(296 days)
Hydrofera Blue PU Antibacterial Wound 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 wound inflicted by trauma.
Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g]. The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam: 1. Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria 2. Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria
The Hydrofera Blue PU Antibacterial Dressing is an absorbent wound dressing intended for the local management of various external wounds.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Hydrofera Blue PU) |
|---|---|---|
| Antimicrobial Activity | Equivalence to predicate devices (K013462 and K060832) for broad-spectrum antimicrobial protection as provided by Methylene Blue and Gentian Violet. | Demonstrates in-vitro antimicrobial activity against a broad spectrum of bacteria and fungi, including common wound pathogens like Bacillus subtilis, E-Coli, MRSA, VRE, Serratia marcescens, Staph aureus, Staph epidermidis, Pseudomonas aeruginosa, Pseudomonas florescens, Enterococcus faecalis, Streptococcus pyogenes, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter aerogenes, Yersinia enterocolitica, Candida albicans, Candida krusei, and Candida glabrata. |
| Biocompatibility (per ISO 10993) | No skin irritation, no sensitization reactions, meets requirements for cytotoxicity (no cell death), no acute systemic toxicity, considered non-irritant. | - Extracts did not cause skin irritation.- Did not cause sensitization reactions.- Meets requirements for cytotoxicity (no cell death).- Did not cause acute systemic toxicity.- Considered non-irritant. |
| Sterility | Sterilized by Gamma irradiation or electron beam radiation. | Sterilized by Gamma irradiation or electron beam radiation. |
| Physical Performance | Functional similarity to predicate devices in areas like dressing flexibility, wound environment suitability (dry to wet), and non-adhesive nature. | Flexible, suitable for dry to wet wound environments, non-adhesive. |
| Indications for Use | Same intended use as predicate devices for local management of various wound types. | Intended for local management of pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes in-vitro testing and does not mention human subject studies or a "test set" in the context of clinical performance evaluation. The "data provenance" for the in-vitro antimicrobial and biocompatibility testing is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being performed for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The study primarily involves in-vitro antimicrobial activity and biocompatibility testing, not clinical studies with expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. This was not a clinical study involving human readers or assessment of clinical outcomes requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Hydrofera Blue PU Antibacterial Dressing was established through:
- Laboratory-based In-vitro Testing: For antimicrobial activity, the ground truth was determined by observing the growth inhibition or killing of specific microbial strains under controlled laboratory conditions.
- Standard Biocompatibility Testing (ISO 10993): The ground truth for biocompatibility was established against predefined criteria and endpoints specified in ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity).
8. The Sample Size for the Training Set
Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is detailed under the "In Vitro Antimicrobial Testing" and "Biocompatibility per ISO 10993" sections of the 510(k) submission.
- In Vitro Antimicrobial Testing: This testing compared the Hydrofera Blue PU dressing's antimicrobial spectrum to its predicate devices (Hydrofera K# 013462 and Retro Tech K#060832). The results demonstrated that the Hydrofera Blue PU dressing exhibits activity against a broad range of microorganisms, including many listed for the predicate devices and additional strains. This established its performance equivalence in antimicrobial function.
- Biocompatibility Testing (per ISO 10993): This included specific tests for sensitization, irritation, systemic toxicity, and cytotoxicity. The conclusions drawn from these tests directly state that:
- The dressing extracts did not cause skin irritation or sensitization reactions.
- The dressing meets the requirements for cytotoxicity (no cell death).
- The dressing did not cause acute systemic toxicity.
- The dressing is considered non-irritant.
The submission concludes that "The above testing demonstrates that the Hydrofera Blue PU Antibacterial Wound Dressing is safe and effective and performs as well as the predicate devices," thereby meeting the acceptance criteria for substantial equivalence. The FDA, in its letter, concurred that the device is "substantially equivalent" based on this information.
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JAN - 2 2014
Premarked Notification 510(k) Hydrofera LLC
510(k) Summary
.
| Manufacture's name: | Hydrofera LLC322 Main StreetWillimantic CT 06226 |
|---|---|
| Phone Number: | (860) 456-0677 |
| Fax Number: | (860) 456- 0898 |
| Name of Contact Person: | Heather S. Somers |
| Phone Number: | (860) 389-4628 |
| Date Summary Prepared: | April 23, 2013 |
| Name of Device: | Hydrofera Blue Antibacterial PU DressingTrade Name or Proprietary Name: Hydrofera Blue Antibacterial PU Dressing |
| Commom or Usual Name: | Absorbent Wound Dressing |
| Classification Name: | Dressing, wound |
| Product Code: | FRO |
| Classification: | Unclassified |
The legally marketed device to which we are claiming equivalence (807.92(a) (3):
| K# | Applicant | Device Name |
|---|---|---|
| K013462 | Hydrofera, LLC | Hydrofera Blue |
| K060832 | Retro-Tech, LLC | RTD Dressing |
Description of the Device:
Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g].
The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam:
- Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria
- Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria
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Indications:
.
-
Hydrofera Blue PU Antibacterial Wound 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 wound inflicted by trauma.
Summary of the technological characteristics of our device compared in the following areas and found to have similar technological characteristics and to be equivalent: -
Indications for Use
-
· Design
-
Materials
-
· Performance
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· Sterility
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· Testing Done
-
In- vitro Antimicrobial Activity
-
Where used
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· Anatomical sites
Comparison Table
| Hydrofera Blue PUdressing | Hydrofera K# 013462 | Retro Tech K#060832 |
|---|---|---|
| Local Management ofwounds including:• Pressure ulcers• Donor sites•Venous stasis ulcersArterial ulcers•Diabetic ulcers•Abrasions•Lacerations•Superficial burns•Post surgical incisions•Any other woundinflicted by trauma | Local management ofwounds including:•Pressure ulcers• Donor sites•Venous stasis ulcersArterial ulcers•Diabetic ulcers•Abrasions•Lacerations•Superficial burns•Post surgical incisions•Any other woundinflicted by trauma | Indicated for moderatelyto heavily exudatingpartial to full thicknesswounds including:•Pressure ulcers•Leg ulcers•Diabetic foot ulcers•Graft wound and donorsite•Skin tears•Surgical wounds•Post operative wounds•Lacerations andabrasions•Any other wound causedby trauma |
In Vitro Antimicrobial Testing
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Premarked Notification 510(k) Hydrofera LŁC
| Hydrofera Blue PUdressing | Hydrofera K# 013462 | Retro Tech K # 060832 |
|---|---|---|
| Bacillus subtilis | Bacillus subtilis | Aspergillus niger |
| E-Coli | E-Coli | Candida albicans |
| MRSA | MRSA | Bacillus subtilis |
| VRE | VRE | Clostridium sporogenes |
| Serratia marcescens | Serratia marcescens | Salmonella cholerasuis |
| Staph aureus | Staph aureus | E-Coli |
| Staph epidermidis | Staph epidermidis | Pseudomonas aeruginosa |
| Pseudomonas aeruginosa | Staph aureus | |
| Pseudomonas florescens | VRE | |
| Enterococcus faecalis | MRSA | |
| Streptococcus pyogenes | ||
| Klebsiella pneumonaie | ||
| Proteus mirabilis | ||
| Proteus vulgaris | ||
| Enterobacter aerogenes | ||
| Yersinia enterocolitica | ||
| Candida albicans | ||
| Candida krusei | ||
| Candida glabrata |
Continued on next page...
| Anatomical Sites | ||
|---|---|---|
| Hydrofera Blue PU Dressing | Hydrofera k # 013462 | Retro Tech k # 060832 |
| Anatomical sites where the following occur:•Pressure ulcers•Donor sites•Venous Stasis ulcers•Arterial ulcers•Diabetic ulcers•Abrasions•Lacerations•Superficial burns•Post surgical incisions | Anatomical sites where the following occur:•Pressure ulcers•Donor sites•Venous stasis ulcers•Arterial ulcers•Diabetic ulcers•Abrasions•Lacerations•Superficial burns•Post surgical incisions | Anatomical sites where the following occur:•Pressure ulcers•Leg ulcers•Diabetic foot ulcers•Graft wound and donor site•Skin tears•Surgical wounds•Post operative wounds•Lacerations and |
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Premarked Notification 510(k) Hydrofera LLC
| Any other wound inflicted Any other wound inflicted abrasionsbv trauma | by trauma | ·Anv other wound caused |
|---|---|---|
| by trauma |
Where Product is Used
| Hydrofera Blue PUDressing | Hydrofera k # 013462 | Retro Tech k # 060832 |
|---|---|---|
| Hospitals, clinics, healthcare facilities,homecare | Hospitals, clinics, healthcare facilities,homecare | Hospitals, clinics, healthcare facilities,homecare |
Continued on next page ...
Design Comparison
| Hydrofera Blue PUDressing | Hydrofera k #013462 | Retro Tech k #060832 | |
|---|---|---|---|
| Silver sodiumZirconiumPhosphate | X | ||
| Gentian violet | X | X | X |
| Methylene Blue | X | X | X |
| Dressing Flexibility | Flexible | Rigid | flexible |
| Woundenvironment | Dry to wet | Wet | Dry to wet |
| Adhesive | Non adhesive | Non adhesive | Non adhesive |
Materials Comparison
| Hydrofera Blue PUDressing | Hydrofera k # 013462 | Retro Tech k # 060832 |
|---|---|---|
| Polyurethane | Polyvinyl alcohol | Polyurethane |
Sterility Comparison
| Sterility Comparison | ||
|---|---|---|
| Hydrofera Blue PUDressing | Hydrofera k # 013462 | Retro Tech k # 060832 |
| Sterilized by Gammairradiation or electronbeam radiation | Sterilized by Gammairradiation or electronbeam radiation | Unknown |
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| Testing performed | ||
|---|---|---|
| Hydrofera Blue PU | Hydrofera k # 013462 | Retro Tech k # 060832 |
| Dressing | ||
| Biocompatibility per ISO | ||
| 10993 | ||
| Sensitization | Sensitization | Sensitization |
| Irritation | Irritation | Irritation |
| Systemic toxicity | Systemic toxicity | Systemic toxicity |
| Hemocompatibility | Not performed | Hemocompatibility |
| Sterilization | Sterilization | Sterilization |
| Pyrogenicity | Pyrogenicity | Pyrogenicity |
sting nerformed
Continued on next page ...
.
The In Vitro Testing shows:
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- The Hydrofera Blue PU Antibacterial Wound Dressing extracts did not cause skin irritation nor did is cause sensitization reactions.
-
- The Hydrofera Blue PU Antibacterial Wound Dressing meets the requirements for cytotoxicity (no cell death).
-
- The Hydrofera Blue PU Antibacterial Wound Dressing did not cause acute systemic toxicity.
-
- The Hydrofera Blue PU Antibacterial Wound Dressing is considered non irritant.
Conclusion:
The above testing demonstrates that the Hydrofera Blue PU Antibacterial Wound Dressing is safe and effective and performs as well as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
Hydrofera, LLC Ms. Heather S. Somers Director International 322 Main Street Willimantic, Connecticut 06226
Re: K130670
Trade/Device Name: Hydrofera Blue PU Antibacterial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 2, 2013 Received: December 3, 2013
Dear Ms. Somers:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Heather S. Somers
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Binita S. Ashar => 2014.01.02 104.01.02 57 -05'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT 2
Premarked Notification 510(k) Hydrofera LLC
K130670 .
Indications for Use Statement
Indications for Use:
510(k) Number : 130670
Device Name: Hydrofera Blue PU Antibacterial Dressing
Hydrofera Blue PU Antibacterial Wound Dressings are intended as external riyal of or use in local management of wounds such as pressure ulcers, donor aresomes for about stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.
Prescription Use __ X (part 21 CFR 801 Subpart D) and/or
Over the Counter Use_ (21 CFR 801 Subpart C)
(please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
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