(1073 days)
No
The device description and performance studies focus on the chemical composition and physical properties of the wound dressing, with no mention of AI or ML.
Yes
The device is described as a "wound dressing" with the explicit purpose of managing "partial and full thickness wounds" and providing "pain reduction," directly indicating a therapeutic intent for healing and symptomatic relief.
No
Explanation: This device is a wound dressing designed for the management and healing of wounds by creating a moist environment and providing antimicrobial and pain-relieving properties. It does not perform any diagnostic functions like analyzing data or identifying medical conditions.
No
The device description clearly states it is a "spray on hydrogel wound dressing" and describes its physical properties and components (polyacrylate polymer matrix with silver hydrosol and lidocaine). This indicates it is a physical medical device, not software only.
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 a wound dressing for the management of various types of wounds. This is a topical application for treating the wound itself, not for diagnosing a condition based on in vitro analysis of a sample from the body.
- Device Description: The description details a spray-on hydrogel that hydrates, seals, and protects dermal injuries. It describes its physical properties and the active ingredients (silver hydrosol and lidocaine) and their functions (antimicrobial and anesthetic). This aligns with a therapeutic or protective device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition. The device acts directly on the wound.
Therefore, the Field Shield® Wound Dressing is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Field Shield® Wound Dressing is indicated for the following:
Rx: Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.
OTC: Management of minor wounds including minor cuts, abrasions, lacerations and burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.
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)
Performance testing has been completed on the device, including Clinical evaluation, Antimicrobial activity testing, Performance testing, Biocompatibility evaluation, Endotoxin testing and Preservative Effectiveness testing, to demonstrate substantial equivalence to the predicate devices.
Clinical Study: Pain Relief provided within 30 minutes of application.
Guinea Pig Maximization Sensitization Test: Passed (Score 0).
Irritation Test: Passed (Score 0).
Acute systemic toxicity: Passed (Non-toxic).
Material Mediated Pyrogenicity Test: Passed.
Subacute/Subchronic Toxicity: Passed.
Implantation: Passed.
USP Antimicrobial Preservative Effectiveness Test: Passed (met USP 51 and PCPC requirements).
USP Modified "Time to Kill" Test: Passed, 99.99% Reduction within 10 minutes of microorganisms including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris.
Endotoxin Analysis: Passed,
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 Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2024
Kericure Inc. % Mehdi Kazemzadeh-Narbat Associate Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC. 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K212521
Trade/Device Name: Field Shield Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 11, 2024 Received: January 11, 2024
Dear Mehdi Kazemzadeh-Narbat:
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 and Part 809 medical device reporting (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,
Julie A. Morabito -S
Julie A. Morabito, PhD Assistant Director Office of Surgical and Infecious Diseases Control Devices (OHT4)
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K212521
Device Name Field Shield® Wound Dressing
Indications for Use (Describe) The Field Shield® Wound Dressing is indicated for the following:
Rx
Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.
OTC
Management of minor wounds including minor cuts, abrasions, lacerations and burns.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Submitted by | KeriCure Medical
Kerriann Greenhalgh, PhD
CEO, CSO
855-888-5374 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared by/Contact | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate
Director, Regulatory Affairs, MCRA, LLC
1050 K Street NW, Suite 1000, Washington, DC 20001
Office: 202.552.6011
mkazemzadeh@mcra.com |
| Date Prepared | July 16, 2024 |
| Device Trade Name | Field Shield Wound Dressing |
| Device Common Name | Hydrogel Wound Dressing |
| Classification | Wound Dressing with Drug or Biologic |
| Product Code, Class | FRO, Unclassified |
| Primary Predicate | ASAP Antibacterial Silver Wound Dressing Gel (K092826) |
| Reference Predicates | Amerigel Wound Dressing PLUS (K092086)
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel (K150799)
Ionsil Gel (K132326)
AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103)
ASAP OTC Wound Dressing Gel (K140483)
Silverlon Wound Contact, Burn Contact Dressing (K190343) |
5
Device Description
The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.
Indications for Use
Prescription Indications:
Management of partial and full thickness wounds including stage I - IV pressure ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.
Over-the-Counter Indications:
Management of minor wounds including minor cuts, abrasions, lacerations and burns.
Technological Characteristics Compared to Predicate Device
Field Shield® Wound Dressing is substantially equivalent in technological characteristics including composition, design, performance, route of administration, and intended use to the ASAP Antimicrobial Silver Wound Dressing Gel (K092826) primary predicate and reference predicate devices listed above. The subject device and the predicate devices are all non-sterile, topical hydrogel wound dressings that donate moisture to a wound and are supplied in multiple use plastic containers. All devices are hydrogels that help maintain a moist wound environment to assist with the wound healing process. The subject device and primary predicate device contain the exact same silver hydrosol ingredient, and both have a substantially equivalent mode of operation (pump dispenser). The subject device, Amerigel Wound Dressing Plus and Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel all provide local pain relief when applied to the skin or wound.
The antimicrobial agents in the proposed Field Shield® Wound Dressing and the predicates have all been shown in laboratory testing to inhibit the growth of microorganisms such as Staphylococcus aureus. Pseudomonas aeruginosa, Escherichia coli. antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing.
6
Any technological differences between the subject device and predicates do not raise different questions of safety or effectiveness in comparison to the predicate devices.
Summary of Performance Testing
Performance testing has been completed on the device, including Clinical evaluation, Antimicrobial activity testing, Performance testing, Biocompatibility evaluation, Endotoxin testing and Preservative Effectiveness testing, to demonstrate substantial equivalence to the predicate devices. Below is a list of some of the testing completed.
| Testing | Results |
|---|---|
| Clinical Study | Pain Relief provided within 30 minutes of |
| application | |
| Guinea Pig Maximization Sensitization Test | Passed (Score 0) |
| Irritation Test | Passed (Score 0) |
| Acute systemic toxicity | Passed (Non-toxic) |
| Material Mediated Pyrogenicity Test | Passed |
| Subacute/Subchronic Toxicity | Passed |
| Implantation | Passed |
| USP Antimicrobial Preservative | |
| Effectiveness Test | Passed (met USP 51 and PCPC |
| requirements) | |
| USP Modified "Time to Kill" Test | Passed, 99.99% Reduction within 10 |
| minutes of microorganisms including | |
| Staphylococcus aureus, Pseudomonas | |
| aeruginosa, Escherichia coli, antibiotic | |
| resistant strains of MRSA and VRE, as | |
| well as fungi such as Candida albicans | |
| and Candida auris | |
| Endotoxin Analysis | Passed, |