(90 days)
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.
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
This 510(k) submission (K973036) for the 3M Tegaderm™ Transparent Dressing is focused on deleting a warning/contraindication regarding its use over arterial catheter sites, rather than introducing a new device or significantly altering the device's fundamental function. Therefore, the traditional format of acceptance criteria and device performance based on a new study is not applicable here.
The submission primarily relies on extant information and regulatory guidance to support the change in labeling.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the context of a new performance study for the device itself. Instead, the "acceptance criteria" for this 510(k) effectively revolve around the justification for removing the warning.
| Acceptance Criteria (for warning deletion) | Reported Device Performance/Justification |
|---|---|
| Lack of supporting literature for warning | "Neither literature, clinical studies, CDC guidelines... nor FDA Device Labeling Guidance re the use of Precautions, Warnings or Contraindications support such a warning." |
| No conclusive clinical studies supporting warning | "Neither... clinical studies... support such a warning." |
| CDC Guidelines for Prevention of Intravascular Device-Related Infections (no mention of arterial catheter warning) | "CDC guidelines for the Prevention of Intravascular Device-Related Infections... support such a warning." (Implicitly, the CDC guidelines do not support the warning, hence its proposed deletion). |
| FDA Device Labeling Guidance (no mention of arterial catheter warning) | "FDA Device Labeling Guidance re the use of Precautions, Warnings or Contraindications support such a warning." (Implicitly, the FDA guidance do not support the warning). |
| Substantial equivalence to other standard transparent dressings without such warning | "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." |
2. Sample Size Used for the Test Set and Data Provenance:
No new "test set" and corresponding sample size are mentioned for this particular 510(k) submission. The submission relies on existing knowledge and the absence of data supporting the warning. The data provenance would be a combination of:
- Retrospective analysis of existing literature and clinical studies.
- Prospective review of CDC guidelines and FDA guidance documents.
- Review of labeling from other commercially available transparent dressings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable to this submission. The "ground truth" here is the lack of evidence to support a warning, which is established through a review of existing scientific and regulatory documentation, rather than a new expert consensus on a test set.
4. Adjudication Method for the Test Set:
Not applicable, as no new test set or expert adjudication process is 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 is not an AI/imaging device submission, nor does it involve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
The "ground truth" used to justify the deletion of the warning is a combination of:
- Absence of supporting scientific literature/clinical studies.
- Compliance with established medical guidelines (CDC).
- Consistency with regulatory guidance (FDA).
- Market precedent (labeling of equivalent devices).
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning or AI algorithm development described.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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NOV 1 2 1997
510(k) Summary of Safety and Effectiveness
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| Manufacturer: | 3M Medical Products Division3M CenterSt. Paul, Minnesota 55133 |
|---|---|
| Regulatory AffairsContact: | Karen C. HolmenRegulatory Affairs Specialist3M Medical Products Group3M Center 275-3E-08P.O. Box 3275St. Paul, Minnesota 55133-3275 |
| Telephone: | (612) 736-1031 |
| Date SummaryPrepared: | 7/25/97 |
| Product Trade Name: | 3M Tegaderm™ Transparent Dressing (original frame style andeasy application frame style)3M Tegaderm™ Transparenet Dressing (First Aid Delivery)3M Tegaderm™ HP Transparent Dressing3M Tegaderm™ Transparent I.V. Dressing |
| Common Name: | Wound dressing, IV Secural dressing |
| Classification: | Intravascular catheter securement device, wound dressings, and/orprotective eye covering, Class I. |
| Predicate Devices: | 3M Tegaderm Transparent Dressings mentioned above, Op-SiteR Transparent Permeable Membrane, OpSiteR I.V. 3000Bioclusive™ Transparent Dressing, Transeal™ TransparentDressing, Conmed Veni-Gard® Dressing, Pro-Clude® TransparentWound Dressing, Polyskin® M.R. Moisture ResponsiveTransparent Dressing |
| Description: | 3M Tegaderm™ Transparent Dressing consists of a thin,polyurethane film backing with a hypoallergenic, acrylate, pressuresensitive adhesive. The dressing is transparent and possess goodoxygen and moisture vapor permeability and yet is impermeable toliquids and bacteria |
| Intended Use: | 3M Tegaderm™ Transparent Dressings can be used over a varietyof IV catheters and other devices, for wound management and as aprotective eye covering. Tegaderm HP dressing provides strongeradhesion, particularly in problem areas. The later was designed tostay on even longer and help reduce unscheduled dressing changesin challenging situations, e.g. diaphoretic patients, conditions ofhigh humidity, febrile patients, any high moisture-prone areas forvenous catheterization, such as the jugular area, and difficult-to-dress wound areas (sacral). |
| SubstantialEquivalence: | This 510(k) proposed to delete a warning on current labeling for3M Tegaderm™ Transparent Dressings, specifically, the warningregarding its use over arterial catheter sites. Neither literature,clinical studies, CDC guidelines for the Prevention of IntravascularDevice-Related Infections, nor FDA Device Labeling Guidance rethe use of Precautions, Warnings or Contraindications support sucha warning. Furthermore, 3M Tegaderm Transparent Dressings aresubstantially equivalent to other standard transparent dressings onthe market, none of which contraindicate or warn against use overarterial catheter sites at this time, as evidenced by labelingpresented in this submission.Note: The term "substantial equivalence" is used only in thecontext of 21 CRF Part 807, Subpart E (Premarket NotificationProcedures). |
| Summary of Testing: | No product data submitted; this submission is seeking deletion of acontraindication/warning from current labeling and relied on knownliterature, lack of conclusive clinical studies, CDC Guidelines forPrevention of Intravascular Device-Related Infections, and FDAguidance as support for the proposed deletion. All data supplied inprevious 510(k)s are not changed and are applicable to this 510(k). |
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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:
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- This device may not be labeled for use on third degree burns.
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- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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- 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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- 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.
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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
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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) |
|---|---|
| ---------------------------------------- | -------------------------------------------------- |
N/A