(269 days)
Not Found
No
The device description focuses on the material properties and biological effects of the copper foam dressing. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
Yes
The device is a wound dressing designed to aid in the healing of various types of wounds by absorbing exudate, maintaining a moist environment, and inhibiting bacterial growth, which aligns with the definition of a therapeutic device.
No
This device is a wound dressing designed for treatment and healing of various wounds, not for diagnosing conditions. Its primary function is to absorb exudate, maintain a moist environment, and inhibit bacterial growth.
No
The device description clearly states it is a "sterile, single-use dressing composed of polyurethane and copper oxide particles," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is a wound dressing applied topically and in direct contact with the wound. It absorbs wound exudate and releases copper ions, but it does not analyze or test any biological samples in vitro (outside the body).
- The purpose of this device is wound management and healing. Its function is to absorb exudate, maintain a moist environment, and potentially inhibit bacterial growth within the dressing. It is not used to diagnose, monitor, or screen for diseases or conditions based on analysis of bodily fluids or tissues.
The information provided aligns with a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prescription use indications (Rx-only):
- Partial and full thickness wounds,
- Pressure ulcers (stage I-IV),
- Diabetic ulcers,
- Venous stasis ulcers,
- Arterial ulcers.
- 1st and partial thickness burns,
- Surgical wounds,
- Vascular access or peripheral IV sites,
- Orthopedic external pin sites, and
- Acute wounds such as lacerations, abrasions, and skin tears.
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Product codes
FRO
Device Description
"Copper Foam Dressing (Prescription and OTC)" is a sterile, single-use dressing composed of polyurethane and copper oxide particles, which absorbs wound exudate and releases copper ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
Based on in vitro laboratory testing, the copper has been shown to inhibit bacterial growth within the dressing for up to 7 days.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
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)
Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
Antibacterial activity was measured following AATCC 100-2004 for clinical relevant bacteria to evaluate antibacterial effectiveness. "Copper Foam Dressing (Prescription and OTC)" has been shown to be effective for antibacterial effect against Gram positive and Gram negative bacteria that lasts for seven days within the dressing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 11, 2024
Roosin Medical Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K231088
Trade/Device Name: Copper Foam Dressing (Prescription and OTC) Regulatory Class: Unclassified Product Code: FRO Dated: December 12, 2023 Received: December 13, 2023
Dear Charles Shen:
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.
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).
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Your device is also subject to, among other requirements, the Quality System (OS) 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.
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.
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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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
2
Indications for Use
510(k) Number (if known) K231088
Device Name
Copper Foam Dressing (Prescription and OTC)
Indications for Use (Describe)
Prescription use indications (Rx-only):
- · Partial and full thickness wounds,
- · Pressure ulcers (stage I-IV),
- · Diabetic ulcers,
- · Venous stasis ulcers,
- · Arterial ulcers.
- · 1st and partial thickness burns,
- · Surgical wounds,
- · Vascular access or peripheral IV sites,
- · Orthopedic external pin sites, and
- · Acute wounds such as lacerations, abrasions, and skin tears.
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: K231088
This 510(K) Summary is being submitted in accordance with the requirements of 21CFR 807.92.
1.0 Submitter & Foreign Manufacture Identification
Roosin Medical Co., Ltd. 8 Yuandong Road, KouAn Town, Gaogang, Taizhou, Jiangsu Province, China 225321 Tel: (086) 523-86908085 Submitter's FDA Registration Number: 3007124979
2.0 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
3.0 Date of Summary: January 6, 2024
4.0 Device Name:
| Trade Name: | "Copper Foam Dressing (Prescription and OTC) |
|---|---|
| Common Name: | Copper Foam Dressing |
| Device Common Name: | Dressing, wound, Drug |
| Product Code: | FRO |
| Classification: | Unclassified |
| Review Panel: | General & Plastic Surgery |
5.0 Predicate Device Information:
- K180643, "MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu (1) ABWDs)", manufactured by "MedCu Technologies, Ltd.", located in Herzliya, Israel
6.0 Device description:
"Copper Foam Dressing (Prescription and OTC)" is a sterile, single-use dressing composed of polyurethane and copper oxide particles, which absorbs wound exudate and
4
releases copper ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
Based on in vitro laboratory testing, the copper has been shown to inhibit bacterial growth within the dressing for up to 7 days.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
| Antibacterial Agent: | Copper Particles |
|---|---|
| Target Pathogens: | Gram positive bacteria, Gram negative bacteria |
| Spectrum of Activity: | In vitro test results show 7-day antibacterial effect |
| within the dressing for Gram positive bacteria and | |
| Gram negative bacteria, such as Escherichia coli , | |
| Klebsiella pneumonia, Pseudomonas aeruginosa, | |
| Staphylococcus aureus, Staphylococcus | |
| epidermidis, Enterococcus faecalis. | |
| Concentration on the device: | Each dressing contains 2.0% w/w copper |
Product Information:
7.0 Indications for Use:
"Copper Foam Dressing (Prescription and OTC)" is indicated for the management of wounds. The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows:
Prescription use indications (Rx-only):
- Partial and full thickness wounds, ●
- o Pressure ulcers (stage I-IV),
- Diabetic ulcers, ●
- . Venous stasis ulcers,
- . Arterial ulcers.
- . 1st and partial thickness burns,
- Surgical wounds,
- Vascular access or peripheral IV sites, ●
- . Orthopedic external pin sites, and
- Acute wounds such as lacerations, abrasions, and skin tears. o
Over-The-Counter (OTC) use indications:
5
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Comparison to Predicate Devices 8.0
"Copper Foam Dressing (Prescription and OTC use)" is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.
- K180643, "MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu (1) ABWDs)", manufactured by "MedCu Technologies, Ltd.", located in Herzliya, Israel
The following table shows similarities and differences of use, design, material, and chemical treatment between our device and the predicate devices.
| Feature | Subject Device | Predicate Device (K180643) |
|---|---|---|
| Indication for use | The Copper Foam Dressings are | |
| indicated for the management of | ||
| wounds. 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: | 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): | Local management of superficial
wounds, minor burns, abrasions
and lacerations (tears). |
| | ✓ Partial and full thickness
wounds,
✓ pressure ulcers(stage I-IV),
✓ diabetic ulcers,
✓ venous stasis ulcers,
✓ arterial ulcers,
✓ 1st and partial thickness burns,
✓ Surgical wounds,
✓ orthopedic external pinsites,
and
✓ acute wounds such as | 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 |
| | lacerations, abrasions, and
skin tears. | sites,
✔ orthopedic external pinsites,
and
✔ acute wounds such as
lacerations, abrasions, and skin
tears. |
| Prescription/ OTC | Both prescription and OTC | Both prescription and OTC |
| Design | ✔ Non-adhesive:
Single Layer of polyurethane
foam with copper oxide
✔ Adhesive: | 2- or 3-layer:
✔ Internal layer made of
absorbent cellulose and
polyester impregnated with
copper oxide
✔ one or two external non- |
| | 2-layers: Polyurethane foam
with copper oxide, and
Polyurethane film with medical
adhesive | adherent nonwoven
polypropylene layers
containing copper oxide |
| Dimensions | ✔ Adhesive:
2 cm x 7.2 cm, 3.8 cm x 7.5
cm,5 cmx5cm, 5 cm x 13cm, 10
cm x 10cm, 20 cm x 20 cm
✔ Non-adhesive:
5 cm x 5 cm, 5 cm x 13 cm, 10
cm x 10 cm, 20 cm × 20 cm | 10 cm x 10 cm, 5 cm x 5 cm |
| Material | Copper oxide, polyurethane
foam, medical adhesive | Copper oxide, polypropylene,
polyester, Cellulose, medical
adhesive |
| Antibacterial agent | Copper oxide | Copper oxide |
| Technology | Wound dressing is impregnated
with copper oxide | Wound dressing is impregnated
with copper oxide |
| Principle of
operation | Antibacterial effect is achieved
via the released copper ions
within the
dressing in moist environment | Antibacterial effect is achieved
via the released copper ions
within the
dressing in moist environment |
| Adhesive/ Non-
adhesive | Both | Both |
| Antibacterial
Effectiveness | Up to 7 days | Up to 7 days |
| Absorbency | > 500% | > 500% |
| Sterilization | Sterile by radiation | Sterile by EtO |
| Single Use | Yes | Yes |
Table 5.1: Comparison of Intended Use, Design, and Material
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"Copper Foam Dressing (Prescription and OTC)" and its predicate devices are made from same materials, utilize same principles of operation, and have same indications for use.
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Per FDA's guidance document entitled "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"", as well as ISO 10993-1: 2018, the following biocompatibility endpoints are considered:
Cytotoxicity (ISO 10993-5) Irritation & Sensitization (ISO 10993-10) Systematic Toxicity (ISO 10993-11) Material-Mediated Pyrogenicity (ISO 10993-11) Implantation (ISO 10993-6)
Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
Antibacterial activity was measured following AATCC 100-2004 for clinical relevant bacteria to evaluate antibacterial effectiveness. "Copper Foam Dressing (Prescription and OTC)" has been shown to be effective for antibacterial effect against Gram positive and Gram negative bacteria that lasts for seven days within the dressing.
Substantial Equivalent Statement 9.0
Based on the comparison of intended use, design, materials, and performance, "Copper Foam Dressing (Prescription and OTC)" is substantially equivalent to its predicate devices.