(344 days)
Not Found
No
The device description and performance studies focus on the material properties and antibacterial effects of the dressing, with no mention of AI or ML.
Yes
Explanation: The device is intended for the management of various types of wounds, indicating a therapeutic purpose to facilitate healing and provide antibacterial activity.
No
The device is a wound dressing designed for treatment and management of wounds, not for diagnosis.
No
The device description clearly describes a physical wound dressing made of calcium alginate fibers with silver, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for managing various types of wounds. This is a topical application for direct interaction with the wound bed.
- Device Description: The description details the physical properties of the dressing, how it interacts with wound exudate, and its antibacterial effect on bacteria in the wound.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are used for diagnostic purposes outside the body.
The device is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are:
- Moderately and heavily exuding
- Superficial or
- Deep
Such as: - Pressure sores
- Arterial Ulcers
- Venous lower leg ulcers
- Diabetic ulcers
- Post-operative wounds
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are soft, conformable wound covers with a high mannuronic acid content. The silver-impregnated calcium alginate fibres, when in contact with wound exudate or blood, form a gel which creates a moist wound healing environment. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days in the in vitro challenge test. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are sterilized by irradiation and must not be re-sterilized. The products are sterile unless the package is opened or damaged. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are for single use only. Calcium Alginate Dressing with Antibacterial Silver
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility of Speciality Fibres and Materials Limited's Suprasorb® A + Ag has been demonstrated in accordance with ISO 10993-1 and the FDA Blue Book memorandum #G95-1. Results were equivalent to those for the predicate devices In vitro testing for silver content, silver release and absorbency, gave similar results to the predicates. Comparable biocompatibility, cytotoxicity, absorbency and silver release results have been demonstrated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
K071442
pg 1093
Section 5
510k Summary
| Name: | Speciality Fibres & Materials Limited | MAY - 1 2008 | |
|---|---|---|---|
| Address: | 101 Lockhurst Lane, Coventry CV6 5RS, U.K. | ||
| Telephone: | 011 44 2476 708200 | ||
| Fax: | 011 44 2476 682737 | ||
| colin.ludford@sfm-limited.com | |||
| Contact Person: | Colin Ludford, Operations Director | ||
| Date: | 30th April 2008 | ||
| Trade Name: | Suprasorb® A + Ag | ||
| Common Name: | As Trade Name | ||
| Classification Name: | Dressing | ||
| Classification | There is currently no classification for this device | ||
| Predicate Devices | Absorbent Antimicrobial Wound Dressing (Aquacel | ||
| Ag) 510(k) No. K013814 | |||
| Antimicrobial Alginate Dressing (Maxorb Extra Ag), | |||
| 510(k) No. K041316 | |||
| Description of the device | Calcium Alginate Dressing with Antibacterial Silver |
:
1
K071442
pg 1 of 3
Suprasorb® A +Ag Calcium Alginate Dressing with Intended use: Antibacterial Silver can be used for the management of wounds which are: Moderate and heavily exuding . Superficial or . Deep . such as: Pressure sores . Arterial Ulcers . Venous lower leg ulcers . Diabetic ulcers ● Post-operative wounds . Suprasorb® A + Ag Calcium Alginate Dressings with Product description Antibacterial Silver are soft, conformable wound covers with a high mannuronic acid content. The silver-impregnated calcium alginate fibres, when in contact with wound exudate or blood, form a gel which creates a moist wound healing environment. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days in the in vitro challenge test. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are sterilized by irradiation and must not be re-sterilized. The products are sterile unless the package is opened or damaged. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are for single use only. The biocompatibility of Speciality Fibres and Materials Performance data Limited's Suprasorb® A + Ag has been demonstrated in accordance with ISO 10993-1 and the FDA Blue Book memorandum #G95-1. Results were equivalent to those for the predicate devices In vitro testing for silver content, silver release and absorbency, gave similar results to the predicates.
2
K011442
pg 303
Statement of substantial equivalence
Suprasorb® A + Ag Calcium Alginate Dressing with Antibacterial Silver is substantially equivalent in construction and performance to both the Aquacel Ag (K013814) and Maxorb Extra Ag (K041316) predicate devices.
Comparable biocompatibility, cytotoxicity, absorbency and silver release results have been demonstrated.
3
Image /page/3/Picture/12 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Specialty Fibres and Materials, Ltd. % Mr. Colin Ludford P.O. Box 111 101 Lockhurst Lane Coventry United Kingdom CV6 5RS
MAY - 1 2008
Re: K071442 Trade/Device Name: Suprasorb® A +Ag
Regulatory Class: Unclassified Product Code: FRO Dated: April 2, 2008 Received: April 15, 2008
Dear Mr. Ludford:
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.
4
Page 2 - Mr. Colin Ludford
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4
Indications for Use
510(k) Number (if known):- K071442
Device Name:
Suprasorb® A +Ag
Indications for Use:
Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are:
- Moderately and heavily exuding ●
- Superficial or �
- Deep �
Such as:
- Pressure sores �
- Arterial Ulcers .
- Venous lower leg ulcers ●
- Diabetic ulcers .
- Post-operative wounds .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rph
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 1671442
Page 4 of 16