(80 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the management of wounds and promotes wound healing by providing a moist environment and releasing silver ions for antimicrobial effects, which directly contribute to the treatment and recovery of the patient.
No
The Silver Alginate II Dressing is described as a wound dressing intended for management of exuding wounds by absorbing exudate and releasing silver ions to protect against microorganisms and maintain a moist environment for healing. Its function is therapeutic, not diagnostic.
No
The device is a physical wound dressing composed of materials like calcium alginate, carboxymethylcellulose, and ionic silver, designed to absorb exudate and release silver ions. It is not software.
No, 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 provided text describes a wound dressing used for the management of various types of wounds. It is applied externally to the wound and works by absorbing exudate and releasing silver ions to protect the dressing from microorganisms. This is a topical medical device used for wound care, not a diagnostic test performed on a sample taken from the body.
The device's function is to treat and manage wounds, not to diagnose a condition based on analysis of a biological sample.
N/A
Intended Use / Indications for Use
The Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:
- Post-operative wounds .
- . Trauma wounds
- . Leq Ulcers
- Pressure Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
Silver Alginate II Dressing is indicated for external use only
Product codes
FRO
Device Description
The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing.
The dressing is an effective barrier to penetration by microorganisms.
The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.
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
Not Found
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
The biocompatibility of Advanced Medical Solutions Ltd's Silver Alginate II Dressing has been demonstrated in accordance with BS EN ISO 10993-1 requirements. Additional in vitro testing has demonstrated that the key performance characteristics of the dressing are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Acticoat® Calcium Alginate Dressing K002896, Absorbent Antimicrobial Wound Dressing K013814
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG - 5 2004
1/2
SECTION 5
510(k) SUMMARY
This 510(k) is to provide notification of substantial equivalence for Advanced Medical Solutions Ltd's Silver Alginate II Dressing, which is substantially equivalent to currently marketed devices intended for wound care.
- Advanced Medical Solutions Ltd., Submitted by: Road Three, Winsford Industrial Estate, Winsford, Cheshire, CW7 3PD, England Mr. John Greenham Contact: Requlatory Affairs Manager 44 (0)1606 545569 Telephone: 44 (0)1606 863600 Fax: john.greenham@admedsol.com e-mail: 19th July 2004 Date prepared: There is currently no classification for wound and burn Classification: dressings Not vet defined [Antimicrobial Alginate Dressing] Trade name: Silver Alginate II Dressing Common name: Acticoat® Calcium Alginate Dressing K002896 Predicate devices: Absorbent Antimicrobial Wound Dressing K013814 Indications for use: Advanced Medical Solutions Ltd's Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites
1
K04 1316
| Product Description: | The dressing is a sterile, non-woven pad composed of a high
G (guluronic acid) calcium alginate, carboxymethylcellulose
(CMC) and ionic silver, which absorbs wound exudate and
releases silver ions in the presence of wound fluid. As
wound exudate is absorbed, the alginate forms a gel, which
assists in maintaining a moist environment for optimal wound
healing, and allows intact removal.
The silver ions protect the dressing from a broad spectrum of
microorganisms over a period of up to four (4) days, based
on in vitro laboratory testing. Odour reduction results from
the antibacterial effect in the dressing.
The dressing is an effective barrier to penetration by
microorganisms.
The dressing has a off-white appearance, and is available in
various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm,
10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm
flat rope dressings; and 30cm x 2g rope dressings). The flat
dressings are packaged in pouches, and the flat rope and
rope dressings are packaged in a blister pack. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing: | The biocompatibility of Advanced Medical Solutions Ltd's
Silver Alginate II Dressing has been demonstrated in
accordance with BS EN ISO 10993-1 requirements.
Additional in vitro testing has demonstrated that the key
performance characteristics of the dressing are substantially
equivalent to the predicate devices. |
Statement of substantial equivalence:
The Silver Alginate II Dressing is a non-woven calcium alginate dressing which is substantially equivalent in construction and/or performance to both the Acticoat® Calcium Alginate Dressing and the Absorbent Antimicrobial Wound Dressing predicate devices. Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its back, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Mr. John Greenham Regulatory Affairs Manager Advanced Medical Solutions, Ltd. Road Three, Winsford Industrial Estate, Winsford, Cheshire, CW7 3PD U.K.
Re: K041316
Trade/Device Name: Silver Alginate II Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 11, 2004 Received: May 17, 2004
Dear Mr. Greenham:
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 for associated in the 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.
3
Page 2 - Mr. John Greenham
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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
4
Indications for Use
510(k) Number (if known): K041316
Device Name: Silver Alginate II Dressing
Indications For Use:
The Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:
- Post-operative wounds .
- . Trauma wounds
- . Leq Ulcers
- Pressure Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
Silver Alginate II Dressing is indicated for external use only
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 861 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_K0413/2/2/3/2/2