(433 days)
No
The summary describes a software-controlled device for cold and compression therapy, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software control appears to be for managing the delivery of compressed air and chilled water based on pre-defined settings, not for learning or adapting based on data.
Yes
The device is described as "intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated," which clearly defines a therapeutic purpose.
No
The device is described as providing cold and compression therapy to treat injuries and reduce symptoms like edema, swelling, and pain. It does not mention diagnosing any conditions.
No
The device description explicitly states it is a "DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint". This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's function is to apply cold and compression therapy externally to the body to reduce edema, swelling, and pain. It does not involve analyzing biological samples.
- Intended Use: The intended use is for treating post-surgical and acute injuries by applying physical therapies, not by performing diagnostic tests on samples.
The device is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
Product codes (comma separated list FDA assigned to the subject device)
IRP, ILO
Device Description
The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
The ICE COMPRESSION System is comprised of the following components:
- Control Unit (FIRST, DUO, or MOOVE) ●
- AC Adapter (to convert line power to DC input power) ●
- Water/Air Connectors (connects Splint to the Control Module)
- Instruction Manual
- Splints (Accessories) ●
- Optional Carry Case
The ICE COMPRESSION System Control Unit is available in three variants or models: FIRST, DUO, and MOOVE. The FIRST and the MOOVE models each have only one Splint connection while the DUO has two Splint connectors. The DUO model is essentially the same as the single-splint connection models (FIRST and MOOVE) but with two of the single-splint connection internal models inside one device module. The FIRST and DUO models use the same outside dimensions and different only by whether they contain one or two single-splint connection internal control units. The DUO model can provide therapy to one patient, wearing two splints, or to two patients at the same time. In the DUO model, each of the two singlesplint connection models inside, are separately controlled with their own user interface and tank. All three models each use only one Power Supply. The MOOVE model is a smaller more portable unit.
The Water/Air Hose Connector connects the Splint to the Control Module. Water from the Hose Connector fills the Splint's water bladder to provide cold therapy. Air from the Hose Connector fills the air bladder to provide compression. All Splints have both air and water bladders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, shoulder, back, leg, articulated knee, hip, wrist.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or 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)
The Sponsor subjected the ICE COMPRESSION FIRST, DUO, & MOOVE Systems System to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, and biocompatibility, These tests verified and validated the proper operation of the current version system. All patient contacting components and accessories have been tested to demonstrate appropriate biocompatibility. No part of the system components or accessories are provided sterile or can be sterilized. Cleaning and disinfection instructions are justified and are included in the labeling for the system and accessories. Therefore, the ICE COMPRESSION FIRST, DUO, & MOOVE System with its Splints are adequately safe and effective for the intended users, its intended uses, and use environments.
The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This device evaluation included relevant data sources related to biological safety of finished device testing, component material history of safe biological use and testing, and where applicable, safe previous use in other cleared products. This biocompatibility evaluation establishes the biological safety for the splints of the ICE COMPRESSION SYSTEM.
The software in the ICE COMPRESSION FIRST, DUO, & MOOVE Systems, including both custom-developed firmware and OTS software, was verified and validated and demonstrated to be safe and effective for its intended use. The software is a Moderate Level of Concern (LOC) per FDA guidance. All required software items required by FDA guidance for moderate LOC are included in this submission.
The ICE COMPRESSION FIRST. DUO. & MOOVE Systems complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601 3.1 edition standards including the ANSI/AAMI/ES60601 with the U.S. deviations, and the 4th edition of collateral standard for EMC.
No animal studies were performed to support this submission.
Although clinical studies were not needed to demonstrate substantial equivalence of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems, the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices" (July 26, 1995), reformatted 12/18/97 requires measure of the lowest skin temperature that the device can generate at its lowest setting. This measurement of the lowest skin temperature was conducted with healthy volunteers.
As required by the FDA guidance for heating and cooling devices, the ICE COMPRESSION FIRST, DUO, & MOOVE Systems was used at its lowest setting with the worst-case splint and location. A minimum skin temperature of 11.7°C (53°F) was measured and has been included in the product labeling.
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.
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
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 11, 2021
mks paris % Natalie Kennel Quality & Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129
Re: K193079
Trade/Device Name: ICE COMPRESSION FIRST, DUO, & MOOVE Systems Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: October 9, 2020 Received: October 13, 2020
Dear Natalie Kennel:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD Assistant Director 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) K193079
Device Name ICE COMPRESSION FIRST, DUO, & MOOVE Systems
Indications for Use (Describe)
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image is a logo for MKS Paris. The logo is in white text on an orange background. The text reads "MKS Paris" on the top line and "VOTRE BIEN-ETRE NOTRE PARI" on the bottom line. There is a line separating the two lines of text.
510(k) Summary
| Sponsor: | mks paris |
|---|---|
| Zone Ecoparc | |
| 27 Rue Meziere | |
| 34690 Fabregues | |
| France | |
| Phone: 04-99-64-21-05 | |
| Fax: 04-99-64-21-06 | |
| Contact Person: | Ms. Natalie J. Kennel |
| Consultant | |
| NJK & Associates, Inc. | |
| 13721 Via Tres Vista | |
| San Diego, CA 92129 USA | |
| Phone: (858) 705-0350 | |
| Fax: (858) 764-9739 | |
| Email: NKennel@njkconsulting.com |
Date Prepared: January 11th, 2021
DEVICE INFORMATION:
| Proprietary Name: | ICE COMPRESSION FIRST, DUO, & MOOVE System |
|---|---|
| Common Name: | Powered inflatable tube massager |
| Classification: | II |
| Product Codes: | IRP, ILO |
| Regulations: | 21 CFR 890.5650 |
| Regulation Name: | Powered Inflatable Tube Massager |
| Classification Panel: | 89- Physical Medicine |
PREDICATE DEVICES:
The predicate devices are listed in Table 1. The primary predicate device is the Game Ready GRPro 2.1 System and the secondary predicate is the Game Ready Med4Elite. The Therm X is the reference device. None of the predicate or reference devices have been subject to design recalls.
4
Table 1 Table of Predicates
| 510(k) | Product | 510(k) Holder | Clearance
Date | Scope of safety and
effectiveness
comparison to
subject device |
|---------|---------------------|----------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| K192114 | GRPro 2.1
System | CoolSystems® (dba
Game Ready) | October 29,
2019 | Compared to all
aspects of the subject
device.
Primary Predicate |
| K171685 | Med4Elite | CoolSystems® (dba
Game Ready) | September 29,
2017 | Compared to the Duo
control module's dual
output functionality.
Compared to the Wrist
Splint and the Hip
Splint.
Secondary Predicate |
| K181149 | Therm X | Zenith Technical
Innovations | August 3, 2018 | Compared to the
subject device static
pressure option.
Reference device |
PRODUCT DESCRIPTION:
The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g.,
5
shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
The ICE COMPRESSION System is comprised of the following components:
- Control Unit (FIRST, DUO, or MOOVE) ●
- AC Adapter (to convert line power to DC input power) ●
- Water/Air Connectors (connects Splint to the Control Module)
- Instruction Manual
- Splints (Accessories) ●
- Optional Carry Case
The ICE COMPRESSION System Control Unit is available in three variants or models: FIRST, DUO, and MOOVE. The FIRST and the MOOVE models each have only one Splint connection while the DUO has two Splint connectors. The DUO model is essentially the same as the single-splint connection models (FIRST and MOOVE) but with two of the single-splint connection internal models inside one device module. The FIRST and DUO models use the same outside dimensions and different only by whether they contain one or two single-splint connection internal control units. The DUO model can provide therapy to one patient, wearing two splints, or to two patients at the same time. In the DUO model, each of the two singlesplint connection models inside, are separately controlled with their own user interface and tank. All three models each use only one Power Supply. The MOOVE model is a smaller more portable unit.
The Water/Air Hose Connector connects the Splint to the Control Module. Water from the Hose Connector fills the Splint's water bladder to provide cold therapy. Air from the Hose Connector fills the air bladder to provide compression. All Splints have both air and water bladders.
INDICATIONS FOR USE:
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
6
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Table 2 is a detailed comparison of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems with its predicates device.
Table 2 Comparison of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems and its predicates
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ICE COMPRESSION
FIRST, DUO, and MOOVE
Systems combine cold and
compression therapies. They are
intended to treat post-surgical
and acute injuries to reduce
edema, swelling, and pain where
cold and compression are
indicated. They are intended to
be used by or on the order of
licensed healthcare professionals
in hospital, outpatient clinics,
athletic training settings, or
home settings. | Game Ready GRPro 2.1 System
is 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. | The Med4 Elite™ combines
cold, heat, contrast and
compression therapies.
It is intended to treat post-
surgical and acute injuries to
reduce edema, swelling and pain
for which cold and compression
are indicated.
It is intended to treat post
traumatic and post surgical
medical and/or surgical
conditions for which localized
thermal therapy (hot or cold or
contrast) are indicated.
It is intended to be used by, or
on the order of, licensed
healthcare professionals in
rehabilitation facilities,
outpatient clinics, and athletic
training settings. | Substantially equivalent to
predicate device; wording differs
slightly. Both devices intended
to treat the same conditions.
Secondary intended use covers
the subject device intended use
AND additional indications not
included in the subject device.
Differences between the subject
device and the predicate device
indications for use do not raise
new safety or effectiveness
questions. |
| Contraindications
and precautions | Provided in Subject Device User
Manual | Available in Predicate Device
User Manual | Available in Predicate Device
User Manual | Similar, minor wording
differences only.
Secondary predicate includes
contraindications for heat, which
does not apply to the subject
device. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Intended Users | Healthcare professionals, athletic
trainers, lay users under the
direction of a healthcare
professional | Healthcare professionals, athletic
trainers, lay users under the
direction of a healthcare
professional | Healthcare professionals only
(prescription use) | Substantially equivalent to
primary predicate device; differs
from secondary predicate device
which is restricted to healthcare
professionals |
| Intended use
environment | Hospitals, outpatient clinics,
athletic training facilities.
prescription home use. | Hospitals, outpatient clinics,
athletic training facilities.
prescription home use. | Intended for indoor use only
such as rehabilitation clinics,
outpatient clinics, athletic
training settings. | Identical to primary predicate.
Differs from secondary predicate
which excludes the home use
environment. |
| Principle of
Operation | Pneumatic and fluid pumps and
flexible multi-chamber wrap
deliver intermittent compression
and cold therapy. | Pneumatic and fluid pumps and
flexible multi-chamber wrap
deliver intermittent compression
and cold therapy. | Pneumatic and fluid pumps and
flexible multi-chamber wrap
deliver intermittent compression,
cold therapy and heat therapy. | Substantially equivalent;
secondary predicate description
includes heat therapy which is
not applicable to subject device |
| Cooling Unit/
Compressor
Description | Small, removable ice water
tank(s); no compressor cooling
unit. | Small, ice box reservoir; no
compressor cooling unit. | Vapor compression cold
reservoir unit and resistance
heating reservoir unit (1 gallon
each). | Similar to primary predicate;
ICE COMPRESSION Systems
have removable water tank(s).
ICE COMPRESSION DUO
System has two units in enclosed
in one system. Differs from
secondary predicate which uses
a compressor cooling unit.
This does not raise new safety
or effectiveness questions. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Treatment
Temperature Range | 41-77°F (5-25°C) | 34 - 50°F (1- 10°F) | 38 - 60°F (3.33-15.56°C) (cold
therapy temperature range) | Substantially equivalent. The
subject device has a warmer
temperature range that does not
raise new issues of safety and
effectiveness. Highest
temperature is driven by the
ambient environment (no heating
unit in subject or primary
predicate). |
| Water Temperature
accuracy | +/-1.8°F (+/-1°C) | +/-4°F (+/-2°C)
Per predicate User Manual | +/-4°F (+/-2°C)
Per predicate User Manual | Similar. Subject device claims a
tighter accuracy than predicate
devices; does not raise new
issues of safety and
effectiveness. |
| Temperature
Adjustment
Mechanism | Software adjusts the flowrate
based on thermosensor feedback. | Patented fluid flow control
technology. | Not publicly available. | Different. Physical mechanism
for temperature adjustment is
different but both the subject
device and the primary predicate
use adjustment of water flow
rate to controlled by software to
adjust temperature. Unable to
compare to the secondary
predicate. No new issues of
safety or effectiveness raised. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Compression range | 0-75 mmHg | 5-75 mmHg
Or 0 mmHg (no pressure) | 5-75 mmHg
Or 0 mmHg (no pressure) | Substantially equivalent. Subject
device has a lower minimum
pressure when oscillating
(dynamic mode); Predicate
devices can be set to 0 pressure:
does not raise different issues of
safety and effectiveness. |
| Pressure
Application time | Dynamic pressure: Adjustable
from 0-55 seconds of pressure
for cycle
Static pressure: Up to 45 minutes
continuous application of
pressure setting | Dynamic pressure: Cyclical
compression applied from 5 to
90 minutes (total) in three levels:
Low (5-15 mmHg) cycled in 5
minutes
Medium (5-50 mmHg) cycled in
3 minutes
High (5-75 mmHg) cycled in 3
minutes
(per User Manual)
No Static pressure | Dynamic pressure: Cyclical
compression applied from 5 to
60 minutes (total) with default of
15 minutes in four levels:
Low (5-15 mmHg) cycled in 5
minutes
Medium-Low (5-30 mmHg)
cycled in 3 minutes
Medium (5-50 mmHg) cycled in
3 minutes
High (5-75 mmHg) cycled in 3
minutes
(per User Manual)
No Static pressure | Similar for pressure application
of dynamic pressure on Subject
device compared to predicate
devices. Subject device has more
flexibility in the cycling timing
of pressure.
Predicate devices do not have
static pressure settings.
Reference device K181149
Therm X has a static pressure
mode like subject device.
Differences do not raise new
safety or effectiveness questions
because the maximum pressure
and range is similar to other
devices |
| Air Pressure
Accuracy | +/- 10mm Hg | +/-10mmHg
Per predicate User Manual | +/-10mmHg
Per predicate User Manual | Same |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Treatment time
adjustment | Adjustable from 0- 45 minutes in
increments of 1 minute | 15 minutes default, increasing or
decreasing in 5-minute
increments to a max of 90 min or
a min of 5 min. | Cold and/or compression
therapy: 15 minutes default,
increasing or decreasing in 5-
minute increments to a max of
60 min or a min of 5 min. | Similar. Subject device
maximum treatment time (45
minutes) is less than predicate
device maximum treatment time
(90 minutes or 60 minutes).
Does not raise any different
issues of safety and
effectiveness. (Cold therapy is
limited by use of ice water for
subject device and primary
predicate device) |
| Treatment Cycle | Manual Mode:
20 min default,
increasing/decreasing in 5-
second increments with a
minimum of 0 min and a
maximum of 45 min. | Manual Mode:
15 minutes default, increasing or
decreasing in 5-minute
increments to a max of 90 min or
a min of 5 min.
Program Mode:
Six (6) pre-programmed
treatment on-off cycles are 30-
30 or 30-60 min. at no pressure,
low pressure, or medium
pressure. | Cold: 5 to 60 minutes, 1 minute
increments
Default 15 minutes
Compression: 5 to 60 minutes,
15 minutes default | Different: Subject has only
manual mode that can be
adjusted up to 45 minutes:
primary predicate devices pre-
programmed treatments are
customizable. Secondary
predicate settings have
adjustable default settings.
Differences do not raise new
issues of safety or effectiveness
raised. |
| Software/ Software
Features | Software controls pressure,
displays battery level, monitors
and adjusts temperature. | Electronic pressure control and
therapy time and temperature
monitoring. Battery voltage
monitoring. | Electronic pressure control and
therapy time and temperature
monitoring. | Substantially equivalent; subject
device uses a different algorithm
to adjust water temperature from
proprietary algorithm in
predicate devices. No different
issues of safety or effectiveness
raised. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| User interface
(Control unit control
panel) | LCD touchscreen display and 9
surrounding button keys | LCD display and 9 buttons | LCD touchscreen displays all
elements | Substantially equivalent to
primary predicate; subject device
provides users with an option to
use the touchscreen or the keys.
Secondary predicate uses only
touchscreen. |
| Number of patients
that can be treated at
the same time | MOOVE: One
FIRST: One
DUO: Two | One patient | Two patients | Substantially equivalent.
Subject FIRST and MOOVE
models have substantially
equivalent capabilities to the
primary predicate. Subject DUO
model is substantially equivalent
to capabilities of the secondary
predicate. |
| Dimensions | MOOVE: 11.4" x 9.45" x 15.35"
(290 x 240 x 390 mm)
FIRST: 12.8" x 18.81" x 15.94"
(327 x 478 x 405 mm)
DUO: 12.8" x 18.81" x 15.94"
(327 x 478 x 405 mm) | 9.25" H x 7.75" W x 16.25" L
(413 x 197 x 235) mm (not
including carrying case) | 32.5" L x 24.75" W x 43"H (83
cm
L x 63 cm W x 109cm H) | Different. Subject device (all
models) is larger than the
primary predicate. Both subject
and primary predicate device are
portable. Subject MOOVE
model has a handle like
predicate device. Subject device
is smaller than the secondary
predicate. Does not raise
different questions of safety or
effectiveness. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Weight
(empty/filled) | MOOVE: 5.5 / 11 lbs.
FIRST: 11 / 15.4 lbs.
DUO: 13 / 22 lbs. | 7.3 / 18 lbs. (approx.) | 172 lbs (78 kg) | Similar to the primary predicate;
the empty predicate device
weighs less than 2 of Subject
models. When filled, the primary
predicate device weight is in
between the Subject FIRST and
DUO models. The primary
predicate device weighs more
when full because of slightly
higher capacity. The weight of
the secondary predicate is
heavier than the subject device
as secondary predicate is not
intended to be portable.
Differences do not raise new
safety or effectiveness
questions. |
| Chilling Mechanism | Ice | Ice | Vapor compressor | Same mechanism as primary
predicate. Mechanism differs
from secondary predicate. |
| Water/Ice Capacity | FIRST & MOOVE: 2,500 mL
DUO: 5,000 mL | Approximately 5100 mL (5.4 qt) | 1 gallon (3.8 L)
Not applicable as ice is not
chilling mechanism. | Similar.: largest subject device
model capacity is similar to
primary predicate capacity.
Secondary predicate capacity is
not applicable because ice water
is not the chilling mechanism.
Differences do not raise new
safety or effectiveness
questions. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices. where
applicable |
| Coolant | Tap water and ice | Tap water and ice | Distilled water (cooled by vapor
condenser) | Same as primary predicate.
Secondary predicate uses
condenser to provide cooling. |
| Water flow rate | 100-350 mL/min | 275-450 mL/min | Not publicly disclosed | Similar. The subject device flow
rate is slightly slower than the
predicate. For both, the flow rate
is driven by temperature control
mechanism. User doesn't set or
control water flow rate. Does not
raise different issues of safety
and effectiveness |
| Power source | Battery; power supply connects
battery to mains to charge. | Mains power from medical
desktop power supply, optional
battery pack | Mains power to control unit | Different. All pass electrical
safety; differences do not raise
different issues of safety or
effectiveness |
| Battery Type | Nickel-Metal Hydride | Lithium, rechargeable | N/A no battery | Different.Both pass electrical
safety; difference does not raise
different issues of safety or
effectiveness |
| Input power | 12V 1A (through AC adapter) | 12V 2.5A (through AC adapter) | 1200 VA | Similar. primary Predicate
amperage is slightly higher. All
pass electrical safety; differences
do not raise different issues of
safety or effectiveness |
| Line Voltage | 100-240 V AC | 100- 240 V AC | 100-240 VAC | Same |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | Same |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Electrical Safety
and EMC standards
met | ANSI/AAMI ES60601 – 1:2005/(R) 2012 &
A1:2012, C1:2009 (R) 2012, A2:2010/(R)
2012- Part 1 CAN/CSA – C22.2 No.
60601- 1:14 Part 1 IEC 60601-1-11:2015 IEC 60601 – 1-2, Ed.
4.0: 2014 | ANSI/AAMI ES60601 – 1:2005/(R) 2012 &
A1:2012, C1:2009 (R) 2012, A2:2010/(R)
2012- Part 1 CAN/CSA – C22.2 No.
60601- 1:14 Part 1 IEC 60601-1-6:2010 +
A1:2013 IEC 60601-1-11:2015 IEC 60601 – 1-2, Ed.
4.0: 2014 BS EN
60601-1-2:2015 IEC 62366:2007 +
A1:2014 IEC 62133:2012 +
C1:2013 | ANSI/AAMI ES60601-
1:2005/(R)2012 CAN/CSA C22.2 No.
60601-1:2014 Type B | Substantially equivalent. Subject
and predicate devices were
tested to similar electrical safety
and EMC standards. Secondary
predicate is not for home use so
IEC 60601-1-11:2015 is not
applicable. Differences do not
raise new safety or
effectiveness questions. |
| Operating
Temperature | 41 – 104 F (5-40 C) | 33.8 – 104 F (1-40 C) | 50°F - 90°F (10°C – 32°C) | Similar. Differences do not
raise new safety or
effectiveness questions. |
| Operating Humidity | 15-90%, non-condensing, but
not requiring a water vapor
partial pressure greater than 50
hPa | Not stated in User Manual | 30 to 90%, Non-condensing | Subject device has acceptable
operating humidity range for
indoor use. Subject device range
similar to secondary predicate.
Differences do not raise new
safety or effectiveness
questions. |
| Max Operating
Altitude | 6,562 Ft (2,000 meters) | 9,843 Ft (3,000 meters) | 9,842 Ft (3,000 meters) | Similar. Subject device cannot
be used at as high an altitude as
predicate devices. Differences
do not raise new safety or
effectiveness questions. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Storage Conditions | -13 to 95°F (-25 to 35°C) at a
relative humidity up to 90%,
non-condensing;
95 - 158°F (>35°C - 70°C) at
water vapor pressure up to 50
hPa | 33-122 F (1 C – 50 C)
Relative humidity of 15-90%,
non-condensing | 33°F - 122°F (1°C to 50°C)
Relative humidity of 30 to 90%,
Non-condensing | Similar. Subject device storage
temperature range is wider than
the predicate devices.
Differences do not raise new
safety or effectiveness questions. |
| Splint/Wrap
technology/characte
ristics | Splint outer cover holds a water
bladder and a separate air
bladder in place to provide cold
and compression therapy. Splint
connects to the water circuit and
the air circuit. | Flexible "Wraps"; outer sleeve
with inner heat exchanger to
deliver compression and cold. 2-
chamber heat exchanger (water
and air). | Flexible "Wraps"; outer sleeve
with inner heat exchanger to
deliver compression and cold. 2-
chamber heat exchanger (water
and air). | Substantially equivalent.
Splint/wrap delivers ice water
and air to provide cold and
compression therapy. Primary
and secondary predicates use the
same wrap design. Differences
do not raise new safety or
effectiveness questions. |
| Splints/Wraps
Types | Various anatomical wraps in
different sizes for:
Ankle, shoulder, back, leg,
articulated knee, hip, wrist. | Various anatomical wraps in
different sizes for:
Ankle, Shoulder, Back, Straight
Knee, Straight Elbow, Traumatic
Amputee, Neck, Lower Limb,
Full Leg Boot and Chest | Various anatomical Wraps in
different sizes for:
Straight Knee, Articulated Knee,
Elbow, Ankle, Shoulder, Back,
Hip-Groin, Hand-Wrist, Flexed
Elbow, Half-leg boot | Overlapping areas/wraps with
primary predicate: Ankle,
shoulder, back, knee
(straight/articulated) and lower
limb/leg
Overlapping areas/wraps with
secondary predicate: Hip and
wrist |
| Primary Patient
Contacting Material | Nylon 210 & non-woven
polyester | 70 Denier nylon & polyester | 70 Denier nylon & polyester | Substantially equivalent. Patient
contact materials are same types
of fabric. No different issues of
safety and effectiveness. |
| Characteristics/
Parameters | ICE COMPRESSION
FIRST, DUO, & MOOVE
Systems
(Subject Device) | GameReady GRPro 2.1,
K192114
(Primary predicate device) | Game Ready Med4Elite,
K171685
(Secondary predicate
device) | Comparison results and
reference devices, where
applicable |
| Biocompatibility | Primary patient contacting
components verified as
acceptable according to ISO
10993-1 using cytotoxicity,
primary irritation and skin
sensitization. | Primary patient contacting
components verified as
acceptable according to ISO
10993-1 using cytotoxicity,
primary irritation and skin
sensitization. Additional
elastomeric materials were
verified as acceptable according
to ISO 10993-1 using acute
systematic toxicity, primary
irritation and skin sensitization. | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-12 | Substantially equivalent. Subject
device does not contain
elastomeric materials. No
different issues of safety and
effectiveness. |
| Sterile or Non-
sterile | Non-sterile only | Non-sterile only | Non-sterile only | Same |
| Control Module
Expected Lifetime | 5 years | 5 years | 5 years | Same |
| Parts and
Accessories
Expected Lifetime
(includes
splints/wraps) | 3-24 months, depending on use | 3-24 months, depending on use | 3-24 months, depending on use | Same |
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PERFORMANCE DATA
The Sponsor subjected the ICE COMPRESSION FIRST, DUO, & MOOVE Systems System to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, and biocompatibility, These tests verified and validated the proper operation of the current version system. All patient contacting components and accessories have been tested to demonstrate appropriate biocompatibility. No part of the system components or accessories are provided sterile or can be sterilized. Cleaning and disinfection instructions are justified and are included in the labeling for the system and accessories. Therefore, the ICE COMPRESSION FIRST, DUO, & MOOVE System with its Splints are adequately safe and effective for the intended users, its intended uses, and use environments.
BIOCOMPATIBILITY
The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This device evaluation included relevant data sources related to biological safety of finished device testing, component material history of safe biological use and testing, and where applicable, safe previous use in other cleared products. This biocompatibility evaluation establishes the biological safety for the splints of the ICE COMPRESSION SYSTEM.
CLEANING, DISINFECTION & SHELF LIFE TESTING
The Sponsor provides the ICE COMPRESSION FIRST, DUO, & MOOVE Systems and system accessories, including the Splints as non-sterile. The ICE COMPRESSION FIRST, DUO, & MOOVE Systems Control Module and system accessories, excluding the Splints, are not patient contacting and have only incidental patient or user contact at most. The user contacts the Splints when setting up or stopping therapy. The unit is not intended for use in a sterile environment. The Sponsor provides cleaning and disinfection instructions in the Instructions Manual.
The ICE COMPRESSION FIRST, DUO, & MOOVE System Splints contact the patient and are intended for use over intact skin or sterile dressings only. The Splints are provided non-sterile and not intended to be user sterilized. The Sponsor provides cleaning and disinfection instructions in the device Instruction manual and in the respective Splint instruction manual.
The expected service life for the systems and splints expected to be five years and 3-24 months based on frequency of use and continued functional performance.
SOFTWARE
The software in the ICE COMPRESSION FIRST, DUO, & MOOVE Systems, including both custom-developed firmware and OTS software, was verified and validated and demonstrated to be safe and effective for its intended use. The software is a Moderate
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Level of Concern (LOC) per FDA guidance. All required software items required by FDA guidance for moderate LOC are included in this submission.
ELECTRICAL SAFETY & EMC
The ICE COMPRESSION FIRST. DUO. & MOOVE Systems complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601 3.1 edition standards including the ANSI/AAMI/ES60601 with the U.S. deviations, and the 4th edition of collateral standard for EMC. Refer to the list of standards in Table 2.
ANIMAL STUDIES
No animal studies were performed to support this submission.
CLINICAL STUDIES
Although clinical studies were not needed to demonstrate substantial equivalence of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems, the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices" (July 26, 1995), reformatted 12/18/97 requires measure of the lowest skin temperature that the device can generate at its lowest setting. This measurement of the lowest skin temperature was conducted with healthy volunteers.
As required by the FDA guidance for heating and cooling devices, the ICE COMPRESSION FIRST, DUO, & MOOVE Systems was used at its lowest setting with the worst-case splint and location. A minimum skin temperature of 11.7℃ (53°F) was measured and has been included in the product labeling.
Further, the ICE COMPRESSION System treatment temperature range and pressure settings are substantially equivalent to the predicate device. The ICE COMPRESSION System Splints have the same anatomical coverage as the predicate and reference devices.
CONCLUSION
The data and information provided in this submission support the conclusion that the ICE COMPRESSION FIRST, DUO, & MOOVE Systems is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.