Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and antimicrobial properties of a wound dressing, with no mention of AI or ML technologies.

Therapeutic

No
The device is an external wound dressing for local management of wounds, with antibacterial properties; it does not claim to treat the underlying cause of the wounds or to provide a therapeutic effect beyond local wound management.

Diagnostic

No
The device is described as an external wound dressing for management of wounds, not for diagnosis. Its components are antimicrobials and it's used for treatment, not for identifying a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile absorptive foam dressing made of physical materials (polyurethane foam, Methylene blue, Crystal violet). It is a physical wound dressing, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description and Intended Use: The description clearly states that the Hydrofera Blue PU Antibacterial Wound Dressings are "external dressings for use in local management of wounds". They are applied directly to the wound on the body.
Lack of In Vitro Testing: The performance studies mentioned are primarily in vitro tests related to the dressing's properties (antimicrobial activity, biocompatibility, etc.), but these are tests of the device itself, not tests performed on human specimens to diagnose or monitor a condition.

The device is a wound dressing, which is a type of medical device used for wound care, not for diagnostic testing of bodily fluids or tissues.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

FRO

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anatomical sites where the following occur:

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 Patient Age Range

Not Found

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 In Vitro Testing shows:

1. The Hydrofera Blue PU Antibacterial Wound Dressing extracts did not cause skin irritation nor did is cause sensitization reactions.
1. The Hydrofera Blue PU Antibacterial Wound Dressing meets the requirements for cytotoxicity (no cell death).
1. The Hydrofera Blue PU Antibacterial Wound Dressing did not cause acute systemic toxicity.
1. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013462, K060832

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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:

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

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.
1. The Hydrofera Blue PU Antibacterial Wound Dressing meets the requirements for cytotoxicity (no cell death).
1. The Hydrofera Blue PU Antibacterial Wound Dressing did not cause acute systemic toxicity.
1. 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)

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Jiyoung Dang -S