(168 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical performance of a hydrocolloid wound dressing, with no mention of AI or ML technologies.
Yes
The device is a wound dressing used for the management of various wounds, including those from injuries, surgeries, and chronic conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a wound dressing designed for the treatment and management of wounds, not for diagnosing medical conditions. It performs a therapeutic function by providing a suitable wound healing environment.
No
The device description clearly states it is a "soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers," which is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing used for the management of various types of wounds. This is a topical application for wound care, not a test performed on biological samples to diagnose a condition.
- Device Description: The description confirms it's a wound dressing made of hydrocolloid fibers.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status. The performance studies focus on wound healing, pain management, and dressing performance, not diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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 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
Product codes (comma separated list FDA assigned to the subject device)
NAC
Device Description
AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).
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 supervision of a health care 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)
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.
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.
Study 1: Management of leg ulcers (ConvaTec Study)
Study Type: Prospective, comparative, randomized clinical study
Population: Forty-four patients with moderately to heavily exudating leg ulcers. 21 managed with AQUACEL®, 23 with Kaltostat® Dressings. Mean age 68.1 years. Etiology was venous for 82% of patients; 89% had shallow ulcer depth. Median duration of ulcers was 10 months.
Key Results: Pain on dressing change for AQUACEL® patients: 76% no pain, 20% mild pain, 3% moderate pain. For Kaltostat treated patients: 83% no pain, 13% mild pain, 4% moderate pain.
Study 2: Multicenter management of leg ulcers (ConvaTec Study)
Study Type: Multicenter, comparative clinical study
Population: Twenty patients managed with AQUACEL® dressings, 20 with an alginate dressing. Majority male (80%), average age 63 years.
Key Results: Based on 269 dressing changes for AQUACEL® and 227 for alginate dressing. Pain on dressing removal for AQUACEL® group: 65% no pain, 16% mild pain, 3.4% moderate pain. For alginate dressing group: 62% no pain, 14% mild pain, 4% moderate pain.
Study 3: Management of pressure ulcers (ConvaTec Study)
Study Type: Comparative clinical study
Population: Eighty-five patients with moderately or heavily exudating Stage III or IV pressure ulcers. AQUACEL® group consisted of 43 patients (536 dressing changes), gauze group consisted of 42 subjects (500 dressing changes).
Key Results: Pain on removal: AQUACEL® rated as excellent or good by 54% and 28% of patients, respectively. Gauze dressing rated as excellent by 7% and good by 17%.
Published Report 1: Management of acute surgical wounds (Foster, et al)
Study Type: Randomized, comparative study
Population: One hundred patients randomized to receive either AQUACEL® or alginate dressing.
Key Results: No or mild pain at first dressing change: 92% of AQUACEL® patients, 80% of alginate patients. On postoperative day 7, 84% of AQUACEL® patients were pain-free while only 58% of alginate patients were pain-free.
Published Report 2: Management of split-thickness skin graft donor sites (Barnea, et al)
Study Type: Prospective, comparative study
Population: Twenty-three (23) adult patients treated with both AQUACEL® and paraffin gauze (half donor site with AQUACEL®, other half with paraffin gauze).
Key Results: Local pain assessed using an analogue scale on days 3, 7, 10-14, and when dressing fell off. Pain scores at all evaluation points were significantly lower for AQUACEL® compared to paraffin gauze (p values ranging from 0.0001 on day 1 to 0.03 on day 15). Authors noted AQUACEL® forms a highly absorbent gel, allowing ease of removal, reducing trauma during dressing changes, and providing a moist wound/dressing interface that protects nerve endings.
Published Report 3: Management of partial-thickness burns (Kogan, et al)
Study Type: Prospective study
Population: Patients (1.5 to 41 years) treated with either AQUACEL® (n=11) or silver sulphadiazine (n=11).
Key Results: Pain assessed during dressing change and a half-hour later using visual analogue scales for adults/children over 7, and by observation of behavior for non-verbal children. Days 1 and 2, pain intensity high (8-9 points) in both groups. At half-hour assessment, pain reduced to 6.1 in AQUACEL® group and 6.9 in silver sulphadiazine group. 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. Authors concluded that the pain relief effect of AQUACEL® was superior to silver sulphadiazine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pain assessment scores (reported as percentage of patients experiencing no/mild/moderate pain or pain scores).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MEPITEL® Non Adherent Silicone Dressing K984371
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
...
SECTION 5: 510(k) SUMMARY
AQUACEL® Hydrofiber® Wound Dressing
APR 1 6 2007
| Applicant: | ConvaTec
A Division of E. R. Squibb & Sons, LLC
200 Headquarters Park Drive
Skillman, New Jersey 08558 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marilyn Konicky
Associate Director, US and International Regulatory Affairs
908-904-2541
fax: 908-904-2235
email: 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 Dressing
K984371 |
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
1
...
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.
2
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
3
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.
4
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.
5
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
6
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
7
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
8
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)
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:
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:
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