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.

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.

AI/ML Overview

I apologize, but the provided text from K984370 for Hypergel® - 20% Hypertonic Saline Gel does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.

The document is a 510(k) summary for a medical device. It focuses on:

Device Description: What the device is composed of and its intended function (providing a moist wound environment for autolytic debridement).
Substantial Equivalence: Comparing the device to a previously marketed predicate device (an earlier formulation of Hypergel). The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an existing one, meaning it's as safe and effective.
Biocompatibility: Stating that biocompatibility was determined according to ISO 10993.
Indications for Use: Listing the specific types of wounds for which the gel is recommended.
FDA Communication: The FDA's letter granting clearance, including specific limitations on labeling claims (e.g., not for third-degree burns, no claims of accelerating healing).

Missing Information:

The document does not include:

Acceptance Criteria or Reported Device Performance: There are no specific quantitative or qualitative criteria for how well the gel should perform (e.g., rate of debridement, reduction in wound size, time to healing) or any study data reporting such performance.
Study Details: Crucially, there is no mention of a clinical or analytical study, its design, sample size, data provenance, ground truth establishment, or expert involvement to prove the device meets any performance criteria.
MRMC, Standalone, Training Set Details: Since no performance study is described, these elements (MRMC, standalone, training set, etc.) are entirely absent.

Conclusion:

Based only on the provided text, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This is typical for a 510(k) summary, as it generally relies on demonstrating equivalence to an already approved device rather than presenting extensive new clinical efficacy data unless specifically required by the FDA. The biocompatibility testing mentioned is for safety, not for the clinical performance criteria you're asking about.

Summary

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K984370

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 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.
1. 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).

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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: -

K984370

Mölnlycke Health Care

Device Name:

Hypergel® - 20% Hypertonic Saline Gel

Indications for Use:

(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

Regulation Number and Section

N/A