Normlyel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.

Device Description

Normlgel® 0.9% Isotonic Saline Gel is a sterile sodium chloride solution in amorphus gel form. Normlgel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Normigel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity. Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 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

The provided text describes a 510(k) submission for a medical device called Normlgel® 0.9% Isotonic Saline Gel. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided documents. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if the technological characteristics and intended use are similar.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

Not applicable / Not provided. The submission does not detail specific quantitative "acceptance criteria" for device performance in a clinical setting, nor does it report such performance metrics. The focus is on demonstrating "substantial equivalence" based on materials, formulation, and intended use compared to an existing device.
The biocompatibility testing mentioned ("in accordance with the ISO 10993 Part I") would have acceptance criteria for biological responses, but these are not explicitly detailed in terms of their thresholds or outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided for clinical performance. There is no indication of a "test set" in the context of clinical performance data. The device is a gel for wound care, and its substantial equivalence is based on its composition and intended use being similar to a predicate device.
Biocompatibility testing would involve in-vitro or in-vivo testing with a "sample size" of cells or animals, but these details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since there's no clinical "test set" described for performance evaluation, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical "test set" and thus no adjudication method are described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical gel, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As noted above, this is a medical gel, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical performance. The "ground truth" in a 510(k) for a device like this is primarily the established safety and efficacy of the predicate device (Normlgel® Protective Wound Gel in this case) and the scientific understanding of the ingredients and their function in wound care.
For biocompatibility, the ground truth would be defined by the ISO 10993 standards and accepted biological responses.

8. The sample size for the training set

Not applicable. This submission doesn't describe a "training set" in the context of machine learning or clinical trials.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

Summary of Acceptance/Equivalence Rationale from the Document:

The acceptance of Normlgel® 0.9% Isotonic Saline Gel by the FDA is based on its substantial equivalence to a previously marketed predicate device, Normlgel® Protective Wound Gel. Key points supporting this were:

Similar intended use: Both are indicated for protecting granulating wounds and maintaining a moist wound environment for various types of open wounds.
Similar composition: The new formulation is presented as an isotonic saline gel with similar base ingredients (water, sodium chloride, etc.) to the predicate. The primary difference noted is a "higher viscosity."
Biocompatibility: The device was tested in accordance with ISO 10993 Part I, demonstrating acceptable biocompatibility.
Safety and Effectiveness: The FDA's 510(k) clearance implies that, based on the provided information, the new device is as safe and effective as the predicate device for its stated indications, subject to certain labeling limitations imposed by the FDA (e.g., no claims for third-degree burns, accelerated healing, long-term dressing, or treatment/cure).

Summary

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*K984368

510(k) SUMMARY

Applicant:	Mölnlycke Health Care500 Baldwin TowerEddystone, PA 19022
Proprietary Name:	Normlgel® 0.9% Isotonic Saline Gel
Contact Person:	Miguel A. Negron, Manager, Regulatory Affairs & QualityTel. 610-499-3383
SubstantiallyEquivalent Device:	Normlgel® Protective Wound Gel

Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity.

Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 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 Normlgel 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).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

FEB 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Miguel A. Negron Manager, Regulatory Affairs and Quality Molnlycke Health Care 500 Baldwin Tower Eddystone. PA 19022

Re: K984368 Trade Name: Normlgel 0.9% Isotonic Saline Gel Regulatory Class: Unclassified 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.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of wound. 4.

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).

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.

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Page 2 - Mr. Miguel A. Negron

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 tollfree number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,
Neil K.P. Ogden for

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

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Indications for Use Statement Section 8:

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number:

K984368

Mölnlycke Health Care

Device Name:

Normigel® 0.9% Isotonic 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 (ODF.)

TKV

(Division Sign-Off)

Division of General Restorative Devices 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

N/A