Who is the manufacturer of HYDROFERA BLUE PU BACTERIOSTATIC DRESSING?

Hydrofera, LLC filed the 510(k) submission for HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (K130670).

What is the FDA product code for HYDROFERA BLUE PU BACTERIOSTATIC DRESSING?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for HYDROFERA BLUE PU BACTERIOSTATIC DRESSING?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HYDROFERA BLUE PU BACTERIOSTATIC DRESSING?

Hydrofera Blue (K013462); RTD Dressing (K060832).

Who can help prepare an FDA 510(k) submission like HYDROFERA BLUE PU BACTERIOSTATIC DRESSING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HYDROFERA BLUE PU BACTERIOSTATIC DRESSING

K130670 · Hydrofera, LLC · FRO · Jan 2, 2014 · SU

Device Facts

Record ID	K130670
Device Name	HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
Applicant	Hydrofera, LLC
Product Code	FRO · SU
Decision Date	Jan 2, 2014
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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.

Device Story

Hydrofera Blue PU Antibacterial Dressing is a sterile, non-adhesive, flexible, absorbent foam dressing. Composed of polyurethane (PU) foam impregnated with Methylene blue and Gentian violet (crystal violet). Antimicrobials provide broad-spectrum protection against gram-negative and gram-positive bacteria. Used in hospitals, clinics, and homecare for local management of various wound types (e.g., pressure, diabetic, surgical). Applied externally by clinicians or patients to manage wound environment. Benefits include antimicrobial protection and exudate absorption, aiding in wound healing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including sensitization, irritation, systemic toxicity, and pyrogenicity. In vitro antimicrobial testing demonstrated efficacy against a broad spectrum of bacteria and fungi, including Bacillus subtilis, E-Coli, MRSA, VRE, Staph aureus, and Candida albicans. Results showed no skin irritation, no sensitization, no acute systemic toxicity, and no cytotoxicity.

Technological Characteristics

Polyurethane foam dressing impregnated with Methylene blue (≤0.00035g/g) and Gentian violet (≤0.00035g/g). Flexible, non-adhesive, absorbent form factor. Sterilized via Gamma irradiation or electron beam radiation. Biocompatibility per ISO 10993.

Indications for Use

Indicated for local management of wounds including pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and trauma-inflicted wounds. For use in hospitals, clinics, healthcare facilities, and homecare settings.

Predicate Devices

Hydrofera Blue (K013462)
RTD Dressing (K060832)

Related Devices

K190268 — Hydrofera Blue READY - Border · Hydrofera, LLC · Nov 6, 2019
K013462 — HYDROFERA BACTERIOSTATIC WOUND DRESSING · Hydrofera, LLC · Jan 11, 2002
K091013 — SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND · Advanced Medical Solutions Limited · Jul 30, 2009
K181197 — PHMB Foam Wound Dressing · Advanced Medical Solutions, Ltd. · Aug 3, 2018
K140954 — LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING · Huizhou Foryou Medical Devices Co., Ltd. · Mar 23, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ K130670 # JAN - 2 2014 Premarked Notification 510(k) Hydrofera LLC 510(k) Summary . | Manufacture's name: | Hydrofera LLC 322 Main Street Willimantic 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 Dressing Trade 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: > 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 {1}------------------------------------------------ ### 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 - · Sterility - · Testing Done - In- vitro Antimicrobial Activity - Where used - · Anatomical sites ### Comparison Table | Hydrofera Blue PU dressing | Hydrofera K# 013462 | Retro Tech K#060832 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Local Management of wounds including: • Pressure ulcers • Donor sites •Venous stasis ulcers Arterial ulcers •Diabetic ulcers •Abrasions •Lacerations •Superficial burns •Post surgical incisions •Any other wound inflicted by trauma | Local management of wounds including: •Pressure ulcers • Donor sites •Venous stasis ulcers Arterial ulcers •Diabetic ulcers •Abrasions •Lacerations •Superficial burns •Post surgical incisions •Any other wound inflicted by trauma | Indicated for moderately to heavily exudating partial to full thickness wounds including: •Pressure ulcers •Leg ulcers •Diabetic foot ulcers •Graft wound and donor site •Skin tears •Surgical wounds •Post operative wounds •Lacerations and abrasions •Any other wound caused by trauma | In Vitro Antimicrobial Testing {2}------------------------------------------------ # Premarked Notification 510(k) Hydrofera LŁC | Hydrofera Blue PU dressing | 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 | {3}------------------------------------------------ ## Premarked Notification 510(k) Hydrofera LLC | Any other wound inflicted Any other wound inflicted abrasions bv trauma | by trauma | ·Anv other wound caused | |--------------------------------------------------------------------------------|-----------|-------------------------| | | | by trauma | ## Where Product is Used | Hydrofera Blue PU Dressing | 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 PU Dressing | Hydrofera k # 013462 | Retro Tech k # 060832 | |-----------------------------------------|-------------------------------|-------------------------|--------------------------| | Silver sodium Zirconium Phosphate | | | X | | Gentian violet | X | X | X | | Methylene Blue | X | X | X | | Dressing Flexibility | Flexible | Rigid | flexible | | Wound environment | Dry to wet | Wet | Dry to wet | | Adhesive | Non adhesive | Non adhesive | Non adhesive | ## Materials Comparison | Hydrofera Blue PU Dressing | Hydrofera k # 013462 | Retro Tech k # 060832 | |-------------------------------|----------------------|-----------------------| | Polyurethane | Polyvinyl alcohol | Polyurethane | ### Sterility Comparison | Sterility Comparison | | | |------------------------------------------------------------------|------------------------------------------------------------------|-----------------------| | Hydrofera Blue PU Dressing | Hydrofera k # 013462 | Retro Tech k # 060832 | | Sterilized by Gamma irradiation or electron beam radiation | Sterilized by Gamma irradiation or electron beam radiation | Unknown | {4}------------------------------------------------ | 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: - 1) The Hydrofera Blue PU Antibacterial Wound Dressing extracts did not cause skin irritation nor did is cause sensitization reactions. - 2) The Hydrofera Blue PU Antibacterial Wound Dressing meets the requirements for cytotoxicity (no cell death). - 3) The Hydrofera Blue PU Antibacterial Wound Dressing did not cause acute systemic toxicity. - 4) 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. #### 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ ### 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) Page 1 of 1 Jiyoung Dang -S