(175 days)
The PlasmaFlight is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. This device can be used to:
- Temporarily increase blood circulation in the treated areas;
- Temporary relief of minor muscle aches and pains.
The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.
The provided text describes the 510(k) summary for the device "PlasmaFlight," a portable inflatable tube massager. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical characteristics and compliance with voluntary standards, rather than extensive clinical efficacy studies with specific acceptance criteria and detailed performance claims.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement for ground truth, and MRMC studies are not present in this document. The document's purpose is to show equivalence and safety/effectiveness via design and performance testing against standards, not to prove clinical performance against new acceptance criteria.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to the predicate device.
Here's an attempt to answer your questions based on the provided text, indicating "Not explicitly stated" where the information is not available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria for clinical performance or a reported device performance in terms of efficacy metrics (e.g., specific percentage increase in blood circulation, or reduction in pain levels). Instead, it focuses on demonstrating that the PlasmaFlight's specifications and functions are "Identical or similar" to the predicate device, thereby showing "Substantial Equivalence".
The "acceptance criteria" for this submission would implicitly be that the device's characteristics and performance, as demonstrated through non-clinical tests and comparison, do not raise new questions of safety or effectiveness compared to the predicate device.
Here's a table summarizing the comparisons (which serve as the basis for "acceptance" in a substantial equivalence claim):
| Characteristic / "Acceptance Criteria" (via Equivalence) | Subject Device (PlasmaFlight) Specification | Primary Predicate Device (PowerPlay Muscle Massager) Specification | Equivalence Status |
|---|---|---|---|
| Intended Use | "Temporarily increase blood circulation in the treated areas; Temporary relief of minor muscle aches and pains." | "Temporarily increase blood circulation in the treated areas; Temporary relief of minor muscle aches and pains." | Identical |
| Prescription or OTC | OTC | OTC | Identical |
| Power Source(s) | 5V DC power supply (100-240 VAC input) and 3.7V rechargeable battery | Not publicly available | Identical or similar. "The voltage difference of power supply used does not change the product performance or parameters, which does not raise any new issue of the safety or effectiveness." |
| Battery Charge Time | Approx. 2-5 hours | Not publicly available | Identical or similar. "The difference of charging time does not change the product performance or parameters, which does not raise any new issue of the safety or effectiveness." |
| Internal rechargeable batteries | Yes | Yes | Identical |
| Compliance with Voluntary Standards | Yes (ANSI AAMI ES60601-1, IEC 60601-1-2) | Yes | Identical (for listed types: Electrical Safety, Mechanical Safety, etc.) |
| Functions and Design | Simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. | Simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. | Identical to the Primary Predicate Device |
| Contraindications | Identical to primary predicate | Suspected, active or untreated: Neuropathy, deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, congestive heart failure, thrombophlebitis or an active infection. On a leg where wraps would interfere with conditions (vein ligation, gangrene, dermatitis, open wounds, etc.), insensitive to pain, where increased circulation is undesirable. | Identical |
| Target Population / Intended Users | Users who need temporary increase of blood circulation in the treated area and temporary relief of minor muscular aches and pains. | Users who need temporary increase of blood circulation in the treated area and temporary relief of minor muscular aches and pains. | Identical to the Primary Predicate Device |
| Where Used | Home, Altitude travel, areas of limited mobility | Home, Altitude travel, areas of limited mobility | Identical to the Primary Predicate Device |
| Application | Non-invasive / external | Non-invasive / external | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Identical |
| Basis of Operation | Using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Identical |
| Anatomical Site / Location of Treatment Application | Lower limb(s) (Calf) | Calf, ankle, knee, hip or shoulder | Identical on the calf |
| System Management | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Identical |
| Operating Modes | Two preset modes of 55mmHg | Not publicly available | Identical or similar. "The subject device has the compression pressure within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness." |
| Working Pressure | Preset at approximately 55 mmHg | Adjusted at 30 - 70 mmHg | Identical or similar. "The subject device has the compression pressure within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness." |
| Cycle Time | Approx. 60 seconds/leg (inflation + rest, deflation) | Approx. 30 - 60 seconds/leg (inflation + rest, deflation) | Identical or similar. "The subject device has the cycle time within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness." |
| System Diagnostics | Audible and visual alarms prompt recognition of system faults | Visual alarms prompt recognition of system faults | Identical (implies the subject device meets or exceeds the predicate's fault recognition) |
| Air delivery from pump to cuff bladder | Via flexible plastic tube(s) connected directly to the air bladder | Via flexible plastic tube(s) connected directly to the air bladder | Identical |
| Sterility | Clean / non-sterile | Clean / non-sterile | Identical |
| Leg cuff usage | Single Patient Use | Single Patient Use | Identical |
| Material Used | Air bladder chambers encased in a covering of soft and nonlatex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. | Air bladder chambers encased in a covering of soft and nonlatex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. | Identical or similar |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Software | Moderate | Moderate | Identical |
| Dimensions | 116x65x19mm | Not publicly available | Identical of similar. "The difference of dimensions does not raise any new issue of safety or effectiveness" |
| Weight | Approx. 0.23kg | Not publicly available | Identical or similar. "The difference of weight does not raise any new issue of safety or effectiveness" |
| Temperature | +10 °C (50 °F) to +40 °C (104 °F) | Not publicly available | Identical |
| Humidity | 30%-75% | Not publicly available | Identical |
| Cleaning and Disinfecting | Specified cleaning instructions (soft cloth, soapy water/70% isopropyl alcohol, air dry) | Not publicly available | Identical or similar (compared to the PlasmaFlow, K160318) |
| Disposal | Instructions for electromechanical device disposal including circuit boards and rechargeable batteries; not in landfill, contact local recycle center or ManaMed, Inc. | Not publicly available | Identical or similar (compared to the PlasmaFlow, K160318) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The submission relies on "Non-Clinical Tests" (bench tests) and comparison to the predicate device, not a specific clinical test set involving human subjects to evaluate new performance metrics.
- Data Provenance: Not applicable for clinical data. The "tests" mentioned are non-clinical (bench tests) and compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is a 510(k) submission for a physical therapy device demonstrating substantial equivalence, not an AI/imaging device requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set requiring adjudication in this document.
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. This is not an AI/imaging device, and no MRMC study was conducted or is relevant for this type of submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical therapy device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth," in the context of this submission, is effectively the established safety and effectiveness profile of the legally marketed predicate device and compliance with recognized voluntary standards for medical device safety and performance. There is no "ground truth" derived from expert consensus, pathology, or outcomes data for new clinical claims.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not a machine learning/AI device, so there is no training set or associated ground truth.
Summary of the Study Proving Substantial Equivalence:
The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to the predicate) is primarily a comparative analysis of technical characteristics and non-clinical bench testing.
-
Non-Clinical Tests Performed:
- Design Validation and Conformance with Voluntary Standards:
- ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)" - for electrical safety.
- IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests" - for electromagnetic compatibility.
- Bench Tests: Performed on physical requirements, electrical requirements, and performance requirements.
- Software Verification: Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (as the device uses a microprocessor).
- Design Validation and Conformance with Voluntary Standards:
-
Conclusion: The tests and comparison performed demonstrate that the PlasmaFlight is substantially equivalent to the predicate device, implying it is as safe and effective as the legally marketed predicate device. The minor differences noted (e.g., in power supply details, charging time, dimensions, weight, operating modes, working pressure, cycle time, cleaning, disposal) were deemed not to raise any new issues of safety or effectiveness.
§ 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).