(217 days)
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns.
Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot 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 and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.
Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.
Absorbent Antimicrobial Wound Dressing is composed of sodium carboxymethylcellulose and ionic silver. In contact with wound exudate, the highly absorbent dressing creates a soft, cohesive gel that forms an intimate contact with the wound surface and maintains a moist woundhealing environment.
The provided text describes a 510(k) premarket notification for a medical device called "Absorbent Antimicrobial Wound Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or available in this document. The submission relies on comparative bench testing and biocompatibility testing to establish substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) process for this device focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance criteria against a predefined standard. The document mentions "comparative bench testing" and "biocompatibility testing," but does not detail the acceptance criteria or specific performance results from these tests in a table format.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "comparative bench testing" but does not specify the sample sizes or data provenance (country of origin, retrospective/prospective). It also mentions "biocompatibility testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or provided. For bench testing and biocompatibility testing, "ground truth" as it relates to expert consensus for diagnostic or prognostic devices is not relevant. The ground truth for such tests typically relies on established laboratory standards and measurement protocols rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, not for bench testing or biocompatibility testing as described.
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
This information is not applicable or provided. The device in question is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. The device is a wound dressing, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility testing, the ground truth would be established through laboratory standards and measurements as defined by relevant ISO or ASTM standards for biocompatibility (e.g., cytotoxicity, sensitization, irritation indices).
For the comparative bench testing, the ground truth would be based on physical and chemical measurements comparing the Absorbent Antimicrobial Wound Dressing's properties (e.g., absorbency, silver release) against those of the predicate device (Acticoat™ Silver Coated Wound Dressing) using defined laboratory protocols. The document does not specify what specific parameters were measured or how ground truth for those parameters was established, other than implying standard laboratory methods.
8. The sample size for the training set
This information is not applicable or provided. The development of a wound dressing does not typically involve a "training set" in the context of machine learning. The product development would involve iterative design, formulation, and testing, but not a training set as understood in AI systems.
9. How the ground truth for the training set was established
This information is not applicable or provided, as there is no "training set" in the context of this traditional medical device submission.
{0}------------------------------------------------
JUN 2 1 2002
Kol 3814 10F2
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, L.L.C200 Headquarters Park Drive, Skillman, NJ 08558 |
|---|---|
| Contact: | Demetrios Kydonieus, Regulatory Affairs(908) 904-2537 |
| Device: | Absorbent Antimicrobial Wound Dressing |
| SubstantiallyEquivalent Device | Acticoat™ Silver Coated Dressing |
The purpose of this 510(k) Premarket Notification is to request clearance to market Absorbent Antimicrobial Wound Dressing.
Absorbent Antimicrobial Wound Dressing is composed of sodium carboxymethylcellulose and ionic silver. In contact with wound exudate, the highly absorbent dressing creates a soft, cohesive gel that forms an intimate contact with the wound surface and maintains a moist woundhealing environment.
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for: minor abrasions, lacerations, minor cuts, minor scalds and burns.
Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, 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 and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma.
Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE
Absorbent Antimicrobial Wound Dressing is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
{1}------------------------------------------------
K013814
20F2
Absorbent Antimicrobial Wound Dressing is substantially equivalent to Acticoat™ Silver Coated Wound Dressing. Both dressings are indicated for acute and chronic wounds. Absorbent Antimicrobial Wound Dressing is similar to Acticoat™ Silver Coated Wound Dressing where both are of a similar composition consisting of silver and absorbent padding to absorb wound exudate, and create a moist wound environment supportive of the healing process. Comparative bench testing was conducted on Acticoar™ Silver Coated Wound Dressing and Absorbent Antimicrobial Wound Dressing.
Absorbent Antinuicrobial Wound Dressing has been subject to biocompatibility testing. The results of this testing show that Absorbent Antimicrobial Wound Dressing has passed toxicity and safety tests.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other.
JUN 2 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Demetrios Kydonieus Director, Regulatory Affairs ConvaTec 200 Headquarters Park Drive Skillman, NJ 08558
Re: K013814
Trade/Device Name: Absorbent Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2002 Received: April 16, 2002
Dear Mr. Kydonieus:
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 – Mr. Demetrios Kydonieus ·
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: Absorbent Antimicrobial Wound Dressing
Indications for Use:
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns.
Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot 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 and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.
Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use (Per 21CFR 801.109)
OR
Over the Counter Use
(Optimal Format 2-96)
Mark N Milkerr
(Division Sign-Off)
Division of General Restorative
of General, Restorative
510(k) Number K013
N/A