(90 days)
The LiteWalk is intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied.
The LiteWalk is a pneumatic sequential foot compression device, designed primarily for temporary improvement in blood flow circulation in the lower limb. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC. The unit is connected through 2 sets of 4-tubes to 2 inflatable sandals. Each sandal has 4 inflatable pressure chambers, located to match the foot anatomy: heel, arch, metatarsals, and toes. The sandals come in a pair, for right and left feet, and in 3 sizes: small, medium, large. The operation is based on sequential inflation of the 4 chambers, from heel to toes.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "LiteWalk." It focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. Crucially, the document explicitly states there was "No clinical study was conducted to support this application." Therefore, there is no information in this document regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria.
The information provided primarily relates to comparisons with a predicate device and compliance with general safety standards.
Here's a breakdown of the specific points requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
No clinical performance acceptance criteria or reported device performance for clinical outcomes are mentioned, as no clinical study was conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications. A summary table of technical comparison is provided in the document:
| Specification | LiteWalk | PPCID | Differences discussion |
|---|---|---|---|
| 510(k) number | Proposed Device | K000655 | NA |
| Manufacturer | VIASONIX LTD. | Medical Dynamics LLC | NA |
| Product Regulation | 21CFR890.5650 - Powered inflatable tube massager | 21CFR890.5650 - Powered inflatable tube massager | Identical |
| Product Code | IRP - Powered inflatable tube massager | IRP - Powered inflatable tube massager | Identical |
| Indications for use | Intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied | Intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied | Identical |
| Contraindications | Use of the LiteWalk is contraindicated in patients for whom: | ||
| • Presumptive evidence of congestive heart failure where increase in blood returned to the heart could be detrimental | |||
| • Pre-existing deep vein thrombosis (DVT) or blood clots | |||
| • Existing hemorrhagic disease or coagulation problems | |||
| • Thrombophlebitis | |||
| • Pulmonary embolism | Use of the PPCID is contraindicated in patients for whom an increase in blood returned to the heart could be detrimental, including those with presumptive evidence of congestive heart failure, pre-existing deep vein thrombosis, thrombophelbitis, existing hemorrhagic disease, coagulation problems, or pulmonary embolism | Identical | |
| Environment of Use | Hospital and Home care | Hospital and Home care | Identical |
| Rx OR OTC | OTC | OTC | Identical |
| Mode of compression | Sequential | Sequential *Not publicly available | Similar to the predicate |
| Use Time [min] | Recommended 30 min | 30 min or more *Not publicly available | Similar to the predicate |
| Sequential cycles time | 2-3 cycles per minute | 2-3 cycles per minute *Not publicly available | Similar to the predicate |
| Modes | 1 mode : Sequential inflation/deflation of 4 chambers from heel to toes | 1 mode : Sequential inflation/deflation of 4 chambers from heel to toes *Not publicly available | Similar to the predicate |
| Specification | LiteWalk | PPCID | Differences discussion |
| Max Pressure | 160 mmHg | 80-200 mmHg *Not publicly available | Similar to the predicate. Within the predicate pressure range |
| Types of Garments | Foot Sandal | Foot Sandal *Not publicly available | Similar to the predicate. Foot Sandal type is supported by the predicate device |
| Garment sizes | 3 sizes: small, medium, large | 3 sizes: small, medium, large *Not publicly available | Similar to the predicate |
| Patient contact materials | Polyester [PVB0123, Colored Fabric] | Not known *Not publicly available | Similar to the predicate. Both sharing a fabric for the Sandals. LiteWalk Polyester skin contact material comply with ISO 10993 |
| Patient contact | Non conductive | Non conductive *Not publicly available | Similar to the predicate |
| Number of chambers | 4 | 4 *Not publicly available | Similar to the predicate |
| Line Voltage / Frequency | 100-240 Vac / 50-60Hz 12V , 2.0A | 115 Vac / 60 Hz, 7W *Not publicly available | Similar to the predicate |
| Power Consumption | 8 W | 7W *Not publicly available | Similar to the predicate |
| Safety feature | Power button on main unit allows user to stop therapy session at any time. | Power button on main unit allows user to stop therapy session at any time. *Not publicly available | Similar to the predicate |
| User Interface | No | No *Not publicly available | Similar to the predicate |
| Indicator | Green led | Led *Not publicly available | Similar to the predicate |
| Technology | Compressor and valve system which sequentially inflates inflatable chambers | Compressor and air distributor system which sequentially inflates inflatable chambers *Not publicly available | Both sharing the same functionality. The valve allows better control over inflation and allows quick deflation. This slight change doesn't impact product safety and performance. |
| Standards | IEC 60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-1-11 | |||
| ISO 10993-1 | IEC 60601-1 | ||
| IEC60601-1-2 | |||
| ISO 10993-1 | |||
| *Not publicly available | Similar to the predicate. The LiteWalk meets all latest standards edition |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical study or test set data for clinical performance was used. The evaluation was based on non-clinical performance (bench tests, verification of specifications, software validation) and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study that would require expert-established ground truth was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study that would require adjudication was conducted.
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 LiteWalk is a pneumatic sequential foot compression device, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The LiteWalk is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study was conducted. The "ground truth" for the substantial equivalence determination relied on demonstrating that the device's technical specifications and safety performance (through non-clinical testing and standard compliance) are comparable to the legally marketed predicate device.
8. The sample size for the training set
Not applicable, as no clinical study involving training data was conducted.
9. How the ground truth for the training set was established
Not applicable, as no clinical study involving training data was conducted.
§ 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).