(66 days)
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
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.
The provided text is a 510(k) summary for a wound dressing (IALUSET® HYDROCOLLOID). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set size, ground truth for training set) are not applicable to this type of device and submission.
The "acceptance criteria" for this device are essentially demonstrating substantial equivalence to existing legally marketed predicate devices in terms of composition, intended use, and technological characteristics, along with biocompatibility.
Here's an attempt to extract relevant information given the limitations of the provided document:
Acceptance Criteria and Device Performance (IALUSET® HYDROCOLLOID)
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices, supported by non-clinical biocompatibility data. The performance is compared feature-by-feature to predicate devices rather than against numerical thresholds for efficacy.
| Characteristic | Acceptance Criterion (Substantial Equivalence to Predicate) | Reported Device Performance (IALUSET® HYDROCOLLOID) |
|---|---|---|
| Composition | Similar hydrocolloid and polyurethane film structure as predicate devices. | Hydrocolloid plus Polyurethane Film (same as predicates) |
| Surface | Similar extruded & laminated surface as predicate devices. | Extruded & Laminated (same as predicates) |
| Indication for Use | Similar range of wound types as predicate devices (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 (same as predicates). Expanded list in official indications for use includes abrasions, lacerations, minor cuts, minor scalds, leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, traumatic wounds. |
| Transparency | Transparent like predicate devices. | Yes (same as predicates) |
| Self-Adhesive | Self-adhesive like predicate devices. | Yes (same as predicates) |
| Sterilization Method | Gamma Irradiation like predicate devices. | Gamma Irradiation (same as predicates) |
| Biocompatibility | No untoward responses in standard biocompatibility tests (Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, Genotoxicity) compared to vehicle control. | No untoward responses, except for evidence of cytotoxicity in the L929 murine fibroblast assay at the two highest concentrations tested (attributed to osmotic effect). The overall conclusion was that extracts were not found to elicit untoward responses. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to existing devices and non-clinical biocompatibility testing, not a test set of patient data to evaluate an algorithm's performance. The biocompatibility tests would have their own sample sizes for in vitro or in vivo models, but these are not specified in the summary.
Data Provenance (Biocompatibility): The document does not specify the country of origin for the biocompatibility test data. The tests are standard biological evaluation tests (Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames)), typically performed in a laboratory setting. The study appears to be non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI algorithm requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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 document is for a wound dressing, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used
For the biocompatibility testing, the "ground truth" would be the established biological responses (e.g., absence of irritation, non-mutagenicity) as determined by validated laboratory assays and compared against control samples. For substantial equivalence, the "ground truth" is the established characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable.
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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
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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 | IALUSETHYDROCOLLOID | ConvaTec(K881050) | Innovative Technologies(K971126) |
|---|---|---|---|
| Composition | Hydrocolloid plusPolyurethane Film | Hydrocolloid plusPolyurethane Film | Hydrocolloid plusPolyurethane 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.
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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.
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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
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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
N/A