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 a physician determines that cold temperature therapy is necessary or desirable.

Device Description

The Squid Active Cold Compression device and Cold Pack 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 pre-programmed 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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Portable Therapeutix Squid Active Cold Compression device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Similar Intended Use: To the predicate devices.	The device's intended use is "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 cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable." This aligns sufficiently with the predicate devices which are also indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, simulating kneading and stroking with an inflatable garment.
Similar Target Treatment Areas: To the predicate devices.	Leg, foot, arm, shoulders, lower back, hands. This is largely consistent with the predicate devices which cover leg & foot, feet, arm, neck and shoulders, lower back, back, hands.
Similar Mechanical Intermittent Compression: To predicates.	The device provides intermittent compression with intensity settings (mild, medium, intense, extra intense) and a pressurization pump and exhaust valve. This is explicitly stated as similar to predicate devices. The pressure ranges (mild – 20-30 mm Hg, medium – 40-60 mm Hg, intense – 70 – 80 mm Hg for the predicate; mild – 30 mm Hg, medium – 50 mm Hg, intense – 70 mm Hg, extra intense – 85 mm Hg for the subject device) are considered for "patient comfort only, and differences do not raise new issues of safety or effectiveness."
No New Issues of Safety or Effectiveness: Compared to predicates, even with differences.	The submission concludes that "Pressure intensities are for patient comfort only, and differences do not raise new issues of safety or effectiveness. The addition of a cold pack also does not raise new issues of safety or effectiveness." This statement directly addresses this acceptance criterion. Additional safety aspects, such as electrical safety, are addressed by conformity to IEC 60601-1.
Conformity to IEC 60601-1 (Electrical Safety):	The device "complies with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety."
Bench and EMC Testing Conducted:	The document states, "Bench and EMC testing has been conducted." However, specific results or detailed acceptance criteria for these tests are not provided in the summary.

Study Proving Device Meets Acceptance Criteria:

The "study" conducted to demonstrate the device meets acceptance criteria is a substantial equivalence comparison to predicate devices, as documented in the provided 510(k) summary. This is a common regulatory pathway for medical devices.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable or not explicitly stated in the provided text. The submission relies on a comparison to predicate devices based on their established safety and effectiveness profiles, rather than a separate clinical "test set" for this specific device to demonstrate its intended use. Performance data is primarily from bench and EMC testing, not clinical trials with "test sets" of patients.
Data Provenance: Not applicable in the context of a clinical test set. The data provenance for the comparison itself is from existing 510(k) submissions of predicate devices (K030437 and K112479) and internal bench/EMC testing for the subject device. There is no mention of country of origin for such data or whether it's retrospective or prospective for a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts & Qualifications: Not applicable. This type of information is typically related to diagnostic devices or clinical trials where expert consensus is needed to establish ground truth for a test set. For this device, regulatory experts at Portable Therapeutix (via MEDIcept, Inc.) performed the substantial equivalence comparison and FDA reviewers (Victor Krauthamer, Ph.D., Acting Director, Division of Neurological and Physical Medicine Devices) made the final regulatory determination.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical "test set" requiring adjudication in the context of this 510(k) summary.

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

MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a physical therapy device like the Squid Active Cold Compression device, which does not involve "readers" or "AI assistance" in a diagnostic context.

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

Standalone Performance: Not applicable. This device is a physical therapy device, not an algorithm. Its operation inherently involves human interaction (applying the device, selecting settings).

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices as previously cleared by the FDA. The submission argues that the subject device is substantially equivalent to these predicates, meaning it shares the same fundamental scientific technology, intended use, and does not raise different questions of safety or effectiveness. For aspects like electrical safety, the ground truth is adherence to internationally recognized standards (IEC 60601-1).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set" in the conventional sense. Device development and testing (bench, EMC) would involve engineering samples and prototypes, but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an algorithm.

Summary

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Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

K123829

	Traditional 510(k) Summary
A)Submitted by:	Portable Therapeutix6446 Auden StreetHouston, TX 770051-617-331-7524
Contact:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721401-330-8264
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 device andCold Pack
Device Regulations:and Class	21 CFR 890.5650, Class II21 CFR 890.5700, Class I 510(k) exempt
Product Codes:	IRP; IME
C) Predicates:	K030437 Relaxor Perfect Touch Air Massaging System, Salton, Inc.,product code IRPK112479 DSJ Massager, Mego Afek, product code IRP

D) Device Description:

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.
  l - l

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Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

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

E) Intended Use/Indication for Use:

The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.

The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

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quid Active Cold Compression device and Cold Pack
raditional 510(k) Premarket-Notification Submission

Comparison to Predicate Device(s) (ਮ

Product code	Portable Therapeutix Squid Active Cold Compression device and Cold Pack	Salton, Inc.Relaxor Perfect Touch Air Massaging System	Mego AfekDJS Massager
IntendedUse/Indication forUse	IRP; IMEThe 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 kneeding and stroking of tissues using an inflatable garment. The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.	K030437IRPThe Perfect Touch Air Massaging System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Perfect Touch simulates kneading and stroking of tissues by using an inflatable garment.	K112479IRPThe DJS Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
Target	Leg, foot, arm, shoulders, lower back, hands	Leg & foot, feet, arm, neck and shoulders, lower back, hands	Boot, leg, arm/shoulder

l -3

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Portable Therapeutix
tional 510(k) Premarket-Notification Sub

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Isumption 36W on with TPU backing wr table Therapeutix St
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Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

Substantial Equivalence Discussion

The Portable Therapeutic Active Cold Compression device and Cold Pack has the same intended use, similar target treatment areas, and similar mechanical intermittent compression as the predicate devices. Pressure intensities are for patient comfort only, and differences do not raise new issues of safety or effectiveness. The addition of a cold pack also does not raise new issues of safety or effectiveness.

Performance

No performance standards have been promulgated for this device. Bench and EMC testing has been conducted.

Conformity to Standards

There are no FDA recognized consensus standards for this device.

This device 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

Conclusion

The Portable Therapeutix Squid Active Cold Compression device and Cold Pack is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

April 3,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

Portable Therapeutix LLC % Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave. Ashland, MA 01721

Re: K123829

Trade/Device Name: Squid Active Cold Compression Device and Cold Pack Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: February 27, 2013 Received: February 28, 2013

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. Iisting 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 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.

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Page 2 - Sharyn Orton, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123829

Device Name: Portable Therapeutix Squid Active Cold Compression device and Cold Pack

Indications for Use:

The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.

The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

Prescription Use X X Over-the-Counter Use AND/OR (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) . .

Concurrence of CDRH, Office of Device Evaluation and Safety (ODE)

Victor Krauthamer -S 2013.04.03 17:37:46 -04'00'

Division of Neurological and Physical Medicine Devices 510(k) Number: K123829

3-1

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).