For Over - the - Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for the management of: leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), second degree burns. Aquacel may also be used for: management of surgical or traumatic wounds that have been left to heal by secondary intention, local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds, the management of painful wounds.

Device Description

AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the AQUACEL® Hydrofiber® Wound Dressing, based on the provided text:

Acceptance Criteria and Device Performance for AQUACEL® Hydrofiber® Wound Dressing

Unfortunately, the provided text does not explicitly state quantitative acceptance criteria for pain reduction. The studies described are comparative, aiming to show that AQUACEL® performs equally well or better than other dressings in terms of pain management. Therefore, the "acceptance criteria" are implied to be demonstrating comparable or superior performance to existing wound dressings.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (AQUACEL®)
Pain on Dressing Change:
- Comparable/Superior to Kaltostat® for leg ulcers	Leg Ulcers (Study 1): 76% no pain, 20% mild pain, 3% moderate pain on dressing change (Kaltostat®: 83% no pain, 13% mild pain, 4% moderate pain) - Comparable
- Comparable/Superior to Alginate for leg ulcers	Leg Ulcers (Study 2): 65% no pain, 16% mild pain, 3.4% moderate pain on dressing removal (Alginate: 62% no pain, 14% mild pain, 4% moderate pain) - Comparable
- Superior to Saline Gauze for pressure ulcers	Pressure Ulcers (Study 3): 82% rated dressing removal as excellent or good (54% excellent, 28% good) (Gauze: 24% excellent or good (7% excellent, 17% good)) - Superior
- Comparable/Superior to Alginate for acute surgical wounds	Acute Surgical Wounds (Foster, et al.): 92% no or mild pain at first dressing change; 84% pain-free on post-operative day 7 (Alginate: 80% no or mild pain at first dressing change; 58% pain-free on post-operative day 7) - Superior
- Superior to Paraffin Gauze for split-thickness donor sites	Split-Thickness Donor Sites (Barnea, et al.): Significantly lower pain scores at all evaluation points (p-values 0.0001 (day 1) to 0.03 (day 15)) - Superior
- Superior to Silver Sulphadiazine for partial-thickness burns	Partial-Thickness Burns (Kogan, et al.): At 30-min assessment: pain reduced to 6.1 (AQUACEL®) vs 6.9 (Silver Sulphadiazine) on day 1-2; pain reduced to 5.2 (AQUACEL®) vs 5.6 (Silver Sulphadiazine) on day 5. Authors concluded superior pain relief.
Pain while Dressing in situ:	Explicit quantitative data for "pain while dressing in situ" is not extracted as readily as "pain on dressing change." The studies generally support the claim that the gelling action "reduce wound pain while the dressing is in situ." The superior pain relief during dressing changes implies better patient comfort overall.
Non-traumatic Removal:	Implied by "ease of removal" and "without damaging newly formed tissue" due to gel formation. The pain reduction during removal directly supports this.
Moist Wound Environment:	Implied by Hydrofiber® technology forming a "clear, cool gel on contact with wound exudate."
Patient Comfort:	Generally supported by reductions in pain during wear and removal.

2. Sample Sizes Used for the Test Set and Data Provenance:

Study/Report	Sample Size (Test Set)	Data Provenance	Test Set Description (if applicable)
ConvaTec Studies:
1. Leg Ulcers (moderately/heavily exudating)	44 patients	Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified, but ConvaTec is a US company.	21 managed with AQUACEL®, 23 with Kaltostat®. Mean age 68.1 years, 82% venous etiology, 89% shallow ulcer depth, median duration 10 months.
2. Leg Ulcers (multicenter)	40 patients	Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified.	20 managed with AQUACEL® (269 dressing changes), 20 with alginate (227 dressing changes). Majority male (80%), average age 63 years.
3. Pressure Ulcers (Stage III/IV)	85 patients	Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified.	43 with AQUACEL® (536 dressing changes), 42 with moist saline dressing/gauze (500 dressing changes). Moderately or heavily exudating.
Published Reports:
1. Acute Surgical Wounds (Foster, et al.)	100 patients	Prospective, randomized, controlled; published in peer review journal. Location not specified.	Randomized to receive either AQUACEL® or alginate dressing.
2. Split-Thickness Donor Sites (Barnea, et al.)	23 adult patients	Prospective, comparative; published in peer review journal. Location not specified.	Each patient used both AQUACEL® and paraffin gauze, with half the donor site covered by each.
3. Partial-Thickness Burns (Kogan, et al.)	22 patients	Prospective; published in peer review journal. Location not specified.	11 patients treated with AQUACEL®, 11 with silver sulphadiazine. Patients aged 1.5 to 41 years.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The ground truth for pain assessment in these studies is primarily patient-reported pain scores (e.g., "no pain, mild pain, moderate pain," "analogue scale," "visual analogue scales") and, in one instance, observation of behavior for non-verbal children.

The text does not specify a number of "experts" used to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the patients themselves provided the primary data for pain perception. Clinicians involved in the studies would have been healthcare professionals managing wounds, but their role was in administering the treatments and collecting patient data, not acting as independent adjudicators of the "truth" of pain.

4. Adjudication Method for the Test Set:

There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for the "test set" in the context of pain assessment. As noted above, the "ground truth" for pain is directly reported by the patient. For observational assessments (e.g., for non-verbal children), the text doesn't specify if multiple observers were used or if a consensus method was employed. The studies are described as "controlled" and "randomized," indicating rigorous design for comparing treatments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Based on the provided text, there is no MRMC comparative effectiveness study described for human readers improving with AI vs. without AI assistance. The device is a wound dressing, and the studies focus on its clinical performance in pain management, not on AI-assisted diagnostic or interpretative tasks.

6. Standalone (Algorithm Only) Performance:

This question is not applicable as AQUACEL® is a physical wound dressing and not an algorithm or AI-powered device.

7. Type of Ground Truth Used:

The primary type of ground truth used is patient-reported outcomes, specifically:

Subjective pain assessment: Rated by patients as "no pain, mild pain, moderate pain," or using "analogue scales" and "visual analogue scales."
Behavioral observation: For non-verbal children, pain was assessed by observation of behavior.

8. Sample Size for the Training Set:

The provided text does not describe a "training set" in the context of machine learning or AI. The studies are clinical trials comparing the dressing's performance against other dressings or standard care. Therefore, there's no distinction between a "training set" and "test set" in the AI sense for this product. The sample sizes mentioned above (e.g., 44, 40, 85 patients in ConvaTec studies, 100, 23, 22 in published reports) represent the total patient cohorts for these clinical performance studies.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" in the AI sense, this question is not applicable. The ground truth for pain assessment in the clinical studies was established directly from patient reporting or observation, as described in point 7.

Summary

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SECTION 5: 510(k) SUMMARY

AQUACEL® Hydrofiber® Wound Dressing

APR 1 6 2007

Applicant:	ConvaTecA Division of E. R. Squibb & Sons, LLC200 Headquarters Park DriveSkillman, New Jersey 08558
Contact:	Marilyn KonickyAssociate Director, US and International Regulatory Affairs908-904-2541fax: 908-904-2235email: marilyn.konicky@bms.com
Device:	AQUACEL® Hydrofiber® Wound Dressing
Classification Name:	Dressing, Wound, Hydrophilic
Product Code:	NAC
Device Class:	Class I
Substantially Equivalent Device:	MEPITEL® Non Adherent Silicone DressingK984371

AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).

AQUACEL® dressing is indicated for the management of wounds and can be used overthe-counter for minor wounds such as abrasions, lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional AQUACEL® dressing may be used for more serious wounds such as leg ulcers, pressure ulcers (Stages II-IV), diabetic ulcers, surgical wounds, donor sites, second degree burns, and wounds that are prone to bleeding. AQUACEL® may also be used for management of surgical or traumatic wounds that have been left open to heal by secondary intention.

AQUACEL® dressing is also indicated for the management of painful wounds. This management of painful wounds is due to the Hydrofiber® technology of AQUACEL® dressing, which forms a clear, cool gel on contact with wound exudate. The gel also assists in the non-traumatic removal of the dressing without damaging newly formed tissue.

ConvaTec, A Division of E.R. Squibb and Sons, L.L.C.

Page 1 of 7

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ConvaTec has conducted three prospective, controlled, randomized studies with AQUACEL® dressings and one similar study with AQUACEL® Ag dressings and has reviewed the literature for published reports. Data from these four ConvaTec studies and from three published studies cover various aspects of wound management including the level of pain while the dressing is in situ, and the measurement of pain during dressing changes. These studies support the management of painful wounds indication. In addition, the studies also support the claim that the gelling action of Hydrofiber® technology in the dressings reduce wound pain while the dressing is in situ, and helps reduce the pain and trauma upon dressing removal.

Regardless of the dressings used (AQUACEL® or AQUACEL® Ag) in each study, these studies are mutually supportive for each product for the management of painful wounds indication because both dressings incorporate Hydrofiber® technology. The only difference between the two dressings is the ionic silver in AQUACEL® Ag, which is included for microbial protection.

Hydrofiber® technology has a gelling action that absorbs and retains wound exudate. Unlike alginate dressings and gauze, the gelling fibers in dressings with Hydrofiber® technology absorb fluid within the structure of the fibers, thus forming a cohesive gel. The gel forms a moist wound environment that provides patient comfort during wear and ease of removal during dressing changes.

For AQUACEL® dressings, three clinical prospective, comparative, randomized studies conducted by ConvaTec are summarized in this section. Two studies compared the performance of the product in the management of leg ulcers and one study evaluated the dressing performance in the management of pressure ulcers. In addition to these clinical studies, three published studies from peer review journals are summarized, which provide data from prospective, randomized, controlled studies in patients with acute surgical wounds, split-thickness donor sites and partial-thickness burns.

Clinical Performance Studies

One study involved the management of moderately to heavily exudating leg ulcers. Forty-four patients were recruited and patients remained in the study for a maximum period of 6 weeks, or to healing, or when the level of exudates decreased to "low." Of the 44 patients recruited, 21 were managed with AQUACEL® and 23 with Kaltostat® Dressings. The mean age was 68.1 years. The etiology was venous for 82% of patients and for 89% of the patients, the ulcer depth was shallow. The median duration of the ulcers was 10 months. No pain, mild pain and moderate pain on dressing change was rated by 76%, 20% and 3% of AQUACEL® patients, respectively. For the Kaltostat treated patients, the results were 83% reporting no pain, 13% reporting mild pain and 4% reporting moderate pain.

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Another study was a multicenter study in the management of leg ulcers. Twenty patients were managed with AQUACEL® dressings and 20 with an alginate dressing. The majority of the patients enrolled were male (80%) and the average age was 63 years. The performance of both dressings was compared including pain upon dressing removal. The results are based on 269 dressing changes for AQUACEL® and 227 dressing changes for the alginate dressing. For the AQUACEL® group, 65% of patients reported no pain on dressing removal, 16% reported mild pain and 3.4 % reported moderate pain versus 62% reporting no pain, 14% reporting mild pain and 4% reporting moderate pain on removal of the alginate dressing.

The third study evaluated the performance of AQUACEL® by comparing it to a moist saline dressing in patients with pressure ulcers. Eighty-five patients with moderately or heavily exudating Stage III or IV pressure ulcers were enrolled. The AQUACEL® dressing group consisted of 43 patients and a total of 536 dressing changes while the gauze group consisted of 42 subjects and a total of 500 dressing changes. The duration of the study was a minimum of 10 days and a maximum of 28 days. For pain on removal, the dressing was rated as excellent or good by 54% and 28% of the patients treated with AQUACEL®, respectively. Only 7% of patients treated with the gauze dressing rated the dressing as excellent while 17% rated the gauze dressing as good for pain on removal.

Published Reports

Foster, et al conducted a study comparing AQUACEL® and an alginate dressing in patients with acute surgical wounds. One hundred patients were randomized prior to surgery to receive either AQUACEL® or the alginate dressing. No or mild pain was experienced at the first dressing change by 92% of the AQUACEL® managed patients and 80% of the alginate managed patients. On postoperative day 7, 84% of the AQUACEL® patients were pain free while only 58% of the alginate patients were pain free.

Barnea, et al published results of a prospective, comparative study in the management of split-thickness skin graft donor sites. Twenty-three (23) adult patients were treated with both AQUACEL® and paraffin gauze with half the donor site covered with AQUACEL® and the other half with paraffin gauze. Local pain was assessed using an analogue scale and pain was measured on days 3, 7, 10 to 14, and when the dressing fell off. Pain scores at all evaluation points were significantly lower for AQUACEL® compared to paraffin gauze with the p values ranging from 0.0001 on day 1 to 0.03 on day 15. The authors note that AQUACEL® dressing forms a highly absorbent gel, which allows ease of removal, reduces trauma during dressing changes and provides a moist wound/dressing interface that protects nerve endings.

In a published report of a prospective study in patients with partial-thickness burns by Kogan, et al, patients (1.5 to 41 years) were treated with either AQUACEL® (n=11) or

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with silver sulphadiazine (n=11). Pain was assessed during dressing change and a halfhour later using visual analogue scales for adults and children over the age of 7 years, and for non-verbal children, pain was assessed by observation of behavior. On days J and 2, pain intensity was high (8-9 points) in children and adults in both groups. At the halfhour assessment, pain was reduced to 6.1 in the AQUACEL® group and 6.9 in the silver sulphadiazine group. On day 3, pain intensity began to decline and by day 5, pain intensity was about 7-8 points in both groups and at the half-hour assessment, pain intensity was 5.2 for the AQUACEL® group and 5.6 for the silver sulphadiazine.group. The authors concluded that the pain relief effect of AQUACEL® was superior to gilver sulphadiazine.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConvaTec % Ms. Marilyn Konicky Associate Director, Regulatory Affairs 200 Headquarters Park Drive Skillman, New Jersey 08558

APR 16 2007

Re: K063271 Trade/Device Name: AQUACEL® Hydrofiber® Wound Dressing AQUACEL® Ag with Hydrofiber® Regulatory Class: Unclassified Product Code: FRO Dated: April 5, 2007 Received: April 10, 2007

Dear Ms. Konicky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Marilyn Konicky

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063271

510(k) Premarket Notification (K063271) AQUACEL® and AQUACEL® Ag

April 5, 2007

SECTION 4: INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K063271

Device names: AQUACEL® Hydrofiber® Wound Dressing

Indications for Use:

For Over - the - Counter use, Aquacel Hydrofiber Wound Dressing may be used for:

abrasions 1
lacerations -
minor cuts -
minor scalds and burns

Under the supervision of a health care professional, Aquacel may be used for the management of:

leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers ﺖ
surgical wounds (post-operative, donor sites, dermatological) -
second degree burns

Aquacel may also be used for:

management of surgical or traumatic wounds that have been left to heal by secondary intention.
local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.
the management of painful wounds1

Prescription Use X

AND/OR

Over-the-Counter Use X

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

ConvaTec, A Division of E.R. Squibb and Sons, L.L.C.

1 New Indication, not previously cleared under K982116

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PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Bumm

510(k) Number 11063271

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SECTION 4: INDICATIONS FOR USE STATEMENT, CONTINUED

510(K) Number (if known):

K063271

Device names: AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing

Indications for Use:

For over-the-counter use, Aquacel-Ag may be used for:

minor abrasions
lacerations

ﺖ

minor cuts -
ー minor scalds and burns

Under the supervision of a health care professional, Aquacel-Ag may be used for the management of:

wounds as an effective barrier to bacterial penetration to help reduce infection; -
partial thickness (second degree) burns; ー
diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness);
surgical wounds left to heal by secondary intent;
traumatic wounds:
wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided;
oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma.
- the management of painful wounds2

Aquacel Ag may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use X (21 CFR 801 Subpart C)

ConvaTec, A Division of E.R. Squibb and Sons, L.L.C.

2 New Indication, not previously cleared under K013814

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PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A