(101 days)
LF-400 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.
LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs. The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff). The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).
The provided text describes a 510(k) premarket notification for the LF-400 Compressible Limb Therapy System, which is a medical device for treating various lymphedema and edema conditions. The document focuses on demonstrating substantial equivalence to a predicate device, the LX7 (V7), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them in the way clinical trials or AI performance evaluations usually do.
Based on the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily related to safety, electrical performance, biocompatibility, and software validation, rather than clinical efficacy metrics like sensitivity or specificity. The "reported device performance" refers to the results of these technical tests, which found the device to be satisfactory and substantially equivalent to the predicate.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO10993-5 (Cytotoxicity test) | |
| ISO 10993-10 (LLNA:BrdU-ELISA for sensitization) | ||
| ISO 10993-10 (Animal Skin Irritation test) | Biocompatibility testing was conducted. No specific results are detailed, but the "Overall Performance Conclusions" state "All test results were satisfactory." | |
| Electrical Safety | IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) | Electrical safety testing was conducted in accordance with the standard. The "Overall Performance Conclusions" state "All test results were satisfactory." Device is Class II, Type BF. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2007 | EMC testing was conducted in accordance with the standard. The "Overall Performance Conclusions" state "All test results were satisfactory." |
| Software Validation | Followed FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern (failure would not directly result in serious injury or death). | Software verification and validation testing were conducted and documented as recommended. The "Overall Performance Conclusions" state "All test results were satisfactory." Software version LF400.c V1.0. |
| Functional Equivalence | Device functionality (e.g., pressure range, modes, sequential compression) and indications for use are substantially equivalent to the predicate device (LX7). Tolerances for cuff sizes (± 2cm). Manufacturer Recommended Pressure Range: 60-120mmHg. | LF-400 pressure range: 20-140mmHg, recommended 60-120mmHg. Modes: A, B, C, Pre-Therapy (new mode described as not for therapy but for reducing fatigue). Therapy time: 5-180 minutes. Cuff material: Nylon (same as predicate). All considered satisfactory and substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data (e.g., patient cases). The performance data cited are from technical tests (biocompatibility, electrical safety, EMC, software). These types of tests typically use specific numbers of samples of the device components or the device itself, rather than a "sample size" of patients or data from medical records. The text does not specify the exact number of units or materials tested for these engineering and materials assessments.
Regarding data provenance:
- The submitter, DaeSung Maref Co., Ltd., is located in the Republic of Korea.
- The standards (ISO, IEC, FDA guidance) are international and US-based.
- The tests are implied to be conducted as part of the device development and regulatory submission process, which would typically be prospective for these types of technical evaluations.
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)
This is not applicable to the type of performance data presented. The "ground truth" for technical standards is the standard itself, and the performance is measured against objective criteria within that standard by qualified test engineers/labs, not by a panel of medical experts establishing consensus on patient-specific data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used for expert review of clinical results or imaging data, which are not part of this document's performance section.
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
This is not applicable. The LF-400 is a physical medical device (compressible limb therapy system), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm. Its software validation ensures its control functions operate correctly, but it does not perform diagnostic interpretation or AI-driven decision-making in a "standalone" algorithmic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance data, the "ground truth" is adherence to established international and national standards (ISO, IEC) for biocompatibility, electrical safety, EMC, and FDA guidance for software. These standards define the acceptable parameters and test methodologies.
8. The sample size for the training set
This is not applicable. This device does not use machine learning or AI that would require a "training set" of data. The software components are for control and user interface, verified through traditional software validation methods.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
§ 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).