 820.5650
21 CFR 890.5720 | 21 CFR 820.5650
21 CFR 890.5720 | Substantially Equivalent. |
| Classification Name | Powered Inflatable Tube Massager;
Water Circulating hot or cold pack | Powered Inflatable Tube Massager;
Water Circulating hot or cold pack | Substantially Equivalent. |
| Regulatory Class | II | II | Substantially Equivalent. |
| 510(K)No.: | (to be assigned) | Primary Predicate Device
K183702 | Conclusion |
| Device name: | Armory Motion and
Armory Force | Polar Care Wave | |
| Product Code | IRP, ILO | IRP, ILO | Substantially Equivalent. |
| Classification Panel | Neurological and Physical Medicine; | Neurological and Physical Medicine; | Substantially Equivalent. |
| Therapy | Cold and Compression
Work together or independently | Cold and Compression
Work together or independently | Substantially Equivalent. |
| Therapy modes | Manually adjustable mode - allows the user
to adjust cold and two compression settings. | Manually adjustable mode - allows the
user to adjust cold and two compression
settings. | Substantially Equivalent. |
| Compression Setting | Available in two levels Low (0-25 mm Hg)
Regular (0-50 mm Hg) | Available in two levels Low (0-25 mm Hg)
Regular (0-50 mm Hg) | Substantially Equivalent |
| Types of Pads | Various anatomical pads: Knee,
Shoulder, Back, calf, Universal/joint,
Foot/Ankle | Various anatomical pads: Knee,
Shoulder, Back, Hip, Universal,
Foot/Ankle | Substantially Equivalent |
| Therapy Temperature Range | 45°F-60°F Cold | 45°F-60°F | Substantially Equivalent |
| Operating fluid and
cooling agent | Tap water and Ice | Tap water and Ice | Substantially Equivalent |
| Single User and
sterility | Single user and non-sterile | Single user and non-sterile | Substantially Equivalent |
| 510(K)No.: | (to be assigned) | Primary Predicate Device
K183702 | Conclusion |
| Device name: | Armory Motion and
Armory Force | Polar Care Wave | |
| Line Voltage /
Frequency | Rechargeable battery and
100-240 VAC 50/60 HZ | 100-240 VAC 50/60 HZ | Substantially Equivalent. |
| Treatment times | 15, 20, 30, 45; compression stops at 30
min max | Continuous, until turn-off byuser | Substantially Equivalent |
| Cooling on/off
times | 15, 20, 30, 45 | Continuous, until turn-off byuser | Substantially Equivalent |
| Pressure Mode | Two compression modes and one cold
therapy mode | Three | Substantially Equivalent |
| Power Supply | 3.7V rechargeable Li-ion Polymer Battery
Power Adapter | Power Adapter | Substantially Equivalent. |
7
8
9
Both the new device Armory Motion and the predicate device Breg Polar Care Wave (K183702) provide continuous intermittent pneumatic massage using inflatable garments. The new device Armory Motion and predicate device have the same indications for use, both operate within the similar parameters and performance specifications. The new device Armory Motion and predicate device use the similar inflation pressures and cycle times.
Furthermore, a subtle difference between the new device Armory Motion and the predicate device is in their respective alarm function. The new device has a malfunction overpressure safety alarm: any time the pressure in the air chamber exceeds 100mmHq. it will stop working and deflate immediately. The device panel shall sleep with the red warning sign on and flash for 20 seconds.
Substantial Equivalence None of the performance or technological differences between the Armory Motion Device and the predicate device raise any new issues of safety and effectivenes.
CONCLUSION:
The data, and information provided in this submission, support the conclusion that the Armory Motion Safety features are Substantially Equivalent to those of Breg Polar Care Wave (K183702). No special safety features have been shown to be necessary for home use without instruction.
10
| FDA recognition No. | Standard Title |
|---|---|
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, |
| C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical | |
| electrical equipment - Part 1: General requirements for basic safety | |
| and essential performance (IEC 60601-1:2005, MOD) | |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02 |
| Medical electrical equipment - Part 1-2: General requirements for | |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01 |
| Medical electrical equipment - Part 1-11: 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. | |
| 5-40 | ISO 14971: Second Edition 2007-03-01 Medical devices- |
| Application of Risk Management To Medical Devices. | |
| 5-89 | IEC 60601-1-6 Edition 3.1 2013-10 |
| Medical electrical equipment - Part 1-6: General requirements for | |
| basic safety and essential performance - Collateral standard: | |
| Usability | |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED |
| VERSION Medical device software - Software life cycle processes | |
| 2-220 | ANSI AAMI ISO 10993-1:2009/(R)2013 |
| Biological evaluation of medical devices - Part 1: Evaluation and | |
| testing within a risk management process |
VII Performance Tests:
V Clinical Testing
No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission.
IX Conclusion:
- � The new device Armory Motion has the same technological characteristics and intended uses as the predicate deivce Breg Polar Care Wave (K183702); and
- � The labelling of the new device Armory Motion is concordant with the predicate device and FDA requirements; and
- � The information submitted to the FDA for the new device Armory Motion does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
Therefore, the new device Armory Motion is substantially equivalent to the predicate device and differences between the devices do not raise any new questions about safety and effectiveness.