(199 days)
LX7(V7) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
LX7(V7) is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
The provided text describes a 510(k) premarket notification for a medical device called the "Compressible Limb Therapy System LX7(V7)". This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints. Therefore, a direct table of acceptance criteria and reported device performance, as typically seen in efficacy studies, is not applicable or present in this document.
The core of this submission is a comparison of the new device (LX7(V7)) to two predicate devices (Lympha Press Plus and WHF-324 (POWER-Q1000 Plus)) to demonstrate that it is "as safe and effective". The "Performance Characteristics" section lists various standards the device applied and conducted tests to, which are related to safety and quality management, but it does not detail specific performance metrics or their acceptance thresholds.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, the document does not present quantitative acceptance criteria or numerical performance data of the LX7(V7) in the way one would expect from an efficacy study. Instead, substantial equivalence is established by comparing the new device's features, intended use, and adherence to safety standards with those of legally marketed predicate devices.
The table below summarizes the comparison between the LX7(V7) and its predicate devices, which serves as the basis for the substantial equivalence determination rather than a direct performance acceptance criteria table.
| Feature | LX7(V7) | Lympha Press Plus (Predicate 1) | WHF-324 (POWER-Q1000 Plus) (Predicate 2) |
|---|---|---|---|
| K Number | None yet (being applied for) | K013331 | K100656 |
| Classification | Class II Device / IRP (21 CFR 890.5650) | Class II Device / JOW (21 CFR 870.5800) | Class II Device / IRP (21 CFR 890.5650) |
| Intended Use | Intended for use by medical professionals and patients at home, under medical supervision, in treating: Primary lymphedema, Edema following trauma and sport injuries, Post-immobilization edema, Venous insufficiencies, Lymphedema. | Treatment of Lymphatic disorders, Venous disorder, Post-mastectomy Lymphedema and Dysfunction of the Muscle Pump. | Intended for use by medical professionals and patients at home, under medical supervision, in treating: Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema. |
| Standards Applied | EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2 | EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2 | EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2 |
| Indications | Primary lymphedema, Edema following trauma and sport injuries, Post-immobilization edema, Venous insufficiencies, Lymphedema. | - (Listed under Intended Use) | Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema. |
| Mode of Compression | Sequential | Sequential | Sequential |
| Mode description | 2 modes | 2 modes (Lympha, Gradient12, Wave, Ballancer, and Pre-Therapy) | 1 mode |
| Power Source | 230 V~, 50/60 Hz; 35W | 230 V~, 50/60 Hz | 220~240V 50/60Hz; 25 watts |
| Therapy Time | 0-30 minutes | 0-10 minutes | 0-30 minutes |
| Max/Min Pressure | 0-230mmHg | 0-200mmHg | 0-235mmHg |
| Number of Chambers | 4 to 8 chambers | 12 chambers | 4 to 8 chambers |
| Compression Cycle Time | 30 min | 30 min | 30 min |
| Garment Sleeve Material | Nylon | - | Nylon |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" in the context of evaluating diagnostic or predictive performance. Instead, it relies on bench and laboratory testing against established safety and quality standards to demonstrate the device's characteristics. Therefore, information on sample size and data provenance for a test set in a performance study is not applicable. The data provenance for the device is from Korea (manufacturer Daesung Maref Co., Ltd.). The study described is a premarket notification for substantial equivalence, not a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because the submission is not based on a clinical study where expert-established ground truth would be necessary for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set data requiring adjudication is presented.
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 'Powered Inflatable Tube Massager' without AI components or diagnostic capabilities that would involve human readers interpreting images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to compliance with recognized international and national standards for medical device safety and quality. The device demonstrated conformance to standards such as:
- Council Directive 93/42/EEC (medical devices)
- IEC 980:2003 (graphical symbols)
- IEC1041:1998 (information supplied by manufacturer)
- ISO 13485:2003 (quality management systems)
- ISO 14155-1:2003 (clinical investigation, Part 1: General requirements - this standard specifies requirements for the design, conduct, recording, and reporting of clinical investigations performed on human subjects to assess the clinical performance or safety of medical devices. Its mention here suggests the potential for clinical investigations, but the document itself doesn't detail one.)
- ISO 14971:2007 (risk management)
- IEC 60601-1 (general requirements for safety)
- IEC 60601-2-10 (safety of nerve and muscle stimulators)
- IEC 60601-1-2 (electromagnetic compatibility)
The "ground truth" for the substantial equivalence claim is that the device's characteristics and performance are comparable to (i.e., "as safe and effective as") the predicate devices, which have already been cleared by the FDA.
8. The sample size for the training set
Not applicable, as there is no mention of an algorithm or machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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).