(90 days)
Not Found
Not Found
No
The device description and intended use are for a transparent dressing, and there is no mention of AI or ML in the provided text.
No
The device is a dressing used to cover and protect wounds and secure devices, creating a moist environment for healing, which is a supportive rather than directly therapeutic function.
No
The device is a transparent dressing used to cover and protect wounds and secure devices to the skin, not to diagnose a medical condition.
No
The device is a physical dressing made of polyurethane film and adhesive, 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 device as a dressing for covering and protecting wounds and catheter sites, creating a moist environment for healing, and securing devices to the skin. These are all external applications and do not involve testing samples taken from the body (in vitro).
- Device Description: The device description details the physical components of the dressing (polyurethane film, adhesive). It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Indicators: 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the 3M Tegaderm Transparent Dressing is a medical device used for wound care and securing other devices, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist environment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facilitate autolytic debridement. Common applications include: IV catheters, other intravascular catheters and percutaneous devices, clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, superficial wounds such as abrasions, skin tears, and blister, first and second degree burns, chafed skin or skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels, protective eye covering during surgery or for patients with corneal abrasions.
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
3M Tegaderm™ Transparent Dressing consists of a thin, polyurethane film backing with a hypoallergenic, acrylate, pressure sensitive adhesive. The dressing is transparent and possess good oxygen and moisture vapor permeability and yet is impermeable to liquids and bacteria
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)
No product data submitted; this submission is seeking deletion of a contraindication/warning from current labeling and relied on known literature, lack of conclusive clinical studies, CDC Guidelines for Prevention of Intravascular Device-Related Infections, and FDA guidance as support for the proposed deletion. All data supplied in previous 510(k)s are not changed and are applicable to this 510(k).
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
NOV 1 2 1997
510(k) Summary of Safety and Effectiveness
・・
| Manufacturer: | 3M Medical Products Division
3M Center
St. Paul, Minnesota 55133 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs
Contact: | Karen C. Holmen
Regulatory Affairs Specialist
3M Medical Products Group
3M Center 275-3E-08
P.O. Box 3275
St. Paul, Minnesota 55133-3275 |
| Telephone: | (612) 736-1031 |
| Date Summary
Prepared: | 7/25/97 |
| Product Trade Name: | 3M Tegaderm™ Transparent Dressing (original frame style and
easy application frame style)
3M Tegaderm™ Transparenet Dressing (First Aid Delivery)
3M Tegaderm™ HP Transparent Dressing
3M Tegaderm™ Transparent I.V. Dressing |
| Common Name: | Wound dressing, IV Secural dressing |
| Classification: | Intravascular catheter securement device, wound dressings, and/or
protective eye covering, Class I. |
| Predicate Devices: | 3M Tegaderm Transparent Dressings mentioned above, Op-SiteR Transparent Permeable Membrane, OpSiteR I.V. 3000
Bioclusive™ Transparent Dressing, Transeal™ Transparent
Dressing, Conmed Veni-Gard® Dressing, Pro-Clude® Transparent
Wound Dressing, Polyskin® M.R. Moisture Responsive
Transparent Dressing |
| Description: | 3M Tegaderm™ Transparent Dressing consists of a thin,
polyurethane film backing with a hypoallergenic, acrylate, pressure
sensitive adhesive. The dressing is transparent and possess good
oxygen and moisture vapor permeability and yet is impermeable to
liquids and bacteria |
| Intended Use: | 3M Tegaderm™ Transparent Dressings can be used over a variety
of IV catheters and other devices, for wound management and as a
protective eye covering. Tegaderm HP dressing provides stronger
adhesion, particularly in problem areas. The later was designed to
stay on even longer and help reduce unscheduled dressing changes
in challenging situations, e.g. diaphoretic patients, conditions of
high humidity, febrile patients, any high moisture-prone areas for
venous catheterization, such as the jugular area, and difficult-to-
dress wound areas (sacral). |
| Substantial
Equivalence: | This 510(k) proposed to delete a warning on current labeling for
3M Tegaderm™ Transparent Dressings, specifically, the warning
regarding its use over arterial catheter sites. Neither literature,
clinical studies, CDC guidelines for the Prevention of Intravascular
Device-Related Infections, nor FDA Device Labeling Guidance re
the use of Precautions, Warnings or Contraindications support such
a warning. Furthermore, 3M Tegaderm Transparent Dressings are
substantially equivalent to other standard transparent dressings on
the market, none of which contraindicate or warn against use over
arterial catheter sites at this time, as evidenced by labeling
presented in this submission.
Note: The term "substantial equivalence" is used only in the
context of 21 CRF Part 807, Subpart E (Premarket Notification
Procedures). |
| Summary of Testing: | No product data submitted; this submission is seeking deletion of a
contraindication/warning from current labeling and relied on known
literature, lack of conclusive clinical studies, CDC Guidelines for
Prevention of Intravascular Device-Related Infections, and FDA
guidance as support for the proposed deletion. All data supplied in
previous 510(k)s are not changed and are applicable to this 510(k). |
1
・・
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 12 1997
Ms. Karen C. Holmen Regulatory Affairs Specialist 3M Health Care 3M Center 275-3E-08 PO Box 3275 St. Paul, Minnesota 55133-3275
Re: K973036 3M™ Tegaderm™ Transparent Dressing Regulatory Class: Unclassified Product Code: MGP Dated: August 7, 1997 Received: August 14, 1997
Dear Ms. Holmen:
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.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- 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.
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.
3
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if Known): _ kg-1303636
3M™ Tegaderm™ Transparent Dressings Device Name:
Indications for Use:
NUV.
3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist enviroment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facilitate autolytic debridement. Common applications include: IV catheters, other intravascular catheters and percutaneous devices, clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, superficial wounds such as abrasions, skin tears, and blister, first and second degree burns, chafed skin or skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels, protective eye covering during surgery or for patients with corneal abrasions.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973036 |
| Prescription Use: (Per 21 CFR 801.109) | OR Over-the-Counter Use (Optional Format 1-2-96) |
|---|---|
| ---------------------------------------- | -------------------------------------------------- |