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 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:

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.
1. 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.
1. Reusable thermogel cold pack

AI/ML Overview

The provided text is a 510(k) Summary for the Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC Use. The primary purpose of this 510(k) is to reclassify an existing prescription-use device (K123829) for over-the-counter (OTC) use. Therefore, the "study that proves the device meets the acceptance criteria" largely refers back to the predicate device's clearance information and a specific usability study for the OTC application.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is primarily for reclassifying an existing device to OTC use, the "acceptance criteria" are implied by the substantial equivalence to the predicate device and the specific performance testing performed for the original clearance (K123829), plus a usability study for the OTC shift.

Acceptance Criteria / Performance Aspect	Reported Device Performance (K133483/K123829)
Biocompatibility	Successfully performed and reported in FDA cleared K123829. (Details not provided in this summary).
Electrical Safety/EMC (including batteries)	Successfully performed and reported in FDA cleared K1233829. Complies with: IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical Electrical Equipment Part 1: General Requirements for Safety) and 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). (Details not provided in this summary).
Bench Testing	Successfully performed and reported in FDA cleared K123829. Includes: 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). (Specific numerical acceptance criteria not provided in this summary, but the tests were "successfully performed").
Shelf Life	Successfully performed and reported in FDA cleared K123829 for batteries and gel pack. (Details not provided in this summary).
Reprocessing/Sterilization	The device is reusable and not supplied sterile. Cleaning instructions are included in the Instructions for Use. (Demonstrates acceptable cleaning protocol).
Usability for OTC Use	A summative Usability Study was successfully conducted on representative users for OTC use. Findings from the study served to validate that the device is usable by its intended users. (Specific metrics or pass/fail criteria for usability not detailed, but the study was "successfully conducted").
Intended Use Equivalence	The device has the same indications for use as the predicate, with the addition of OTC use. (No change in functionality for the specified indications).
Mechanical Characteristics	Intermittent compression, 4 intensity settings (1-30 mmHg, 2-50 mmHg, 3-70 mmHg, 4-85 mmHg), pressure range 0-85 mmHg, total treatment time 15 minutes, microprocessor and pressure sensor control, pressurization pump inflation, exhaust valve deflation. These are identical to the predicate device.
Components	Same components as the predicate device (portable external pump-controller, wraps with air bladder, reusable thermogel cold pack), with the addition of alignment markers on wraps/gel pack for user assistance.

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

Test Set (for Usability Study): "representative users for OTC use." The specific sample size is not disclosed in this summary.
Data Provenance: Not explicitly stated, but the submission is to the US FDA, implying an expectation of US-centric or internationally recognized standards. The usability study would have been prospective to evaluate OTC use. The original K123829 performance data would have been generated during the device's development/validation.

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

There is no mention of "experts" to establish ground truth for a test set in the context of medical image analysis or diagnosis. For this device (cold compression massager), the evaluation is against engineering specifications and user comprehension/safety.
For the usability study, "representative users" were involved, not "experts" establishing ground truth in a diagnostic sense.

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

Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert interpretations of data (e.g., medical images). The usability study would likely have involved user observation and task completion rates.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices (e.g., AI-powered image analysis) where the performance of human readers (e.g., radiologists) is compared with and without AI intervention. The Portable Therapeutix Squid is a physical therapy device, not a diagnostic tool where "human readers" are involved in interpretation.

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

This is not applicable to the Portable Therapeutix Squid device. There is no "algorithm" in the sense of AI or image processing being evaluated in a standalone mode. The device's function is mechanical compression and cold therapy. Its "standalone performance" refers to its ability to meet engineering specifications (e.g., pressure output, safety). These were part of the bench testing for K123829.

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

For K123829 (Predicate device performance): The ground truth was based on engineering specifications, safety standards compliance (e.g., electrical safety), and the successful execution of various bench tests (e.g., pressure verification, leak tests, shelf life).
For K133483 (OTC Usability): Ground truth was established by demonstrating that representative lay users could safely and effectively operate the device and understand its instructions for use without professional guidance. This typically involves observing task completion, questionnaire responses, and identifying critical use errors.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that requires a "training set" in that context. The "training" for the device's function would be its design, manufacturing, and calibration processes.

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

Not applicable, as there is no "training set" in the machine learning sense for this device.

Summary

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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 Therapeutix4254 Bluebonnet DrStafford, TX 774771-617-331-7524
Contact:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721401-330-8264
Date prepared:	January 31, 2014
B) Classification Name:	Massager, Powered Inflatable Tube - Product code IRPPack, Cold, Reusable - Product code IME
Common Name:	Powered inflatable tube massagerCold Pack
Proprietary Name:	Portable Therapeutix Squid Active Cold Compression deviceand Cold Pack for OTC Use
Device Regulations:and Class	21 CFR 890.5650, Class II21 CFR 890.5700, Class I 510(k) exempt
Product Codes:	IRP; IME
C) Predicates:	K123829 Portable Therapeutix Squid Active ColdCompression Cold Pack

D) Device Description:

6-1

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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.
1. 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.
1. 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 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 SquidActive Cold Compression deviceand Cold Pack for OTC Use	Portable Therapeutix SquidActive Cold Compression deviceand Cold PackK123829
Product code	IRP; IME	IRP; IME
Indication forUse	The Squid Active ColdCompression device and ColdPackfor OTC use is indicated forthe temporary relief of minormuscle aches and pains.	The Squid Active ColdCompression device and ColdPack is indicated for thetemporary relief of minor muscleaches and pains.
	The compression device isindicated for temporary increasein circulation of the treated areasin people who are in good health,and simulates kneading andstroking of tissues using aninflatable garment.	The compression device isindicated for temporary increasein circulation of the treated areasin people who are in good health,and simulates kneading andstroking of tissues using aninflatable garment.
	The cold pack is indicated forlocalized therapy in situationswhere cold temperature therapyis necessary or desirable.	The cold pack is indicated forlocalized therapy in situationswhere a physician determinesthat cold temperature therapy isnecessary or desirable.
Target	Leg, foot, arm, shoulders, lower back, hands
OTC use	Yes	No

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	Portable Therapeutix SquidActive Cold Compression deviceand Cold Pack	Portable Therapeutix SquidActive Cold Compressiondevice and Cold PackK123829
Principle ofOperation/Mechanicalcharacteristics	Intermittent compression4 intensity settings (modes)1 – 30 mm Hg2 – 50 mm Hg3 – 70 mm Hg4 – 85 mm Hg
Pressurerange	0 – 85 mm Hg
Totaltreatmenttime	15 minutes
Pressurecontrol	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 36WLithium 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 (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

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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 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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Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).