(118 days)
No
The description details a mechanical device with a preprogrammed air pump and does not mention any AI/ML components or capabilities.
Yes.
The device description and intended use clearly state its purpose for temporary relief of muscle aches and pains, increasing circulation, and localized cold therapy, which are all therapeutic functions.
No
The device description and intended use/indications for use sections clearly state that this device is for temporary relief of minor muscle aches and pains, temporary increase in circulation, and localized cold therapy. It simulates kneading and stroking of tissues. There is no mention of it being used to diagnose any condition or disease.
No
The device description explicitly lists hardware components such as a pump-controller unit, a wrap with an air bladder, and a reusable thermogel cold pack. This indicates it is a physical device with software controlling the hardware, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of minor muscle aches and pains, temporary increase in circulation, and localized cold therapy. These are all therapeutic or physical therapy applications, not diagnostic testing performed on samples taken from the human body.
- Device Description: The device components (pump, wrap, cold pack) are designed for external application to the body for physical therapy purposes. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The description does not include any elements typical of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims (e.g., diagnosing a disease or condition)
- Use in a laboratory setting
The device is clearly intended for over-the-counter use for physical therapy and pain relief, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Squid Active Cold Compression device and Cold Pack for OTC use is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Product codes
IRP; IME
Device Description
The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
The device is manufactured with the following components:
-
- A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
-
- A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
-
- Reusable thermogel cold pack
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg, foot, feet, arm, shoulders, lower back, hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
There were no changes to the K123829 device. The following were described or testing successfully performed and reported in FDA cleared K123829:
- . Biocompatibility
- Electrical Safety/EMC (including batteries) .
- Bench testing including the following tests: Baseline Verification;Compression . Bladder Leak Verification Test; Blow out Valve Test; Gel Pack Seal Leak Test; Low Pressure Verification Test; Max Pressure, -Total Time, -Max Compression Time, -Min Compression Time, -Max Deflation Time, -Min Deflation Time, -Pressure Gauge Data; Solenoid Valve Release Test (High pressure release)
- . Shelf life of batteries and gel pack
- Reprocessing/sterilization the device is reusable and not supplied sterile. . Cleaning instructions are included in the Instructions for Use.
For this application (K133483) a summative Usability Study was successfully conducted on representative users for OTC use. Findings from the study served to validate that the Squid - Active Cold Compression device and Cold Pack is usable by the devices' intended users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123829 Portable Therapeutix Squid Active Cold Compression Cold Pack
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
MAR 1 1 2014
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K133483
| A) Submitted by: | Portable Therapeutix
4254 Bluebonnet Dr
Stafford, TX 77477
1-617-331-7524 |
|----------------------------------|-------------------------------------------------------------------------------------------------|
| Contact: | Sharyn Orton, Ph.D.
MEDIcept, Inc.
200 Homer Ave
Ashland, MA 01721
401-330-8264 |
| Date prepared: | January 31, 2014 |
| B) Classification Name: | Massager, Powered Inflatable Tube - Product code IRP
Pack, Cold, Reusable - Product code IME |
| Common Name: | Powered inflatable tube massager
Cold Pack |
| Proprietary Name: | Portable Therapeutix Squid Active Cold Compression device
and Cold Pack for OTC Use |
| Device Regulations:
and Class | 21 CFR 890.5650, Class II
21 CFR 890.5700, Class I 510(k) exempt |
| Product Codes: | IRP; IME |
| C) Predicates: | K123829 Portable Therapeutix Squid Active Cold
Compression Cold Pack |
D) Device Description:
The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
6-1
1
The device is manufactured with the following components:
-
- A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
-
- A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
-
- Reusable thermogel cold pack
The Squid Active Cold Compression device and Cold Pack was cleared for marketing as a prescription use device in K123829. The Squid Active Cold Compression device and Cold Pack described in this 510(k) Summary will be marketed as an over-the-counter (OTC) use device.
E) Intended Use/Indication for Use:
The Squid Active Cold Compression device and Cold Pack for OTC use is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
F) Comparison to Predicate Device(s):
The Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC use is the same device as K123829. There were no changes to the K123829 device.
2
| | Portable Therapeutix Squid
Active Cold Compression device
and Cold Pack for OTC Use | Portable Therapeutix Squid
Active Cold Compression device
and Cold Pack
K123829 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | IRP; IME | IRP; IME |
| Indication for
Use | The Squid Active Cold
Compression device and Cold
Packfor OTC use is indicated for
the temporary relief of minor
muscle aches and pains. | The Squid Active Cold
Compression device and Cold
Pack is indicated for the
temporary relief of minor muscle
aches and pains. |
| | The compression device is
indicated for temporary increase
in circulation of the treated areas
in people who are in good health,
and simulates kneading and
stroking of tissues using an
inflatable garment. | The compression device is
indicated for temporary increase
in circulation of the treated areas
in people who are in good health,
and simulates kneading and
stroking of tissues using an
inflatable garment. |
| | The cold pack is indicated for
localized therapy in situations
where cold temperature therapy
is necessary or desirable. | The cold pack is indicated for
localized therapy in situations
where a physician determines
that cold temperature therapy is
necessary or desirable. |
| Target | Leg, foot, arm, shoulders, lower back, hands | |
| OTC use | Yes | No |
.
.
:
3
| | Portable Therapeutix Squid
Active Cold Compression device
and Cold Pack | Portable Therapeutix Squid
Active Cold Compression
device and Cold Pack
K123829 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Principle of
Operation/
Mechanical
characteristics | Intermittent compression
4 intensity settings (modes)
1 – 30 mm Hg
2 – 50 mm Hg
3 – 70 mm Hg
4 – 85 mm Hg | |
| Pressure
range | 0 – 85 mm Hg | |
| Total
treatment
time | 15 minutes | |
| Pressure
control | Microprocessor and pressure sensor | |
| Inflation by | Pressurization pump | |
| Deflation by | Exhaust valve | |
| Power source | 120V 60 Hz, consumption 26W; AC adapter: 120V 60 Hz,
consumption 36W
Lithium battery | |
| Cold Pack | Yes | |
Substantial Equivalence Discussion
The Portable Therapeutix Squid Cold Compression System for OTC use is the same device as the FDA cleared Squid. Treatment targets, total treatment time and mechanical intermittent compression are the same. There is no change to the software, materials used, or power source. There is the addition of alignment markers on the wraps and gel pack to assist in the aligning the wrap with the gel pack for Velcro attachment.
The Portable Therapeutix Squid Cold Compression System has the same indications for use as the predicate device, with the addition of OTC use.
Performance Testing
There were no changes to the K123829 device. The following were described or testing successfully performed and reported in FDA cleared K123829:
- . Biocompatibility
- Electrical Safety/EMC (including batteries) .
- Bench testing including the following tests: Baseline Verification;Compression . Bladder Leak Verification Test; Blow out Valve Test; Gel Pack Seal Leak Test; Low Pressure Verification Test; Max Pressure, -Total Time, -Max Compression Time, -
Portable Therapeutix OTC Squid Traditional 510(k) Premarket Notification
4
Min Compression Time, -Max Deflation Time, -Min Deflation Time, -Pressure Gauge Data; Solenoid Valve Release Test (High pressure release)
- . Shelf life of batteries and gel pack
- Reprocessing/sterilization the device is reusable and not supplied sterile. . Cleaning instructions are included in the Instructions for Use.
For this application (K133483) a summative Usability Study was successfully conducted on representative users for OTC use. Findings from the study served to validate that the Squid - Active Cold Compression device and Cold Pack is usable by the devices' intended users.
Conformity to Standards
There is no change in conformance standards from K123829. The Squid complies with:
- IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment Part 1: . General Requirements for Safety, 1988; Amendment 1, 1991-11; Amendment 2, 1995).
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and Tests
Conclusion
The Portable Therapeutix Squid Cold Compression System device and Cold Pack for OTC use is substantially equivalent to the predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11. 2014
Portable Therapeutix, LLC c/o MEDIcept, Inc. Attn: Sharyn Orton Ph.D., Senior Consultant 200 Homer Avenue Ashland, MA 01721
Re: K133483
Trade Name: Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for OTC use Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP, IME Dated: February 5, 2014 Received: February 7, 2014
Dear Dr. Orton:
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. 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 requirements, including, but not limited to: registration and listing (21
6
Page 2 of 3 - Sharyn Orton, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133483
Device Name
Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC use
Indications for Use (Describe)
The Squid Active Cold Compression device and Cold Pack for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Type of Use (Select one or both, as applicable)
[ ] Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
8
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