(773 days)
No
The device description and performance studies focus on the physical and antimicrobial properties of a wound dressing. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is a wound dressing used for the management of various types of wounds, including burns, ulcers, and surgical wounds, which are conditions that require therapeutic intervention.
No
Explanation: The device is a wound dressing with antimicrobial properties intended for the management of wounds, not for diagnosing any medical condition. Its function is to absorb exudate, provide a moist wound environment, and prevent bacterial colonization within the dressing.
No
The device description clearly states it is a "soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver," which is a physical wound dressing, not software. It is also described as a "combination product, code FRO," indicating it combines different types of regulated components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of wounds. It describes how the dressing interacts with the wound environment (absorbing exudate, forming a gel, antimicrobial effect) to aid in the healing process. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the physical composition and mechanism of action of the wound dressing. It explains how it absorbs exudate, forms a gel, and provides an antimicrobial effect within the dressing. This is consistent with a wound care product, not a diagnostic test.
- Performance Studies: The performance studies focus on characteristics relevant to a wound dressing, such as antimicrobial efficacy, absorbency, tensile strength, biocompatibility, and sterilization. There are no studies related to detecting or measuring substances in a sample to diagnose a condition, which is the core function of an IVD.
- Key Metrics: The key metrics listed (antimicrobial efficacy, silver release, absorbency, tensile strength) are all related to the performance of a wound dressing, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function. It is a wound dressing used to manage existing wounds.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, Venus Ag may be used for the management of:
- · wounds with moderate to heavy exudate
- · partial thickness burns
- · leg ulcers, pressure ulcers and diabetic ulcers
- · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites)
- · traumatic wounds (e.g. abrasions and lacerations)
- wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites.
The product is for a single use only.
Product codes
FRO
Device Description
Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound.
The device is a combination product, code FRO.
Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.
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
5.5.1 Performance Testing (Bench)
- Antimicrobial efficacy according to modified AATCC 100 was found to consistently meet requirement of a log 4 reduction within the dressing when compared to a control against gram-negative, gram-positive, yeast and mould.
- Silver release profile within the dressing was found to be equivalent to that of the predicate device in simulated wound fluid over 24 hours, 5 days and 7 days.
- The silver content of the product remains at the same silver content throughout accelerated and real-time stability studies, therefore the release profile within the dressing is not tested at all time-points as no change is expected.
- Absorbency according to British Pharmacopoeia; Test Method for absorbency of Alginate dressings/Surgical dressings, and European Standard EN13726-1 and product consistently meets specifications.
- Tensile strength according to British Pharmacopoeia meets the specifications set for this product.
- Stability Studies
5.5.2 Biocompatibility Testing
The following testing was conducted to demonstrate that the proposed device is as safe as the cleared 510(k) predicate device. Biocompatibility testing was conducted according to ISO 10993-1:
- Cytotoxicity according to ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Tests for In Vitro Cytotoxicity
- Intracutaneous Irritation studies according to ISO 10993-10. Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization
- Acute Systemic Toxicity according to ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Tests for Systemic Toxicity
- Sub-acute Systemic Toxicity and Implantation according to ISO 10993 standards: Biological Evaluation of Medical Devices, Part 2: Animal welfare requirements, Part 6: Tests for local effects after implantation and Part 11: Tests for Systemic Toxicity
- Sensitization according to ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization
- Material Mediated Pyrogenicity ISO 10993-11. Biological evaluation of medical devices, Part 11; Tests for systemic toxicity according to United States Pharmacopoeia (USP) 42 - National Formulary 37. And European Pharmacopeia, 10th edition
- Biological and Toxicological Risk Assessment according to ISO 10993-17. Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
5.5.3 Performance Data (Animal)
A porcine wound healing study was conducted in accordance with ISO 10993-6 with a comparison to a legally marketed device. Venus Ag was tested alongside the predicate device Aquacel Ag+ Extra, as well as one control dressing. Overall, Venus Ag did not impair the wound healing process as observed from the various histology parameters analyzed and as compared to the predicate.
5.5.4 Performance Data (Clinical)
No clinical testing was required to support substantial equivalence.
5.6 Non-Performance Testing
The following testing was conducted to ensure the integrity of the end product:
- Sterilisation Validation according to ISO 11137-1 and ISO 11137-2. Sterilisation of health care products, and results confirmed that Venus Ag successfully met its predetermined acceptance criteria as per standards.
- Packaging Validation and Integrity Testing according to ASTM F1886/ F1886M Standard test Method for determining Integrity of Seals for Flexible Packaging by Visual Inspection, ASTM F1929, ASTM F1929 Standard test Method for Detecting Seal Leak, ASTM F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Venus Ag successfully met its predetermined acceptance criteria as per standards.
- Shelf-life Testing A maximum shelf life of 24 months (based on real time aged Final Finished Device) has been assigned when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
Key Metrics
Not Found
Predicate Device(s)
Titan Ag 200 K173844, Aquacel Ag Extra K121275, Aquacel Ag+ Extra K173675, Kerracel Ag K162508
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2024
Speciality Fibres and Materials Ltd. Nyerngoor Hewitt Director of Regulatory Affairs and Ouality Galaxy House Binley Industrial Estate, 31 Herald Way Coventry, West Midlands CV6 5SF United Kingdom
Re: K222740
Trade/Device Name: Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber.
Regulatory Class: Unclassified Product Code: FRO Dated: September 8, 2022 Received: September 9, 2022
Dear Nyerngoor Hewitt:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222740
Device Name
Venus Ag 120 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 160 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber. Venus Ag 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber.
Indications for Use (Describe)
Under the supervision of a healthcare professional, Venus Ag may be used for the management of:
- · wounds with moderate to heavy exudate
- · partial thickness burns
- · leg ulcers, pressure ulcers and diabetic ulcers
- · surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites)
- · traumatic wounds (e.g. abrasions and lacerations)
- wounds that are prone to bleeding, such as wounds that have been mechanically debrided and donor sites.
The product is for a single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (Venus Ag)
Details of the device Venus Ag herewith applied for is as follows:
5.1 Administrative Information
| Applicant | Speciality Fibres and Materials Limited,
Galaxy House, Binley Industrial Estate, 31 Herald
Way, Coventry CV3 2RQ, United Kingdom | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent and
Contact Details | Nyerngoor Korda Hewitt
Director of Regulatory Affairs and Quality
Telephone: +44 (0) 2476 708 229,
+44 (0) 7725 786 717
E-mail: nyerngoor.kordahewitt@sfm-limited.com | |
| Date Prepared | Initial 29 October 2021, 1st October 2024 Updated | |
| Device Details | 510(k) Number | K222740 |
| | Product
Name(s) | Venus Ag 120 Wound Dressing with Antimicrobial
Silver and Strengthening Cellulose Fiber.
Venus Ag 160 Wound Dressing with Antimicrobial
Silver and Strengthening Cellulose Fiber.
Venus Ag 200 Wound Dressing with Antimicrobial
Silver and Strengthening Cellulose Fiber. |
| | Classification Name | Unclassified |
| | Product Code | FRO |
| | Panel | General & Plastic Surgery |
| | Combination | Yes, the device is a
combination product |
| Legally Marketed Predicate
Device(s) | Primary Predicate Device:
Titan Ag 200 K173844
Additional Predicate Devices:
Aquacel Ag Extra K121275
Aquacel Ag+ Extra K173675
Kerracel Ag K162508 | |
5
5.2 Description of the Device
Venus Ag 120, 160 and 200 Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber are a soft, conformable non-woven fabrics made from sodium carboxymethyl cellulose and strengthening cellulose fiber(s) with antimicrobial silver. The silver in the wound dressing, when in contact with wound exudate or blood present in wound exudate, has an antimicrobial effect on bacteria held within the dressing, preventing it from being colonized. The absorption of exudate into the dressing forms a gel which assists in maintaining a moist wound environment, supporting autolytic debridement, protects the wound edge and surrounding skin from maceration. Through the gel formation the structure of the dressing remains intact. Debris and any bacteria found in the wound exudate can be retained inside the dressing and removed when the dressing is changed. When dry, Venus Ag can easily be cut to the size of the wound.
The device is a combination product, code FRO.
Venus Ag dressings are supplied in a variety of sizes, configurations, and weights.
6
5.3 Indications for Use
Under the supervision of a healthcare professional, Venus Aq may be used for the
management of:
- Wounds with moderate to heavy exudate
- Partial thickness burns ●
- Leg ulcers, pressure ulcers and diabetic ulcers .
- Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent . and donor/graft sites)
- . Traumatic wounds (e.g. abrasions and lacerations)
- Wounds that are prone to bleeding, such as wounds that have been . mechanically or surgically debrided and donor sites
The product is for a single use only.
5.4 Summary of Technological Characteristics
Venus Ag technological characteristics are deemed comparable to those of the predicate devices. Venus Ag has the same intended use and general characteristics as the predicate devices as detailed in the table below. Minor technological differences are addressed in Table 5-1.
7
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /
Justification for
Equivalence |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| Identification | Subject Device | Primary Predicate
Device | Additional Predicate Device | Secondary
Predicate | Additional
Predicate Device | N/A |
| 510(k) Number | K222740 | K173844 | K121275 | K173675 | K162508 | N/A |
| Product Code | FRO | FRO | FRO | FRO | FRO | Equivalent. |
| Regulation
Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound, Drug | Equivalent. |
| Intended Use | Management of wounds with
moderate to heavy exudate.
The dressing absorbs wound
exudate, forms a gel, and may
retain bacteria in the wound
exudate within 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. | This conformable and highly
absorbent dressing absorbs
wound fluids, creating a soft gel
which maintains a moist
environment and supports the
body's healing process. | This dressing absorbs wound fluid
and creates a soft gel that
conforms to the wound surface,
maintains a moist environment
and aids in the removal of
non-viable tissue from the wound
(autolytic debridement). A moist
wound environment supports the
body's healing process. The silver
preservative in the dressing
provides an effective barrier to
bacterial penetration of the
dressing as this may help reduce
infection. | The silver in the dressing
provides an antibacterial
barrier that inhibits
bacterial growth in the
dressing
for up to seven days.
Absorbs high
amounts of wound fluid
and creates a soft cohesive
gel that intimately conforms
to the wound surface and
maintains a moist wound
healing environment. | Substantially Equivalent.
Venus Ag has an
Antimicrobial claim which
is addressed in Section
18. Risk of infection are
not within the scope of the
Venus Ag indications. |
| Indications
for Use | Management of wounds with
moderate to heavy exudate | Management of wounds with
moderate to heavy exudate | Management of wounds as an
effective barrier to bacterial
penetration of the dressing as
this may help reduce infection | Aquacel Ag+ Extra
dressings are indicated
for: | Management of acute
and chronic, partial and
full thickness wounds
including pressure ulcers,
leg ulcers, diabetic foot
ulcers, surgical wounds,
traumatic wounds, first
and second degree
burns. | Equivalent to primary
predicate. Malignant
wounds in the additional
predicate are not within the
scope of the Venus Ag
indications. |
| | Partial thickness burns | Partial thickness burns | Partial thickness (second
degree) burns | Partial thickness burns | | |
| | Leg ulcers, pressure ulcers
and diabetic ulcers | Leg ulcers, pressure ulcers
and diabetic ulcers | Diabetic foot ulcers, leg
ulcers, (venous stasis
ulcers, arterial ulcers and
leg ulcers of mixed
etiology) and | Leg ulcers, including:
Venous stasis ulcers
Arterial ulcers. Legs ulcers of
mixed aetiology Diabetic foot
ulcers. Pressure ulcers/injuries | and second degree
burns. | |
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /
Justification
for
Equivalence |
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| | | | pressure ulcers/sores (partial
and full thickness); | | | |
| | Surgical wounds (e.g. post-
operative wounds left to heal
by secondary intent and
donor/graft sites) | Surgical wounds (e.g. post-
operative wounds left to heal
by secondary intent and
donor/graft sites) | 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 | Surgical wounds | | |
| | | | incisions (e.g. orthopedic and
vascular) | | | |
| | Traumatic wounds (e.g.
abrasions and lacerations) | Traumatic wounds (e.g.
abrasions and lacerations) | Traumatic wounds | Traumatic wounds | | |
| | Wounds that are prone to
bleeding such as wounds that
have been mechanically or
surgically debrided and donor
sites | Wounds that are prone to
bleeding such as wounds that
have been mechanically or
surgically debrided and donor
sites | Wounds that are prone to
bleeding such as wounds that
have been mechanically or
surgically debrided and donor
sites | Surgical wounds | | |
| | | | Painful wounds; Infected
wounds | | | |
| | | | | Malignant 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. | Should not be used on
individuals who are sensitive
to or who have had an
allergic reaction to the
dressing or its components. | Aquacel Ag+ Extra dressings
should not be used on
individuals who are sensitive
to or have had an allergic
reaction to silver, sodium
carboxymethyl cellulose
ethylenediaminetetraacetic
acid di-sodium salt (EDTA)
or benzethonium chloride
(BECI) | Individuals with a known
allergy or hypersensitivity
to any of the components
of KerraCel® Ag should
not use the dressing. | Equivalent with primary
device. |
| Prescription
Use | Prescription Use | Prescription Use | OTC use
Prescription Use | OTC use
Prescription Use | Prescription Use | Equivalent with primary
predicate device. |
| 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 | Seven days per dressing
and maximum repeat
dressings of 30 days | Aquacel Ag+ Extra
dressings can be worn for
up to seven days. Dressings
should be changed earlier if
clinically indicated.
On partial thickness
(second degree) burns,
dressings may remain in
place for up to 14 days.
The requirement for
Aquacel Ag+ Extra
dressings should be re-
assessed after 14 days and
alternative wound
management considered
where appropriate | The dressing can be left in
place for up to seven
days. | Equivalent with primary
predicate device. |
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Aquacel Ag+ Extra | Kerracel Ag | Significant Differences /
Justification for
Equivalence |
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Convatec Inc | Crawford | N/A |
| Device
Description | Soft, sterile, non-woven pad
or ribbon dressing composed
of sodium carboxymethyl
cellulose, cellulose and silver
which are blended by
combining fibres in a carding
and needling process. | Soft, sterile, non-woven pad or
ribbon dressing composed of
sodium carboxymethyl
cellulose, cellulose and silver
which are blended by
combining
fibres in a carding and needling
process. | Soft, sterile, non-woven pad
or ribbon dressing
composed of sodium
carboxymethylcellulose,
which is incorporated in the
form of a non-woven fleece
held together by cellulose
yarn
using a stitch bonding
process. | A soft, sterile dressing made
from two layers of 1.2% ionic
silver impregnated sodium
carboxymethylcellulose fiber
with added
Ethylenediaminetetraacetic
Acid Disodium Salt (EDTA)
and Benzethonium Chloride
and stitched together with
strengthening fibers.
The two Hydrofiber layers
are nominally 77gsm (grams
per square meter) weight
each. Aquacel Ag+ also
includes added
Ethylenediaminetetraacetic
Acid Disodium Salt (EDTA)
and Benzethonium Chloride
(BECL).
See foot note 2. | Soft, sterile, nonwoven
wound dressing made of
sodium carboxymethyl
cellulose (CMC),
cellulose fibers, and
silver. | Equivalent (see discussion
in footnote 5). |
| Silver Content | 18mg/100cm² | 7mg/100cm² | 23mg/100cm² | 1.3 % w/w
(Approx. 22mg/100cm²) | 20mg/100cm² | Venus Ag has a higher silver
content than the Titan Ag 200;
this increase in silver content
does not affect the safety profile
or the in vivo activity as
substantiated by the
biocompatibility studies performed
with the subject device, as well
the effectiveness of the device, as
substantiated by the substantial
equivalence analysis. Both Venus
Ag and Titan Ag release ionic
silver from silver nanoparticles.
The additional predicate devices
Aquacel Ag Extra and Aquacel Ag
- Extra demonstrate that ionic
silver used at the percentage of
1.3%w/w
(23mg/100cm2) is safe and
Kerracel Ag demonstrates that
ionic silver used at the |
| | | | | | percentage of 1.7%w/w
(20mg/100cm2) is safe. Venus Ag
has ionic silver at 1.5% w/w
(18mg/100cm2) which is less. The
safety and performance are further
supported by the in vivo and in
vitro tests and the antimicrobial
test. The safety testing of the
nanoparticle silver confirmed that
the concentration of 18mg/100cm
used in this device is safe. | |
Table 5-1: Substantial Equivalence Comparison of Characteristics and Intended Use
8
9
10
11
12
| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Kerracel Ag | Significant Differences /
Justification for
Equivalence |
|------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Crawford | N/A |
| Antimicrobial
Agent | Ionic silver released from
elemental silver nanoparticles
within the dressing. | Ionic silver released from
elemental silver nanoparticles
within the dressing. | Ionic silver released
form silver compounds
within the dressing. | Silver ions released from
silver oxysalts (Ag7NO11)
within the dressing. | Equivalent to primary predicate
device.
Both Venus Ag and Titan Ag
antimicrobial agent is ionic silver
released from elemental silver
nanoparticles within the
dressing, while Aquacel Ag Extra
releases ionic silver from silver
compounds within the dressing,
and Kerracel Ag release silver
ions from silver oxysalts within
the dressing. The agent in each
case works
through the release of silver
ions into the |
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| Device Name | Venus Ag | Titan Ag 200 | Aquacel Ag Extra | Kerracel Ag | Significant Differences /
Justification for
Equivalence |
|---------------|-----------------|-----------------|------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SFM Ltd | SFM Ltd | Convatec Inc | Crawford | N/A |
| | | | | | dressing. The silver ions released
in a moist environment from
nanoparticles or silver salts are
identical. Therefore, the
difference in silver composition
between Venus Ag and the
predicates (Titan Ag, Aquacel Ag
Extra and Kerracel Ag) do not
impact safety and performance as
substantiated by the
biocompatibility reports and the
substantial
equivalence analysis. |
| Sterilisation | Sterile (Gamma) | Sterile (Gamma) | Sterile (Gamma) | Sterile (Gamma) | Equivalent. |
| Packaging | Foil | Paper pouch | Foil | Foil | The foil pouch used is equivalent
to the pouch used in the
additional predicate Kerracel Ag
and Aquacel Ag Extra.
Studies on packaging integrity
and accelerated aging
demonstrated the packaging is
appropriate for maintaining
device
integrity and sterility. |
| Single-Use | Single-Use | Single-Use | Single-Use | Single-Use | Equivalent |
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5.5 Summary of Non-Clinical and Clinical and Performance Data
The following standards were adhered to during performance testing:
- . ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
5.5.1 Performance Testing (Bench)
- Antimicrobial efficacy according to modified AATCC 100 was found to ● consistently meet requirement of a log 4 reduction within the dressing when compared to a control against gram-negative, gram-positive, yeast and mould.
- Silver release profile within the dressing was found to be equivalent to that of the ● predicate device in simulated wound fluid over 24 hours, 5 days and 7 days.
- The silver content of the product remains at the same silver content throughout ● accelerated and real-time stability studies, therefore the release profile within the dressing is not tested at all time-points as no change is expected.
- Absorbency according to British Pharmacopoeia; Test Method for absorbency of ● Alginate dressings/Surgical dressings, and European Standard EN13726-1 and product consistently meets specifications.
- Tensile strength according to British Pharmacopoeia meets the specifications set for this product
- Stabilitv Studies ●
5.5.2 Biocompatibility Testing
Venus Ag devices are classified as surface devices with prolonged use (>24h to 30 days) and the relevant Biocompatibility studies were performed.
The following testing was conducted to demonstrate that the proposed device is as safe as the cleared 510(k) predicate device. Biocompatibility testing was conducted according to ISO 10993-1:
- . Cytotoxicity according to ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Tests for In Vitro Cytotoxicity
- . Intracutaneous Irritation studies according to ISO 10993-10. Biological Evaluation of Medical Devices, Part 10; Tests for Irritation and skin sensitization
- . Acute Systemic Toxicity according to ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Tests for Systemic Toxicity
- . Sub-acute Systemic Toxicity and Implantation according to ISO 10993 standards: Biological Evaluation of Medical Devices, Part 2: Animal welfare requirements, Part 6: Tests for local effects after implantation and Part 11: Tests for Systemic Toxicity
- Sensitization according to ISO 10993-10, Biological Evaluation of Medical . Devices, Part 10; Tests for Irritation and skin sensitization
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- Material Mediated Pvrogenicity /SO 10993-11. Biological evaluation of medical ● devices, Part 11; Tests for systemic toxicity according to United States Pharmacopoeia (USP) 42 - National Formulary 37. And European Pharmacopeia, 10th edition
- Biological and Toxicological Risk Assessment according to /SO 10993-17 . Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
The performance studies indicate that Venus Ag wound dressings does not raise new questions regarding safety or performance with respect to the predicate device and is safe for its indication for use.
The non-clinical testing detailed in this submission supports the substantial equivalence of the subject device to the predicate device.
5.5.3 Performance Data (Animal)
A porcine wound healing study was conducted in accordance with ISO 10993-6 with a comparison to a legally marketed device. Venus Ag was tested alonqside the predicate device Aquacel Ag+ Extra, as well as one control dressing. Overall, Venus Ag did not impair the wound healing process as observed from the various histology parameters analyzed and as compared to the predicate.
5.5.4 Performance Data (Clinical)
No clinical testing was required to support substantial equivalence.
5.6 Non-Performance Testing
The following testing was conducted to ensure the integrity of the end product:
- Sterilisation Validation according to ISO 11137-1 and ISO 11137-2. Sterilisation . of health care products, and results confirmed that Venus Ag successfully met its predetermined acceptance criteria as per standards.
- . Packaging Validation and Integrity Testing according to ASTM F1886/ F1886M Standard test Method for determining Integrity of Seals for Flexible Packaging by Visual Inspection, ASTM F1929, ASTM F1929 Standard test Method for Detecting Seal Leak, ASTM F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Venus Ag successfully met its predetermined acceptance criteria as per standards.
- Shelf-life Testing A maximum shelf life of 24 months (based on real time aged . Final Finished Device) has been assigned when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
5.7 Statement of Substantial Equivalence
Venus Ag (subject device, K222740) is substantially equivalent to the cleared primary predicate device Titan Ag 200 (K173844) and supporting additional predicate devices Aquacel Ag Extra (K121275), Aquacel Ag+ Extra K173675 and Kerracell Ag (K162508).
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Venus Ag's equivalence is based on the following:
- lt has the same intended use as the primary predicate device; and displays ● performance equivalent to that of the predicate device.
- It has the same composition of carboxymethyl cellulose, reqenerated cellulose and . ionic silver released into dressing as the primary predicate device.
- The minor technological characteristic differences, compared to the primary predicate, do not influence the substantial equivalence.
With the information included in this section, we aim to summarise the information used to:
- demonstrate that the device applied for raises no concerns in terms of device ● performance and,
- . demonstrate that the device is at least as safe and effective as the legally marketed predicate device.
The data provided demonstrates that there are no new questions of safety and effectiveness compared to the predicate, and the subject device is substantially equivalent to the predicate device.