(80 days)
Not Found
Not Found
No
The summary describes a transparent dressing for wound management and contains no mention of AI, ML, or related technologies.
Yes
The device is a dressing indicated for the management of moderately draining wounds, which is a therapeutic intervention.
No
Explanation: The device is indicated for the management of wounds, not for diagnosing them. It is a transparent dressing used for wound care.
No
The device description clearly states "Transparent Dressing," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the Giltech Plus Transparent Dressing as a wound dressing for managing various types of wounds. This is a topical application for wound care, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description simply states "Transparent Dressing," which aligns with a wound care product.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic or monitoring information
Therefore, the Giltech Plus Transparent Dressing falls under the category of a medical device for wound management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:
(a) Stage I and II pressure sores (decubitus ulcers)
(b) Skin tears or lacerations
(c) Superficial burns and abrasions
(d) Surgical wounds
Product codes
MGP
Device Description
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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): 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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Mr. William J. Giliam President Giltech Plus Company, Inc. P.O. Box 728 Milford, Pennsylvania 18337
3 1999
Re: K992005 Trade Name: Transparent Dressing Regulatory Class: Unclassified Product Code: MGP Dated: June 10, 1999 Received: June 15, 1999
Dear Mr. Gilliam:
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 – Mr. William J. Giliam
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.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
"INDICATIONS FOR USE"
Page _ 1 of of 1
510(k) Number (if known): K992005
Device Name: _Giltech Plus Transparent Dressing
Indications For Use:
The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:
(a) Stage I and II pressure sores (decubitus ulcers)
(b) Skin tears or lacerations
(c) Superficial burns and abrasions
(d) Surgical wounds
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Asteves
(Division Sign-Off)
Division of General Restorative Devices K992005
510(k) Number.
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OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)