(112 days)
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 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.
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
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.
§ 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).