(79 days)
HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding. HeliDerm™ may be used for the management of exudating wounds such as: PRESSURE ULCERS, VENOUS STASIS ULCERS, DIABETIC ULCERS, ACUTE WOUNDS, for example trauma and surgical wounds, PARTIAL-THICKNESS BURNS.
HeliDerm™ Collagen Wound Dressing is a white, absorbent collagen in microfibrillar form for the management of moderately to heavily exudating wounds, and the control of minor bleeding. It provides a physiologically favorable environment that encourages wound healing. When interacting with the wound fluid, it immediately begins to absorb the exudate which may impair tissue regeneration. HeliDerm™ is made from natural materials that contain the proteins that constitute the major building blocks of normal skin and connective tissue. HeliDerm™ protects the wound bed and delicate new tissue. In normal healing wounds, collagen is produced in large quantities by fibroblasts that are recruited to the injured site during the proliferation phase of healing. Collagen and collagen materials may augment fibroblast recruitment and endogenoous collagen production which may encourage and enhance this phase for chronic wounds. The intended use is comparable to absorbent gauze, medical fibers powdered sponges and absorbent heads in that its primary function is to absorb wound exudate. HeliDerm™ is purified bovine flexor tendon collagen. HeliDerm™ can absorb greater than 10 ml of wound exudate and will absorb wound fluids, bacteria, protein products and other microscopic debris that may retard the healing process. In addition, HeliDerm™, being comprised of microfibrillar collagen, is an excellent hemostatic agent which can be used to control minor bleeding. HeliDerm™ is supplied sterile, nonpyrogenic, and for single use in a single blister package.
The provided text describes the 510(k) Premarket Notification for the HeliDerm™ Collagen Wound Dressing. This document is a regulatory submission for a medical device seeking to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo acceptance criteria through a clinical study.
Therefore, the concept of "acceptance criteria" in the context of this document refers to demonstrating that the new device is as safe and effective as selected predicate devices. The "study" isn't a traditional clinical trial with specific performance metrics and statistical significance, but rather a comparison of technological characteristics and safety data to established predicates.
Here's a breakdown based on the information provided, and where information is not present (which is typical for a 510(k) summary relying on substantial equivalence):
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be the characteristics of the predicate devices. The "reported device performance" is the HeliDerm™'s matching or similar characteristics.
| Feature / Acceptance Criteria (from Predicate Device) | HeliDerm™ Collagen Wound Dressing Performance |
|---|---|
| Primary Function: Absorb wound exudate | HeliDerm™'s primary function is to absorb wound exudate. |
| Composition: Collagen (Type I/Bovine Flexor Tendon) | Comprised of Type I collagen from purified bovine flexor tendon. |
| Indications for Use: | |
| - Management of moderately to heavily exudating wounds | Indicated for management of moderately to heavily exudating wounds. |
| - Control of minor bleeding | Indicated for control of minor bleeding. |
| - Specific wound types (Pressure, Venous Stasis, Diabetic, Acute, Partial-thickness burns) | May be used for Pressure Ulcers, Venous Stasis Ulcers, Diabetic Ulcers, Acute Wounds, Partial-Thickness Burns. |
| Biocompatibility: | Non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing. |
| Sterility: | Sterile (Ethylene Oxide). |
| Non-pyrogenic: | Yes. |
| Biodegradable: | Yes. |
| Storage Conditions: | Room temperature. |
| Absorption Capacity (Implied) | Can absorb greater than 10 ml of wound exudate. (Note: A specific comparative criterion from predicates isn't given, but this is a stated capability of HeliDerm™.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study with "test set" and "training set" as understood for AI/ML device approval.
- Data Provenance: The biocompatibility studies cited are likely internal to Integra LifeSciences Corporation or conducted by contract research organizations on their behalf. The source material for the device (purified bovine flexor tendon collagen) is a key aspect. The context is a regulatory submission, not a new clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to a 510(k) submission for this type of device. There isn't a "ground truth" established by experts in the sense of image interpretation or diagnostic accuracy for this wound dressing. The "ground truth" for proving substantial equivalence relies on established properties of the materials and the predicate devices.
4. Adjudication method for the test set
- Not applicable. No "test set adjudication" as would be seen in an AI/ML diagnostic effectiveness study.
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 not an AI/ML device, and no MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices based on regulatory clearances and historical use, combined with standard biocompatibility testing for the new device material.
- Biocompatibility Studies: These studies (Cytotoxicity, Primary Skin Irritation, Pyrogenicity, Sensitization/Maximization, Subcutaneous Implant, Systemic Toxicity, Hemolysis, Intracutaneous Toxicity) serve as the "ground truth" for the safety of the material. They confirm the material's interaction with biological systems is acceptable.
- Substantial Equivalence to Predicates: The core "ground truth" is that the functional claims, material properties, and intended use of HeliDerm™ are comparable to devices already deemed safe and effective by the FDA.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" presented in this K990086 document is a substantial equivalence comparison. The Integra LifeSciences Corporation submitted data demonstrating that the HeliDerm™ Collagen Wound Dressing is as safe and effective as several predicate devices already on the market.
The key elements of this "proof" included:
- Comparison Table (Table 2): A direct comparison of technological characteristics between HeliDerm™ and its identified predicates (hycure®, KALTOSTAT™, VitaChoice®, Chronicure™, Fibracol™) across various features such as indications for use, materials, collagen source, biodegradability, biocompatibility, sterility, and storage conditions. This table highlights the similarities.
- Biocompatibility Studies: A series of standard biological tests were performed on the HeliDerm™ to demonstrate its safety (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing). These studies provide direct evidence of the new device's safety profile, aligning with expectations for such a device.
- Manufacturing Compliance: The device's manufacturing process complies with FDA regulations and European standards for animal tissue sourcing and viral inactivation.
- Historical Context: The submission emphasizes that HeliDerm™ is part of a family of collagen products from Integra LifeSciences with a 17-year history of safety and effectiveness, leveraging the established understanding of collagen's role in wound healing and hemostasis.
The FDA's decision (MAR 3 1 1999 letter) indicates that they reviewed this information and determined the device to be substantially equivalent to legally marketed predicate devices, with specific limitations on labeling claims to prevent misrepresentation beyond what was demonstrated by equivalence. This determination effectively means the device meets the acceptance criteria for market clearance by demonstrating parity with existing safe and effective products.
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