(22 days)
The DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions.
The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.
The DYNA-FLEX* Multi-Layer Compression System is a kit that is comprised of one wound dressing component and three bandage layers for the management of venous leg ulcers and related conditions and is packaged in a polyethylene resealable bag. The description of each of these components/bandage layers is as follows:
- The wound dressing component is the ADAPTIC* Non-Adhering Dressing (Sterile). . This non-adherent 5" x 9 " pad is impregnated with a petrolatum emulsion and is packaged in a polyester polyethylene film that is heat sealed prior to sterilization.
- The first bandage layer is the DYNA-FLEX* Layer One (Padding/Absorption Layer). . This polyurethane stretch foam/cotton wrap (non-sterile) is packaged in a polyurethane shrink wrap. Layer One is supplied in a 4" x 156" roll. (unstretched).
- . The second bandage layer is the DYNA-FLEX* Layer Two (Compression Bandage). This non-sterile compression wrap is comprised of absorbent yarns knitted with elastomeric and nylon yarns and is packaged in a polyurethane shrink wrap. Layer Two is supplied in a 4" x 90" roll (unstretched). To assist the healthcare professional in wrapping, this bandage layer is knitted with a rectangle design, such that as the bandage is extended it will change to a square design thus indicating a satisfactory compression range.
- . The third bandage layer is the DYNA-FLEX* Layer Three (Cohesive Compression Bandage). This non-sterile cohesive compression bandage is comprised of a nonwoven . fabric with spandex elastic yarns bonded with a natural rubber cohesive latex based system. Layer Three is supplied in a 4" x 216" roll (stretched).
This 510(k) submission describes the DYNA-FLEX* Multi-Layer Compression System, a medical device intended for the management of venous leg ulcers. The submission focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness through biocompatibility testing and sustained compression data.
Based on the provided text, here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sustained compression for up to seven days at both the ankle and below the knee (when used according to package insert directions). | "Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions." |
| Biocompatibility: Non-sensitizing | "Safety tests conducted in accordance with ISO 10993 Part-1 'Biological Evaluation Of Medical Devices' demonstrate the DYNA-FLEX* Multi-Layer Compression System is non-sensitizing..." |
| Biocompatibility: Non-cytotoxic | "...non-cytotoxic..." |
| Biocompatibility: Non-systemic toxic | "...non-systemic toxic..." |
| Biocompatibility: Non-irritating | "...non-irritating and is suitable for its intended use." |
| Suitable for its intended use (management of venous leg ulcers and related conditions, usable on patients with ankle circumference ≥ 18cm) | The device is indicated for "management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded)." The biocompatibility section also states it is "suitable for its intended use." |
2. Sample size used for the test set and the data provenance
The document states, "testing was done to demonstrate that sustained compression for up to seven days at both the ankle and below the knee was maintained, when used according to package insert directions." However, the specific sample size used for this compression test and the data provenance (e.g., country of origin, retrospective/prospective) are not provided in the submitted text.
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 in the document. The compression data referred to appears to be objective physiological measurements, not expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided in the document, as the "ground truth" for compression data would be objective measurements, not subject to expert adjudication.
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 comparative effectiveness study was done. This device is a physical compression system, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. There is no algorithm or AI component involved. The "standalone" performance would refer to the device's physical function in providing compression. The text indicates that "compression data" was collected to demonstrate this function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the sustained compression criteria, the "ground truth" would be objective physiological measurements of compression (e.g., pressure readings) over time. This is implied by the phrase "Compression data indicates...".
For the biocompatibility criteria, the ground truth was established through standardized safety tests conducted in accordance with ISO 10993 Part-1. These tests typically involve in-vitro and/or in-vivo studies to assess biological responses.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/provided as there is no training set for this device.
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.