HYCURE

• K Number: K955506
• Device Name: HYCURE
• Manufacturer: THE HYMED GROUP CORP.
• Date Cleared: 1996-01-17 ( 47 days)
• Product Code: KGN
• Regulation Number: N/A

Intended Use

for the indications for use stated in the enclosure

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The provided 510(k) summary lacks detailed information about the device description, image processing, or any explicit mention of AI/ML terms. Without this information, it's impossible to determine if AI/ML is incorporated.

Therapeutic

No
The provided information does not contain a device description or any indication of a therapeutic function. The "Intended Use" refers to an enclosure that is not provided, and the "Predicate Device(s)" entry refers to devices marketed prior to May 1976, which offers no clarity on the current device's function.

Diagnostic

No
The provided text does not contain enough information to determine if the device is diagnostic. The "Intended Use / Indications for Use" section refers to an enclosure that is not provided, and there is no other descriptive information about the device's function.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, it is not possible to definitively determine if this device is an IVD.

Here's why:

• The "Intended Use / Indications for Use" section is the most crucial for determining if a device is an IVD. It states "for the indications for use stated in the enclosure". Without the content of this enclosure, we cannot see if the device is intended for the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease or other conditions. This is the core definition of an IVD.
• The other sections are "Not Found". While the absence of information about image processing, AI, anatomical site, etc., might suggest it's less likely to be a complex imaging-based IVD, it doesn't rule out other types of IVDs (e.g., a simple test kit).

To determine if this device is an IVD, you would need to review the "indications for use stated in the enclosure". If those indications involve testing human specimens for diagnostic or related purposes, then it is likely an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

(for the indications for use stated in the enclosure)

Product codes

KGN

Device Description

Not Found

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are connected to a wavy line at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

George D. Petito, Ph.D. President The Hymed Group Corporation 1890 Bucknell Drive Bethlehem, Pennsylvania 18015

K955506 Re: Trade Name: HYCURE™ Regulatory Class: Unclassified Product Code: KGN Dated: December 22, 1995 Received: December 28, 1995

Dear Dr. Petito:

This letter corrects our substantially equivalent letter of January 17, 1996.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 and the following limitations:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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4. 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).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I carrer agencies: "100 mm 11sting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device s rolly premainteted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. lelkersc Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health