(66 days)
No
The device description and performance studies focus on the material composition and physical properties of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the treatment of various wounds, including abrasions, lacerations, burns, and ulcers, which directly implies a therapeutic function.
No
The device description indicates that IALUSET HYDROCOLLOID is a wound dressing that absorbs exudate to promote healing, and its intended use is for treating various types of wounds. It does not perform any diagnostic function such as detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a wound dressing comprised of physical materials (hydrocolloids, polyurethane film, silicone release liner) and is applied to wounds, indicating it 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 clearly describes the application of the device to various types of wounds (abrasions, cuts, burns, ulcers, surgical wounds, traumatic wounds). This is a direct application to the body for therapeutic purposes (wound healing).
- Device Description: The device is described as a wound dressing that absorbs exudate and creates a moist environment for healing. This is a physical barrier and absorbent material applied externally.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are used in vitro (outside the body) to perform these diagnostic tests.
The device is a wound dressing, which falls under the category of medical devices used for treatment and management of wounds, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:
- abrasions
- lacerations
- minor cuts
- minor scalds
- minor burns
Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to: - leg ulcers (venous stasis ulcers, arterial ulcers)
- diabetic ulcers
- pressure ulcers (stage I IV)
- surgical wounds (postoperative, dermatological excisions, donor sites)
- burns (first and second degree only)
- traumatic wounds
Product codes
FRO
Device Description
IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.
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
"IALUSET HYDROCOLLOID may be applied to minor wounds such as abrasions. lacerations, cuts, scalds, or burns by a patient not under the care of a health care professional, and if under the care of a health care professional, it may be applied to leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, first and second degree burns, and traumatic wounds."
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)
Non-Clinical Performance Data: Extracts of IALUSET HYDROCOLLOID were evaluated in five standard biocompatibility test systems: Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames). Except for evidence of cytotoxicity in the L929 murine fibroblast assay at the two highest concentrations tested, presumably due to an osmotic effect, IALUSET HYDROCOLLOID extracts were not found to elicit any untoward responses as compared to a vehicle control.
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
Not Found
N/A
0
510(K) SUMMARY
MAR 1 4 2002
Submitter's Name, Address, and Phone/Fax Numbers
Institut Biochimique SA (IBSA) Via Del Piano P.O. Box 266 CH-6915 Pambio-Noranco Switzerland +41 91 985 76 76 (phone) +41 91 985 76 77 (fax)
Contact Person
Clarence Jones, Ph.D. 8602 Mossford Drive Huntington Beach, CA 92646
Date 510(k) Summary Prepared
January 4, 2002
Name of the Device
Trade Name: IALUSET® HYDROCOLLOID Common Name: Hydrocolloid Wound Dressing Classification Name: Dressing, Wound and Burn, Occlusive (878.4020)
Predicate Device
IALUSET HYDROCOLLOID is substantially equivalent to two other hydrocolloid wound dressings, one from ConvaTec (K881050) and the other from Innovative Technologies (K971126).
Device Description
IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.
Intended Use
IALUSET HYDROCOLLOID may be applied to minor wounds such as abrasions. lacerations, cuts, scalds, or burns by a patient not under the care of a health care
ﻠﺴﺴ
1
professional, and if under the care of a health care professional, it may be applied to leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, first and second degree burns, and traumatic wounds. If a patient is unsure of the type of wound he or she has, they should consult with a health care professional before using this product.
| Characteristic | IALUSET
HYDROCOLLOID | ConvaTec
(K881050) | Innovative Technologies
(K971126) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Hydrocolloid plus
Polyurethane Film | Hydrocolloid plus
Polyurethane Film | Hydrocolloid plus
Polyurethane Film |
| Surface | Extruded & Laminated | Extruded & Laminated | Extruded & Laminated |
| Indication for Use | Superficial Wounds,
Dermal Ulcers,
Burns (1st & 2nd Degree),
Donor Sites,
Postoperative Wounds,
Protective Dressings | Superficial Wounds,
Dermal Ulcers,
Burns (1st & 2nd Degree),
Donor Sites,
Postoperative Wounds,
Protective Dressings | Superficial Wounds,
Dermal Ulcers,
Burns (1st & 2nd Degree),
Donor Sites,
Postoperative Wounds,
Protective Dressings |
| Transparent | Yes | Yes | Yes |
| Self Adhesive | Yes | Yes | Yes |
| Packaging | Blister Pack | Pouch | Blister Pack |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
Technological Characteristics in Comparison to Predicate Device
Non-Clinical Performance Data
Extracts of IALUSET HYDROCOLLOID were evaluated in five standard biocompatibility test systems: Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames). Except for evidence of cytotoxicity in the L929 murine fibroblast assay at the two highest concentrations tested, presumably due to an osmotic effect, IALUSET HYDROCOLLOID extracts were not found to elicit any untoward responses as compared to a vehicle control.
Conclusions
IALUSET HYDROCOLLOID is substantially equivalent to other hydrocolloid wound dressings.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes, suggesting movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Institut Biochimique SA c/o Clarence E. Jones, Ph.D. 8602 Mossford Drive Huntington Beach, CA 92646
Re: K020041
Trade/Device Name: Ialuset® Hydrocolloid Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 4, 2002 Received: January 7, 2002
Dear Dr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Clarence E. Jones, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE FORM
510(k) Number: _ K 0 2 0 0 41
Device Name: IALUSET® HYDROCOLLOID Wound Dressing
Indications for Use:
For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:
- abrasions ●
- lacerations .
- minor cuts ●
- minor scalds ●
- minor burns .
Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:
- leg ulcers (venous stasis ulcers, arterial ulcers) .
- diabetic ulcers .
- pressure ulcers (stage I IV) ●
- surgical wounds (postoperative, dermatological excisions, donor sites) .
- burns (first and second degree only) .
- traumatic wounds ●
Miriam C. Provost
Division of General, Restorative and Neurological Devices
KO20041 510(k) Number -
Concurrence of Office of Device Evaluation, Center for Devices and Radiological Health
Prescription Use:
Over-the-Counter Use
Institut Biochimique SA (IBSA) Pambio-Noranco, Switzerland