(233 days)
Aquacel Ag Extra, 510(k) No. K121275
No
The device description and performance studies focus on the material properties and antibacterial effects of the wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to help manage and heal various types of wounds, including burns, ulcers, and surgical wounds, by preventing bacterial colonization and absorbing exudate. These functions are therapeutic as they aid in the recovery and treatment of damaged tissue.
No
The device, Titan Ag 200 Wound Dressing, is used for the management and healing of wounds, not for diagnosis. Its description and intended use focus on treatment and protection, such as antibacterial effects and absorption, rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a "soft, conformable non-woven fabric" made from physical materials like cellulose fibers and metallic silver, indicating it is a physical wound dressing, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds and burns. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing that interacts with wound exudate and blood to provide an antibacterial effect and manage the wound environment. This is a physical and chemical interaction within the wound, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) to diagnose a condition, determine a state of health, or monitor a treatment. The device's function is directly on the wound itself.
- Performance Studies: The performance studies focus on the dressing's properties (antibacterial efficacy, silver release, absorbency, tensile strength, biocompatibility) and its effect on wound healing. These are relevant to a wound care product, not an IVD.
In summary, the Titan Ag 200 Wound Dressing is a therapeutic device intended for direct application to wounds, not a diagnostic device used to test samples.
N/A
Intended Use / 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 .
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was done according to standards where an accepted industry standard exists:
- 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.
Biocompatibility testing was conducted according to ISO 10993-1- 2009. Testing included:
- Toxicological Risk Assessment according to ISO 10993-17.
- Acute systemic toxicity according to ISO 10993-11.
- Sub-acute Systemic Toxicity according to ISO 10993 standards: Part 2, Part 6, and Part 11.
- Irritation studies according to ISO 10993-10.
- Cytotoxicity according to ISO 10993-5.
- Sensitisation according to ISO 10993-10.
- Material mediated pyrogenicity ISO 10993-11 according to United States Pharmacopoeia (USP) 39 – National Formulary 34. And European pharmacopeia, 8th edition.
- Genotoxicity according to ISO 10993-3.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Silver Release: 2880-3560 ppb/24hrs (0.025-0.030mg /10cm2/24 hrs) for subject device, compared to 2420-4250 ppb / 24hrs (0.021 -0.031 mg/ 10cm2/24 hrs) for predicate. Deemed Similar, statistically insignificant difference.
- Absorbency: 30g/100cm2 for subject device, compared to 24g/100cm2 for predicate. Deemed Equivalent.
- Antibacterial activity: Log reduction for various bacteria at corresponding time-points > 4 for subject device. Deemed to meet requirement (> 4 log reduction).
- Wet tensile Strength: 3 – 5.9 N/cm for subject device, compared to 15.9 N/cm for predicate. Deemed Equivalent.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aquacel Ag Extra, 510(k) No. K121275
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Ross Ru Wound Dressing Gel (K162017), Acticoat Flex 7 (K083113), Opticell Ag (K100693), Durafiber Ag (K103793/K161289)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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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
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
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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 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.
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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 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
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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 |
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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
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,"
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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 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
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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.