(271 days)
Not Found
No
The summary describes a passive wound dressing with antibacterial properties and an adhesive border. There is no mention of any computational analysis, image processing, or data-driven decision-making, which are characteristic of AI/ML technologies in medical devices. The performance studies focus on material properties and antibacterial efficacy, not algorithmic performance.
Yes
The device is described as an external dressing for managing various types of wounds, which is a therapeutic purpose.
No
This device is an absorptive foam dressing intended for the management of exuding wounds. Its primary function is to absorb fluid and provide an external dressing, not to diagnose a condition. The performance studies focus on physical properties and antibacterial efficacy, not diagnostic accuracy.
No
The device description clearly states it is a sterile absorptive foam dressing made of polyurethane foam with added substances and an outer film backing with silicone adhesive border, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "external dressing for use in local management of moderate to heavily exuding wounds". This describes a device applied to the body for therapeutic purposes (wound management), not a device used to test samples from the body to diagnose or monitor a condition.
- Device Description: The description details a sterile absorptive foam dressing with specific chemical components and an adhesive border. This aligns with the description of a wound dressing, not an in vitro diagnostic test.
- Performance Studies: The performance studies focus on characteristics relevant to a wound dressing, such as antibacterial efficacy, fluid retention, border adhesion, and biocompatibility. These are not the types of performance metrics typically associated with IVD devices (e.g., sensitivity, specificity, accuracy in detecting analytes).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information.
In summary, the Hydrofera Blue READY - Border is a therapeutic device intended for wound management, not a diagnostic device used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
Product codes
FRO
Device Description
Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
❖ Chronic wounds
Pressure sores/ulcers
Diabetic ulcers
Venous stasis ulcers
Arterial Ulcers
❖ Acute wounds
Traumatic wounds
Surgical wounds
Post-surgical incisions
Donor sites
Superficial burns
Skin abrasions
Lacerations
Indicated Patient Age Range
However, the product has not been tested or evaluated on the pediatric or neonatal patient populations
Intended User / Care Setting
Hospitals, clinics, healthcare facilities, homecare
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)
The following performance data is provided in support of the substantial equivalence determination:
-
Antibacterial Efficacy ASTM E2149-10 (modified)
- Acceptance Criteria: ge 4 log reduction over 7 days
- Subject Device Testing (K190268): 8 gram + Organisms tested; 8 ge 6 log reduction; 10 gram - Organisms tested; 10 ge 6 log reduction
-
Zone of Inhibition -AATCC 147-2011
- Acceptance Criteria: no zone of inhibition
- Subject Device Testing (K190268): No evidence of growth surrounding the Dressing
-
Dye Leachable
- Acceptance Criteria: , (rabbit pyrogen test) device is considered non-pyrogenic.
- Local effects after implantation: Performed per ISO 10993-6. In the rabbit muscle study, the device was considered passing.
- Acute systemic toxicity: Performed per ISO 10993-11 (implantation in rabbit abdomen), device showed no signs of acute systemic toxicity.
- Hemolysis/Interaction with blood: Performed per ASTM Hemolysis Test and passed
- Toxicology Risk Assessment: Performed per ISO standards 10993-1. 10993-11. 10993-3, 10993-17, 10993-18, 21726, and 14971. Toxicity is not expected from the intended use of the device.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hydrofera, LLC Sean Anderson Director of Regulatory Affairs and Quality Assurance 340 Progress Drive Manchester, Connecticut 06042
Re: K190268
Trade/Device Name: Hydrofera Blue READY - Border Regulatory Class: Unclassified Product Code: FRO Dated: October 2, 2019 Received: October 3, 2019
Dear Sean Anderson:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cynthia J. 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) K190268
Device Name Hydrofera Blue READY - Border
Indications for Use (Describe)
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
| 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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| Section 5: 510(k) Summary | Hydrofera Blue READY - Border Traditional 510(k) |
|---|---|
| K190268 |
Date Prepared: November 6, 2019
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92(c):
| 1. Applicant | |
|---|---|
| Company: | Hydrofera, LLC |
| 340 Progress Drive | |
| Manchester, CT 06042 USA Telephone: | |
| 860-337-7466 | |
| Fax: 860-337-7462 | |
| Official Correspondent: | John O'Gara |
| Hydrofera, LLC | |
| 340 Progress Drive | |
| Manchester, CT 06042 USA Telephone: | |
| 860-337-7741 | |
| Fax: 860-337-7462 | |
| Email: johno@hydrof.com |
| 2. Device Details | |
|---|---|
| Common Name: | Absorbent Wound Dressing |
| Trade Name(s) – Type: | • Hydrofera Blue READY™ – Border |
| Classification Name: | |
|---|---|
| Regulatory Class: | |
| Product Code: | |
| Panel: |
Dressing, Wound, Drug Unclassified FRO General & Plastic Surgery
3. Predicate Device(s)
Predicate Device Name:
Hydrofera Blue PU Antibacterial Dressing (K130670)
4
| Section 5: 510(k) Summary | Hydrofera Blue READY - Border |
|---|---|
| Traditional 510(k) |
4. Device Description
Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.
5. Intended Use/Indications for Use
Indications for Use:
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
6. Technological/Design Characteristics and Substantial Equivalence
Hydrofera Blue READY - Border is substantially equivalent to the predicate device with respect to material composition, device characteristics, and intended use. Table 5-1 below provides a comparison of the technological/design characteristics of the subject device compared to the predicate device.
5
| | Predicate Device
K130670, Hydrofera Blue PU
Antibacterial
Dressing | Modified Device
K190268, Hydrofera Blue
READY - Border | Substantial
Equivalence
Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Indications for Use | Hydrofera Blue PU
antibacterial foam dressings
are intended as external
dressings for use in local
management of wounds such
as pressure ulcers, donor
sites, venous stasis ulcers,
arterial ulcers, diabetic
ulcers, abrasions, lacerations,
superficial burns, post-
surgical incisions, and other
external wounds inflicted by
trauma. | Hydrofera Blue READY –
Border is intended as an
external dressing for use in
local management of
moderate to heavily
exuding wounds such as
pressure ulcers, donor sites,
venous stasis ulcers, arterial
ulcers, diabetic ulcers,
abrasions, lacerations,
superficial burns, post-
surgical incisions, and other
external wounds inflicted
by trauma. | Same as predicate |
| Where Used | Hospitals, clinics, healthcare
facilities,
homecare | Hospitals, clinics, healthcare
facilities,
homecare | Same as predicate |
Table 5-1. Comparison of Technological/Design Characteristics with the Predicate Device
6
| Section 5: 510(k) Summary | | Hydrofera Blue READY - Border
Traditional 510(k) | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Anatomical Sites | | | |
| | ❖ Chronic wounds Pressure sores/ulcers Diabetic ulcers Venous stasis ulcers Arterial Ulcers ❖ Acute wounds Traumatic wounds Surgical wounds Post-surgical incisions Donor sites Superficial burns Skin abrasions Lacerations | ❖ Chronic wounds Pressure sores/ulcers Diabetic ulcers Venous stasis ulcers Arterial Ulcers ❖ Acute wounds Traumatic wounds Surgical wounds Post-surgical incisions Donor sites Superficial burns Skin abrasions Lacerations | Same as predicate |
7
| Section 5: 510(k) Summary | | | Hydrofera Blue READY - Border
Traditional 510(k) | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Design/Materials
Comparison | Layers:
- Polyurethane FoamPad
- Polyurethane Film (with
printed white ink) | Layers: - Polyurethane Foam Pad
- Polyurethane Film (with
printed white ink) - Silicone Adhesive
Border - Polycarbonate Release
Liner | 1. Same as predicate - Same as predicate
- The subject device
adds a silicone
adhesive border,
which has a long
history of safe use
in wound
dressings. - The subject device
adds a
polycarbonate
release liner to
protect the
silicone adhesive
prior to
application. The
liner has a long
history of safe use
in wound
dressings and is
removed priorto
patient contact. | | |
| Primary Mode of
Action | Absorption of exudate | Absorption of exudate | Same as predicate | | |
| Section 5: 510(k) Summary | | Hydrofera Blue READY - Border
Traditional 510(k) | | | |
| | | | | | |
| Antibacterial
Content | PU Foam Pad contains:
• Gentian Violet: less
than or equal to
0.00035g/g
• Methylene Blue: less
than or equal to
0.00035g/g | PU Foam Pad contains:
• The combined total of
Gentian Violet and
Methylene Blue are less
than or equal to 0.0007
g/g
• Gentian Violet: greater
than or equal to
0.00005 g/g
• Methylene Blue: greater
than or equal to 0.00005
g/g | The subject and
predicate devices use
the same antibacterial
dyes. The maximum
combined total of
both dyes is the same
for the subject and
predicate.
The subject device
adds a minimum dye
specification.
Overall, a two-sided
specification is created
that is tighter than, yet
falls within, the
predicate
device's range. | | |
| Biocompatibility
Testing (per ISO
- | • Cytotoxicity
• Irritation
• Acute Systemic
Reactivity
• Sensitization
• Hemolysis | | • Cytotoxicity
• Irritation
• Acute Systemic
Reactivity
• Sensitization
• Hemolysis
• Material-Mediated
Pyrogenicity
• Implantation
• Toxicity Risk
Assessment | The subject device
adds, material-
mediated
pyrogenicity,
implantation, and a
Toxicity Risk
Assessment
All tests passed | |
8
9
Section 5: 510(k) Summary
Hydrofera Blue READY - Border Traditional 510(k)
| In Vitro
Antibacterial
Testing in
Simulated Wound
Fluid | NA | Staphylococcus aureus Streptococcus
pneumoniae Bacillus subtilis Pseudomonas aeruginosa Escherichia coli Enterobacter cloacae | The subject device
adds test data using
simulated wound
fluid.
All tests passed. |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| In Vitro
Antibacterial
Testing in Saline | Methicillin Resistant
Staphylococcus Aureus
(MRSA) Staphylococcus aureus Staphylococcus
epidermidis (coagulase
neg.) Pseudomonas
aeruginosa Pseudomonas
florescens Escherichia coli Enterococcus faecalis Vancomycin Resistant
Enterococcus (VRE) Streptococcus
pyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacter
aerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcus
pneumoniae Candida albicans Candida krusei Candida glabrata | Methicillin Resistant
Staphylococcus Aureus
(MRSA) Staphylococcus aureus Staphylococcus
epidermidis (coagulase
neg.) Pseudomonas
aeruginosa Pseudomonas
florescens Escherichia coli Enterococcus faecalis Vancomycin Resistant
Enterococcus (VRE) Streptococcus
pyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacter
aerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcus
pneumoniae Candida albicans Candida krusei Candida glabrata | Same as predicate |
Hydrofera, LLC Additional Information – K190268
10
| Section 5: 510(k) Summary | Hydrofera Blue READY - Border
Traditional 510(k) | | |
|---------------------------|-----------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Method | Gamma Radiation | Ethylene Oxide | The subject and
predicate devices are
both provided sterile
and are sterilized
using traditional
methods. A Sterility
Assurance Level
(SAL) of 10-6 was
achieved for the
subject device. |
| Energy Source | No energy sources are
utilized | No energy sources are
utilized | Same as predicate |
11
7. Performance Data
The following performance data is provided in support of the substantial equivalence determination:
| | Parameter
Evaluated | Acceptance
Criteria | Predicate Device
Testing (K130670)
(Appendix L) | Subject Device Testing (K190268) |
|---|----------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Antibacterial
Efficacy
ASTM E2149-10
(modified) | $\u2265$ 4 log
reduction
over 7 days | 20 Organisms tested
20 $\u2265$ 4 log reductions | 8 gram + Organisms tested
8 $\u2265$ 6 log reduction
10 gram - Organisms tested
10 $\u2265$ 6 log reduction |
| 2 | Zone of Inhibition
-AATCC 147-
2011 | no zone of
inhibition | No evidence of growth
surrounding the
Dressing | No evidence of growth surrounding
the Dressing |
| 3 | Dye Leachable | , (rabbit pyrogen test) device ● is considered non-pyrogenic.
- Local effects after implantation: Performed per ISO 10993-6. In the rabbit muscle study, ● the device was considered passing.
- Acute systemic toxicity: Performed per ISO 10993-11 (implantation in rabbit abdomen), ● device showed no signs of acute systemic toxicity.
- Hemolysis/Interaction with blood: Performed per ASTM Hemolysis Test and passed ●
- . Toxicology Risk Assessment: Performed per ISO standards 10993-1. 10993-11. 10993-3, 10993-17, 10993-18, 21726, and 14971. Toxicity is not expected from the intended use of the device. However, the product has not been tested or evaluated on the pediatric or neonatal patient populations
13
| Section 5: 510(k) Summary | Hydrofera Blue READY - Border |
|---|---|
| Traditional 510(k) |
No clinical data was required to support substantial equivalence, and the testing performed demonstrates that the Hydrofera Blue READY - Border meets all performance specifications and is as safe and effective as the predicate device .
8. Conclusion
Based on the information provided in this 510(k), Hydrofera, LLC believes that the proposed Hydrofera Blue READY - Border is substantially equivalent to Hydrofera Blue PU Antibacterial Dressing (K130670) in terms of its intended use, design, operational and technological characteristics. The subject device raises no new issues of safety and met all test specifications, and the non-clinical testing performed effectiveness. demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device.