(233 days)
Under the supervision of a healthcare professional, Titan Ag 200 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 prone to bleeding such as wounds that have been mechanically or surgically ● debrided or donor sites .
Titan Ag 200 Wound Dressing is a soft, conformable non-woven fabric made from a blend of cellulose fiber(s) impreqnated with metallic silver (in the form of silver nano-particles), sodium carboxymethyl cellulose fibres and strengthening cellulose fiber(s). The ionic silver released into the wound dressing when in contact with wound exudate or blood has an antibacterial effect on wound bacteria held within the dressing, preventing it from being colonized. The structure of the dressing remains intact through the gel formation. Debris and any bacteria absorbed in the wound exudate and retained within the dressing are removed when the dressing is changed.
The provided text describes the Titan Ag 200 wound dressing and its substantial equivalence to the predicate device, Aquacel Ag Extra (K121275). Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Titan Ag 200) | Comparison |
|---|---|---|---|
| Silver Release | 2420-4250 ppb / 24hrs (0.021-0.031 mg/10cm²/24 hrs) | 2880-3560 ppb/24hrs (0.025-0.030mg/10cm²/24 hrs) | Similar; Statistical analysis showed no significant difference over 7 days. |
| Absorbency | 24g/100cm² | 30g/100cm² | Equivalent |
| Antibacterial Activity | Assumed to meet criteria of > 4 log reduction | > 4 log reduction for various bacteria at corresponding time-points | Meets requirement; effectiveness confirmed. |
| Wet Tensile Strength | 15.9 N/cm | 3 – 5.9 N/cm | Equivalent |
| Biocompatibility | Assumed to pass applicable ISO 10993 tests | Comprehensive biocompatibility testing confirmed no safety concerns | Meets requirement; demonstrated in accordance with FDA Use of ISO 10993-1. |
| Sterilization Validation | Not specified (assumed to meet standards) | Successfully met predetermined acceptance criteria as per ISO 11137-1/EN ISO 11137-2 | Met requirements |
| Packaging Integrity | Not specified (assumed to meet standards) | Successfully met predetermined acceptance criteria as per ASTM F1886/F1929/F88/F88M | Met requirements |
| Shelf-Life | Three years (for predicate) | 12 months | N/A (SFM will apply more stringent use until more post-marketing data is available) |
Notes on "Equivalent" and "Similar" in the context of this document: The document explicitly states that "Statistical analysis of the difference in results obtained for silver release over 7 days for the subject and predicate devices was statistically insignificant. Therefore the devices are deemed to have equivalent silver release." This suggests that "similar" or "equivalent" in this context means statistically comparable performance that meets the safety and effectiveness requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the various performance tests (e.g., number of dressings tested for silver release, absorbency, or wet tensile strength).
- Data Provenance: The studies are described as non-clinical performance data, indicating they were conducted in a laboratory setting. There is also mention of a porcine wound healing study, which would be an in vivo animal study. The document does not specify the country of origin for these specific tests, but the submitting company is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for performance testing is typically established by adhering to recognized international standards and test methods (e.g., AATCC 100 for antibacterial efficacy, British Pharmacopoeia for absorbency, ISO 10993 for biocompatibility). These standards define the methodology and acceptance criteria, rather than relying on expert consensus for each individual test result within the submission.
4. Adjudication Method for the Test Set
This information is not applicable in the context of the performance testing described. The tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers is not described in this document. The studies focus on the physical and biological performance of the wound dressing itself, not on human interpretation or effectiveness with and without AI assistance. This device is a wound dressing, not an AI-powered diagnostic or therapeutic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone algorithm performance study was not done. This document pertains to a physical medical device (wound dressing), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests were based on:
- Standardized test methods and predetermined acceptance criteria: For silver release, absorbency, antibacterial activity, wet tensile strength, sterilization validation, and packaging integrity. These are objective measures against predefined thresholds.
- Biological evaluation standards (ISO 10993 series) and FDA guidance: For biocompatibility. This involves a battery of tests to assess different biological responses.
- Comparison to a legally marketed predicate device: The performance of the Titan Ag 200 was directly compared to the Aquacel Ag Extra (K121275) to demonstrate substantial equivalence.
- Porcine wound healing study: This is an in vivo animal model used to assess the device's effect on the wound healing process.
8. The Sample Size for the Training Set
This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.
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August 9, 2018
Speciality Fibres and Materials Ltd. Lindie Turvey Senior Regulatory Affairs Officer 101 Lockhurst Lane Coventry, CV6 5SF United Kingdom
Re: K173844
Trade/Device Name: Titan Ag 200 Regulatory Class: Unclassified Product Code: FRO Dated: December 14, 2017 Received: December 19, 2017
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5
510(k) Summary K173844
Details of the device Titan Aq 200 herewith applied for is 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 708 253 or +44 (0)73 79 333 207Fax: +44 (0) 2476 682737E-mail: Lindie.turvey@sfm-limited.com | ||||||||||||
| Date prepared: | 6 July 2018 | ||||||||||||
| Device Details: | Trade Name: Titan Ag 200 Classification Name: Dressing, Wound, Drug Common Name: Wound Dressing with antibacterial silverand strengthening cellulose fibre Product Code: FRO Classification: Unclassified Panel: General & Plastic Surgery | ||||||||||||
| Legally MarketedPredicate Device(s): | Aquacel Ag Extra, 510(k) No. K121275 | ||||||||||||
| Legally MarketedReference Devices | Ross Ru Wound Dressing Gel (K162017)Acticoat Flex 7 (K083113)Opticell Ag (K100693)Durafiber Ag (K103793/K161289) |
5.2 DESCRIPTION OF THE DEVICE:
Titan Ag 200 Wound Dressing is a soft, conformable non-woven fabric made from a blend of cellulose fiber(s) impreqnated with metallic silver (in the form of silver nano-particles), sodium carboxymethyl cellulose fibres and strengthening cellulose fiber(s). The ionic silver released into the wound dressing when in contact with wound exudate or blood has an antibacterial effect on wound bacteria held within the dressing, preventing it from being colonized. The structure of the dressing remains intact through the gel formation. Debris and any bacteria absorbed in the wound exudate and retained within the dressing are removed when the dressing is changed.
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Exudate is absorbed into the dressing. In addition, the dressing assists in maintaining a moist wound environment, supports autolytic debridement, and protects the wound edge and surrounding skin from maceration, thus supporting the healing process.
5.3 INDICATIONS FOR USE:
Under the supervision of a healthcare professional, Titan Ag 200 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 prone to bleeding such as wounds that have been mechanically or surgically ● debrided or donor sites .
5.4 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Titan Ag 200 technological characteristics are deemed comparable to those of the predicate device.
Important technological characteristics of Titan Ag 200 to consider are the presence of antibacterial silver in the dressing which reduces bacterial growth within the dressing. and the absorbency capacity of the dressing when compared to the predicate device, as these characteristics constitute the mode of action of the device. Therefore, the chosen predicate device is composed of the same material (carboxymethyl cellulose and regenerated cellulose) as the Titan Aq 200, shares the ability to absorb and retain wound fluid together with any bacteria and wound debris that may be present in the fluid, and has an equivalent silver release pattern into the dressing. The results of testing are summarised below. Based on the evidence generated the Titan Ag 200 releases silver ions into the dressing and not silver nanoparticles.
Titan Ag 200 has the same intended use and general characteristics as the predicate device as detailed in the table below. Minor technological differences are addressed in the tables below.
| Manufacturer | Convatec inc | Speciality Fibres andMaterials Ltd. | Comparison |
|---|---|---|---|
| Trade Name | Aquacel Ag Extra | Titan Ag 200 | |
| 510(k) | K121275 | K173844 | |
| Number | (Predicate Device) | (Subject Device) | |
| Product Code | FRO | FRO | Equivalent |
| RegulationName | Dressing, Wound Drug | Dressing, Wound Drug | Equivalent |
| 510(k)Number | K121275(Predicate Device) | K173844(Subject Device) | Comparison |
| Intendeduse | Management of woundswith moderate to heavyexudate. The dressingabsorbs wound exudate andforms a gel which retains thebacteria laden woundexudate in the dressing.This ensures a moist woundhealing environment. Thedressing also has anantimicrobial action which isexerted by the silverreleased into 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. As per FDArecommendations wewish to only claimantibacterial action in-line with the availabledata. |
| Indicationsfor Use | Management of wounds asan effective barrier tobacterial penetration of thedressing as this may helpreduce infection | Management of wounds withmoderate to heavy exudate | Equivalent |
| Partial thickness (seconddegree) burns | Partial thickness burns | ||
| Diabetic foot ulcers, legulcers, (venous stasisulcers, arterial ulcers and legulcers of mixed etiology) andpressure ulcers/sores(partial and full thickness); | Leg ulcers, pressure ulcersand diabetic ulcers | ||
| Surgical wounds left to healby secondary intention suchas dehisced surgicalincisions;Surgical wounds that healby primary intent such asdermatological and surgicalincisions (e.g. orthopedicand vascular) | Surgical wounds (e.g. post-operative wounds left to healby secondary intent anddonor/graft sites) | ||
| Traumatic wounds | Traumatic wounds (e.g.abrasions and lacerations) | ||
| Wounds that are prone tobleeding such as woundsthat have been mechanicallyor surgically debrided anddonor sites; | Wounds prone to bleedingsuch as wounds that havebeen mechanically orsurgically debrided or donorsites | ||
| Painful wounds;Infected wounds | - | ||
| Contra-indications | 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. | Equivalent |
| PrescriptionUse | OTC usePrescription Use | Prescription Use Only | SFM will apply morestringent use untilenough post marketingsurveillance databecomes available. Aseparate 510(k) will besubmitted in the eventof extending use toOTC |
| MaximumPeriod of Use | Seven days per dressingand maximum repeatdressings of 30 days | Seven days per dressing andmaximum repeat dressingsof 30 days | Equivalent |
| Devicedescription 1 | Soft, sterile, non-wovenpad or ribbon dressingcomposed of sodiumcarboxymethylcellulosecontaining silver, which isincorporated in the form ofa non-woven fleece heldtogether by cellulose yarnusing a stitch bondingprocess. | Soft, sterile, non-wovenpad or ribbon dressingcomposed of sodiumcarboxymethylcellulose,cellulose and silver whichare blended by combiningfibres in a carding andneedling process. | Equivalent |
| Silver content | 1.3 % m/m1.3 mg silver per 10x10 cmdressing | 0.35% m/m0.35 mg silver per 10cm x10cm dressing | The subject device hasa lower silver contentthan the predicatedevice. This is becausethe use of silvernanoparticles that havea high surface area toweight ratio provides arate of sustainedrelease of silver ionsinto the dressing that iscomparable to that ofthe predicate device.This is substantiatedby in vitro test data andantibacterialeffectiveness test data |
| Active anti-bacterialagent | Ionic silver released fromsilver compounds | Ionic silver released fromelemental silvernanoparticles | Equivalent |
| Sterile | Sterile (Gamma) | Sterile (Gamma) | Equivalent |
| Packaging | Foil | Paper pouch | Although thepackaging materialdiffers, studies onpackaging integrity andaccelerated agingdemonstrated thepackaging isappropriate formaintaining device |
| integrity and sterility. | |||
| Shelf Life | Three years | 12months | N/A |
| Re-enforcingfibres 3 | Regenerated cellulosefibres 18% | Regenerated cellulosefibres 40% | The subject device andpredicate device havesubstantially the samecomposition with amajority of the productcomprising sodiumcarboxymethylcellulose fibres. Thedifference in thepercentage of gelforming carboxymethylcellulose fibres doesnot affect theperformance of thedevices as shown bytesting.The method ofreinforcement is adifference between thetwo devices. SFM havechosen to increase thestrength of the subjectdevice byhomogenouslyblending regeneratedcellulose fibres in thenon-woven fabric. Thebiological risk of theadditional cellulosecontent wasconsidered as part ofthe risk assessment |
| Absorbent gelforming fibres | Sodium carboxymethylcellulose | Sodium carboxymethylcellulose | Equivalent |
Table 5-1 Substantial Equivalence Comparison of Characteristics and Intended use
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SFM
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SFM
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Reference Device comparison
| 510(k)Number | K121275(Predicate Device) | K173844(Subject Device) | Comparison |
|---|---|---|---|
| ReferenceDevice 1 | Durafiber AgK103793/K161289Description:DURAFIBER Ag is a non-woven dressing made of cellulose and cellulose ethylsulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antimicrobial properties intended to reduce or inhibit microbial colonization of the device. The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.Blending technology:Standard non-woven technology, e.g. carding and cross folding.Dressing material:Cellulose and cellulose ethylsulphonate with silver. | TITAN Ag 200K173844DescriptionNon-woven dressing made of carboxymethyl cellulose, cellulose and cellulose with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antibacterial properties intended to reduce or inhibit bacterial colonization of the device. The silver is present as PVP capped silver particles. Silver ions are produced from silver particles on contact with wound fluid. The ionic form of silver is the active agent.Blending technology:Standard non-woven technology, e.g. carding and cross folding.Dressing material:Carboxymethyl cellulose with strengthening cellulose fibres | Similar blending technology but difference in materials |
| ReferenceDevice 2 | Opticell AgK100693DescriptionA soft, sterile, non-woven pad or ribbon dressing. The dressing is comprised of chitosan, chitosan derivatives and structural materials with the addition of ionic silver. | Titan Ag 200K173844DescriptionNon-woven dressing made of carboxymethyl cellulose, cellulose and cellulose with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antibacterial properties intended to reduce or inhibit bacterial colonization of the device. | Similar blending technology but difference in materials |
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510(k) K121275 K173844 Comparison Number (Predicate Device) (Subject Device) The silver is present as PVP capped silver particles. Silver ions are produced from silver particles on contact with wound fluid. The ionic form of silver is the active agent. Blending technology: Blending technology: Unknown - believed to be Standard non-woven technology, e.g. carding via standard non-woven technology, e.g. carding and and cross folding. cross folding. Dressing material: Dressing material: Chitosan, chitosan Carboxymethyl cellulose with strengthening cellulose derivatives and structural materials with ionic silver fibres Acticoat Flex Titan Ag 200 Reference Similar intended use. Device 3 K083113 K173844 Device description: Device description: Effective antimicrobial Non-woven dressing made barrier dressings. The of carboxymethyl Nanocrystalline silver cellulose, cellulose and coating rapidly kills a cellulose with silver. The broad spectrum of bacteria product is an absorbent in as little as 30mins. fibrous dressing that gels ACTICOAT Flex 3 & 7 on contact with wound consist of a single layer of fluid. The silver provides knitted polyester to ensure the antibacterial properties ultimate flexibility and intended to reduce or comfort during wear time inhibit bacterial for the patient. colonization of the device. The silver is present as PVP capped silver particles. Silver ions are produced from silver particles on contact with wound fluid. The ionic form of silver is the active agent. Silver content Silver content Nano-crystaline silver Silver-nanoparticles unknown concentrations (0.35%) Silver release Silver release PVP-capped silver Mechanism unknown nanoparticles release silver ions when in contact with
wound fluid
Reference Device comparison
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| ReferenceDevice 4 | Ross Ru WoundDressing GelK092826 | Titan Ag 200K173844 | Both dressings containnano-silver |
|---|---|---|---|
| DescriptionRoss Ru is a wounddressing gel that helpsmaintain a moist woundenvironment that isconducive to healing, byeither absorbing ordonating the moisture andwound exudates. Ross RuWound Dressing Gel issupplied in a collapsiblelow density polyethylenetube sealed at one endand fitted with adispensing orifice at theother end accessible bythe removal of its screwcap. | Device description:Non-woven dressing madeof carboxymethylcellulose, cellulose andcellulose with silver. Theproduct is an absorbentfibrous dressing that gelson contact with woundfluid. The silver providesthe antibacterial propertiesintended to reduce orinhibit bacterialcolonizationof the device.The silver is present asPVP capped silverparticles. Silver ions areproduced from silverparticles on contact withwound fluid. The ionicform of silver is the activeagent. | ||
| MaterialsPurified water, nano-silverat 0.1 micron, TEA,carbopol, propylene glycol | MaterialsPVP-capped nano-silver,carboxymethylcellulosedressings and cellulosefibres |
Footnotes and discussion of equivalence
Construction of dressings
There is a minor difference in the methods of constructing the dressings between the predicate and subject device. The predicate device is, SFM believe, created by a process of carding and needling fibres into a web before bonding two webs together by a stitch bonding process. The subject device dressing is created by a process of blending fibres and then carding and needling them into a dressing. This fibre blending process is used for other FDA 510(k) cleared devices.
ર્સ્ડ SUMMARY OF NON-CLINICAL AND CLINICAL 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,"
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- 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.
| Performance Characteristics | |||
|---|---|---|---|
| Manufacturer | Convatec inc | Speciality Fibres andMaterials Ltd. | Comparison |
| Trade Name | Aquacel Ag Extra | Titan Ag 200 | |
| 510(k) number | K121275 | K173844 | |
| Predicate device | Test device | ||
| Mode of action | Releases silver ionson contact withwound exudate.Absorbing woundexudate and forminga gel trapping debrisand bacteria in thedressing | Releases silver ionson contact with woundexudate. The silverions are released intothe wound dressing,but not into the woundbed.Absorbing woundexudate and forminga gel trapping debrisand bacteria in thedressing | Equivalent |
| SilverRelease 4 | 2420-4250 ppb /24hrs0.021 -0.031 mg/10cm2/24 hrs | 2880-3560 ppb/24hrs24 – 30 ppm/10 cm2 /24hrs0.025-0.030mg/10cm2/24 hrs | SimilarStatistical analysisofthedifference in results obtainedfor silver release over 7 daysfor the subject and predicatedeviceswasstatisticallyinsignificant. Thereforethedevices are deemed to haveequivalent silver release. .It should be noted that the120gsm and 200 gsm productshave a similar silver releaseprofile. |
| Absorbency | 24g/100cm2 | 30g/100cm2 | Equivalent |
| Performance Characteristics | |||
| Antibacterialactivity | Assumed to meet thecriteria of a > 4 logreduction | Log reduction forvarious bacteria atcorresponding time-points > 4. | Meets requirement:Antibacterial activity remainsabove the log reduction of 4,which confirms theeffectiveness of the device forits the intended use. |
| Wet tensileStrength | 15.9 N/cm | 3 – 5.9 N/cm | Equivalent |
| Biocompatibility | Assumed to pass therequirements ofapplicable ISO 10993tests | Comprehensivebiocompatibilitytesting confirmed thatthe device raises nosafety concerns. | Meets requirement.The biocompatibility of Titan Ag200 has been demonstrated inaccordance with FDA Use ofInternational Standard ISO10993-1, "Biological evaluationof medical devices - Part 1:Evaluation and testing within arisk management process". |
Table 5-2 Substantial Equivalence Comparison of Performance Characteristics
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5.5.1 Discussion on Performance testing
Performance testing was done according to standards where an accepted industry standard exists:
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- Antibacterial efficacy 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 than that of the predicate device in . similated wound fluid over 7 days.
- . 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.
5.5.2 Discussion on Biocompatibility Testing
Titan Ag 200 is classified as a surface device with prolonged use and the relevant biocompatibility studies were performed.
Biocompatibility testing was conducted according to ISO 10993-1- 2009 and the following concluded.
Testing included:
- Toxicological Risk Assessment according to ISO 10993-17 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances, overall, it was concluded that the detected extractables would not pose significant health risks to patients, even if they were to be genuine leachables from the dressing, reach the patients, and be entirely absorbed into the blood stream.
- · Acute systemic toxicity according to ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Tests for Systemic Toxicity and Under the conditions of this study, there was no evidence of significant systemic toxicity or mortality after test article extracts iniection
- · Sub-acute Systemic Toxicity according to ISO 10993 standards: Biological Evaluation of Medical Devices, Part 2 (2006): Animal welfare requirements, Part 6 (2007): Tests for local effects after implantation and Part 11 (2006): Tests for Systemic Toxicity, there was no evidence of adverse systemic toxicity or local effects that could be attributed to Titan Ag 200 following repeated topical applications
- · Irritation studies according to ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization, met the requirements of the intracutaneous injection test in the rabbit.
- · Cytotoxicity according to ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Tests for In Vitro Cytotoxicity test article extract showed no cytotoxicity potential to L-929 mouse fibroblast cells.
- · Sensitisation according to ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization and the test article was not considered a sensitizer in the guinea pig maximization model.
- · Material mediated pyrogenicity ISO 10993-11 according to United States Pharmacopoeia (USP) 39 – National Formulary 34. And European pharmacopeia, 8th edition and the article was judged non-pyrogenic
- · Genotoxicity according to ISO 10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity test article extracts were considered to be nonmutagenic
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The overall Biological risk assessment was conducted using the following standards and it was concluded that Titan Ag 200 Antibacterial Wound Dressing is considered to be a biocompatible medical device, with respect to ISO 10993 and US FDA (2016) quidance, 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 quidance.
- 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 Titan Ag 200 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.
5.5.3 Discussion on Performance data (Animal)
A porcine wound healing study with a comparison to a legally marketed device, the chosen predicate Aquacel Ag Extra was performed. Overall it was concluded that Titan Ag did not impair the wound healing process.
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 Titan Ag 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 F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Titan Ag 200 successfully met its predetermined acceptance criteria as per standards
- Shelf-life testing A maximum shelf life of 12 months has been assigned when . stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
5.7 STATEMENT OF SUBSTANTIAL EQUIVALENCE:
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The subject device, Titan Ag 200, described in this submission is substantially equivalent to the predicate device Aquacel Ag Extra (K121275)
Titan Ag 200:
- has the same intended use as the predicate; and displays performance equivalent to . that of the predicate device.
- . has the essentially same composition of carboxymethyl cellulose, regenerated cellulose and ionic silver released into dressing.
- minor technological characteristic differences to the predicate, which 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.
N/A