(84 days)
Not Provided
Not Found
No
The device description and intended use focus on the chemical composition and physical properties of a gel for wound care. There is no mention of AI or ML in the provided text, and the performance studies are related to biocompatibility, not algorithmic performance.
Yes
The device is used for the softening and removal of dry necrosis in various types of wounds, which are conditions that require therapeutic intervention to promote healing.
No
Explanation: The device, Hypergel, is described as providing a moist wound environment for the softening and removal of dry necrosis in wounds. Its function is therapeutic (wound care), not diagnostic. It does not identify or detect a disease, condition, or health status.
No
The device description clearly states it is a sterile solution in amorphous gel form, composed of chemical ingredients and provided in aluminum tubes. This indicates a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing a moist wound environment to support autolytic debridement and the softening and removal of dry necrosis in various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and physical form of a gel applied to wounds. It does not describe any components or processes related to testing samples from the body (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analyte," "sample," "in vitro," etc.
- Anatomical Site: The anatomical site is external wounds, not internal bodily fluids or tissues used for diagnostic testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is applied directly to a wound for therapeutic effect.
N/A
Intended Use / Indications for Use
Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
Product codes
MGQ
Device Description
Hypergel® 20% Hypertonic Saline Gel is a sterile solution in amorphus gel form. Hypergel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
Hypergel® 20% Hypertonic Saline Gel represents a new formulation of Mölnlycke Health Care currently marketed Hypergel Protective Wound Gel product. This new formulation provides a higher viscosity.
Hypergel® 20% Hypertonic Saline Gel is provided in 5 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The biocompatibility of Hypergel have been determined when tested in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hypergel® - 20% Hypertonic Protective Wound Gel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) SUMMARY
Hypergel® - 20% Hypertonic Saline Gel
Applicant:
Mölnlycke Health Care 500 Baldwin Tower Eddystone, PA 19022
Proprietary Name:
Miguel A. Negron, Manager, Regulatory Affairs & Quality 610-499-3383 Tel.
Substantially Equivalent Device:
Contact Person:
Hypergel® - 20% Hypertonic Protective Wound Gel
Hypergel® 20% Hypertonic Saline Gel is a sterile solution in amorphus gel form. Hypergel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
Hypergel® 20% Hypertonic Saline Gel represents a new formulation of Mölnlycke Health Care currently marketed Hypergel Protective Wound Gel product. This new formulation provides a higher viscosity.
Hypergel® 20% Hypertonic Saline Gel is provided in 5 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
The biocompatibility of Hypergel have been determined when tested in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).
P. 8
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Miguel A. Negron Manager, Regulatory Affairs and Quality Mölynlycke Health Care 500 Baldwin Tower Eddystone, Pennsylvania 19022
Re: K984370
Trade Name: Hypergel® - 20% Hypertonic Saline Gel Regulatory Class: Unclassifed Product Code: MGQ Dated: December 4, 1998 Received: December 7, 1998
Dear Mr. Negron:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
2
Page 2 - Mr. Miguel A. Negron
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation-(21 CFR Part 820) and that, through periodic GMP 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.
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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/2 description: The image shows a series of handwritten characters, "K984370", in bold black ink. To the right of the characters, there is a smaller "P.7" also written in black ink. The characters are large and take up most of the image, while "P.7" is smaller and positioned in the upper right corner.
Indications for Use Statement Section 8:
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number: -
Mölnlycke Health Care
Device Name:
Hypergel® - 20% Hypertonic Saline Gel
Indications for Use:
Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
(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
Division Sign-Off)
Division of General Restorative Devices
510(k) Number 510(k) Number
Premarket Notification: Hypergel®
Mölnlycke Health Care