Who is the manufacturer of Titan Ag 200?

Specialty Fibres and Materials, Ltd. filed the 510(k) submission for Titan Ag 200 (K173844).

What is the FDA product code for Titan Ag 200?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Titan Ag 200?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Titan Ag 200?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Titan Ag 200

K173844 · Specialty Fibres and Materials, Ltd. · FRO · Aug 9, 2018 · SU

Device Facts

Record ID	K173844
Device Name	Titan Ag 200
Applicant	Specialty Fibres and Materials, Ltd.
Product Code	FRO · SU
Decision Date	Aug 9, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Management of wounds with moderate to heavy exudate. The dressing absorbs wound exudate and may retain bacteria in the wound exudate within the dressing. This ensures a moist wound healing environment. The dressing contains silver, which limits the growth of bacteria within the dressing.

Device Story

Titan Ag 200 is a soft, sterile, non-woven wound dressing composed of sodium carboxymethyl cellulose, cellulose, and elemental silver nanoparticles. Used in clinical settings under healthcare professional supervision, the dressing is applied to wounds to absorb exudate and maintain a moist healing environment. Upon contact with wound exudate or blood, the silver nanoparticles release ionic silver into the dressing, which provides an antibacterial effect by limiting bacterial growth within the dressing matrix. The dressing forms a gel that retains absorbed exudate, bacteria, and debris, which are then removed during dressing changes. It supports autolytic debridement and protects surrounding skin from maceration. The device is intended for prescription use only.

Clinical Evidence

No human clinical trials were conducted. Evidence includes bench testing (antibacterial efficacy per AATCC 100, silver release profiles, absorbency per British Pharmacopoeia/EN 13726-1, wet tensile strength) and a porcine wound healing study comparing Titan Ag 200 to the predicate. Biocompatibility testing followed ISO 10993-1, including cytotoxicity, sensitization, irritation, acute/sub-acute systemic toxicity, genotoxicity, and material-mediated pyrogenicity. All tests met predetermined acceptance criteria.

Technological Characteristics

Non-woven fabric dressing; materials: sodium carboxymethyl cellulose, cellulose, and elemental silver nanoparticles. Sensing/actuation: passive absorption and ionic silver release. Dimensions: pad or ribbon. Connectivity: none. Sterilization: Gamma radiation. Software: none.

Indications for Use

Indicated for management of wounds with moderate to heavy exudate, including partial thickness burns, leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative, secondary intent, donor/graft sites), and traumatic wounds (abrasions, lacerations). Also indicated for wounds prone to bleeding such as those mechanically or surgically debrided or donor sites. Contraindicated for individuals sensitive to or with a history of allergic reaction to the dressing or its components.

Predicate Devices

Aquacel Ag Extra (K121275)

Reference Devices

Ross Ru Wound Dressing Gel (K162017)
Acticoat Flex 7 (K083113)
Opticell Ag (K100693)
Durafiber Ag (K103793/K161289)

Related Devices

K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch · Speciality Fibres and Materials, Ltd. · Oct 21, 2024
K210466 — Silver Gelling Fiber Dressing · Winner Medical Co., Ltd. · Jan 14, 2022
K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) · Qingdao Bright Moon Biomedical Materials Co., Ltd. · Dec 19, 2025
K143017 — Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver · Laboratoires Urgo · Aug 7, 2015
K143335 — Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) · Roosin Medical Devices Co., Ltd. · Jun 1, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services - USA logo, which features a stylized eagle. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for SFM, which is displayed in red, bold letters. The logo is positioned at the top of the image. Below the logo, there is a geometric design in shades of green and gray, creating a modern and professional look. ## Section 5 K173844 ## 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 Kingdom Establishment Registration No.: 3005818605 | | | | | | | | | | | | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--| | Contact details: | Lindie Turvey Regulatory Affairs Officer Telephone: +44 (0)2476 708 253 or +44 (0)73 79 333 207 Fax: +44 (0) 2476 682737 E-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 silver and strengthening cellulose fibre Product Code: FRO Classification: Unclassified Panel: General & Plastic Surgery | | | | | | | | | | | | | | Legally Marketed Predicate Device(s): | Aquacel Ag Extra, 510(k) No. K121275 | | | | | | | | | | | | | | Legally Marketed Reference 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for SFM, which is displayed in red, bold letters. Below the logo is a geometric design in shades of green and gray. The design appears to be a stylized representation of a mountain range or a similar natural feature. 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 and Materials Ltd. | Comparison | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Aquacel Ag Extra | Titan Ag 200 | | | 510(k) | K121275 | K173844 | | | Number | (Predicate Device) | (Subject Device) | | | Product Code | FRO | FRO | Equivalent | | Regulation Name | Dressing, Wound Drug | Dressing, Wound Drug | Equivalent | | 510(k) Number | K121275 (Predicate Device) | K173844 (Subject Device) | Comparison | | Intended use | Management of wounds with moderate to heavy exudate. The dressing absorbs wound exudate and forms a gel which retains the bacteria laden wound exudate in the dressing. This ensures a moist wound healing environment. The dressing also has an antimicrobial action which is exerted by the silver released into the dressing. | Management of wounds with moderate to heavy exudate. The dressing absorbs wound exudate and may retain bacteria in the wound exudate within the dressing. This ensures a moist wound healing environment. The dressing contains silver, which limits the growth of bacteria within the dressing. | Equivalent. As per FDA recommendations we wish to only claim antibacterial action in- line with the available data. | | Indications for Use | Management of wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection | Management of wounds with moderate to heavy exudate | Equivalent | | | Partial thickness (second degree) burns | Partial thickness burns | | | | Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial and full thickness); | Leg ulcers, pressure ulcers and diabetic ulcers | | | | Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g. orthopedic and vascular) | Surgical wounds (e.g. post- operative wounds left to heal by secondary intent and donor/graft sites) | | | | Traumatic wounds | 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; | Wounds prone to bleeding such as wounds that have been mechanically or surgically debrided or donor sites | | | | Painful wounds; Infected wounds | - | | | Contra- indications | Should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components. | Should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components. | Equivalent | | Prescription Use | OTC use Prescription Use | Prescription Use Only | SFM will apply more stringent use until enough post marketing surveillance data becomes available. A separate 510(k) will be submitted in the event of extending use to OTC | | Maximum Period of Use | Seven days per dressing and maximum repeat dressings of 30 days | Seven days per dressing and maximum repeat dressings of 30 days | Equivalent | | Device description 1 | Soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose containing silver, which is incorporated in the form of a non-woven fleece held together by cellulose yarn using a stitch bonding process. | Soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose, cellulose and silver which are blended by combining fibres in a carding and needling process. | Equivalent | | Silver content | 1.3 % m/m 1.3 mg silver per 10x10 cm dressing | 0.35% m/m 0.35 mg silver per 10cm x 10cm dressing | The subject device has a lower silver content than the predicate device. This is because the use of silver nanoparticles that have a high surface area to weight ratio provides a rate of sustained release of silver ions into the dressing that is comparable to that of the predicate device. This is substantiated by in vitro test data and antibacterial effectiveness test data | | Active anti- bacterial agent | Ionic silver released from silver compounds | Ionic silver released from elemental silver nanoparticles | Equivalent | | Sterile | Sterile (Gamma) | Sterile (Gamma) | Equivalent | | Packaging | Foil | Paper pouch | Although the packaging material differs, studies on packaging integrity and accelerated aging demonstrated the packaging is appropriate for maintaining device | | | | | integrity and sterility. | | Shelf Life | Three years | 12months | N/A | | Re-enforcing fibres 3 | Regenerated cellulose fibres 18% | Regenerated cellulose fibres 40% | The subject device and predicate device have substantially the same composition with a majority of the product comprising sodium carboxymethyl cellulose fibres. The difference in the percentage of gel forming carboxymethyl cellulose fibres does not affect the performance of the devices as shown by testing. The method of reinforcement is a difference between the two devices. SFM have chosen to increase the strength of the subject device by homogenously blending regenerated cellulose fibres in the non-woven fabric. The biological risk of the additional cellulose content was considered as part of the risk assessment | | Absorbent gel forming fibres | Sodium carboxymethyl cellulose | Sodium carboxymethyl cellulose | Equivalent | Table 5-1 Substantial Equivalence Comparison of Characteristics and Intended use {5}------------------------------------------------ SFM {6}------------------------------------------------ SFM {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for SFM, which is in red text. The logo is positioned at the top of the image. Below the logo is a geometric design in shades of green and gray. The design appears to be a stylized mountain range. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the acronym "SFM" in bold red letters at the top. Below the acronym is a geometric design in shades of green and gray. The design appears to be a stylized representation of a mountain range or a series of overlapping triangles. ### Reference Device comparison | 510(k) Number | K121275 (Predicate Device) | K173844 (Subject Device) | Comparison | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Reference Device 1 | Durafiber Ag K103793/K161289 Description: 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 200 K173844 Description Non-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 | | Reference Device 2 | Opticell Ag K100693 Description A 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 200 K173844 Description Non-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 | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for SFM, which is displayed in red, bold letters. Below the logo is a geometric design in shades of green and gray. The design appears to be a series of overlapping triangles, creating a modern and abstract visual element. #### 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 {10}------------------------------------------------ | Reference Device 4 | Ross Ru Wound Dressing Gel K092826 | Titan Ag 200 K173844 | Both dressings contain nano-silver | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | | Description Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates. Ross Ru Wound Dressing Gel is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap. | Device description: Non-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 bacterialcolonization 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. | | | | Materials Purified water, nano-silver at 0.1 micron, TEA, carbopol, propylene glycol | Materials PVP-capped nano-silver ,carboxymethylcellulose dressings and cellulose fibres | | #### 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," {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for SFM. The letters SFM are in red, and the background is white. There is a green triangle in the lower left corner of the image. The bottom of the image has a geometric design in shades of green and gray. - 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 and Materials Ltd. | Comparison | | Trade Name | Aquacel Ag Extra | Titan Ag 200 | | | 510(k) number | K121275 | K173844 | | | | Predicate device | Test device | | | Mode of action | Releases silver ions on contact with wound exudate. Absorbing wound exudate and forming a gel trapping debris and bacteria in the dressing | Releases silver ions on contact with wound exudate. The silver ions are released into the wound dressing, but not into the wound bed. Absorbing wound exudate and forming a gel trapping debris and bacteria in the dressing | Equivalent | | Silver Release 4 | 2420-4250 ppb / 24hrs 0.021 -0.031 mg/ 10cm2/24 hrs | 2880-3560 ppb/24hrs 24 – 30 ppm/10 cm2 /24 hrs 0.025-0.030mg /10cm2/24 hrs | Similar 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. . It should be noted that the 120gsm and 200 gsm products have a similar silver release profile. | | Absorbency | 24g/100cm2 | 30g/100cm2 | Equivalent | | Performance Characteristics | | | | | Antibacterial activity | Assumed to meet the criteria of a > 4 log reduction | Log reduction for various bacteria at corresponding time- points > 4. | Meets requirement: Antibacterial activity remains above the log reduction of 4, which confirms the effectiveness of the device for its the intended use. | | Wet tensile Strength | 15.9 N/cm | 3 – 5.9 N/cm | Equivalent | | Biocompatibility | Assumed to pass the requirements of applicable ISO 10993 tests | Comprehensive biocompatibility testing confirmed that the device raises no safety concerns. | Meets requirement. The biocompatibility of Titan Ag 200 has been demonstrated in accordance with FDA Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". | Table 5-2 Substantial Equivalence Comparison of Performance Characteristics {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for SFM, which is written in red, bold letters. Below the letters is a geometric design in shades of green and gray. The design appears to be a stylized mountain range or abstract shapes. The background is white. ## 5.5.1 Discussion on Performance testing Performance testing was done according to standards where an accepted industry standard exists: {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for SFM, which is displayed in red, and is positioned in the upper portion of the image. Below the logo is a green, geometric design that appears to be a stylized mountain range or abstract shape. The background is white, providing a clean and simple backdrop for the logo and design elements. - 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 Cytotox…