(88 days)
Not Found
Not Found
No
The summary describes an absorbent dressing for hip arthroplasty and contains no mention of AI, ML, image processing, or any related concepts.
Yes
The device is an "absorbent dressing" used in "hip arthroplasty", indicating it is used for medical treatment or management of a disease/condition.
No
The provided text describes an "absorbent dressing" indicated for use in "hip arthroplasty." This device type is not typically used for diagnosis, but rather for wound care or protection during or after a surgical procedure.
No
The 510(k) summary describes an "absorbent dressing," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in hip arthroplasty." This describes a surgical procedure performed on a patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or instruments to perform tests on biological samples.
An absorbent dressing used in surgery is a medical device, but it functions in vivo (within the body during the procedure) and is not used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The absorbent dressing is indicated for use in hip arthroplasty.
Product codes
EFQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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