PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE

K133483 · Portable Therapeutix · IRP · Mar 11, 2014 · Physical Medicine

Device Facts

• Record ID: K133483
• Device Name: PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
• Applicant: Portable Therapeutix
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device combines intermittent pneumatic compression with cold therapy. Input: user-selected intensity setting (1-30, 2-50, 3-70, or 4-85 mm Hg). Operation: microprocessor-controlled pump inflates garment air bladders to simulate kneading/stroking; exhaust valve manages deflation. Output: mechanical compression and cold application via reusable thermogel pack. Used in home/OTC setting by patient. Healthcare provider/patient uses output to manage minor muscle aches and improve circulation. Benefits: non-invasive relief of minor aches and localized cold therapy.

Clinical Evidence

No clinical data. Evidence consists of bench testing (baseline verification, compression, bladder leak, valve tests, pressure gauge data, shelf life) and a summative usability study validating OTC use by representative users.

Technological Characteristics

Portable pump-controller with pneumatic compressor; AC/DC or lithium battery power. Wrap with air bladder and Velcro attachments; reusable thermogel cold pack. Pressure range 0-85 mm Hg; 4 intensity settings. Microprocessor-based pressure control. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for healthy individuals requiring temporary relief of minor muscle aches and pains, temporary increase in local circulation, and localized cold therapy. Applicable to leg, foot, arm, shoulders, lower back, and hands.

Regulatory Classification

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.

Predicate Devices

• Portable Therapeutix Squid Active Cold Compression Cold Pack (K123829)

Submission Summary (Full Text)

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# MAR 1 1 2014

## Traditional 510(k) Summary as required by 21 CFR 807.92(a) K133483

| A) Submitted by: | Portable Therapeutix<br>4254 Bluebonnet Dr<br>Stafford, TX 77477<br>1-617-331-7524 |
|----------------------------------|-------------------------------------------------------------------------------------------------|
| Contact: | Sharyn Orton, Ph.D.<br>MEDIcept, Inc.<br>200 Homer Ave<br>Ashland, MA 01721<br>401-330-8264 |
| Date prepared: | January 31, 2014 |
| B) Classification Name: | Massager, Powered Inflatable Tube - Product code IRP<br>Pack, Cold, Reusable - Product code IME |
| Common Name: | Powered inflatable tube massager<br>Cold Pack |
| Proprietary Name: | Portable Therapeutix Squid Active Cold Compression device<br>and Cold Pack for OTC Use |
| Device Regulations:<br>and Class | 21 CFR 890.5650, Class II<br>21 CFR 890.5700, Class I 510(k) exempt |
| Product Codes: | IRP; IME |
| C) Predicates: | K123829 Portable Therapeutix Squid Active Cold<br>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.

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The device is manufactured with the following components:

- 1. 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.
- 2. 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.
- 3. 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.

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| | Portable Therapeutix Squid<br>Active Cold Compression device<br>and Cold Pack for OTC Use | Portable Therapeutix Squid<br>Active Cold Compression device<br>and Cold Pack<br>K123829 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | IRP; IME | IRP; IME |
| Indication for<br>Use | The Squid Active Cold<br>Compression device and Cold<br>Packfor OTC use is indicated for<br>the temporary relief of minor<br>muscle aches and pains. | The Squid Active Cold<br>Compression device and Cold<br>Pack is indicated for the<br>temporary relief of minor muscle<br>aches and pains. |
| | The compression device is<br>indicated for temporary increase<br>in circulation of the treated areas<br>in people who are in good health,<br>and simulates kneading and<br>stroking of tissues using an<br>inflatable garment. | The compression device is<br>indicated for temporary increase<br>in circulation of the treated areas<br>in people who are in good health,<br>and simulates kneading and<br>stroking of tissues using an<br>inflatable garment. |
| | The cold pack is indicated for<br>localized therapy in situations<br>where cold temperature therapy<br>is necessary or desirable. | The cold pack is indicated for<br>localized therapy in situations<br>where a physician determines<br>that cold temperature therapy is<br>necessary or desirable. |
| Target | Leg, foot, arm, shoulders, lower back, hands | |
| OTC use | Yes | No |

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| | Portable Therapeutix Squid<br>Active Cold Compression device<br>and Cold Pack | Portable Therapeutix Squid<br>Active Cold Compression<br>device and Cold Pack<br>K123829 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Principle of<br>Operation/<br>Mechanical<br>characteristics | Intermittent compression<br>4 intensity settings (modes)<br>1 – 30 mm Hg<br>2 – 50 mm Hg<br>3 – 70 mm Hg<br>4 – 85 mm Hg | |
| Pressure<br>range | 0 – 85 mm Hg | |
| Total<br>treatment<br>time | 15 minutes | |
| Pressure<br>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,<br>consumption 36W<br>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

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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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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

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