(30 days)
The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation:
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria. Instead, it describes a 510(k) premarket notification for the "PlasmaWave" device, asserting its substantial equivalence to predicate devices (PlasmaFlow and Cirona 6200 Deep Vein Thrombosis Prevention System).
Therefore, I cannot provide all the requested information. However, I can extract what is available regarding acceptance criteria and the methods used to demonstrate substantial equivalence.
Here's a summary based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table (Table 1) between the subject device (PlasmaWave) and two predicate devices (PlasmaFlow, K160318; Cirona 6200, K141578) to demonstrate substantial equivalence. It implies that the "acceptance criteria" are met if the subject device is either identical or sufficiently similar to the predicate devices without raising new issues of safety or effectiveness.
| Feature / Criteria | Subject Device (PlasmaWave) | Primary Predicate Device (PlasmaFlow, K160318) | Predicate Device (Cirona 6200, K141578) | Equivalence / Performance Statement |
|---|---|---|---|---|
| Intended Use | Aid in prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in lower limbs. Aid in DVT prophylaxis for stationary persons. | (Identical statement as Subject Device) | Preventatively to increase venous blood flow in patients at risk of DVT. | Identical (to PlasmaFlow); Similar (to Cirona 6200) |
| Prescription or OTC | Prescription | Prescription | Prescription | Identical |
| Power Source(s) | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical |
| Battery Specifications | 3.7V rechargeable battery | 3.7V rechargeable battery | 10.8V rechargeable battery | Identical or similar. Voltage difference will not raise any new safety/effectiveness issue. |
| Battery Charge Time | ~4 hours (from depleted) | ~4 hours (from depleted) | ~5 hours (from depleted) | Identical or similar. Charging time difference does not change product performance/parameters, will not raise new safety/effectiveness issue. |
| Power Supply | Input: 100-240 Vac, 50-60 Hz; Output: 12 Vdc @ 2 A | Input: 100-240 Vac, 50-60 Hz; Output: 5 Vdc @ 1 A | Input: 100-240 Vac, 50-60 Hz; Output: 14 Vdc @ 2 A | Similar. Voltage difference does not change product performance/parameters, will not raise new safety/effectiveness issue. |
| Internal Recharg. Batt. | Yes | Yes | Yes | Identical |
| Compliance Std. | Yes | Yes | Yes | Identical |
| Safety (Elec, Mech, Chem, Therm, Rad) | Yes | Yes | Yes | Identical |
| Functions and design | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress lower extremities. | (Identical statement as Subject Device) | (Identical statement as Subject Device) | Identical |
| Contraindication(s) | Persons with suspected, active or untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection. On legs where cuffs interfere with: vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity. On any neuropathy. On insensitive extremities. Where increased venous or lymphatic return is undesirable. | (Identical statement as Subject Device) | Severe atherosclerosis or other ischemic vascular diseases, suspected/known acute DVT, severe CHF, existing pulmonary edema/embolisms, extreme limb deformity. Local skin/tissue condition where garments interfere: gangrene, untreated/infected wounds, recent skin graft, dermatitis, known malignancy in legs, limb infections (cellulitis) without antibiotic coverage, lymphangiosarcoma. | Identical (to PlasmaFlow); Similar (to Cirona 6200) |
| Target Population | Patients who need venous return. | Patients who need venous return. | Patients who need venous return. | Identical |
| Where Used | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility. | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility. | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility. | Identical |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | Identical |
| Basis of operation | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress lower extremities. | (Identical statement as Subject Device) | (Identical statement as Subject Device) | Identical |
| Anatomical Site | Lower extremities | Lower extremities | Lower extremities | Identical |
| System management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Identical |
| Pressure Source | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Identical |
| Operating Mode | Continuous Operation | Continuous Operation | Continuous Operation | Identical |
| Working Pressure | Preset at 55 mmHg | Preset at 55 mmHg | Preset at 40 mmHg | Identical (to PlasmaFlow); Similar (to Cirona 6200). Will not raise new safety/effectiveness issue. |
| Cycle Time | Approximately 60 seconds | Approximately 60 seconds | Approximately 60 seconds | Identical |
| System diagnostics | Audible and visual alarms prompt recognition of system faults | Audible and visual alarms prompt recognition of system faults | Audible and visual alarms prompt recognition of system faults | Identical |
| Air delivery from pump to cuff bladder | Via flexible plastic tube(s) connected to the air bladder. | Via flexible plastic tube(s) connected to the air bladder. | Via flexible plastic tube(s) connected to the air bladder. | Identical |
| Sterility | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Identical |
| Leg cuff usage | Single Patient Use | Single Patient Use | Single Patient Use | Identical |
| Material Used | Single air bladder encased in soft, nonlatex, non-woven medical fabric or equivalent, for comfort and biocompatibility. | (Identical statement as Subject Device) | (Identical statement as Subject Device) | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Identical. No issue or concern of biocompatibility due to identical materials/formulation. |
| Software | Moderate | Moderate | Moderate | Identical |
| Dimensions | 220x70x48.5 mm | 116x65x19 mm | 110x180x270 mm | Different. Difference in dimensions does not change product performance/parameters, will not raise new safety/effectiveness issue. |
| Weight | Approx. 0.38kg | 0.23kg | 2.3kg | Different. Difference in weight does not change product performance/parameters, will not raise new safety/effectiveness issue. |
| Temperature | +10 °C (50 °F) to +40 °C (104 °F) | +10 °C (50 °F) to +40 °C (104 °F) | +5 °C (41 °F) to +40 °C (104 °F) | Identical or similar |
| Humidity | 30%-75% | 30%-75% | 15%-93% | Identical or similar |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the sense of patient data used for evaluating the device's clinical performance. The evaluation is based on a comparison to predicate devices and non-clinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of experts establishing ground truth for a clinical test set.
4. Adjudication method for the test set
Not applicable. There is no clinical test set mentioned.
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
Not applicable. The device is a pneumatic compression pump, not an AI-assisted diagnostic or imaging device. There is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. The submission relies on demonstrating substantial equivalence to a mechanically similar predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the purpose of the 510(k) submission, the "ground truth" for "acceptability" is implicitly established by the legally marketed predicate devices. The subject device is deemed acceptable if it can demonstrate substantial equivalence to these predicates without raising new questions of safety or effectiveness. This is supported by:
- Comparison of technical characteristics: Detailed feature-by-feature comparison.
- Compliance with voluntary standards: Adherence to established safety and electromagnetic compatibility standards (ANSI AAMI ES60601-1, IEC 60601-1-2).
- Bench tests: Verification of physical, electrical, and performance requirements.
- Software verification: According to FDA guidelines.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).