(344 days)
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.
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.
The provided 510(k) summary for K071442, "Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver," describes a new device and its substantial equivalence to predicate devices, but does not contain details of a clinical study or acceptance criteria in the typical sense for algorithm performance. Instead, it focuses on demonstrating comparable performance to existing, legally marketed devices through in vitro testing and biocompatibility assessments.
Therefore, the requested tables and specific study details in several sections cannot be fully completed as the document does not describe the types of studies pertinent to algorithm performance, expert ground truth, or MRMC studies.
Below is an attempt to structure the available information provided in the format requested, with specific notes where information is not present in the document.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Assessment Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Equivalence to predicate devices (Aquacel Ag K013814, Maxorb Extra Ag K041316) per ISO 10993-1 and FDA Blue Book memorandum #G95-1 | Results were equivalent to those for the predicate devices. |
| Silver Content | Similar results to predicate devices | Gave similar results to the predicates. |
| Silver Release | Similar results to predicate devices | Gave similar results to the predicates. |
| Absorbency | Similar results to predicate devices | Gave similar results to the predicates. |
| Antibacterial Effect | Demonstrated antibacterial effect against Staphylococcus aureus and Escherichia Coli. Protection from a broad spectrum of bacterial contamination over a period of up to 3 days in in vitro challenge test. | Has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. Silver ions protect the dressing from bacterial contamination for up to 3 days in vitro. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The studies mentioned are in vitro tests and biocompatibility assessments, not a test set for an algorithm. No "data provenance" in the sense of patient data is relevant for these types of tests.
- Data Provenance: The biocompatibility tests were conducted in accordance with ISO 10993-1 and FDA Blue Book memorandum #G95-1. The in vitro tests for silver content, release, and absorbency, and antibacterial effect were also conducted. The country of origin for the device manufacturer is the U.K.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a medical dressing and its performance evaluation does not involve ground truth established by experts in the context of diagnostic algorithms or imaging. The "ground truth" for the performance characteristics (e.g., silver release, absorbency) would be determined by established laboratory measurement techniques, not expert consensus on medical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no test set in the context of expert review or algorithm output adjudication is mentioned.
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
- Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing with antibacterial properties, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance characteristics (biocompatibility, silver content, silver release, absorbency, antibacterial effect) was established through laboratory testing and standardized in vitro methods according to relevant international standards (ISO 10993-1) and FDA guidance, and comparison to the performance of predicate devices. This does not involve expert consensus on clinical cases, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set
- Not applicable. This device is a physical medical dressing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an algorithm.
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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 (AquacelAg) 510(k) No. K013814 | ||
| Antimicrobial Alginate Dressing (Maxorb Extra Ag),510(k) No. K041316 | |||
| Description of the device | Calcium Alginate Dressing with Antibacterial Silver |
:
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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.
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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.
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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.
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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
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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
N/A