(376 days)
SP-1000/2000 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.
Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers which are sequentially inflated from the first air chamber to the fourth chamber. SP-1000 can adjust the pressure values of all chambers at once. The SP-2000 can adjust the pressure value for each channel. This device is composed of a power supply, a pump, a control unit, and a wearable unit. The power applied from the power supply is applied to the pump. And user can adjust the time through time control knob, during which time power is supplied to the air pump. When the set time is over, the pump will stop working. Air pump creates air pressure and transmits it to the Synchro motor. The air delivered to the synchro motor distributes the air to each channel of the sleeve. And there is a pressure control valve between the synchro motor, the user can adjust the pressure of each sleeve through the pressure control knob. The sleeve prevents blood from accumulating by repeatedly applying inflation/deflation to the wearing to the type of the sleeve, it can apply to the leg, lower body, and arm.
The provided text is a 510(k) Summary for the SP-1000 and SP-2000 devices. It states that clinical testing was NOT required to demonstrate substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria, as per the typical structure of an FDA clearance for AI/ML or diagnostic devices that require clinical validation, was not performed.
The document primarily focuses on demonstrating substantial equivalence through:
- Comparison of Indications for Use: Both the proposed devices and the predicate device are indicated for "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."
- Comparison of Technological Characteristics: Similar operating principles (air inflation, 4 chambers), power sources, time settings, pressure ranges, and accessories (leg, arm, body sleeves).
- Non-Clinical Testing: Compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series) and usability.
Since no clinical study was conducted for this 510(k) clearance, I cannot provide details on:
- Acceptance Criteria Table: No clinical acceptance criteria were defined or met through a clinical study.
- Sample Size/Data Provenance: No test set or patient data was used for clinical evaluation.
- Number of Experts/Qualifications: Not applicable as no ground truth was established from clinical data.
- Adjudication Method: Not applicable.
- MRMC Study/Effect Size: Not applicable.
- Standalone Performance: Not applicable.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size: Not applicable as the device is not an AI/ML product and did not involve a training set as understood in AI/ML validation.
- Ground Truth for Training Set: Not applicable.
In summary, the FDA cleared the SP-1000/SP-2000 based on substantial equivalence to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and compliance with relevant non-clinical (electrical safety, EMC, usability) standards, without the need for a clinical study.
§ 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).