(269 days)
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, 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 "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added. The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content. 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 5 days in the in vitro challenge test. The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
The provided text describes a medical device, Suprasorb A + Ag "R", a calcium alginate dressing with antibacterial silver, and its substantial equivalence to a predicate device, Suprasorb A + Ag (K071442). The document focuses on demonstrating that the modified device, despite adding regenerated cellulose fibers for strengthening, maintains equivalent safety and performance.
However, the document does not describe a study that uses acceptance criteria in the context of a diagnostic or AI-driven device's performance metrics like sensitivity, specificity, or AUC, or human reader performance. Instead, the "acceptance criteria" discussed are related to the biological and physical properties of a wound dressing, which are verified through various physical and chemical tests.
Therefore, many of the specific points requested in the prompt related to acceptance criteria for device performance (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or
available from this document.
Below, I will present the information that is present in the document, framed as closely as possible to your request, and explicitly state what information is not available.
Acceptance Criteria and Device Performance for Suprasorb A + Ag "R"
The acceptance criteria and reported device performance are based on the comparison of the subject device (Suprasorb A + Ag "R") to its predicate device (Suprasorb A + Ag, K071442). The "performance" in this context refers to the physical, chemical, and biological properties of the wound dressing, rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Suprasorb A + Ag "R") | Comparison/Outcome |
|---|---|---|---|
| Intended Use | Same as predicate: Management of wounds in adult patients that are moderately/heavily exuding, superficial or deep (e.g., Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds). | Same as predicate. | Equivalent |
| Mode of Action | Releases silver ions into dressing, absorbs wound exudate, forms gel, traps debris/bacteria. | Same as predicate. | Equivalent |
| Silver Release | 22 ppm at 7 days (predicate) | 200 gsm: 22 ppm at 7 days; 120 gsm: 21.7 ppm at 7 days | Equivalent |
| Absorbency | 19 g/100cm² (predicate) | 200 gsm: 12 g/100cm²; 120 gsm: 22 g/100cm² | Similar |
| Tensile Wet Strength | MD 1.4 N/cm; CD 0.6 N/cm (predicate) | 200 gsm: MD 4.3 N/cm, CD 12.1 N/cm; 120 gsm: MD 2.4 N/cm, CD 5.5 N/cm | Equivalent (improved for subject device) |
| Antibacterial Activity | Log reduction for various bacteria > 4 | Log reduction for 4 gram positive and 3 gram negative bacteria > 4. | Meets requirement |
| Biocompatibility | Pass biocompatibility requirements of applicable standards (ISO 10993-1, etc.) | Comprehensive biocompatibility testing confirmed no safety concerns. | Meets requirements |
| Sterilization Validation | Meets predetermined acceptance criteria as per standards (ISO 11137-1, EN ISO 11137-2). | Successfully met predetermined acceptance criteria. | Met standards |
| Packaging Integrity | Meets predetermined acceptance criteria as per standards (ASTM F1886/F1886M, F1929, F88/F88M). | Successfully met predetermined acceptance criteria. | Met standards |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the document in terms of specific numbers of samples for each test (e.g., how many dressings were tested for silver release or tensile strength). The document generally refers to "testing" that was conducted.
- Data Provenance: The tests are conducted according to international standards (e.g., ISO, ASTM, British Pharmacopoeia, AATCC), implying laboratory-based testing rather than clinical study data from a specific country or retrospective/prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable and not provided. The "ground truth" for the device's physical and biological properties is established by the results of standardized tests against defined criteria. There is no mention of human expert consensus or clinical adjudication for these types of performance evaluations.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Adjudication is typically associated with human interpretation of medical data, which is not what is being evaluated here. The device's performance is measured against objective laboratory test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- This information is not applicable and not provided. This document describes a wound dressing, which is a medical device, not an AI or diagnostic tool that involves human readers interpreting medical images. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- This information is not applicable and not provided. This device is a wound dressing, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective measurements from laboratory tests conducted according to recognized international and pharmacopoeia standards (e.g., AATCC 100 for antibacterial activity, British Pharmacopoeia for absorbency and wet tensile strength, ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM for packaging). These standards themselves define what constitutes acceptable performance for each characteristic.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. This product is a physical medical device (wound dressing), not a software algorithm that requires a training set. The "training" for such a device involves manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided for the reasons mentioned in point 8.
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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2019
Speciality Fibres and Materials Ltd. Lindie Turvey Senior Regulatory Affairs Officer 101 Lockhurst Lane Coventry, CV6 5SF Gb
Re: K183208
Trade/Device Name: Suprasorb A + Ag "R" Regulatory Class: Unclassified Product Code: FRO Dated: July 15, 2019 Received: July 16, 2019
Dear Lindie Turvey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Cynthia Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183208
Device Name Suprasorb A +Ag "R"
Indications for Use (Describe)
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are:
- · Moderately and heavily exuding
- · Superficial or
- · Deep
- Such as:
- Pressure sores
- Arterial Ulcers
- · Venous lower leg ulcers
- · Diabetic ulcers
- · Post-operative wounds
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for SFM. The letters SFM are in red and are stacked on top of each other. Below the letters is a geometric design in shades of green and gray. The background is white.
Details of the device Suprasorb A + Ag "R" herewith applied for are as follows:
5.1 ADMINISTRATIVE INFORMATION
| Submitted by: | Speciality Fibres and Materials Limited.101 Lockhurst Lane,Coventry,CV6 5SF,United KingdomEstablishment Registration No.: 3005818605 | ||
|---|---|---|---|
| Contact details: | Lindie TurveyRegulatory Affairs OfficerTelephone: +44 (0)2476 708 253Fax: +44 (0) 2476 682737E-mail: Lindie.turvey@sfm-limited.com | ||
| Date prepared: | 15 July 2019 | ||
| Device Details: | Trade Name: | Suprasorb A+ Ag “R” | |
| Classification Name: | Dressing, Wound, Drug | ||
| Common Name: | Wound Dressing | ||
| Product Code: | FRO | ||
| Classification: | Unclassified | ||
| Panel: | General & Plastic Surgery | ||
| Legally MarketedPredicateDevice(s): | Suprasorb A +Ag – K071442 | ||
| Legally MarketedReferenceDevices | N/A this is a device modification of the predicate device |
5.2 DESCRIPTION OF THE DEVICE:
Suprasorb® A + Ag "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added.
The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content.
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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 5 days in the in vitro challenge test.
The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
Suprasorb® A + Ag "R"is packed in paper pouches and are available in the sizes and thickness listed below:
| Product | Dimensions | Weight(g/sm) | Packaging | Packaging Configuration | |
|---|---|---|---|---|---|
| 42 755 | Flat | 2in. x 2in. (5cm x 5cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 756 | Flat | 4in. x 4in.(10cm x 10cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 757 | Flat | 4in. x 5in.(10cm x 12.5cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 758 | Flat | 6in. x 6in. (15cm x 15cm) | 200 | Paper | 5 pouches per 1 carton |
| 42 759 | Rope | 1in. x 18in. (2cm x 45cm) | 200 | Paper | 5 pouches per 1 carton |
| 43 755 | Flat | 2in. x 2in. (5cm x 5cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 756 | Flat | 4in. x 4in.(10cm x 10cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 757 | Flat | 4in. x 5in.(10cm x 12.5cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 758 | Flat | 6in. x 6in. (15cm x 15cm) | 120 | Paper | 5 pouches per 1 carton |
| 43 759 | Rope | 1in. x 18in. (2cm x 45cm) | 120 | Paper | 5 pouches per 1 carton |
5.3 INDICATIONS FOR USE:
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are:
- Moderately and heavily exuding
- Superficial or
- Deep
Such as:
- Pressure sores
- Arterial Ulcers
- Venous lower leg ulcers
- . Diabetic ulcers
- . Post-operative wounds
5.4 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The fundamental technological characteristics are similar to the cleared predicate device (Suprasorb A + Ag K071442).
Important technological characteristics of Suprasorb A+ Ag "R" to consider are as follows,
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- a) the presence of antibacterial silver in the dressing which reduces bacterial growth within the dressing
- b) improved tensile strength when compared to the predicate device,
- c) equivalent absorbency when compared to predicate device
- d) silver release profile when compared to the predicate device
Table 5-1 Substantial Equivalence Comparison of Characteristics and Intended Use
| Manufacturer | Speciality Fibres andMaterials Ltd. | Speciality Fibres andMaterials Ltd. | Comparison |
|---|---|---|---|
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| 510(k)Number | K071442 | K183208 | |
| Product Code | FRO | FRO | Equivalent |
| RegulationName | Dressing, Wound Drug | Dressing, Wound Drug | Equivalent |
| Devicedescription 1 | Soft, sterile, non-woven pador ribbon dressingcomposed of calciumalginate and silver which areblended by combining fibresin a carding and needlingprocess. | Soft, sterile, non-woven pador ribbon dressing composedof calcium alginate and silverwhich are blended bycombining fibres in a cardingand needling process. | Equivalent |
| Variants | 130 gsm | 120 gsms & 200 gsm | N/A |
| Intended Use | |||
| Indicationsfor Use | Suprasorb® A + Ag "R"calcium alginate dressingwith antibacterial silver canbe used for themanagement of woundswhich are:• Moderately and heavilyexuding wounds• Superficial wounds• Deep wounds such as• Pressure sores• Arterial ulcers• Venous lower legulcers• Diabetic ulcers• Post-operative wounds | Suprasorb® A +Ag "R"can be used for themanagement of wounds,in adult patients only,which are:• Moderately and heavilyexuding• Superficial or• DeepSuch as:• Pressure sores• Arterial Ulcers• Venous lower leg ulcers• Diabetic ulcers• Post-operative wounds | Equivalent |
| Intendeduse | Management of wounds withmoderate to heavy exudate.The dressing absorbs woundexudateand may retainbacteriain the woundexudate within the dressing.This ensures a moist woundhealing environment. Thedressing containssilver,which limits the growth ofbacteria within the dressing. | Management of woundswith moderate to heavyexudate. The dressingabsorbs wound exudateand may retain bacteria inthe wound exudate withinthe dressing. This ensuresa moist wound healingenvironment. The dressingcontains silver, which limitsthe growth of bacteriawithin the dressing | Equivalent - nochange to intendeduse |
| Manufacturer | Speciality Fibres andMaterials Ltd. | Speciality Fibres andMaterials Ltd. | Comparison |
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| Contra-indications | Should not be used onindividuals who are sensitiveto or who have had an allergicreaction to the dressing or itscomponents. | Should not be used onindividuals who are sensitive toor who have had an allergicreaction to the dressing or itscomponents. For use on adultpatients only. | Equivalent |
| PrescriptionUse | Prescription Use Only | Prescription Use Only | Equivalent |
| MaximumPeriod of Use | Three (3) days per dressingand maximum repeatdressings of 30 days | Five (5) days per dressing andmaximum repeat dressings of30 days | Additional 2 daywear time proposedaccording toantibacterial resultsobtained withAATCC100 resultsfor real-time stabilitysamples |
| Single-use | Single-use | Single-use | Equivalent |
| General Information | |||
| Active anti-bacterialagent | Ionic silver | Ionic silver | Equivalent |
| Sterile | Sterile (Gamma) | Sterile (Gamma) | Equivalent |
| Packaging | Paper | Paper pouch | Equivalent |
| Shelf Life | Three years | 4 years | N/A |
| Fundamental technology | |||
| Silver content | $1.5 + 0.3% w/w$ | $1.5 + 0.3% w/w$ | Equivalent |
| Silvercontainingalginate fibres | $7.0\pm0.7%$ | $7.0\pm0.7%$ | Equivalent |
| Absorbantfibres | Calcium alginate 93% | Calcium alginate 73% | No impact on thefundamentalscientific technologyor biocompatibility1 |
| Re-enforcingfibres | Does not contain | Regenerated cellulose fibres(Tencel® 20%) | Increases strengthof dressing butdoes not influencefundamentaltechnology orbiocompatibility1 |
| Silver release | 23.1 ppm at 7 days | 200 gsm: 22 ppm at 7 days120 gsm: 21.7 ppm at 7 days | Equivalent |
| Absorbency | 19 g/100cm² | 200 gsm: 12 g/100cm²120 gsm: 22 g/100cm² | Similar |
| Tensile wetstrength | MD1.4 N/cmCD 0.6 N/cm | 200 gsm:MD 4.3 N/cm | Equivalent |
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| Manufacturer | Speciality Fibres andMaterials Ltd. | Speciality Fibres andMaterials Ltd. | Comparison |
|---|---|---|---|
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| CD 12.1 N/cm120 gsm:MD 2.4 N/cmCD 5.5 N/cm |
Footnotes and discussion of equivalence
- The only change proposed to the legally marketed predicate device is the addition of cellulose fibres. The fundamental technologically of the device has not changed, the Performance has not changed (As described in Section18) and the biocompatibility testing described in Section 15 confirms that the addition of Tence® Cellulose fibres does not affect the safety profile of the modified device.
5.5 SUMMARY OF PERFORMANCE DATA:
The following standards were adhered to during performance testing
- . ISO 10993-1 (2009/Cor1: 2010): Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,
- EN ISO 14971 (2012)ISO 14971 (2007): Medical Devices Application of risk ● management to medical devices, Annex I: Guidance on Risk Analysis Procedures for Biological Hazards."
- ISO/TR 15499 (2012): Biological evaluation of medical devices Guidance on the . conduct of biological evaluation within a risk management process,""
- The European Union Medical Device Directive 93/42/EEC amended 2007/47/EC, " ●
The critical performance characteristics of the predicate and subject device are compared in the table below.
Table 5-2 Substantial Equivalence Comparison of Performance Characteristics
| Performance Characteristics | |||
|---|---|---|---|
| Manufacturer | Speciality Fibres andMaterials Ltd. | Speciality Fibres andMaterials Ltd. | Comparison |
| Trade Name | Suprasorb A+Ag | Suprasorb A+ Ag “R” | |
| 510(k) number | K071442Predicate device | K183208Subject device | |
| Mode of action | Releases silver ions oncontact with woundexudate. The silver ionsare released into thewound dressing, but notinto the wound bed.Absorbing woundexudate and forming agel trapping debris andbacteria in the dressing | Releases silver ions oncontact with woundexudate. The silver ionsare released into thewound dressing, but notinto the wound bed.Absorbing woundexudate and forming agel trapping debris andbacteria in the dressing | Equivalent |
| SilverRelease 4 | 22 ppm at 7 days | 200 gsm: 22 ppm at7 days120 gsm: 21.7 ppm at7 days | Equivalent |
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| Performance Characteristics | |||
|---|---|---|---|
| Absorbency | 19 g/100cm² | 200 gsm: 22 ppm at 7 days120 gsm: 21.7 ppm at 7 days | Equivalent |
| Tensile wet strength | MD1.4 N/cmCD 0.6 N/cm | 200 gsm:MD 4.3 N/cmCD 12.1 N/cm120 gsm:MD 2.4 N/cmCD 5.5 N/cm | Equivalent |
| Antibacterial activity | Log reduction for various bacteria > 4 | Log reduction for 4 gram positive and 3 gram negative bacteria > 4. | Meets requirement:Antibacterial activity remains above the log reduction of 4, which confirms the effectiveness of the device for the intended use. |
| Biocompatibility | Pass the biocompatibility requirements of applicable at time of clearance | Comprehensive biocompatibility testing confirmed that the device raises no safety concerns. | Meets requirements |
5.5.1 Discussion on Performance testing
Performance testing was done according to standards where an accepted industry standard exists:
- Antibacterial effectiveness testing according AATCC 100 was ● found to consistently meet requirement of a log 4 reduction when compared to a control
- . Silver release profile was found to be similar to that of the predicate device in simulated wound fluid.
- Absorbancy according to British Pharmacopoeia; Test Method for . absorbency of Alginate dressings/Surgical dressings, and European Standard EN13726-1 March 2002 and product consistently meets specifications.
- Wet Tensile strength according to British Pharmacopoeia meets the . specifications set for this product and displays a strength better than that of the predicate device which has been modified for this application.
- Silver content is identical for both the predicate and subject device ●
5.5.2 Discussion on Biocompatibility Testing
Suprasorb A+Ag "R" is classified as a surface device with prolonged use and the relevant biocompatibility studies as per the requirements of ISO 10993-1(2009) and the FDA requirements were performed. Below Table 5-3 Contains a summary of the testing conducted, the relevant standards and
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| Table 5-3 Summary of Biocompatibility studies | |
|---|---|
| ----------------------------------------------- | -- |
| Test | Relevant standard |
|---|---|
| ChemicalCharacterisation | ISO 10993-18 Chemical Characterisation |
| Cytotoxicity | ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Testsfor In Vitro Cytotoxicity |
| Sensitisation | ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; |
| Irritation studies | ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; |
| Acute systemictoxicity | ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Testsfor Systemic Toxicity |
| Material mediatedpyrogenicity | ISO 10993-11 according to Biological Evaluation of MedicalDevices, Part 11; Tests for Systemic Toxicity |
| Subacute systemictoxicity | ISO 10993-11, Biological Evaluation of Medical Devices, Part 11;Tests for Systemic Toxicity |
| Implantation | ISO 10993, Biological Evaluation of Medical Devices Part 6 (2016):Tests for Local Effects after Implantation |
The overall Biological risk assessment was conducted using the following standards and it was concluded that Suprasorb A+ Ag "R" considered to be a biocompatible medical device, with respect to ISO 10993 and US FDA (2016) guidance, when applied for its intended use.
International Standard ISO 10993 series. Biological evaluation of medical devices.
- . International Standard ISO 10993-1. Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process (ISO, 2009a).
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (EC, ● 1993) asamended, together with relevant guidance.
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process." Guidance for Industry and Food and Drug Administration Staff. Document issued on June 16, 2016 (US FDA, 2016).
The performance studies indicate that Suprasorb A + Ag "R" wound dressing does not raise new questions in regards to safety or effectiveness with respect to the predicate device and is safe for its indication for use.
The non-clinical testing detailed in this submission supports the substantial equivalence of the subject device to the predicate device.
5.6 NON-PERFORMANCE TESTING
The following testing was conducted to ensure the integrity of the end product
- Sterillisation validation according to ISO 11137-1 and EN ISO 11137-2. Sterilisation ● of health care products, and results confirmed that Suprasorb A+Ag "R" successfully " met its predetermined acceptance criteria as per standards
- . Packaging integrity testing according to ASTM F1886/ F1886M Standard test Method for determining Integrity of Seals for Flexible Packaging by Visual Inspection. ASTM F1929, ASTM F1929 Standard test Method for Detecting Seal Leak, ASTM
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F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Suprasorb A+Aq "R" 200 successfully met its predetermined acceptance criteria as per standards
- Shelf-life testing A maximum shelf life of 48 months has been assigned when . stored unopened at ambient temperature (25°C), in accordance with the manufacturer's recommendations.
5.7 STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The subject device, Suprasorb A + Ag "R", described in this submission is substantially equivalent to the predicate device Suprasorb A + Ag (K071442)
Suprasorb A + Aq has
- the same intended use as the predicate; and displays performance equivalent to . that of the predicate device.
- essentially the same composition with the addition of strengthening cellulose fibres, ● which does not change the fundamental technology
- minor technological characteristic differences to the predicate, which do not . influence the performance
With the information included in this section, we aim to summarise the information used to:
- demonstrate that the device applied for raises no concerns in terms of device . performance and,
- . demonstrate that the device is at least as safe and effective as the legally marketed predicate device.
N/A