HYDROFERA BACTERIOSTATIC WOUND DRESSING

K013462 · Hydrofera, LLC · FRO · Jan 11, 2002 · SU

Device Facts

• Record ID: K013462
• Device Name: HYDROFERA BACTERIOSTATIC WOUND DRESSING
• Applicant: Hydrofera, LLC
• Product Code: FRO · SU
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Hydrofera Bacteriostatic 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, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.

Device Story

Hydrofera Bacteriostatic Wound Dressing is a synthetic, absorbent, sponge-like material; contains Methylene Blue and Crystal Violet pigments to provide bacteriostatic properties. Used as an external wound dressing for various wound types including ulcers, abrasions, and surgical incisions. Applied by healthcare providers or patients to the wound site to manage local wound environment. Benefits include bacteriostatic action to assist in wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbent polyvinyl alcohol (PVA) sponge; contains Methylene Blue (<= 0.00025 gr/gr) and Crystal Violet (<= 0.00025 gr/gr); formaldehyde < 5 ppm. Sterilized via gamma or electron beam radiation to SAL 10^-6 per Method I Bioburden validation.

Indications for Use

Indicated for local management of wounds including pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial post-surgical incisions, and traumatic wounds.

Predicate Devices

• Ultrafera wound dressing (K964614)
• Hydrofera Bacteriostatic Nasal Dressing (K983276)

Submission Summary (Full Text)

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K013462

## JAN 11 2002

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## -510(K) SUMMARY

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| A. Device Proprietary Name:<br>Device Common Name: | Hydrofera Bacteriostatic Wound Dressing<br>Wound dressing external use |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | Hydrofera Bacteriostatic Wound Dressings are<br>blue in color and manufactured from a pure<br>white synthetic material with absorbent sponge-<br>like characteristics. The two pigments have been<br>added to render the material bacteriostatic.<br>Please see Instructions for Use |
| B. Establishment Registration Number: | 1225532 |
| Establishment Name & Address: | Hydrofera LLC<br>322 Main Street<br>Willimantic CT 06226 |
| C. Device Classification of Category: | Unclassified |
| 1). Performance standards: | None |
| E. Proposed Labeling: | Draft Labeling is attached |
| F. Substantial Equivalence: | The subject wound dressing have the same<br>intended use as the predicate device:<br>Ultrafera wound dressing(K964614)<br>and Hydrofera Bacteriostatic Nasal Dressing<br>(K983276) |
| G. Materials: | Hydrofera Bacteriostatic Wound Dressings<br>are comprised of absorbent polyvinyl alcohol<br>PVA, free formaldehyde <5 ppm)Methylene<br>Blue(less than or equal to 0.00025 gr/gr) and<br>Crystal Violet (less than or equal to<br>0.00025gr/gr) |
| H. Sterility: | Hydrofera Bacteriostatic Wound Dressings<br>will be sterilized by either gamma or<br>electron beam radiation to an SAL 10-6. The<br>process will be followed in accordance with<br>Method I Bioburden and validated with<br>subsequent quarterly dose audits. |
| I. Packaging: | Each Hydrofera Bacteriostatic Wound<br>Dressing will be individually packaged in a<br>Mylar to Poly Tyvek (chevron) pouch. |
| J. S & E Summary: | Hydrofera LLC certifies that safety and<br>effectiveness information will be provided<br>for this marketed device upon request by<br>interested persons. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 11 2002

Heather H. Bond Director Polymer Technology Hydrofera, LLC. 322 Main Street Willimantic, Connecticut 06226

Re: K013462 Trade Name: Hydrofera Bacteriostatic Wound Dressing Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 15, 2001 Received: October 18, 2001

Dear Ms. Bond:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 Bond

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter will anow you to ough finding of substantial equivalence of your device to a legally premaince notificated. The are in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific arrive to: Jou in vitro diagnostic devices), please contact the Office of additionally 21 OF IC F C L . Additionally, for questions on the promotion and advertising of Compination at (301) 59 + + the Office of Compliance at [phone]. Also, please note the your deviced, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ource general mionination of you. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden C.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ of _**

510(k) NUMBER (IF KNOWN): K013462

DEVICE NAME: HYDROFERA BACTERIOSTATIC WOUND DRESSING

INDICATIONS FOR USE:

Hydrofera Bacteriostatic 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, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.

for cmo

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

**10(k) Number** K013462

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over - The - Counter - Use (Optional Format 1-2-96)