HYDROFERA FEMORAL WICK
Device Facts
| Record ID | K974316 |
|---|---|
| Device Name | HYDROFERA FEMORAL WICK |
| Applicant | Hydrofera, LLC |
| Product Code | EFQ · SU |
| Decision Date | Feb 13, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Indications for Use
The absorbent dressing is indicated for use in hip arthroplasty.
Device Story
Hydrofera Femoral Wick is an absorbent dressing used in the context of hip arthroplasty. The device is applied by clinicians in a surgical or clinical setting to manage wound exudate. It functions as a passive absorbent material to facilitate wound care post-procedure. The device aids in maintaining a clean wound environment, potentially benefiting the patient by supporting healing and managing fluid accumulation at the surgical site.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Absorbent dressing material. Form factor is a wick designed for femoral application. Non-active device.
Indications for Use
Indicated for use in patients undergoing hip arthroplasty.
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Ms. Heather S. Bond Director Hydrofera, LLC 322 Main Street, Suite 1101 Willimantic, Connecticut 06226
Re: K974316 Trade Name: Hydrofera Femoral Wick Regulatory Class: Unclassified Product Code: EFQ Dated: October 22, 1997 Received: November 17, 1997
Dear Ms. Bond:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542
{1}------------------------------------------------
Page 2 - Ms. Bond
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
14:00
## Indication for use
510 (k) Number (if known): k974316
Device Name: Femoral wick
Indications for Use: The absorbent dressing is indicated for use in hip arthroplasty.
Concurrence of CDRH, Office of Device Evaluation(ODE)
**Prescription Use**
**(Per 21 CFR 801.109)**
Paoilo
(Division an-Off) Divisini Seneral Restorative Devices 1974316 510(k) Number
