(532 days)
BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including:
- pressure ulcers,
- venous stasis ulcers,
- diabetic ulcers,
- partial and full thickness wounds,
- surgical and traumatic wounds,
- surgicul and other bleeding surface wounds
- dehisced surgical incisions
- draining wounds
- lacerations
- podiatric
- post-laser surgery
The product is supplied sterile and for one-time-use only.
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure.
BIOPAD® is a sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon.
When applied to a wound, BIOPAD® constitutes a barrier for wound against exogenous infective agents.
BIOPAD® is the ideal first-aid means to control minor bleeding.
The device may be used by healthcare professionals.
BIOPAD® is supplied sterile and for one-time use only.
This document is a 510(k) Premarket Notification Summary for the BIOPAD® collagen wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a modern AI/software as a medical device (SaMD) submission would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This submission predates the common expectation for comprehensive performance studies for software-based devices.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: | |
| Biocompatibility: Non-cytotoxic, non-irritant, non-sensitizing. | BIOPAD® was confirmed to be non-cytotoxic, non-irritant, and non-sensitizing according to UNI EN ISO 10993 Part 10. Acute skin irritation and 28-day repeated skin irritation studies (UNI EN ISO 10993 Parts 5 and 10) demonstrated non-irritancy. A reverse mutation study (Ames Test) (UNI EN ISO 10993 Part 3) confirmed it to be non-mutagenic. |
| Non-pyrogenic: Absence of pyrogens. | Bacterial endotoxins tests (LAL) according to USP 27 confirmed BIOPAD® to be non-pyrogenic. |
| Sterility: Sufficiently sterile (e.g., SAL better than 10^-6). | BIOPAD® is supplied sterile and gamma-ray irradiated at a validated dose level, assuring a SAL better than 10^-6. |
| No reported serious adverse effects. | "No side or adverse effects have ever been reported" (though this is based on post-market surveillance/historical data rather than a specific study). |
| Effectiveness: | |
| Ability to control minor bleeding. | BIOPAD® "demonstrated its efficacy in clinical applications to control minor bleeding." |
| Ability to manage wounds (e.g., pressure ulcers, diabetic ulcers, surgical wounds, etc.). | BIOPAD® "demonstrated its efficacy... in the management of wounds." The device is intended for local management of moderately to heavy exuding wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, surgical and traumatic wounds, bleeding surface wounds, dehisced surgical incisions, draining wounds, lacerations, podiatric wounds, and post-laser surgery wounds. When applied, it constitutes a barrier against exogenous infective agents. The 510(k) submission relies on substantial equivalence to predicate devices (HeliDerm, Fibracol Plus, SIS Wound Dressing II) that are already marketed for similar indications. |
| Maintain material, function, intended use, and performance equivalence to predicates. | The submission states BIOPAD® is "substantially equivalent in material, function, intended use and performance to the following commercially available wound dressings..." (listed predicate devices). This is the primary "acceptance criterion" for a 510(k) submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific clinical efficacy studies. The biocompatibility and sterility tests would have used specific sample sizes as per their respective standards, but these details are not provided here.
- Data Provenance: The biocompatibility, mutagenicity, and pyrogenicity tests are laboratory-based. The claim of clinical efficacy for bleeding control and wound management is stated as "demonstrated its efficacy in clinical applications," suggesting some form of clinical observation or studies, but no specifics on study design, sample size, or country of origin are given. For a 510(k), such clinical data is often not required if substantial equivalence can be shown through technological comparison and non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a wound dressing, not a diagnostic AI/SaMD that requires expert consensus for ground truth.
4. Adjudication Method for the Test Set
- Not applicable.
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. This is a wound dressing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical wound dressing, not a software algorithm.
7. The Type of Ground Truth Used
- Biocompatibility/Safety: Measured directly through laboratory assays (e.g., cytotoxicity assays, irritation tests on animal models, bacterial endotoxin tests).
- Efficacy: Stated as "clinical applications" for minor bleeding and wound management. For a 510(k), "ground truth" for efficacy is often established by demonstrating substantial equivalence to legally marketed predicate devices with known efficacy through similar intended use, technological characteristics, and performance data. Specific objective clinical outcome data (e.g., wound healing rates, time to hemostasis) with direct "ground truth" establishment are not detailed here.
8. The Sample Size for the Training Set
- Not applicable. This is a physical wound dressing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
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