(116 days)
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Not Found
No
The summary describes a passive dressing with no mention of computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended to treat or alleviate a disease, injury, or wound by absorbing exudate, maintaining a moist hypertonic environment to support autolytic debridement, and is indicated for various types of wounds, including ulcers and surgical incisions.
No
The device is a dressing intended for wound care, absorption of exudate, and maintaining a moist environment to support wound healing. It does not perform any diagnostic functions.
No
The device description clearly states it is a "dry dressing impregnated with crystalline seawater salt," indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Thalafix Natural Sea-Salt Dressing is a wound dressing applied directly to the body's surface.
- IVDs are used to provide information about a physiological state, health, or disease. This dressing is used to manage wounds by absorbing exudate and creating a specific environment, not to diagnose or provide information about a patient's internal condition.
- The description focuses on the physical properties and application of the dressing to a wound. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Thalafix Natural Sea-Salt Dressing falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
Product codes
KMF
Device Description
The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1998
Sharmini Atheray Dumex Medical Surgical Products, LTD 104 Shorting Road Scarborough, Ontario M1S3S4
K980779 Re: Trade Name Thalafix Natural Sea Salt Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 10, 1998 Received: June 11, 1998
Dear Sharmini Atheray:
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 2. 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 4. 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
1
Page 2 - Sharmini Atheray
registration, listing of devices, good manufacturing practices, 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 (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.
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
FDA CDRH ODE
9
of
Page
Form B
Indications for Use Form
510(k) Number (if known): と 980ママ 9
Device Name: Dhalafix Natural dea Palt
Indications for Use:
The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
storative Devices
Reply Number 2980779