(52 days)
The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- Treatment of lymphedema
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is 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, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.
The provided FDA 510(k) summary (K240011) describes the "Lymphedema Compression" device and its substantial equivalence to a predicate device, ManaFlow (K200353).
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly list "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the substantial equivalence relies on demonstrating that the subject device's characteristics and performance are identical to or similar to the predicate device. The primary "acceptance criterion" is functional and technical equivalence to the predicate.
Here's a table based on the comparison provided in the 510(k) summary:
| Feature/Criterion | Acceptance Criteria (Based on Predicate Device: ManaFlow K200353) | Reported Subject Device Performance (Lymphedema Compression) | Equivalence |
|---|---|---|---|
| Intended Use | To provide graduated compression in both sustained and intermittent settings for: Treatment of lymphedema, chronic venous insufficiency, stasis dermatitis/venous stasis ulcers (healing & reducing healing time), reducing edema due to venous stasis, enhancing venous return. For home and hospital use. | Identical to Predicate: To provide graduated compression in both sustained and intermittent settings for: Treatment of lymphedema, chronic venous insufficiency, stasis dermatitis/venous stasis ulcers (healing & reducing healing time), reducing edema due to venous stasis, enhancing venous return. For home and hospital use. | Identical |
| Pressure Setting | Pre-set to 50 mmHg (cannot be adjusted) or adjustable (20-80 mmHg) by physician. | Pre-set to 50 mmHg (cannot be adjusted) or adjustable (20-80 mmHg) by physician. | Identical |
| Prescription/OTC | Prescription | Prescription | Identical |
| Power Source | 5V DC supply (100-240 VAC input) and 3.7V rechargeable battery | 5V DC supply (100-240 VAC input) and 3.7V rechargeable battery | Identical |
| Battery Charge Time | Approx. 4 hours from depleted state | Approx. 4 hours from depleted state | Identical |
| Power Supply (Input/Output) | Input: 100-240 Vac, 50-60 Hz; Output: 5 Vdc @ 2 Amp | Input: 100-240 Vac, 50-60 Hz; Output: 5 Vdc @ 2 Amp | Identical |
| Internal Rechargable Batteries | Yes | Yes | Identical |
| Compliance with Voluntary Standards | Yes (Electrical Safety, Mechanical Safety, Chemical Safety, Thermal Safety, Radiation Safety) | Yes (ANSI AAMI ES60601-1, IEC 60601-1-2) | Identical |
| Functions and Design | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities. | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities. | Identical |
| Contraindications | MUST NOT be used for: Suspected DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection; on legs interfering with: vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity; on any neuropathy; on insentitive extremities; where increased venous/lymphatic return is undesirable. | Identical to Predicate. | Identical |
| Target Population / Users | Patients needing venous return and lymphedema treatment | Patients needing venous return and lymphedema treatment | Identical |
| Where Used | 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 | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Identical |
| Basis of operation | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities. | Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities. | Identical |
| Anatomical Site | Leg (for predicate) | Extremities | Identical or Similar |
| System management | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Identical |
| Operating Modes | Preset and adjustable modes | Preset and adjustable modes | Identical |
| Working Pressure | Preset at 50 mmHg and adjustable from 20-80 mmHg | Preset at 50 mmHg and adjustable from 20-80 mmHg | Identical |
| Cycle Time | Inflation in sequence (foot-up), then deflation; repeats. | Inflation in sequence (foot-up), then deflation; repeats. | Identical |
| System diagnostics | Audible and visual alarms for system faults | Audible and visual alarms for system faults | Identical |
| Air delivery | Via flexible plastic tube(s) connected directly to air bladder. | Via flexible plastic tube(s) connected directly to 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 in soft, non-latex medical fabric or equivalent for comfort/biocompatibility. | Air bladder chambers in soft, non-latex medical fabric or equivalent for comfort/biocompatibility. | Identical |
| Fastening | Snap and screw | Snap and screw | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Software | Moderate | Moderate | Identical |
| Operating Temperature | +10 ℃ (50 ºF) to +40 ºC (104 ºF) | +10 ℃ (50 ºF) to +40 ºC (104 ºF) | Identical |
| Humidity | 30%-75% | 30%-75% | Identical |
| Cleaning and Disinfecting | Specific instructions for pump unit and cuffs; air dry. | Specific instructions for pump unit and cuffs; air dry. | Identical |
| Disposal | Electromechanical device with PCBs and rechargeable batteries; not for landfill; consult local requirements/recycle center. | Electromechanical device with PCBs and rechargeable batteries; not for landfill; consult local requirements/recycle center. | Identical |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."
Therefore, there was no clinical test set of patient data, no sample size of patients, and no data provenance relevant to clinical performance evaluation. The "test set" for the device's technical specifications consists of the individual components and the assembled device that underwent non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Since no clinical testing was performed, there was no ground truth established by experts on patient cases. The evaluation of electrical safety, EMC, and physical/performance requirements relies on adherence to published voluntary standards and internal company specifications, not expert consensus on clinical outcomes.
4. Adjudication method for the test set
Not applicable. As no clinical testing or human reader study was conducted, there was no need for an adjudication method.
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 MRMC study was conducted. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (pneumatic compression) and does not involve an algorithm with standalone performance in the context of diagnostic interpretation. Its "performance" is based on mechanical and electrical parameters (e.g., pressure output, cycle time, safety features).
7. The type of ground truth used
The "ground truth" for this submission is adherence to recognized voluntary standards for medical device safety and performance (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the technical specifications and functional characteristics of the legally marketed predicate device. Bench tests validated that the subject device met its own design specifications, which were shown to be identical or very similar to the predicate.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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).