(195 days)
Not Found
No
The device description and performance studies focus on the material properties and iodine release mechanism of the foam dressing, with no mention of AI or ML.
Yes
The device aids in cleaning, absorbing exudate, and releasing iodine to kill bacteria in wounds, which directly contributes to healing and managing various types of ulcers and wounds, thus serving a therapeutic function.
No
The device is a wound dressing designed for cleaning and absorbing fluids from wounds, not for diagnosis. While it changes color to indicate iodine depletion, this is a functional indicator of the dressing's state, not a diagnosis of the patient's condition.
No
The device description clearly states it is a sterile, single-use absorptive foam dressing made of polyvinyl alcohol (PVA) foam complexed with iodine. This 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 states that the Iodofoam® Iodophor Foam Dressing is for use in "cleaning wet ulcers and wounds." This is a direct application to the patient's body for therapeutic purposes (wound care).
- Device Description: The description details a dressing that absorbs fluids, removes debris, and releases iodine to kill bacteria in the wound dressing. This is a topical treatment applied to the wound itself.
- Lack of In Vitro Testing for Diagnosis: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any testing of patient specimens or any diagnostic claims. The performance studies described are related to the device's properties (iodine release) and its effect on wound healing in an animal model, not diagnostic testing of human samples.
In summary, the Iodofoam® Iodophor Foam Dressing is a wound care product applied directly to the body for treatment, not a device used to test specimens outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Product codes
FRO, KOZ
Device Description
Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted.
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
In distilled water under agitation at 37°C, an independent in vitro study was conducted to compare the iodine release profiles of Iodofoam® to the predicate devices Iodosorb® and Iodoflex®. The cumulative release of iodine (in ppm) was recorded every hour for a 12 hour duration. Both average profiles and lot specific profiles were assessed for three independent lots of each device. The results demonstrated that the cumulative release of iodine over time was reproducible between lots, and well controlled for all three devices. The cumulative release of iodine from Iodofoam® was fully bracketed between the predicate profiles of Iodoflex® and Iodosorb® at all time points. This study demonstrated the substantial equivalence of Iodofoam® to the predicate devices for reproducibility of iodine release and cumulative iodine release over time.
Biocompatibility testing (per ISO 10993) performed on the device demonstrated that the device is safe for the indications of use. Iodofoam as well as the iodine based predicates Iodosorb® Gel and Iodoflex® all failed the Cytotoxicity testing. The significance of this finding was further evaluated in an in vivo porcine wound healing model. In this study, application of Iodofoam was not found to delay the time to or incidence of wound healing. No significant differences between Iodofoam®, Iodoflex® and PVA controls were found. In addition, Iodofoam® was found to be non-reactive and non-sensitizing by ISO Intracutaneous Reactivity and ISO Guinea Pig Maximization testing, respectively.
Key Metrics
Cumulative Iodine release (in vitro at 12 hours): 255 ppm
Iodine Dose (per cm² wound area): 1.8 mg (per label)
Cytotoxicity (ISO): Fail
In Vivo Histology: No Aberration
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
1122634
| Submitter:
Progressive WoundCare Technologies | Iodofoam® Iodophor Foam Dressing
Premarket Notification: Traditional 510(k) |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | |
| Submitter Name: | Progressive Wound Care Technologies, LLC |
| Submitter Address: | 125 Busbridge Cove
Pooler, Georgia 31322 |
| Phone Number:
Fax Number: | 912-201-8138
877-329-0079 |
| Contact Person: | Mason Diamond, DDS
Texel Fortis, LLC
150 Levinberg Lane
Wayne, NJ 07470
Phone: 508-333-0108
Fax: 973-305-0213 |
| Date Prepared: | 7 March, 2013 |
| Device Trade Name: | Iodofoam® Iodophor Foam Dressing |
| Common Name | Hydrophilic wound dressing |
| Classification Name,
Number and
Product Code:
Subsequent Product
Code: | Dressing, Wound, Drug
Unclassified
FRO
KOZ |
lodosorb® Gel (Perstorp AG) (KOZ): K905069 Predicate Devices: lodoflex® Pads (Oclassen) (KMF): K940414
lodofoam ® is a sterile, single use absorptive foam dressing Device Description consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, lodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted
The lodofoam® lodophor Foam Dressing is indicated for use in Statement of cleaning wet ulcers and wounds, including diabetic ulcers, Indications for Use . pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Section 5.0: 510(k) Summary
1
Summary of Technological Characteristics lodofoam® is designed to be highly absorbent while providing a protective, moist wound healing environment. As a hydrophilic foam dressing, lodofoam® absorbs significantly more fluid than it's original weight. As an iodophor, lodofoam® slowly releases iodine as wound fluid is absorbed. Depending upon exudate levels, iodine is released slowly for up to 24-72 hours.
When the foam is saturated with exudate repeatedly. and all iodine is released, the blue/black color of lodofoam® changes to off-white. This is an indication to change the lodofoam® dressing. lodofoam may help promote wound healing by:
- Effectively removing exudate and debris from the . wound bed, and
- Providing a moist wound healing environment. .
In addition, the non-adherent PVA foam may also reduce pain and trauma during dressing changes, thereby encouraging patient compliance.
In distilled water under agitation at 37°C, an independent in vitro study was conducted to compare the iodine release profiles of lodofoam® to the predicate devices lodosorb® and lodoflex®. The cumulative release of iodine (in ppm) was recorded every hour for a 12 hour duration. Both average profiles and lot specific profiles were assessed for three independent lots of each device. The results demonstrated that the cumulative release of iodine over time was reproducible between lots, and well controlled for all three devices. The cumulative release of iodine from lodofoam® was fully bracketed between the predicate profiles of lodoflex® and lodosorb® at all time points. This study demonstrated the substantial equivalence of lodofoam® to the predicate devices for reproducibility of iodine release and cumulative iodine release over time.
Biocompatibility testing (per ISO 10993) performed on the device demonstrated that the device is safe for the indications of use. lodofoam as well as the iodine based predicates lodosorb® Gel and lodoflex® all failed the Cytotoxicity testing. The significance of this finding was further evaluated in an in vivo porcine wound healing model. In this study, application of lodofoam was not found to delay the time to or incidence of No significant differences between lodofoam®, wound healing. lodoflex® and PVA controls were found. In addition, lodofoam® was found to be non-reactive and non-sensitizing by ISO Intracutaneous Reactivity and ISO Guinea Pig Maximization testing, respectively.
2
| Submitter: |
|---|
| Progressive WoundCare Technologies |
.
| Substantial
Equivalence | lodofoam ® lodophor Foam Dressing device is substantially
equivalent to the predicates, lodosorb® Gel (K905069) and
lodoflex® Pads (K940414), with respect to technical and design
features. The submitted device poses no new questions about
safety or effectiveness as compared to the predicate devices. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The information discussed above demonstrates that the
lodofoam® lodophor Foam Dressing device is substantially
equivalent to the predicate devices. |
| Declarations | • This summary includes only information that is also covered in
the body of the 510(k).
• This summary does not contain any unsubstantiated labeling
claims.
• This summary does not contain any raw data, i.e., contains
only summary data.
• This summary does not contain any trade secret or confidential
commercial information.
• This summary does not contain any patient identification
information. |
.
ﻟﮯ
3
Summary of Substantial Equivalence
| Feature | Iodofoam®
Iodophor Foam Dressing | Iodosorb Gel
(Perstorp AG) | Iodoflex® Pads
(Oclassen) |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| 510(k) Number | K122634 | K95069 | K940414 |
| Class | Unclassified | | |
| Classification | Dressing, Wound, Drug | Beads, Hydrophilic for
Wound Exudate
Absorption | Bandage, Liquid |
| Regulation | Pre-Amendment | 878.4018 | 880.5090 |
| Product Code(s) | FRO
KOZ | KOZ | KMF |
| Intended Use | The Iodofoam® Iodophor
Foam Dressing is indicated
for use in cleaning wet ulcers
and wounds, including
diabetic ulcers, pressure
ulcers, arterial ulcers, venous
stasis ulcers, and infected
traumatic or surgical wounds
and burns. | IODOSORB® Gel - For
use in cleaning wet
ulcers and wounds such
as venous stasis ulcers,
pressure sores, diabetic
foot ulcers, and infected
traumatic and surgical
wounds. | IODOFLEX® Pads - For use
in cleaning wet ulcers and
wounds such as venous
stasis ulcers, pressure
sores, diabetic foot ulcers,
and infected traumatic and
surgical wounds. |
| Dressing Material | PVA polymer | Modified Starch polymer | Modified Starch polymer |
| Antimicrobial
Agent | iodophor complex
(8% w/w iodine) | iodophor complex
(0.9% w/w iodine) | iodophor complex
(0.9% w/w iodine) |
| Cumulative Iodine
release
(in vitro at 12
hours) | 255 ppm | 200 ppm | 377 ppm |
| Iodine Dose
(per cm² wound
area) | 1.8 mg
(per label) | 3.0 to 6.0 mg
(per label) | 1.9 mg
(per label) |
| Cytotoxicity (ISO) | Fail | Fail | Fail |
| In Vivo Histology | No Aberration | Not Tested | No Aberration |
Section 5.0: 510(k) Summary
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol consists of three overlapping shapes that resemble a human figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002
Progressive Woundcare Technologies, LLC % Texel Fortis, LLC Mr. Mason Diamond Regulatory Consultant 150 Levinberg Lane Wayne, New Jersey 07470
March 12, 2013
Re: K122634
Trade/Device Name: Iodofoam® Iodophor Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 05, 2013 Received: February 07, 2013 ~
Dear Mr. Diamond:
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. Iisting 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.
5
Page 2 - Mr. Mason Diamond
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, FOR
Peter DERRumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K122634
Iodofoam® Iodophor Foam Dressing Device Name:
Indications for Use:
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122634
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