(269 days)
N/A this is a device modification of the predicate device
No
The device description and performance studies focus on the material properties and antibacterial effectiveness of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the management of wounds and claims antibacterial effects, indicating a therapeutic purpose.
No
Explanation: The device is a wound dressing designed for the management and treatment of wounds. It does not perform any diagnostic functions like detecting, characterizing, or monitoring diseases or conditions.
No
The device description clearly indicates it is a physical wound dressing made of calcium alginate and regenerated cellulose fibers with antibacterial silver. It is a tangible product, not 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 the device is for the "management of wounds" in adult patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing with antibacterial properties. It describes its physical composition and function in wound care.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on the physical properties of the dressing (absorbancy, tensile strength), antibacterial effectiveness, and silver release profile – all relevant to its function as a wound dressing, not a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is to directly manage and treat wounds.
N/A
Intended Use / Indications for Use
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are: Moderately and heavily exuding, Superficial or Deep Such as: Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Suprasorb® A + Ag "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added. The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 5 days in the in vitro challenge test. The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds)
Indicated Patient Age Range
Adult patients only
Intended User / Care Setting
Prescription Use
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 effectiveness testing 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 to that of the predicate device in simulated wound fluid.
- 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 which has been modified for this application.
- Silver content is identical for both the predicate and subject device.
Biocompatibility testing: Suprasorb A+Ag "R" is classified as a surface device with prolonged use and the relevant biocompatibility studies as per the requirements of ISO 10993-1(2009) and the FDA requirements were performed. Tests conducted include Chemical Characterisation (ISO 10993-18), Cytotoxicity (ISO 10993-5), Sensitisation (ISO 10993-10), Irritation studies (ISO 10993-10), Acute systemic toxicity (ISO 10993-11), Material mediated pyrogenicity (ISO 10993-11), Subacute systemic toxicity (ISO 10993-11), Implantation (ISO 10993, Part 6). The overall Biological risk assessment was conducted using ISO 10993 series and Council Directive 93/42/EEC. It was concluded that Suprasorb A+ Ag "R" is a biocompatible medical device.
Non-performance testing:
- Sterilisation validation according to ISO 11137-1 and EN ISO 11137-2.
- Packaging integrity testing according to ASTM F1886/ F1886M, ASTM F1929, ASTM F88/ F88M.
- Shelf-life testing assigned a maximum shelf life of 48 months.
The performance studies indicate that Suprasorb A + Ag "R" 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Antibacterial activity: Log reduction for various bacteria > 4. Log reduction for 4 gram positive and 3 gram negative bacteria > 4.
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.
Suprasorb A +Ag – K071442
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.
N/A this is a device modification of the predicate device
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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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2019
Speciality Fibres and Materials Ltd. Lindie Turvey Senior Regulatory Affairs Officer 101 Lockhurst Lane Coventry, CV6 5SF Gb
Re: K183208
Trade/Device Name: Suprasorb A + Ag "R" Regulatory Class: Unclassified Product Code: FRO Dated: July 15, 2019 Received: July 16, 2019
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
for Cynthia Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183208
Device Name Suprasorb A +Ag "R"
Indications for Use (Describe)
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are:
- · Moderately and heavily exuding
- · Superficial or
- · Deep
- Such as:
- Pressure sores
- Arterial Ulcers
- · Venous lower leg ulcers
- · Diabetic ulcers
- · Post-operative wounds
| 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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Image /page/3/Picture/0 description: The image shows the logo for SFM. The letters SFM are in red and are stacked on top of each other. Below the letters is a geometric design in shades of green and gray. The background is white.
Details of the device Suprasorb A + Ag "R" herewith applied for are 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
Fax: +44 (0) 2476 682737
E-mail: Lindie.turvey@sfm-limited.com | | |
| Date prepared: | 15 July 2019 | | |
| Device Details: | Trade Name: | Suprasorb A+ Ag “R” | |
| | Classification Name: | Dressing, Wound, Drug | |
| | Common Name: | Wound Dressing | |
| | Product Code: | FRO | |
| | Classification: | Unclassified | |
| | Panel: | General & Plastic Surgery | |
| Legally Marketed
Predicate
Device(s): | Suprasorb A +Ag – K071442 | | |
| Legally Marketed
Reference
Devices | N/A this is a device modification of the predicate device | | |
5.2 DESCRIPTION OF THE DEVICE:
Suprasorb® A + Ag "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added.
The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content.
4
The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 5 days in the in vitro challenge test.
The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
Suprasorb® A + Ag "R"is packed in paper pouches and are available in the sizes and thickness listed below:
| | Product | Dimensions | Weight
(g/sm) | Packa
ging | Packaging Configuration |
|--------|---------|----------------------------|------------------|---------------|-------------------------|
| 42 755 | Flat | 2in. x 2in. (5cm x 5cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 756 | Flat | 4in. x 4in.(10cm x 10cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 757 | Flat | 4in. x 5in.(10cm x 12.5cm) | 200 | Paper | 10 pouches per 1 carton |
| 42 758 | Flat | 6in. x 6in. (15cm x 15cm) | 200 | Paper | 5 pouches per 1 carton |
| 42 759 | Rope | 1in. x 18in. (2cm x 45cm) | 200 | Paper | 5 pouches per 1 carton |
| 43 755 | Flat | 2in. x 2in. (5cm x 5cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 756 | Flat | 4in. x 4in.(10cm x 10cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 757 | Flat | 4in. x 5in.(10cm x 12.5cm) | 120 | Paper | 10 pouches per 1 carton |
| 43 758 | Flat | 6in. x 6in. (15cm x 15cm) | 120 | Paper | 5 pouches per 1 carton |
| 43 759 | Rope | 1in. x 18in. (2cm x 45cm) | 120 | Paper | 5 pouches per 1 carton |
5.3 INDICATIONS FOR USE:
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, which are:
- Moderately and heavily exuding
- Superficial or
- Deep
Such as:
- Pressure sores
- Arterial Ulcers
- Venous lower leg ulcers
- . Diabetic ulcers
- . Post-operative wounds
5.4 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The fundamental technological characteristics are similar to the cleared predicate device (Suprasorb A + Ag K071442).
Important technological characteristics of Suprasorb A+ Ag "R" to consider are as follows,
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- a) the presence of antibacterial silver in the dressing which reduces bacterial growth within the dressing
- b) improved tensile strength when compared to the predicate device,
- c) equivalent absorbency when compared to predicate device
- d) silver release profile when compared to the predicate device
Table 5-1 Substantial Equivalence Comparison of Characteristics and Intended Use
| Manufacturer | Speciality Fibres and
Materials Ltd. | Speciality Fibres and
Materials Ltd. | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| 510(k)
Number | K071442 | K183208 | |
| Product Code | FRO | FRO | Equivalent |
| Regulation
Name | Dressing, Wound Drug | Dressing, Wound Drug | Equivalent |
| Device
description 1 | Soft, sterile, non-woven pad
or ribbon dressing
composed of calcium
alginate and silver which are
blended by combining fibres
in a carding and needling
process. | Soft, sterile, non-woven pad
or ribbon dressing composed
of calcium alginate and silver
which are blended by
combining fibres in a carding
and needling process. | Equivalent |
| Variants | 130 gsm | 120 gsms & 200 gsm | N/A |
| Intended Use | | | |
| Indications
for Use | Suprasorb® A + Ag "R"
calcium alginate dressing
with antibacterial silver can
be used for the
management of wounds
which are:
• Moderately and heavily
exuding wounds
• Superficial wounds
• Deep wounds such as
• Pressure sores
• Arterial ulcers
• Venous lower leg
ulcers
• Diabetic ulcers
• Post-operative wounds | Suprasorb® A +Ag "R"
can be used for the
management of wounds,
in adult patients only,
which are:
• Moderately and heavily
exuding
• Superficial or
• Deep
Such as:
• Pressure sores
• Arterial Ulcers
• Venous lower leg ulcers
• Diabetic ulcers
• Post-operative wounds | Equivalent |
| 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. | 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 - no
change to intended
use |
| Manufacturer | Speciality Fibres and
Materials Ltd. | Speciality Fibres and
Materials Ltd. | Comparison |
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| 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. For use on adult
patients only. | Equivalent |
| Prescription
Use | Prescription Use Only | Prescription Use Only | Equivalent |
| Maximum
Period of Use | Three (3) days per dressing
and maximum repeat
dressings of 30 days | Five (5) days per dressing and
maximum repeat dressings of
30 days | Additional 2 day
wear time proposed
according to
antibacterial results
obtained with
AATCC100 results
for real-time stability
samples |
| Single-use | Single-use | Single-use | Equivalent |
| | General Information | | |
| Active anti-
bacterial
agent | Ionic silver | Ionic silver | Equivalent |
| Sterile | Sterile (Gamma) | Sterile (Gamma) | Equivalent |
| Packaging | Paper | Paper pouch | Equivalent |
| Shelf Life | Three years | 4 years | N/A |
| | Fundamental technology | | |
| Silver content | $1.5 + 0.3% w/w$ | $1.5 + 0.3% w/w$ | Equivalent |
| Silver
containing
alginate fibres | $7.0\pm0.7%$ | $7.0\pm0.7%$ | Equivalent |
| Absorbant
fibres | Calcium alginate 93% | Calcium alginate 73% | No impact on the
fundamental
scientific technology
or biocompatibility1 |
| Re-enforcing
fibres | Does not contain | Regenerated cellulose fibres
(Tencel® 20%) | Increases strength
of dressing but
does not influence
fundamental
technology or
biocompatibility1 |
| Silver release | 23.1 ppm at 7 days | 200 gsm: 22 ppm at 7 days
120 gsm: 21.7 ppm at 7 days | Equivalent |
| Absorbency | 19 g/100cm² | 200 gsm: 12 g/100cm²
120 gsm: 22 g/100cm² | Similar |
| Tensile wet
strength | MD1.4 N/cm
CD 0.6 N/cm | 200 gsm:
MD 4.3 N/cm | Equivalent |
6
7
| Manufacturer | Speciality Fibres and
Materials Ltd. | Speciality Fibres and
Materials Ltd. | Comparison |
|--------------|-----------------------------------------|---------------------------------------------------------------|------------|
| Trade Name | Suprasorb A +Ag | Suprasorb A+ Ag "R" | |
| | | CD 12.1 N/cm
120 gsm:
MD 2.4 N/cm
CD 5.5 N/cm | |
Footnotes and discussion of equivalence
- The only change proposed to the legally marketed predicate device is the addition of cellulose fibres. The fundamental technologically of the device has not changed, the Performance has not changed (As described in Section18) and the biocompatibility testing described in Section 15 confirms that the addition of Tence® Cellulose fibres does not affect the safety profile of the modified device.
5.5 SUMMARY OF 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."
- 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.
Table 5-2 Substantial Equivalence Comparison of Performance Characteristics
| Performance Characteristics | |||
|---|---|---|---|
| Manufacturer | Speciality Fibres and | ||
| Materials Ltd. | Speciality Fibres and | ||
| Materials Ltd. | Comparison | ||
| Trade Name | Suprasorb A+Ag | Suprasorb A+ Ag “R” | |
| 510(k) number | K071442 | ||
| Predicate device | K183208 | ||
| Subject device | |||
| Mode of action | 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 | 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 | 22 ppm at 7 days | 200 gsm: 22 ppm at | |
| 7 days | |||
| 120 gsm: 21.7 ppm at | |||
| 7 days | Equivalent |
8
| Performance Characteristics | |||
|---|---|---|---|
| Absorbency | 19 g/100cm² | 200 gsm: 22 ppm at 7 days | |
| 120 gsm: 21.7 ppm at 7 days | Equivalent | ||
| Tensile wet strength | MD1.4 N/cm | ||
| CD 0.6 N/cm | 200 gsm: | ||
| MD 4.3 N/cm | |||
| CD 12.1 N/cm | |||
| 120 gsm: | |||
| MD 2.4 N/cm | |||
| CD 5.5 N/cm | Equivalent | ||
| Antibacterial activity | Log reduction for various bacteria > 4 | Log reduction for 4 gram positive and 3 gram negative bacteria > 4. | Meets requirement: |
| Antibacterial activity remains above the log reduction of 4, which confirms the effectiveness of the device for the intended use. | |||
| Biocompatibility | Pass the biocompatibility requirements of applicable at time of clearance | Comprehensive biocompatibility testing confirmed that the device raises no safety concerns. | Meets requirements |
5.5.1 Discussion on Performance testing
Performance testing was done according to standards where an accepted industry standard exists:
- Antibacterial effectiveness testing 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 to that of the predicate device in simulated wound fluid.
- 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 which has been modified for this application.
- Silver content is identical for both the predicate and subject device ●
5.5.2 Discussion on Biocompatibility Testing
Suprasorb A+Ag "R" is classified as a surface device with prolonged use and the relevant biocompatibility studies as per the requirements of ISO 10993-1(2009) and the FDA requirements were performed. Below Table 5-3 Contains a summary of the testing conducted, the relevant standards and
9
| Table 5-3 Summary of Biocompatibility studies | |
|---|---|
| ----------------------------------------------- | -- |
| Test | Relevant standard |
|---|---|
| Chemical | |
| Characterisation | ISO 10993-18 Chemical Characterisation |
| Cytotoxicity | ISO 10993-5, Biological Evaluation of Medical Devices, Part 5; Tests |
| for In Vitro Cytotoxicity | |
| Sensitisation | ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; |
| Irritation studies | ISO 10993-10, Biological Evaluation of Medical Devices, Part 10; |
| Acute systemic | |
| toxicity | ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; Tests |
| for Systemic Toxicity | |
| Material mediated | |
| pyrogenicity | ISO 10993-11 according to Biological Evaluation of Medical |
| Devices, Part 11; Tests for Systemic Toxicity | |
| Subacute systemic | |
| toxicity | ISO 10993-11, Biological Evaluation of Medical Devices, Part 11; |
| Tests for Systemic Toxicity | |
| Implantation | ISO 10993, Biological Evaluation of Medical Devices Part 6 (2016): |
| Tests for Local Effects after Implantation |
The overall Biological risk assessment was conducted using the following standards and it was concluded that Suprasorb A+ Ag "R" considered to be a biocompatible medical device, with respect to ISO 10993 and US FDA (2016) guidance, 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 guidance.
- 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 Suprasorb A + Ag "R" 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.
5.6 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 Suprasorb A+Ag "R" 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
10
F88/ F88M Standard test method for Seal Strength of Flexible Barrier Materials and Suprasorb A+Aq "R" 200 successfully met its predetermined acceptance criteria as per standards
- Shelf-life testing A maximum shelf life of 48 months has been assigned when . stored unopened at ambient temperature (25°C), in accordance with the manufacturer's recommendations.
5.7 STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The subject device, Suprasorb A + Ag "R", described in this submission is substantially equivalent to the predicate device Suprasorb A + Ag (K071442)
Suprasorb A + Aq has
- the same intended use as the predicate; and displays performance equivalent to . that of the predicate device.
- essentially the same composition with the addition of strengthening cellulose fibres, ● which does not change the fundamental technology
- minor technological characteristic differences to the predicate, which do not . influence the performance
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.