(274 days)
Not Found
No
The description focuses on the chemical and physical properties of the wound dressing material and does not mention any computational or algorithmic components.
Yes
The "Intended Use / Indications for Use" section explicitly states that IODOSORB is "indicated for use in managing wet ulcers and wounds" and "assists in wound area protection and in reducing the microbial load." These described actions clearly indicate its therapeutic purpose.
No
The device, IODOSORB, is described as a treatment for wounds, aiming to manage wet ulcers, reduce microbial load, and protect the wound area. Its function is therapeutic, not diagnostic, as it does not identify diseases or conditions.
No
The device description clearly states it consists of physical beads made of cadexomer and iodine, which are hardware components, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of IODOSORB is for managing wet ulcers and wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical composition and mechanism of action of the beads in the wound. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, IODOSORB is a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IODOSORB is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOSORB assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
IODOSORB consists of 0.1mm diameter biodegradable spherical hydrophilic beads of cadexomer which incorporate 0.9% weight per weight iodine mixed with polyethylene glycols and poloxamer. The beads are composed of a three dimensional network of macromolecular chains of cross-linked cadexomer which is large enough to allow substances with a molecular weight of less than 1,000 to enter freely. As with all products having these characteristics, substances with a molecular weight of 1000 - 5000 enter the beads less freely, while those with a molecular weight greater than 5000 remain in the interspaces between the beads.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
Smith & Nephew Medical Ltd. Ana Castillo Senior Regulatory Affairs Specialist 101 Hessle Road Hull East Riding of Yorkshire, HU3 2BN GB
Re: K190730
Trade/Device Name: IODOSORB Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2019 Received: October 2, 2019
Dear Ana Castillo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190730
Device Name IODOSORB
Indications for Use (Describe)
IODOSORB is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOSORB assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.
Type of Use (Select one or both, as applicable) | |
---|---|
X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(k) Owner: | Smith + Nephew Medical Ltd
101 Hessle Road
Hull East Riding Of Yorkshire,
UNITED KINGDOM HU3 2BN |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 12, 2019 |
| Submitted by (Contact
Person): | Ana Castillo, Regulatory Affairs Specialist II, AWM
Smith + Nephew, Inc.
T (817) 916-1441
F (817) 302-3983 |
| Name of Device: | IODOSORB° |
| Common Name: | Beads, Hydrophilic, For Wound Exudate Absorption |
| Device Classification
Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Panel Code: | General & Plastic Surgery |
| Product Code: | FRO |
| Predicate Device: | IODOSORB GEL- K905069
The predicate devices have not been subject to a design
related recall. |
510(K) SUMMARY
4
Device Description:
IODOSORB consists of 0.1mm diameter biodegradable spherical hydrophilic beads of cadexomer which incorporate 0.9% weight per weight iodine mixed with polyethylene glycols and poloxamer. The beads are composed of a three dimensional network of macromolecular chains of cross-linked cadexomer which is large enough to allow substances with a molecular weight of less than 1,000 to enter freely. As with all products having these characteristics, substances with a molecular weight of 1000 - 5000 enter the beads less freely, while those with a molecular weight greater than 5000 remain in the interspaces between the beads.
Indications for Use
IODOSORB is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOSORB assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable
Comparison of Technological Characteristics with the Predicate Device
No changes have been made to the product other than labeling changes (e.g. contraindications, precautions/warnings). As the changes to the labeling do not affect the product performance, the product remains substantially equivalent to the predicate device.