(350 days)
Lympha-Flow(LF1200) 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.
Lympha-Flow(LF1200) is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. Lympha-Flow(LF1200) comprises of 12-step sleeves and accelerates the circulation of body fluid by evenly distributing the pressure to limbs.
This looks like a 510(k) summary for a medical device called Lympha-Flow (LF1200), an intermittent pneumatic compression system. The document focuses on demonstrating substantial equivalence to a predicate device (LX7, K102320), rather than a standalone clinical study to prove effectiveness against explicitly stated acceptance criteria.
However, I can extract information related to performance testing and substantial equivalence, which serves a similar purpose in the regulatory context.
Acceptance Criteria and Reported Device Performance
The document doesn't present explicit "acceptance criteria" in the format of a clinical study goal (e.g., "achieve 90% sensitivity"). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a legally marketed predicate device. The "reported device performance" is primarily the successful completion of these tests and the determination of substantial equivalence.
Here's a table based on the provided text, outlining the performance data submitted:
| Acceptance Criteria Category (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Met: Testing conducted according to ISO10993-5 (Cytotoxicity) and ISO10993-10 (Irritation and Skin Sensitization). |
| Electrical Safety and Performance | Met: Testing conducted according to standard IEC 60601-1:2005 + CORR.1(2006) + CORR(2007). The subject device's basis safety and essential performance are not affected by technical variations between IEC 60601-1 and ANSI/AAMI 60601-1. |
| Electromagnetic Compatibility (EMC) | Met: Testing conducted in accordance with standard IEC 60601-1-2:2007. |
| Software Verification and Validation | Met: Testing conducted and documented as recommended by FDA's guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "minor" level of concern. |
| Substantial Equivalence to Predicate Device (LX7) | Met: The Lympha-Flow(LF1200) Intermittent Pneumatic Compression system is determined to be substantially equivalent to the LX7(V7) predicate device in terms of indications for use, fundamental operating principle, and safety/performance characteristics. Differences in power source, pressure increment, operating time, and number of chambers were evaluated and deemed not to raise new safety concerns or alter fundamental efficacy. |
Study Details (Based on available information)
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" with a specific sample size. The testing described (biocompatibility, electrical safety, EMC, software V&V) is typically performed on a limited number of device units or components, not a patient sample. This is not a study with data provenance in terms of country of origin or retrospective/prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. For technical standard compliance (IEC, ISO, EMC), "ground truth" is established by the successful execution of tests according to the standard's methodology and acceptance criteria. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device. There is no mention of external experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set with human subject data requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for diagnostic imaging devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is a therapy device (pneumatic massager), not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" as typically understood in AI/ML medical devices is not directly applicable. The device's performance is standalone in the sense that its mechanical and electrical functions are tested independently and against standards.
7. The Type of Ground Truth Used:
The "ground truth" here is the adherence to recognized international and national standards for medical devices (ISO, IEC, AAMI, FDA guidance) and the established safety and efficacy profile of the predicate device (LX7(V7), K102320).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-based device that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8).
Summary of Device and Study Type:
The Lympha-Flow (LF1200) is an intermittent pneumatic compression system. The study presented here is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device, LX7). This involves comparing the new device's technological characteristics, indications for use, and performance data (biocompatibility, electrical safety, EMC, software V&V) to those of the predicate device and relevant standards. It is not a clinical trial to establish de novo safety and effectiveness or to demonstrate improvement over human performance. The "acceptance criteria" are implicitly met through compliance with recognized standards and a successful demonstration of substantial equivalence.
§ 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).