(75 days)
No
The summary describes a wound dressing made from calcium alginate and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is a wound dressing that aids healing by providing a moist environment and controlling bleeding, but it does not actively deliver therapy or treat a disease.
No
The device is described as a nonwoven dressing, intended for use on wounds. Its function is to absorb exudate and provide a moist wound environment, which is a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a nonwoven dressing made from calcium alginate, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device 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 (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description details the material and function of the dressing in contact with wound exudate. This aligns with a wound care product, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a wound care product, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Innovative Technologies Calcium Alginate dressings are intended for use under the supervison of health care professionals on moderate to heavy exudate wounds. They may be used for pressure ulcers, anorial ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, and other dermal lesions. For OTC use on abrasions, lacerations, minor cuts and grazes, minut scalds and minut burns. They also are intended to help control minor bleeding via the adsorbtive properties of the dressing or by the physical application of the dressing to the wound.
Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.
Product codes
KMF
Device Description
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterlle, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment. Use of any dressing, including Tegagon HC and HI alginate dressings, should be part of a well delined protocol for dermal wound managoment.
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
Under the supervision of health care professionals; Over The Counter Use
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)
Biocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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.
0
SEP 8 1998
K98 2234
Summary of Safety and Effectiveness for Innovative Technologies Calclum Alginate Dressing
Manufacturer:
Requiatory Affairs Contact:
Telephone:
Date Summary Prepared:
Device Trade Name:
Common or Usual Name:
Classification:
Description:
Intended Use:
Substantial Equivalence:
Testing Summary:
Innovative Technologies, I imitad Road Three, Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom
Chris Oakes, Manager
44 1606 863 500
June 18, 1998
Al-Gen Calcium Alginate Wound Dressings.
Alginate Wound Dressings
Wound Dressings, currently unclassified by FDA.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterlle, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment. Use of any dressing, including Tegagon HC and HI alginate dressings, should be part of a well delined protocol for dermal wound managoment,
Innovative Technologies Calcium Alginate dressings are intended for use under the supervison of health care professionals on moderate to heavy exudate wounds. They may be used for pressure ulcers, anorial ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, and other dermal lesions. For OTC use on abrasions, lacerations, minor cuts and grazes, minut scalds and minut burns. They also are intended to help control minor bleeding via the adsorbtive properties of the dressing or by the physical application of the
If at any time you are unsure of the above conditions or type of wound consult a health care professional.
dressing to the wound.
Substantial equivalence was provided in 510(k) K953781
Riocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data.
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/3 description: The image shows a partial view of a logo or emblem, likely from a document or publication. The visible portion includes stylized, thick, curved lines that appear to be part of a larger design. To the left, there is a partial word, possibly a department or organization name, oriented vertically.
SEP 8 1098
Mr. Christopher J. Oakes Regulatory Affairs Manager Innovative Technologies Group, Limited Road Three, Winsford Industrial Estate Winsford. Cheshire CW7 3PD United Kingdom
Re: K982234
Trade Name: Al- Gen Calcium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 19, 1998 Received: June 25, 1998
Dear Mr. Oakes:
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:
- 1 . 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.
2
Page 2 - Mr. Christopher J. Oakes
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,
f
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
3
Page 1 of 1
1982234 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device name: Innovative Technologies Calcium Alginate Dressings
Indications For Use:
Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg:
Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions
And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns.
They are also intended to help control minor bleeding.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| OR Over The Counter Use | |
| (Optional Format 1-2-96) | X |
(Sign-Off)
of General Restorative Devices
| 510(k) Number | K982234 |
|---|---|
| --------------- | --------- |