(773 days)
Under the supervision of a healthcare professional, Venus Ag may be used for the management of:
- · wounds with moderate to heavy exudate
- · partial thickness burns
- · leg ulcers, pressure ulcers and diabetic ulcers
- · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites)
- · traumatic wounds (e.g. abrasions and lacerations)
- wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites.
The product is for a single use only.
Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound.
The device is a combination product, code FRO.
Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.
The provided text describes the regulatory clearance of a medical device (Venus Ag 120, 160, and 200 Wound Dressing) by the FDA, primarily by establishing substantial equivalence to existing predicate devices. However, it does not contain a typical study design with acceptance criteria for device performance in the sense of a clinical trial or a standalone algorithm-only study for AI/ML devices.
Instead, the document details non-clinical performance testing (bench testing), biocompatibility testing, and a porcine wound healing study to demonstrate that the Venus Ag wound dressing is as safe and effective as its predicate devices.
Here's an attempt to structure the information based on your request, acknowledging that some of the requested fields are not directly applicable to this type of device clearance and the information provided:
Acceptance Criteria and Device Performance
The device's acceptance criteria are framed in terms of meeting established standards (ISO, British Pharmacopoeia, European Standard) and demonstrating equivalence to predicate devices, rather than specific quantitative performance metrics against a clinical outcome.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Antimicrobial Efficacy | Modified AATCC 100: Log 4 reduction within the dressing against gram-negative, gram-positive, yeast, and mould. | Consistently met the requirement of a log 4 reduction within the dressing when compared to a control. |
| Silver Release Profile | Equivalent to predicate device in simulated wound fluid over 24 hours, 5 days, and 7 days. | Found to be equivalent to that of the predicate device. Silver content remained stable throughout accelerated and real-time stability studies. |
| Absorbency | British Pharmacopoeia; Test Method for absorbency of Alginate dressings/Surgical dressings, and European Standard EN13726-1: Must meet specified absorbency levels. | Consistently met specifications. |
| Tensile Strength | British Pharmacopoeia: Must meet specified tensile strength. | Met the specifications set for this product. |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices. Specific tests: Cytotoxicity (ISO 10993-5), Intracutaneous Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Sub-acute Systemic Toxicity and Implantation (ISO 10993-6, 11), Sensitization (ISO 10993-10), Material Mediated Pyrogenicity (ISO 10993-11, USP, European Pharmacopeia), Biological and Toxicological Risk Assessment (ISO 10993-17). | All relevant biocompatibility studies were performed as per ISO 10993 standards. Testing demonstrated that the proposed device is as safe as the cleared 510(k) predicate device and does not raise new safety concerns. |
| Wound Healing (Animal) | ISO 10993-6: No impairment of the wound healing process compared to the predicate and controls in a porcine model. | Did not impair the wound healing process as observed from histology parameters when compared to the predicate (Aquacel Ag+ Extra) and a control dressing. |
| Sterilization Validation | ISO 11137-1 and ISO 11137-2: Meet predetermined acceptance criteria for sterilization. | Successfully met its predetermined acceptance criteria as per standards. |
| Packaging Validation | ASTM F1886/F1886M, ASTM F1929, ASTM F88/F88M: Meet predetermined acceptance criteria for packaging integrity. | Successfully met its predetermined acceptance criteria as per standards. Packaging demonstrated appropriate maintenance of device integrity and sterility, also through accelerated aging studies. |
| Shelf-life Testing | Maintain performance and integrity for a maximum shelf life. | A maximum shelf life of 24 months (based on real-time aged Final Finished Device) was assigned, stored unopened at ambient temperature. |
| Overall Equivalence | No new questions of safety or effectiveness compared to predicate devices. | Non-clinical testing, including bench and animal studies, supports substantial equivalence to predicate devices (Titan Ag 200, Aquacel Ag Extra, Aquacel Ag+ Extra, Kerracell Ag), demonstrating it is at least as safe and effective for its intended use despite minor technological differences (e.g., silver content/formulation). |
Additional Study Information
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document refers to various non-clinical (bench) and biocompatibility tests. For these types of tests, "sample size" refers to the number of samples or specimens tested (e.g., dressings, materials). Specific numerical sample sizes are not explicitly stated in the provided text for each individual test (e.g., "5 samples for absorbency test").
- The "porcine wound healing study" is an animal study, not human clinical trial. No specific sample size (number of animals or wounds) is provided.
- Data provenance (country of origin, retrospective/prospective): Not specified in the document. These are non-clinical studies typically conducted in controlled laboratory environments.
-
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 question is not applicable to the type of studies described. The "ground truth" for non-clinical tests is determined by adherence to established scientific standards, validated test methods, and quantifiable measurements, not expert consensus in the diagnostic sense. For the porcine study, histological analyses would be performed by trained pathologists, but the number and qualifications are not listed.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept of adjudication (often used in clinical image review or complex diagnostic tasks) is not applicable to the non-clinical, bench, and animal studies described for this wound dressing.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive technologies, which this wound dressing is not.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a wound dressing, not an AI/ML algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For antimicrobial efficacy: Established microbiological culture methods and count reductions, compared against controls.
- For silver release, absorbency, tensile strength: Material property measurements obtained through standardized analytical and mechanical testing methods.
- For biocompatibility: Histological analysis (for implantation and irritation), cytotoxicity assays, pyrogenicity tests, and systemic observation based on ISO 10993 standards.
- For porcine wound healing study: Histology parameters analyzed to assess the healing process (comparison to predicate and control).
- For sterilization, packaging, shelf-life: Standardized physical, chemical, and biological indicators and tests to confirm sterility, integrity, and stability within specified limits.
-
The sample size for the training set:
- This concept of a "training set" is not applicable as this device does not involve AI/ML or a learning algorithm.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" for this device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2024
Speciality Fibres and Materials Ltd. Nyerngoor Hewitt Director of Regulatory Affairs and Ouality Galaxy House Binley Industrial Estate, 31 Herald Way Coventry, West Midlands CV6 5SF United Kingdom
Re: K222740
Trade/Device Name: Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber.
Regulatory Class: Unclassified Product Code: FRO Dated: September 8, 2022 Received: September 9, 2022
Dear Nyerngoor Hewitt:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about medical devices and radiation-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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K222740
Device Name
Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber.
Indications for Use (Describe)
Under the supervision of a healthcare professional, Venus Ag may be used for the management of:
- · wounds with moderate to heavy exudate
- · partial thickness burns
- · leg ulcers, pressure ulcers and diabetic ulcers
- · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites)
- · traumatic wounds (e.g. abrasions and lacerations)
- wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites.
The product is for a single use only.
| 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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510(k) Summary (Venus Ag)
Details of the device Venus Ag herewith applied for is as follows:
5.1 Administrative Information
| Applicant | Speciality Fibres and Materials Limited,Galaxy House, Binley Industrial Estate, 31 HeraldWay, Coventry CV3 2RQ, United Kingdom | |
|---|---|---|
| Official Correspondent andContact Details | Nyerngoor Korda HewittDirector of Regulatory Affairs and QualityTelephone: +44 (0) 2476 708 229,+44 (0) 7725 786 717E-mail: nyerngoor.kordahewitt@sfm-limited.com | |
| Date Prepared | Initial 29 October 2021, 1st October 2024 Updated | |
| Device Details | 510(k) Number | K222740 |
| ProductName(s) | Venus Ag 120 Wound Dressing with AntimicrobialSilver and Strengthening Cellulose Fiber.Venus Ag 160 Wound Dressing with AntimicrobialSilver and Strengthening Cellulose Fiber.Venus Ag 200 Wound Dressing with AntimicrobialSilver and Strengthening Cellulose Fiber. | |
| Classification Name | Unclassified | |
| Product Code | FRO | |
| Panel | General & Plastic Surgery | |
| Combination | Yes, the device is acombination product | |
| Legally Marketed PredicateDevice(s) | Primary Predicate Device:Titan Ag 200 K173844Additional Predicate Devices:Aquacel Ag Extra K121275Aquacel Ag+ Extra K173675Kerracel Ag K162508 |
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5.2 Description of the Device
Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound.
The device is a combination product, code FRO.
Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.
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5.3 Indications for Use
Under the supervision of a healthcare professional, Venus Aq may be used for the
management of:
- Wounds with moderate to heavy exudate
- Partial thickness burns ●
- Leg ulcers, pressure ulcers and diabetic ulcers .
- Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent . and donor/graft sites)
- . Traumatic wounds (e.g. abrasions and lacerations)
- Wounds that are prone to bleeding, such as wounds that have been . mechanically or surgically debrided and donor sites
The product is for a single use only.
5.4 Summary of Technological Characteristics
Venus Ag technological characteristics are deemed comparable to those of the predicate devices. Venus Ag has the same intended use and general characteristics as the predicate devices as detailed in the table below. Minor technological differences are addressed in Table 5-1.
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| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /Justification forEquivalence |
|---|---|---|---|---|---|---|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| Identification | Subject Device | Primary PredicateDevice | Additional Predicate Device | SecondaryPredicate | AdditionalPredicate Device | N/A |
| 510(k) Number | K222740 | K173844 | K121275 | K173675 | K162508 | N/A |
| Product Code | FRO | FRO | FRO | FRO | FRO | Equivalent. |
| RegulationName | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Equivalent. |
| Intended Use | Management of wounds withmoderate to heavy exudate.The dressing absorbs woundexudate, forms a gel, and mayretain bacteria in the woundexudate within the dressing.This ensures a moist woundhealing environment. Thedressing also has anantimicrobial action which isexerted by the silver releasedinto the dressing. | Management of wounds withmoderate to heavy exudate. Thedressing absorbs woundexudate and may retain bacteriain the wound exudate within thedressing. This ensures a moistwound healing environment. Thedressing contains silver, whichlimits the growth of bacteriawithin the dressing. | This conformable and highlyabsorbent dressing absorbswound fluids, creating a soft gelwhich maintains a moistenvironment and supports thebody's healing process. | This dressing absorbs wound fluidand creates a soft gel thatconforms to the wound surface,maintains a moist environmentand aids in the removal ofnon-viable tissue from the wound(autolytic debridement). A moistwound environment supports thebody's healing process. The silverpreservative in the dressingprovides an effective barrier tobacterial penetration of thedressing as this may help reduceinfection. | The silver in the dressingprovides an antibacterialbarrier that inhibitsbacterial growth in thedressingfor up to seven days.Absorbs highamounts of wound fluidand creates a soft cohesivegel that intimately conformsto the wound surface andmaintains a moist woundhealing environment. | Substantially Equivalent.Venus Ag has anAntimicrobial claim whichis addressed in Section18. Risk of infection arenot within the scope of theVenus Ag indications. |
| Indicationsfor Use | Management of wounds withmoderate to heavy exudate | Management of wounds withmoderate to heavy exudate | Management of wounds as aneffective barrier to bacterialpenetration of the dressing asthis may help reduce infection | Aquacel Ag+ Extradressings are indicatedfor: | Management of acuteand chronic, partial andfull thickness woundsincluding pressure ulcers,leg ulcers, diabetic footulcers, surgical wounds,traumatic wounds, firstand second degreeburns. | Equivalent to primarypredicate. Malignantwounds in the additionalpredicate are not within thescope of the Venus Agindications. |
| Partial thickness burns | Partial thickness burns | Partial thickness (seconddegree) burns | Partial thickness burns | |||
| Leg ulcers, pressure ulcersand diabetic ulcers | Leg ulcers, pressure ulcersand diabetic ulcers | Diabetic foot ulcers, legulcers, (venous stasisulcers, arterial ulcers andleg ulcers of mixedetiology) and | Leg ulcers, including:Venous stasis ulcersArterial ulcers. Legs ulcers ofmixed aetiology Diabetic footulcers. Pressure ulcers/injuries | and second degreeburns. | ||
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /JustificationforEquivalence |
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| pressure ulcers/sores (partialand full thickness); | ||||||
| Surgical wounds (e.g. post-operative wounds left to healby secondary intent anddonor/graft sites) | Surgical wounds (e.g. post-operative wounds left to healby secondary intent anddonor/graft sites) | Surgical wounds left to healby secondary intention suchas dehisced surgicalincisions; Surgical woundsthat heal by primary intentsuch as dermatological andsurgical | Surgical wounds | |||
| incisions (e.g. orthopedic andvascular) | ||||||
| Traumatic wounds (e.g.abrasions and lacerations) | Traumatic wounds (e.g.abrasions and lacerations) | Traumatic wounds | Traumatic wounds | |||
| Wounds that are prone tobleeding such as wounds thathave been mechanically orsurgically debrided and donorsites | Wounds that are prone tobleeding such as wounds thathave been mechanically orsurgically debrided and donorsites | Wounds that are prone tobleeding such as wounds thathave been mechanically orsurgically debrided and donorsites | Surgical wounds | |||
| Painful wounds; Infectedwounds | ||||||
| Malignant wounds | ||||||
| Contraindications | Should not be used onindividuals who are sensitive toor who have had an allergicreaction to the dressing or itscomponents. | Should not be used onindividuals who are sensitiveto or who have had anallergic reaction to thedressing or its components. | Should not be used onindividuals who are sensitiveto or who have had anallergic reaction to thedressing or its components. | Aquacel Ag+ Extra dressingsshould not be used onindividuals who are sensitiveto or have had an allergicreaction to silver, sodiumcarboxymethyl celluloseethylenediaminetetraaceticacid di-sodium salt (EDTA)or benzethonium chloride(BECI) | Individuals with a knownallergy or hypersensitivityto any of the componentsof KerraCel® Ag shouldnot use the dressing. | Equivalent with primarydevice. |
| PrescriptionUse | Prescription Use | Prescription Use | OTC usePrescription Use | OTC usePrescription Use | Prescription Use | Equivalent with primarypredicate device. |
| MaximumPeriod of Use | Seven days per dressing andmaximum repeat dressings of30 days | Seven days per dressing andmaximum repeat dressings of30 days | Seven days per dressingand maximum repeatdressings of 30 days | Aquacel Ag+ Extradressings can be worn forup to seven days. Dressingsshould be changed earlier ifclinically indicated.On partial thickness(second degree) burns,dressings may remain inplace for up to 14 days.The requirement forAquacel Ag+ Extradressings should be re-assessed after 14 days andalternative woundmanagement consideredwhere appropriate | The dressing can be left inplace for up to sevendays. | Equivalent with primarypredicate device. |
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /Justification forEquivalence |
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| DeviceDescription | Soft, sterile, non-woven pador ribbon dressing composedof sodium carboxymethylcellulose, cellulose and silverwhich are blended bycombining fibres in a cardingand needling process. | Soft, sterile, non-woven pad orribbon dressing composed ofsodium carboxymethylcellulose, cellulose and silverwhich are blended bycombiningfibres in a carding and needlingprocess. | Soft, sterile, non-woven pador ribbon dressingcomposed of sodiumcarboxymethylcellulose,which is incorporated in theform of a non-woven fleeceheld together by celluloseyarnusing a stitch bondingprocess. | A soft, sterile dressing madefrom two layers of 1.2% ionicsilver impregnated sodiumcarboxymethylcellulose fiberwith addedEthylenediaminetetraaceticAcid Disodium Salt (EDTA)and Benzethonium Chlorideand stitched together withstrengthening fibers.The two Hydrofiber layersare nominally 77gsm (gramsper square meter) weighteach. Aquacel Ag+ alsoincludes addedEthylenediaminetetraaceticAcid Disodium Salt (EDTA)and Benzethonium Chloride(BECL).See foot note 2. | Soft, sterile, nonwovenwound dressing made ofsodium carboxymethylcellulose (CMC),cellulose fibers, andsilver. | Equivalent (see discussionin footnote 5). |
| Silver Content | 18mg/100cm² | 7mg/100cm² | 23mg/100cm² | 1.3 % w/w(Approx. 22mg/100cm²) | 20mg/100cm² | Venus Ag has a higher silvercontent than the Titan Ag 200;this increase in silver contentdoes not affect the safety profileor the in vivo activity assubstantiated by thebiocompatibility studies performedwith the subject device, as wellthe effectiveness of the device, assubstantiated by the substantialequivalence analysis. Both VenusAg and Titan Ag release ionicsilver from silver nanoparticles.The additional predicate devicesAquacel Ag Extra and Aquacel Ag+ Extra demonstrate that ionicsilver used at the percentage of1.3%w/w(23mg/100cm2) is safe andKerracel Ag demonstrates thationic silver used at the |
| percentage of 1.7%w/w(20mg/100cm2) is safe. Venus Aghas ionic silver at 1.5% w/w(18mg/100cm2) which is less. Thesafety and performance are furthersupported by the in vivo and invitro tests and the antimicrobialtest. The safety testing of thenanoparticle silver confirmed thatthe concentration of 18mg/100cmused in this device is safe. |
Table 5-1: Substantial Equivalence Comparison of Characteristics and Intended Use
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| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Kerracel Ag | Significant Differences /Justification forEquivalence |
|---|---|---|---|---|---|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Crawford | N/A |
| AntimicrobialAgent | Ionic silver released fromelemental silver nanoparticleswithin the dressing. | Ionic silver released fromelemental silver nanoparticleswithin the dressing. | Ionic silver releasedform silver compoundswithin the dressing. | Silver ions released fromsilver oxysalts (Ag7NO11)within the dressing. | Equivalent to primary predicatedevice.Both Venus Ag and Titan Agantimicrobial agent is ionic silverreleased from elemental silvernanoparticles within thedressing, while Aquacel Ag Extrareleases ionic silver from silvercompounds within the dressing,and Kerracel Ag release silverions from silver oxysalts withinthe dressing. The agent in eachcase worksthrough the release of silverions into the |
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| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Kerracel Ag | Significant Differences /Justification forEquivalence |
|---|---|---|---|---|---|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Crawford | N/A |
| dressing. The silver ions releasedin a moist environment fromnanoparticles or silver salts areidentical. Therefore, thedifference in silver compositionbetween Venus Ag and thepredicates (Titan Ag, Aquacel AgExtra and Kerracel Ag) do notimpact safety and performance assubstantiated by thebiocompatibility reports and thesubstantialequivalence analysis. | |||||
| Sterilisation | Sterile (Gamma) | Sterile (Gamma) | Sterile (Gamma) | Sterile (Gamma) | Equivalent. |
| Packaging | Foil | Paper pouch | Foil | Foil | The foil pouch used is equivalentto the pouch used in theadditional predicate Kerracel Agand Aquacel Ag Extra.Studies on packaging integrityand accelerated agingdemonstrated the packaging isappropriate for maintainingdeviceintegrity and sterility. |
| Single-Use | Single-Use | Single-Use | Single-Use | Single-Use | Equivalent |
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5.5 Summary of Non-Clinical and Clinical and Performance Data
The following standards were adhered to during performance testing:
- . ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
5.5.1 Performance Testing (Bench)
- Antimicrobial efficacy according to modified AATCC 100 was found to ● consistently meet requirement of a log 4 reduction within the dressing when compared to a control against gram-negative, gram-positive, yeast and mould.
- Silver release profile within the dressing was found to be equivalent to that of the ● predicate device in simulated wound fluid over 24 hours, 5 days and 7 days.
- The silver content of the product remains at the same silver content throughout ● accelerated and real-time stability studies, therefore the release profile within the dressing is not tested at all time-points as no change is expected.
- Absorbency according to British Pharmacopoeia; Test Method for absorbency of ● Alginate dressings/Surgical dressings, and European Standard EN13726-1 and product consistently meets specifications.
- Tensile strength according to British Pharmacopoeia meets the specifications set for this product
- Stabilitv Studies ●
5.5.2 Biocompatibility Testing
Venus Ag devices are classified as surface devices with prolonged use (>24h to 30 days) and the relevant Biocompatibility studies were performed.
The following testing was conducted to demonstrate that the proposed device is as safe as the cleared 510(k) predicate device. Biocompatibility testing was conducted according to ISO 10993-1:
- . Cytotoxicity according to ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Tests for In Vitro Cytotoxicity
- . Intracutaneous Irritation studies according to ISO 10993-10. Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization
- . Acute Systemic Toxicity according to ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Tests for Systemic Toxicity
- . Sub-acute Systemic Toxicity and Implantation according to ISO 10993 standards: Biological Evaluation of Medical Devices, Part 2: Animal welfare requirements, Part 6: Tests for local effects after implantation and Part 11: Tests for Systemic Toxicity
- Sensitization according to ISO 10993-10, Biological Evaluation of Medical . Devices, Part 10; Tests for Irritation and skin sensitization
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- Material Mediated Pvrogenicity /SO 10993-11. Biological evaluation of medical ● devices, Part 11; Tests for systemic toxicity according to United States Pharmacopoeia (USP) 42 - National Formulary 37. And European Pharmacopeia, 10th edition
- Biological and Toxicological Risk Assessment according to /SO 10993-17 . Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
The performance studies indicate that Venus Ag wound dressings does not raise new questions regarding safety or performance 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.
5.5.3 Performance Data (Animal)
A porcine wound healing study was conducted in accordance with ISO 10993-6 with a comparison to a legally marketed device. Venus Ag was tested alonqside the predicate device Aquacel Ag+ Extra, as well as one control dressing. Overall, Venus Ag did not impair the wound healing process as observed from the various histology parameters analyzed and as compared to the predicate.
5.5.4 Performance Data (Clinical)
No clinical testing was required to support substantial equivalence.
5.6 Non-Performance Testing
The following testing was conducted to ensure the integrity of the end product:
- Sterilisation Validation according to ISO 11137-1 and ISO 11137-2. Sterilisation . of health care products, and results confirmed that Venus Ag successfully met its predetermined acceptance criteria as per standards.
- . Packaging Validation and 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 F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Venus Ag successfully met its predetermined acceptance criteria as per standards.
- Shelf-life Testing A maximum shelf life of 24 months (based on real time aged . Final Finished Device) has been assigned when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
5.7 Statement of Substantial Equivalence
Venus Ag (subject device, K222740) is substantially equivalent to the cleared primary predicate device Titan Ag 200 (K173844) and supporting additional predicate devices Aquacel Ag Extra (K121275), Aquacel Ag+ Extra K173675 and Kerracell Ag (K162508).
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Venus Ag's equivalence is based on the following:
- lt has the same intended use as the primary predicate device; and displays ● performance equivalent to that of the predicate device.
- It has the same composition of carboxymethyl cellulose, reqenerated cellulose and . ionic silver released into dressing as the primary predicate device.
- The minor technological characteristic differences, compared to the primary predicate, do not influence the substantial equivalence.
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.
The data provided demonstrates that there are no new questions of safety and effectiveness compared to the predicate, and the subject device is substantially equivalent to the predicate device.
N/A