(157 days)
The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of:
- Pressure sores
- Diabetic ulcers
- Leg ulcers
- Donor sites and graft sites
- Surgical wounds
- Skin abrasions and lacerations
- 1st and 2nd degree burns
- Trauma wounds
Over-The-Counter Use (21 CFR 801 Subpart C):
- The gel-e Bandage may be used for the management of:
- Minor cuts
- Minor scalds and 1st degree burns
- Abrasions
- Lacerations
Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal.
The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.
The Gel-e Bandage (gel-e, Inc.) K172010 is a medical device and therefore the acceptance criteria are not based on performance metrics such as accuracy or sensitivity, but rather on demonstrating substantial equivalence to a legally marketed predicate device. The study that "proves" the device meets acceptance criteria is a 510(k) Pre-market Notification submission to the FDA, which includes various tests and comparisons to establish substantial equivalence.
Here's the breakdown of how the device meets its "acceptance criteria" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are primarily established through demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance is reported in terms of various testing results compared to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Gel-e Bandage) |
|---|---|
| Intended Use/Indications for Use Similarity | Matches Predicate: The gel-e Bandage has essentially the same intended use/indication for use as the predicate device (KA01 Chitosan Wound Dressing). Both are indicated for management of moderately to heavily exuding chronic wounds and acute wounds, with specific lists of conditions including pressure sores, diabetic ulcers, leg ulcers, donor/graft sites, surgical wounds, skin abrasions, lacerations, and 1st and 2nd degree burns (both prescription and OTC indications). |
| Device Design Similarity | Similar Principle: Single layer, non-woven pad attached to skin-adhesive backing. While the predicate can be cut or folded, the core design principle is similar. |
| Material Similarity | Similar Composition: Composed of a soft, sterile, non-woven palmitoyl-N-acetylglucomasine (chitosan), a cellulosic polymer. The predicate is also a non-woven poly-N- acetylglucosamine (chitosan), a cellulosic biopolymer. |
| Physical Characteristics (Mechanism of Action) | Similar Mechanism: Absorbs wound exudate, forms a gel to maintain a moist environment for optimal wound healing, and allows intact removal. This is identical to the predicate's described mechanism. |
| Sterility | Matches Predicate: 10^6 SAL - Terminally sterilized with gamma radiation, for single use only. |
| Biocompatibility Testing | Acceptable Results: Testing performed for cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity. These results were deemed acceptable to demonstrate substantial equivalence, and covered the same categories as the predicate (cytotoxicity, irritation, sensitization, systemic toxicity) plus pyrogenicity. |
| Performance Testing (Bench Testing) | Acceptable Results: Testing performed for pH, moisture content, absorbency. These results were deemed appropriate and covered the same categories as the predicate. |
| Animal Testing | Acceptable Results: Comparative animal testing was conducted, demonstrating equivalence. |
| Packaging Testing | Acceptable Results: Burst pressure and dye penetration testing were conducted. |
| Sterilization Validation Testing | Acceptable Results: Testing conducted to validate the sterilization process. |
| Shelf-life Stability Testing | Acceptable Results: Real-time shelf-life stability testing was conducted. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample sizes used for the various tests (comparative animal testing, bench testing, biocompatibility, packaging, sterilization validation, shelf-life stability).
The data provenance is from the manufacturer, gel-e, Inc., as part of their 510(k) submission to the FDA. The data is pre-clinical, meaning it was generated in a controlled laboratory setting (bench, animal models) rather than human clinical trials. The country of origin of the data is not explicitly stated but is implicitly the country where gel-e, Inc. operates and where the testing facilities are located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to a 510(k) submission for a wound dressing based on substantial equivalence. The "ground truth" for these tests relates to established scientific methods and pass/fail criteria for biocompatibility, physical properties, etc., not subjective expert interpretation of medical images or patient outcomes. The FDA reviews the testing methodology and results against recognized standards.
4. Adjudication Method for the Test Set
This concept is not applicable to the type of pre-clinical testing described. Adjudication methods like 2+1 or 3+1 typically refer to resolving discrepancies in expert interpretations (e.g., radiologists reviewing images). For the described tests, results are objective measurements (e.g., pH value, absorbency, successful sterilization) or observations (e.g., presence/absence of cytotoxicity) and do not require expert adjudication in that context.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The Gel-e Bandage is a physical wound dressing and does not involve AI or human readers for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone algorithm performance study was not done. As mentioned, this device is a physical wound dressing and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the various tests includes:
- Established scientific standards and specifications: For biocompatibility (ISO standards for cytotoxicity, irritation, etc.), physical properties (pH, moisture content, absorbency), packaging integrity, and sterility (10^-6 SAL).
- Validated animal models: For comparative animal testing, where the "ground truth" would be the observed biological response to the device in comparison to a control or accepted standard.
- Reference predicate device performance: The "ground truth" for substantial equivalence is that the device's performance is comparable to or better than the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. The Gel-e Bandage is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
N/A