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510(k) Data Aggregation
(323 days)
Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L
The device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Air Pressure Therapy System is a powered inflatable tube massager. The device simulates manual kneading and stroking of tissues by sequential inflated cuffs, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It consists of a main unit, a 4-chamber leg cuff, and an air hose for connecting the unit to the cuff. Only one leg is treated during the treatment process. The cuff inflates and deflates sequentially to apply the pressure on the leg which is controlled by the main unit. Each cuff is equipped with a dedicated air hose. It is to be used by adults.
The FDA 510(k) clearance letter for the Intermittent Pressure Compression System (K242615) does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance (e.g., how effectively it relieves muscle aches or increases circulation). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (K243320) by meeting recognized safety and performance standards relevant to medical devices of its type.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical characteristics to those of the predicate device and highlights regulatory compliance. The acceptance criteria for clearance are primarily based on demonstrating that the subject device is as safe and effective as the predicate device by meeting recognized safety standards and showing that differences in technical characteristics do not raise new safety or efficacy concerns.
| Feature | Acceptance Criteria (Implied from Predicate or Standards) | Reported Device Performance | Substantial Equivalence Discussion |
|---|---|---|---|
| Indications for Use | "To temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health." (Matching Predicate) | "To temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health." | Same |
| Classification | Class II Device, IRP (21 CFR 890.5650) | Class II Device, IRP (21 CFR 890.5650) | Same |
| Mode of Compression | Sequential (Matching Predicate) | Sequential | Same |
| Max/Min Pressure | Within acceptable therapeutic range, safe operation. Predicate: 30-240 mmHg (Tolerance: ±20mmHg) | 20-200 mmHg (Tolerance: ±20mmHg) | Different - "[L]ower than the predicate device, so there is no safety issue concerned and as for the efficacy, it remains valid since its performance has been demonstrated by the performance testing data included in this submission." |
| Number of Chambers | Sufficient for intended compression (Predicate: 6 chambers) | 4 Chambers | Different - "The 'applicable treatment site' and 'usage instructions' of the subject device fall within the same range as the predicate device, these differences do not impact safety and effectiveness." |
| Therapy Time | Suitable for intended use (Predicate: 5-99 mins) | 0-30 min, selection (10, 20, 30min) | Different - "Shorter treatment time enhances the safety of use." |
| Power Source | Safe and effective (Predicate: Rechargeable Li-ion battery, AC input) | 100-240Vac 50/60Hz (main unit) | Different - "The voltage and current of the power supply are the same. The difference in battery specifications will not affect safety." |
| Safety Feature | Power button allows stop therapy session at any time. | Power button on main unit allows stop therapy session at any time. | Same |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 compliance. | Tested and met the requirements of: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. | Met required safety and essential performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "testing was performed and results demonstrated that the Intermittent Pressure Compression System is as safe and effective as the predicate device." However, it does not specify any clinical test set sample size, data provenance, or details of a clinical study to prove efficacy in humans. The testing mentioned refers to compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series), not clinical trials.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
Not applicable. The clearance is based on substantial equivalence to a predicate device and compliance with device safety standards, not on a clinical ground truth established by experts for performance assessment in humans.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a clinical test set or an adjudication method for human performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is more common for diagnostic imaging devices involving human interpretation. The provided document concerns an intermittent pressure compression system, which is a therapeutic device, and does not mention any MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent in its mechanical and electrical operation, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is primarily established by:
- Substantial Equivalence: Comparison to a legally marketed predicate device (K243320) with known safety and efficacy.
- Compliance with Recognized Standards: Meeting international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). These standards serve as the "ground truth" for basic safety and essential performance.
There is no mention of clinical outcomes data, pathology, or expert consensus specific to the subject device's clinical efficacy in the provided document.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
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