(428 days)
The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers
- Diabetic/Neuropathic Ulcers
- Venous Insufficiency Ulcers
- Traumatic Wounds
- Post-Operative and Dehisced Surgical Wounds
- Skin Flap and Grafts
The UNI NPWT Foam Dressing Kit without pump is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The UNI NPWT Foam Dressing Kit includes the (1) foam dressing, (2) occlusive drape and (3) silicon suction dome with (4) negative pressure tubing.
UNI NPWT Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large.
Here's an analysis of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical device called the "UNI NPWT Foam Dressing Kit." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a standalone clinical trial for novel device approval.
It's important to note that for a 510(k) submission, the "acceptance criteria" are often related to demonstrating equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than meeting pre-defined clinical performance metrics for a completely new device.
Based on the provided text, here's the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Material Equivalence: Flexible polyether and polyester polyurethane foam dressing material, hydrophobic. | The UNI NPWT Foam Dressing Kit is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The discussion states both devices use "flexible polyether and polyester polyurethane foam dressing material" and are "hydrophobic." |
| Sterility: Provided sterile. | The discussion states both devices "are provided sterile." Non-clinical tests include "ANSI/AAMI/ISO 11137-2 Sterilization of health care products." |
| Size Variability: Offered in various sizes. | The UNI NPWT Foam Dressing Kit is available in three sizes: small, medium, and large. The discussion states both devices "offer various size dressings." |
| Intended Use: For negative pressure wound therapy. | The UNI NPWT Foam Dressing Kit is intended for use in conjunction with NPWT pumps for the application of negative pressure wound therapy. The discussion states both devices are "used for negative pressure wound therapy" and have the "same indications for use." |
| Mechanical Performance Equivalence: Similar tensile strength, stress (elongation), ultimate elongation, tear resistance, and fluid removal rate compared to the predicate device. | A "mechanical comparative test was conducted between the UNI NPWT Foam Dressing Kit and that of the predicate. The results of these tests demonstrated that the UNI NPWT Foam Dressing Kit is substantially equivalent in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance and fluid removal rate." Non-clinical tests include "ASTM D3574-11 Standard Test Methods for Flexible Cellular Materials - Slab, Bonded, and Molded Urethane Foams." |
| Biocompatibility: Non-toxic, non-irritating, non-sensitizing, and non-pyrogenic. | Non-clinical tests conducted include: ISO 10993-5 Cytotoxicity, ISO 10993-10 Irritation and Sensitization, ISO 10993-11 Tests for Systemic Toxicity, USP 35, NF 30 Bacterial Endotoxins Test (LAL), and USP Pyrogen Test. |
| Sterile Barrier Integrity: Packaging maintains sterility. | Non-clinical tests include: ASTM F88-09 Seal Strength Test and ASTM F1929-98 Dye Penetration Test. |
| Risk Management: Adherence to medical device risk management standards. | Non-clinical tests include: ISO 14971 Medical Devices Application of Risk Management to Medical Devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: Not applicable in the context of a 510(k) non-clinical submission. The document explicitly states: "No clinical study was conducted." The "test set" here refers to samples of the device and predicate device used for mechanical and biocompatibility testing, not patient data.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are based on recognized international (ISO) and national (ASTM, USP) standards. The study is not a clinical study, so terms like "retrospective" or "prospective" clinical data don't apply. It's a non-clinical, laboratory-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no clinical study was conducted, there was no "ground truth" derived from expert consensus for clinical outcomes. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles behind the test methods (e.g., how to measure tensile strength, how to assess cytotoxicity).
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical study involving human assessment or interpretation for which adjudication would be needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance
- Not applicable. This device is a negative pressure wound therapy foam dressing kit, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Not applicable. This device is a dressing kit, not an algorithm or software.
7. The Type of Ground Truth Used
- Non-Clinical Ground Truth: For the mechanical and biocompatibility tests, the "ground truth" is defined by the validated and standardized test methods themselves (e.g., ISO 10993, ASTM F88, USP pyrogen test). The results are compared against these established standards or directly against the predicate device's performance under identical testing conditions. There is no pathology, outcomes data, or expert consensus on clinical findings mentioned to establish a "ground truth."
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no training set exists, no ground truth was established for it.
Summary of the Study:
The study described is a non-clinical comparative study designed to demonstrate substantial equivalence of the UNI NPWT Foam Dressing Kit to a legally marketed predicate device (Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing) per 21 CFR 807.92(a)(6) and 807.92(b)(1). The key findings are:
- Technological Characteristics Comparison: The device shares the same indications for use, uses similar materials (flexible polyether and polyester polyurethane foam), is hydrophobic, sterile, and offered in various sizes as the predicate.
- Non-Clinical Testing: A series of standardized biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, bacterial endotoxins, pyrogen) and physical/mechanical tests (sterilization, seal strength, dye penetration, foam properties) were conducted.
- Mechanical Comparative Test: A specific mechanical comparative test against the predicate demonstrated substantial equivalence in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance, and fluid removal rate.
- No Clinical Study: Importantly, no clinical studies were performed to establish safety or effectiveness directly from patient data. The assertion of safety and effectiveness relies on the demonstrated substantial equivalence to a device already deemed safe and effective.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.