K Number
K080383
Device Name
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Date Cleared
2008-05-02

(80 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-the-Counter Use, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection - Partial thickness (second degree) burns - Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness) - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions - Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular) - Traumatic wounds - Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites - Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma - Management of painful wounds - Infected Wounds For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of: - Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers - Surgical wounds (post-operative, donor sites, dermatological) - Partial thickness (second degree) burns - Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions - Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular) - Traumatic wounds - Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites - Management of painful wounds
Device Description
AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection. AQUACEL® Hydrofiber® Wound Dressings are soft, sterile, non-woven pad or ribbon dressings composed of hydrocolloid fibers (sodium carboxymethylcelulose) These conformable and highly absorbent dressings absorb wound fluids and create a soft sel which maintains a moist environment which supports the body's healing process.
More Information

Not Found

No
The device description and performance studies focus on the material properties and clinical outcomes of the wound dressing, with no mention of AI or ML.

Yes
The device is a wound dressing designed to aid in the healing process of various types of wounds, which is a therapeutic function.

No.
The device is a wound dressing designed for the management and healing of various wounds, not for diagnosing medical conditions.

No

The device description clearly states it is a "soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver" or "hydrocolloid fibers (sodium carboxymethylcelulose)", indicating it is a physical dressing, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description and intended use of AQUACEL® dressings clearly indicate that they are topical wound dressings applied directly to the wound surface. They function by absorbing wound fluid, creating a moist environment, providing an antimicrobial barrier (in the case of AQUACEL® Ag), and aiding in debridement. These are all actions performed on the wound itself, not on a sample taken from the body for analysis.
  • Lack of Diagnostic Function: The device does not perform any tests or analyses on biological samples to provide diagnostic information. Its purpose is to manage and protect the wound to facilitate healing.

Therefore, AQUACEL® dressings fall under the category of wound care devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing
For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:

  • Abrasions
  • Lacerations -
  • Minor cuts -
  • Minor scalds and burns -

Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of:

  • Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection
  • Partial thickness (second degree) burns
  • Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness)
  • Surgical wounds left to heal by secondary intention such as dehisced surgical incisions
  • Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular)
  • Traumatic wounds
  • Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites
  • Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
  • Management of painful wounds
  • Infected Wounds

AQUACEL® Hydrofiber® Wound Dressing
For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:

  • Abrasions
  • Lacerations
  • Minor cuts
  • Minor scalds and burns

Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of:

  • Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
  • Surgical wounds (post-operative, donor sites, dermatological)
  • Partial thickness (second degree) burns
  • Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions+
  • Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)
  • Traumatic wounds
  • Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites
  • Management of painful wounds

Product codes (comma separated list FDA assigned to the subject device)

FRO, NAC

Device Description

AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing
AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

AQUACEL® Hydrofiber® Wound Dressing
AQUACEL® Hydrofiber® Wound Dressings are soft, sterile, non-woven pad or ribbon dressings composed of hydrocolloid fibers (sodium carboxymethylcelulose) These conformable and highly absorbent dressings absorb wound fluids and create a soft sel which maintains a moist environment which supports the body's healing process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-Counter Use, Under the direction of a healthcare professional, Under the supervision of a healthcare professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

AQUACEL® hydrofiber dressing has been shown to be safe and effective as a primary dressing on surgical incisions which heal by primary intent. The studies consisted of randomized, controlled, clinical trials in hip, knee and arthroplasty surgeries comparing the use of AQUACEL® / Tegaderm™ to control treatment.

AQUACEL® /Tegaderm™ was used as a primary dressing in hip and knee surgeries compared to control in 183 patients (85 patients were randomized to AQUACEL® / Tegaderm™ and 98 patients to control) and the results demonstrated that AQUACEL® / Tegaderm™ was 5.8 times more likely to result in a wound with no complications than control* (95% CI 2.8-12.5; p

N/A

0

K080383 pag

Revised April 21, 2008

SECTION 5: 510(k) SUMMARY

MAY - 2 2008

AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing

Applicant:

ConvaTec A Division of E. R. Squibb & Sons, LLC 200 Headquarters Park Drive Skillman, New Jersey 08558

Contact:

Marilyn Konickv Associate Director, US and International Regulatory Affairs 908-904-2541 fax: 908-904-2235 email: marilyn.konicky@bms.com

Device:

AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing

Classification Name: Dressing, Wound, Drug

Device Class: Unclassified

Product Code: FRO

Substantially Equivalent Device:

AQUACEL® Hydrofiber® Wound Dressing K943258,K982116,K063271

AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

AQUACEL® Ag dressing is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional. AOUACEL® Ag dressing may be used for more serious wounds such as diabetic foot and leg ulcers, pressure ulcers (partial and full-thickness), surgical wounds or traumatic wounds left to

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Revised April 21, 2008

heal by secondary intent, and partial thickness burns (second degree), wounds that are prone to bleeding, oncology wounds and management of painful wounds.

AQUACEL® Ag Hydrofiber® Dressing is indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that, as a protocol of care, may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria provided by AQUACEL® Ag Dressings support the body's healing process and help reduce the risk of wound infection.

A majority of postoperative surgical incisions are sutured, stapled or glued and are covered with some form of dressing. This first dressing, frequently referred to as the primary dressing, acts to absorb drainage, maintain a clean environment and serve as a barrier against further trauma to the delicate incision surface. Careful selection of nonadherent, absorptive dressings that do not become incorporated within the incision serves greatly to reduce the potential of surgical incision injury, and reduce pain upon dressing change when the time comes for the initial dressing to be removed.

A careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of surgical incisions healing with primary intent. The capacity to absorb, conform and the relative ease of removal are important attributes of AQUACEL® Ag, which probably play an important role in healing by primary intent for surgical wounds. Hydrofiber® dressings absorb fluid directly into the body of the dressing, significantly increasing the volume of fluid that can be absorbed - a process called vertical wicking. This process removes excess exudate from the wound, prevents lateral wicking that can cause maceration of the wound edges, but still maintain a moist environment for wound healing. All the studies which have been reviewed suggest that, compared to standard dressings, using a Hydrofiber® dressing (AQUACEL®) leads to significantly less dressing changes.

In addition, reduction in blister formation, hematoma and edema and decreased pain were observed in some of the studies. It is important to note that a majority of the clinical trials were randomized controlled trials. More importantly, there were no undue safety concerns which were observed in the trials. Although the studies were predominantly in orthopedic surgery, utilization of Hydrofiber® dressings (AQUACEL®) in vascular surgery also has been discussed.

Based on the evidence provided, we propose that Hydrofiber® based products (AQUACEL® dressings and AQUACEL® Ag dressings) can be used safely and effectively as primary dressings on surgical incisions which heal by primary intent. A brief summary of some of the clinical information follows:

AQUACEL® hydrofiber dressing has been shown to be safe and effective as a primary dressing on surgical incisions which heal by primary intent. The studies consisted of randomized, controlled, clinical trials in hip, knee and arthroplasty surgeries comparing the use of AQUACEL® / Tegaderm™ to control treatment. AQUACEL® /Tegaderm™

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Revised April 21, 2008

was used as a primary dressing in hip and knee surgeries compared to control in 183 patients (85 patients were randomized to AQUACEL® / Tegaderm™ and 98 patients to control) and the results demonstrated that AQUACEL® / Tegaderm™ was 5.8 times more likely to result in a wound with no complications than control* (95% CI 2.8-12.5; p