(256 days)
No
The device description and performance studies focus on the physical and chemical properties of the wound dressing, specifically the copper-oxide impregnation and its antibacterial effects. There is no mention of any computational analysis, data processing, or learning algorithms that would indicate the use of AI or ML.
Yes
The device is indicated for the management of various types of wounds, including partial and full thickness wounds, ulcers, and burns, and is designed to inhibit bacterial growth and provide a barrier against bacterial penetration, which are therapeutic functions.
No
The device, MedCu Antibacterial Wound Dressings with Copper-Oxide, is a wound dressing designed for the management of wounds and to provide a physical bacterial barrier. It absorbs fluid and inhibits bacterial growth; it does not diagnose medical conditions.
No
The device is a physical wound dressing made of nonwoven fabric and fibers impregnated with copper-oxide particles. It is a tangible product applied topically to wounds.
Based on the provided text, the MedCu Antibacterial Wound Dressings with Copper-Oxide are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of wounds and to provide a physical bacterial barrier. This involves direct application to the wound on the body.
- Device Description: The device is a wound dressing designed to absorb fluid and inhibit bacterial growth within the dressing and serve as a barrier. These are all functions related to treating a wound on the body.
- Lack of In Vitro Testing for Diagnosis: The performance studies mention in-vitro testing for antibacterial effectiveness within the wound dressing, but this is to demonstrate the device's function, not to diagnose a condition by testing a sample outside the body.
- No Mention of Analyzing Samples: The description does not mention the device being used to analyze samples of blood, tissue, or other bodily fluids for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The MedCu wound dressing is applied directly to the body for therapeutic and protective purposes.
N/A
Intended Use / Indications for Use
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows:
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Prescription use indications (Rx-only):
· Partial and full thickness wounds,
· Pressure ulcers (stage I-IV),
· Diabetic ulcers,
· Venous stasis ulcers,
· Arterial ulcers,
· 1st and 2nd degree burns.
· Surgical wounds,
· Vascular access or peripheral IV sites,
· Orthopedic external pin sites, and
· Acute wounds such as lacerations, abrasions, and skin tears.
Product codes
FRO
Device Description
The MedCu Antibacterial Wound Dressings with Copper-Oxide are sterile, soft, single use, barrier wound dressings composed of an internal absorbent layer and one or two external nonwoven layers (only the adhesive contour model serves as physical barrier). The external layer(s) are made of Polypropylene nonwoven fabric and the internal layer is made of needle punch layer made of Polyester and Cellulose fibers. The wound dressings achieve at least 500% fluid absorbency.
Both the internal and external layers are impregnated with copper-oxide particles. The one or two external layers cover the internal layer from one or both sides, accordingly. The wound dressing size is of 10 cm x 10 cm or 5 cm x 5 cm (other variations may be included as well), and may be provided with or without an adhesive contour (adhesive border), which provides physical bacterial barrier. The wound dressings without an adhesive contour can be cut per wound shape. The Copper-Oxide ions are released within the wound dressing from the polymeric matrix of each layer in the presence of moisture. The MedCu ABWDs, reduced the tested bacteria by more than 4 log within the wound dressing based on in-vitro testing.
MedCu ABWDs absorb wound fluid, contain copper-oxide to inhibit bacterial growth within the dressing and serves as a barrier against bacterial penetration.
*Note: Barrier against bacterial penetration is achieved only by the adhesive contour model.
The wound dressing is provided sterile and kept sterile in a sterilization pouch for its entire shelf life.
Body contact materials were evaluated for biocompatibility with accordance to FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing with a Risk Management Process, dated June 16, 2016 and the ISO 10993-1:2009 standard.
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
Not Found
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)
MedCu Antibacterial Wound Dressings with Copper-Oxide have been successfully tested through laboratory non-clinical tests to support the safety and effectiveness of the device and the determination of substantial equivalence with predicate devices. MedCu conducted the following tests:
- 7.1 Chemical and biological tests according to ISO 10993-1, ISO 10993-12, ISO 10993-18 and FDA Guidance document for Biological Evaluation June 2016: Exhaustive extractions, FTIR, GC-MS, ICP-OES, UPLC-MS, Cytotoxicity, Skin irritation and Intracutaneous reactivity, Acute systemic toxicity, Sensitization (Maximization), Wound healing study on large animal (porcine).
- 7.2 Antibacterial effectiveness testing per AATCC 100 following real-time aging products showing more than 4 log reduction of viable titers of 6 bacteria for the device intended use duration. The bacteria tested are: E. coli, E. faecalis, E. aerogenes, K. pneumoniae, S. epidermis and MRSA.
- 7.3 Bacterial barrier effectiveness for the device intended use duration (adhesive contour model only).
- 7.4 Absorbance capacity of at least 500% of the wound dressing weight.
- 7.5 Copper Oxide particles size and shape analyses using ICP (Inductively Coupled Plasma), SEM (Scanning Electron Microscopy) and EDS (Energy Dispersive X-ray Spectrometry) analyses.
- 7.6 Copper Oxide particle size distribution using DLS (Dynamic Light Scattering) method.
- 7.7 Copper Oxide leachables in order to determine if copper oxide particles were released from the antibacterial wound dressing, using DLS method.
- 7.8 MEC (Minimal Effective Concentration) study evaluating the minimal effective concentration required to achieve at least 4 log reduction of the tested microorganisms.
- 7.9 Packaging shelf life using accelerated aging method according to ISO 11607-1.
- 7.10 Sterilization validation using EtO half cycle method according to ISO 11135:2014, including EtO/ECH residuals according to ISO 10993-7:2008.
- 7.11 Pyrogenicity test using LAL method and Material-Mediated Pyrogen study.
Tests results support all MedCu's antibacterial wound dressing labeling claims in order to establish substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
November 23, 2018
MedCu Technologies, Ltd. % Tali Hazan RA Consultant Talmed Ltd. MP Upper Galilee Ramot Naftali, 1383000 IL
Re: K180643
Trade/Device Name: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) Regulatory Class: Unclassified Product Code: FRO Dated: October 20, 2018 Received: October 23, 2018
Dear Tali Hazan:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,
Kimberly Ferlin -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180643
Device Name
MedCu Antibacterial Wound Dressings with Copper-Oxide (also identified as MedCu ABWDs)
Indications for Use (Describe)
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows:
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Prescription use indications (Rx-only):
- · Partial and full thickness wounds,
- · Pressure ulcers (stage I-IV),
- · Diabetic ulcers,
- · Venous stasis ulcers,
- · Arterial ulcers,
- · 1st and 2nd degree burns.
- · Surgical wounds,
- · Vascular access or peripheral IV sites,
- · Orthopedic external pin sites, and
- · Acute wounds such as lacerations, abrasions, and skin tears.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "MEDCu" in a stylized font. The letters "MED" are in blue, while the letters "Cu" are in brown and slightly overlap the "D". The font is bold and sans-serif, giving the word a modern and clean look. The overall design is simple yet eye-catching, with the contrasting colors adding visual interest.
510(K) SUMMARY FOR MEDCU ANTIBACTERIAL WOUND DRESSINGS WITH COPPER-OXIDE (ABWDS)
DATE PREPARED: November 11, 2018
- 510(K) OWNER NAME 1.
| Company Name: | MedCu Technologies Ltd. |
|---|---|
| Address: | 23 David Elazar St. |
| Herzliya 4627703 | |
| Israel | |
| Phone: | +972-546-611287 |
| E-mail: | gadib@medcu.com (Dr. Gadi Borkow) |
| Contact Person | |
| Name: | Tali Hazan, RA Consultant |
| Address: | Ramot-Naftali, 1383000 |
| Israel | |
| Phone: | +972-505-292304 |
| Fax: | +972-72-2448981 |
| E-mail: | tali.hazan@talmed.co.il |
2. DEVICE NAME
| Common/Usual Name: | Wound Dressings |
|---|---|
| Proprietary/Trade name: | MedCu Antibacterial Wound Dressings with Copper- |
| Oxide (also identified as MedCu ABWDs) |
Classification: The MedCu Antibacterial Wound Dressings with Copper-Oxide are unclassified medical devices under the following classification names:
| Classification Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Dressing, Wound, Drug | FRO | Pre-Amendment, | |
| Unclassified | General and | ||
| Plastic Surgery |
4
MEDCU
3. PREDICATE DEVICES
MedCu Antibacterial Wound Dressings with Copper-Oxide are substantially equivalent to the following Predicate Devices:
- 3.1 Argentum Medical's Silverlon® Wound Pad Dressing & Silverlon® Island Wound Dressing, cleared under 510(k) number K143001 at November 7, 2014;
- 3.2 ProCyte Corporation's Lamin® Wet Dressing (Copper-Saline), cleared under 510(k) number K964468 at February 3, 1997.
DEVICE DESCRIPTION 4.
The MedCu Antibacterial Wound Dressings with Copper-Oxide are sterile, soft, single use, barrier wound dressings composed of an internal absorbent layer and one or two external nonwoven layers (only the adhesive contour model serves as physical barrier). The external layer(s) are made of Polypropylene nonwoven fabric and the internal layer is made of needle punch layer made of Polyester and Cellulose fibers. The wound dressings achieve at least 500% fluid absorbency.
Both the internal and external layers are impregnated with copper-oxide particles. The one or two external layers cover the internal layer from one or both sides, accordingly. The wound dressing size is of 10 cm x 10 cm or 5 cm x 5 cm (other variations may be included as well), and may be provided with or without an adhesive contour (adhesive border), which provides physical bacterial barrier. The wound dressings without an adhesive contour can be cut per wound shape. The Copper-Oxide ions are released within the wound dressing from the polymeric matrix of each layer in the presence of moisture. The MedCu ABWDs, reduced the tested bacteria by more than 4 log within the wound dressing based on in-vitro testing.
MedCu ABWDs absorb wound fluid, contain copper-oxide to inhibit bacterial growth within the dressing and serves as a *barrier against bacterial penetration.
*Note: Barrier against bacterial penetration is achieved only by the adhesive contour model.
The wound dressing is provided sterile and kept sterile in a sterilization pouch for its entire shelf life.
Body contact materials were evaluated for biocompatibility with accordance to FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing with a Risk Management Process, dated June 16, 2016 and the ISO 10993-1:2009 standard.
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Image /page/5/Picture/1 description: The image shows the word "MEDCU" in a stylized font. The letters "MED" are in a bright blue color, while the letters "CU" are in a copper color. The "C" and "U" overlap the "D" in the word.
5. INTENDED USE
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows:
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Prescription use indications (Rx-only):
- Partial and full thickness wounds, ●
- Pressure ulcers (stage I-IV),
- Diabetic ulcers, ●
- Venous stasis ulcers, ●
- Arterial ulcers, ●
- 1st and 2nd degree burns,
- Surgical wounds,
- Vascular access or peripheral IV sites. ●
- Orthopedic external pin sites, and ●
- Acute wounds such as lacerations, abrasions, and skin tears. ●
TECHNOLOGICAL CHARACTERISTICS 6.
The MedCu non-adherent Antibacterial Wound Dressings with Copper-Oxide are impregnated with copper-oxide particles, which serve as an antibacterial agent to achieve log reduction of at least 4 log of wide range of bacteria within the wound dressing.
The device containing adhesive contour also serves as a bacterial barrier to confer additional protection to the wound.
The wound dressings' non-adherent external layer reduces pain during dressing removal.
7. PERFORMANCE DATA
MedCu Antibacterial Wound Dressings with Copper-Oxide have been successfully tested through laboratory non-clinical tests to support the safety and effectiveness of the device and the determination of substantial equivalence with predicate devices. MedCu conducted the following tests:
..............................................................................................................................................................................
6
EDCu
- 7.1 Chemical and biological tests according to ISO 10993-1, ISO 10993-12, ISO 10993-18 and FDA Guidance document for Biological Evaluation June 2016: Exhaustive extractions, FTIR, GC-MS, ICP-OES, UPLC-MS, Cytotoxicity, Skin irritation and Intracutaneous reactivity, Acute systemic toxicity, Sensitization (Maximization), Wound healing study on large animal (porcine).
- 7.2 Antibacterial effectiveness testing per AATCC 100 following real-time aging products showing more than 4 log reduction of viable titers of 6 bacteria for the device intended use duration. The bacteria tested are: E. coli, E. faecalis, E. aerogenes, K. pneumoniae, S. epidermis and MRSA.
- 7.3 Bacterial barrier effectiveness for the device intended use duration (adhesive contour model only).
- 7.4 Absorbance capacity of at least 500% of the wound dressing weight.
- 7.5 Copper Oxide particles size and shape analyses using ICP (Inductively Coupled Plasma), SEM (Scanning Electron Microscopy) and EDS (Energy Dispersive X-ray Spectrometry) analyses.
- 7.6 Copper Oxide particle size distribution using DLS (Dynamic Light Scattering) method.
- Copper Oxide leachables in order to determine if copper oxide particles were 7.7 released from the antibacterial wound dressing, using DLS method.
- 7.8 MEC (Minimal Effective Concentration) study evaluating the minimal effective concentration required to achieve at least 4 log reduction of the tested microorganisms.
- 7.9 Packaging shelf life using accelerated aging method according to ISO 11607-1.
- 7.10 Sterilization validation using EtO half cycle method according to ISO 11135:2014, including EtO/ECH residuals according to ISO 10993-7:2008.
- 7.11 Pyrogenicity test using LAL method and Material-Mediated Pyrogen study.
Tests results support all MedCu's antibacterial wound dressing labeling claims in order to establish substantial equivalency.
8. SUBSTANTIAL EQUIVALENCE
MedCu Antibacterial Wound Dressings with Copper-Oxide is substantial equivalent to the predicate devices selected in terms of indication for use, technology, performances, patient population and nature of body contact.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/7/Picture/1 description: The image shows the word "MEDCu" in a stylized font. The letters "MED" are in a bright blue color, while the letters "Cu" are in a brown color. The "Cu" overlaps with the "D" in "MED", creating a visual effect.
The substantial equivalent decision was received based on the following comparison with the predicate devices:
| Feature | Silverlon® Wound Pad
Dressing & Silverlon®
Island Wound Dressing
Primary Predicate
Device Cleared under
K143001 | ProCyte Corp. LaminⓇ
Wet Dressing
(Copper Saline)
Reference Predicate
Device Cleared under
K964468 | MedCu Antibacterial
Dressing with
Copper-Oxide
- Subject Device - |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Silverlon® Island Wound
Dressing and Silverlon®
Wound Pad Dressing are
multi-layer,
sterile, non-adherent,
antimicrobial barrier
wound dressings
for The Over-The-
Counter Indications:
Local management of
superficial wounds
minor burns abrasions
and lacerations.
and for Prescription
Indications:
Under the supervision of
a healthcare professional
Silverlon® Island Wound
Dressings
and Silverlon® Wound
Pad Dressings are
intended for up to 7 day
use for wounds such
as vascular access or
peripheral IV sites,
orthopedic external pin
sites, wound drain sites,
surgical wounds (donor
and graft sites, incisions),
partial to full thickness
dermal
ulcers (stage I-IV
pressure sores, venous
stasis ulcers, arterial | The device is a hydrogel
for the dressing and
management of both
graft recipient and donor
sites, postoperative
incisions, pressure
ulcers, diabetic ulcers,
stasis ulcers, 1st and 2nd
degree burns, arterial
ulcers, pressure sores,
and skin conditions
associated with
peristomal care. The
dressing is intended to
cover a wound or burn
on a patient's skin,
provide a moist wound
environment, absorb
wound exudate, and
protect against abrasion,
friction, desiccation, and
contamination. | The MedCu
Antibacterial Wound
Dressings with Copper-
Oxide are indicated for
the management of
wounds and to provide a
physical bacterial
barrier. The dressings
are applied topically and
are in direct contact with
the wound. The
dressings are intended to
be used for indications
as follows:
Over-The-Counter
(OTC) use indications:
Local management of
superficial wounds,
minor burns, abrasions
and lacerations (tears).
Prescription use
indications (Rx-only):
Partial and full thickness
wounds, pressure ulcers
(stage I-IV), diabetic
ulcers,
venous stasis ulcers,
arterial ulcers, 1st and 2nd
degree burns, surgical
wounds, vascular access
or peripheral IV sites,
orthopedic external pin
sites, and acute wounds
such as lacerations, |
| Feature | Silverlon® Wound Pad Dressing & Silverlon® Island Wound Dressing
Primary Predicate Device Cleared under K143001 | ProCyte Corp. Lamin® Wet Dressing
(Copper Saline) Reference Predicate Device Cleared under K964468 | MedCu Antibacterial Dressing with Copper-Oxide - Subject Device - |
| Prescription / OTC | Both prescription and OTC | Unknown | Both prescription and OTC |
| Design | 4 (Pad) or 5 (Island) Layers:
Layer 1 - no-adherent knitted nylon fiber coated with metallic silver Layer 2 - polyethylene film used to bond the nylon substrate to the Layer 3; Layer 3 - absorptive laminate pad Layer 4 - polyethylene film that bonds the pad to Layer 5, Layer 5 – adhesive polyester fabric | 1- Layer of cotton-blend non-woven gauze saturated with copper saline | 2- or 3-layer: Internal layer made of absorbent cellulose and polyester layer containing copper-oxide one or two external non-adherent nonwoven polypropylene layers containing copper-oxide |
| Dimensions | Multiple sizes including 10 cm x 10 cm and 5 cm x 5 cm | Unknown | 10 cm x 10 cm, or 5 cm x 5 cm |
| Material | Nylon, polyethylene, polyester | Cellulose | Polypropylene, Polyester, Cellulose |
| Antimicrobial agent | Silver / Silver-oxide | Copper-saline | Copper-oxide |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Sterilization | Sterile (EtO) | Sterile | Sterile (EtO) |
| Principle of operation | Antimicrobial effect is achieved via the released silver ions within the dressing in moist environment | Copper saline dressing provides a moist wound environment and protects the wound | Antibacterial effect is achieved via the released copper ions within the dressing in moist environment |
| Technology | Only the layer in contact with the skin is made of nylon fiber covered (coated) with silver | Copper saline wet dressing | All layers of the wound dressing are impregnated with copper-oxide |
| Feature | Silverlon® Wound Pad
Dressing & Silverlon® Island Wound Dressing
Primary Predicate
Device Cleared under
K143001 | ProCyte Corp. Lamin®
Wet Dressing
(Copper Saline)
Reference Predicate
Device Cleared under
K964468 | MedCu Antibacterial
Dressing with
Copper-Oxide - Subject Device - |
| Adhesive / non-
adhesive contour | Both | No | Both |
| Recommended
dressing change | Up to 7 days | Unknown | Up to 7 days |
| Absorbency | 65 oz/yd² | Absorbs wound exudate | 2 layers: ~79.4 oz/yd²
3 layers: ~75.6 oz/yd² |
| Single Use | Yes | Yes | Yes |
8
MEDCu
б
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Image /page/9/Picture/1 description: The image shows the word "MEDCu" in a stylized font. The letters "MED" are in a bright blue color, while the letters "Cu" are in a reddish-brown color. The "D" and "C" overlap, creating a visual effect where the colors blend together. The overall design is simple and modern.
Substantial Equivalence Discussion
As can be seen in the above comparison table, same claims are covered under the indications for use statement of MedCu proposed device as compared to both predicate devices.
Certain differences exist between the subject and predicate devices in terms of number of the dressing layers and antibacterial agent (silver used for Silverlon, while Lamin and MedCu are copper based).
Unlike Silverlon in MedCu ABWD the antibacterial agent exists in all layers (except for the adhesive contour layer, when such layer is included). This difference does not affect the intended purpose of the device or its safe use. The successful biocompatibility tests confirmed that the existence of the antibacterial agent throughout the entire dressing does not affect the safe use of the device. The ABWDs have an antibacterial effect within the dressing. This claim, which narrows the cleared Silverlon antimicrobial claim. does not affect the safe use of the device.
The predicate dressings' materials consist of biocompatible polymeric materials with and without cellulose. MedCu ABWD includes biocompatible polymeric materials and cellulose in all subject models. This difference does not alter the intended purpose of the device or its safe use since the intended use of both devices remains the same while MedCu chose to provide ABWDs only as absorbent wound dressings. The device was evaluated under full absorbency capacity simulating worst case clinical use and performed as intended.
All three dressings (two predicates and the subject device) absorb wound exudates, are provided sterile, biocompatible and intended for single use only.
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Image /page/10/Picture/1 description: The image shows the word "MEDCu" in a stylized font. The letters "MED" are in a bright blue color, while the letters "Cu" are in a reddish-brown color. The "Cu" letters are slightly overlapping the "D" letter, creating a visual effect.
The similarities and differences were thoroughly discussed within the 510(k) submission and it was concluded that the differences do not critically affect the intended clinical use and do not raise new questions of safety and effectiveness with regards to the proposed device.
In light of the above, we have concluded that substantial equivalence of the MedCu ABWD with the predicate devices was established.
9. CONCLUSIONS
After considering all substantial equivalency features of the predicate devices against the subject device, and after discussing similarities and differences of these features, we have concluded that MedCu ABWD (subject device) meets all proposed labeling claims and specification requirements. Certain differences between the predicate devices and the subject device were discussed and addressed within the 510(k) submission and found to be not significant in terms of safety and effectiveness. The evaluation of our device performances demonstrates that it is as safe and as effective as the predicate devices, and therefore the requirements of substantial equivalency are met.
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