(329 days)
Not Found
Not Found
No
The description focuses on the physical properties and function of a wound dressing, with no mention of AI or ML.
Yes
The device aids in the healing process of wounds, which is a therapeutic function.
No
The device is described as a wound dressing pad designed to support healing, absorb exudate, and protect wounds. Its function is therapeutic and protective, not diagnostic.
No
The device is described as a multi-layer wound dressing pad with a super-absorbent polymer, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of Medline TenderWet™ clearly indicate it is a wound dressing applied externally to the body to manage wounds. It does not involve testing samples taken from the body.
Therefore, Medline TenderWet™ falls under the category of a wound care device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding partial and full thickness wounds such as: First and second degree burns, superficial injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. Medline TenderWet™ should be used under direction of a health care professional for Stage I-IV Pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology. Medline TenderWet™ may be used to condition wound sites prior to skin transplants.
Product codes
MGQ
Device Description
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professional (for specific indications)
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)
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 U.S. Department of Health and Human Services. 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 presented in black and white, emphasizing its official and formal nature.
Public Health Service
APR 1 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060
K991755 Re:
Trade Name: TenderWet™ Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: February 24, 2000 Received: February 25, 2000
Dear Ms. Simmons:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Lara N. Simmons
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 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 device, 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,
Donna R. Lochner.
( 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
Page 1
510(k) Number (if known): K99)イらら
Device Name: Medline TenderWet™ Wound Dressing
Indications For Use:
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding partial and full thickness wounds such as: First and second degree burns, superficial injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. Medline TenderWet™ should be used under direction of a health care professional for Stage I-IV Pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology. Medline TenderWet™ may be used to condition wound sites prior to skin transplants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | Damon P. Vochner | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number K991755 | ||
| Prescription Use | ||
| (Per 21 CFR 801.109) | X OR | Over-The-Counter Use |
(Optional Format 1-2-96)