(85 days)
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.
Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge-like characteristics. The two pigments have been added to render the material bacteriostatic.
This 510(k) summary (K013462) describes a wound dressing and does not contain the detailed information required to answer all parts of your request. This type of regulatory submission focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with specific acceptance criteria and detailed test results as would be found in a clinical trial report or a more extensive engineering test report.
Based on the provided text, here's what can be extracted and what information is not available:
Information from the document:
- Device Proprietary Name: Hydrofera Bacteriostatic Wound Dressing
- Device Common Name: Wound dressing external use
- Intended Use: External dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, and superficial post-surgical incisions, and other external wounds inflicted by trauma.
- Predicate Devices: Ultrafera wound dressing (K964614) and Hydrofera Bacteriostatic Nasal Dressing (K983276)
- Sterility: Sterilized by either gamma or electron beam radiation to an SAL 10-6.
Based on the provided text, the following information is NOT available and therefore cannot be included in the table:
- A table of acceptance criteria and the reported device performance: This document is a 510(k) summary, which focuses on substantial equivalence. It does not contain performance acceptance criteria or a study detailing device performance against such criteria. The "Performance standards: None" entry refers to the absence of specific FDA-mandated performance standards for this unclassified device type, not a lack of internal performance testing.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 is a physical wound dressing, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wound dressing, not an algorithm.
- The type of ground truth used: Not applicable for this type of device and submission.
- The sample size for the training set: Not applicable for this type of device and submission.
- How the ground truth for the training set was established: Not applicable for this type of device and submission.
The 510(k) summary indicates that "safety and effectiveness information will be provided for this marketed device upon request by interested persons." This suggests that performance data may exist but is not part of this summary document. For a physical device like a wound dressing, performance data would typically involve biocompatibility testing, tensile strength, absorption rates, bacteriostatic efficacy (as claimed by the device name, though not detailed in this summary), and potentially clinical observations for efficacy, but these details are absent from the provided 510(k) summary.
{0}------------------------------------------------
JAN 11 2002
.
.
-510(K) SUMMARY
.
:
| A. Device Proprietary Name:Device Common Name: | Hydrofera Bacteriostatic Wound DressingWound dressing external use |
|---|---|
| Description: | Hydrofera Bacteriostatic Wound Dressings areblue in color and manufactured from a purewhite synthetic material with absorbent sponge-like characteristics. The two pigments have beenadded to render the material bacteriostatic.Please see Instructions for Use |
| B. Establishment Registration Number: | 1225532 |
| Establishment Name & Address: | Hydrofera LLC322 Main StreetWillimantic 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 sameintended use as the predicate device:Ultrafera wound dressing(K964614)and Hydrofera Bacteriostatic Nasal Dressing(K983276) |
| G. Materials: | Hydrofera Bacteriostatic Wound Dressingsare comprised of absorbent polyvinyl alcoholPVA, free formaldehyde <5 ppm)MethyleneBlue(less than or equal to 0.00025 gr/gr) andCrystal Violet (less than or equal to0.00025gr/gr) |
| H. Sterility: | Hydrofera Bacteriostatic Wound Dressingswill be sterilized by either gamma orelectron beam radiation to an SAL 10-6. Theprocess will be followed in accordance withMethod I Bioburden and validated withsubsequent quarterly dose audits. |
| I. Packaging: | Each Hydrofera Bacteriostatic WoundDressing will be individually packaged in aMylar to Poly Tyvek (chevron) pouch. |
| J. S & E Summary: | Hydrofera LLC certifies that safety andeffectiveness information will be providedfor this marketed device upon request byinterested persons. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is presented in black and white.
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.
{2}------------------------------------------------
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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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)
N/A