Who is the manufacturer of IODOFOAM IODOPHOR FOAM DRESSING?

Progressive Wound Care Technologies, LLC filed the 510(k) submission for IODOFOAM IODOPHOR FOAM DRESSING (K122634).

What is the FDA product code for IODOFOAM IODOPHOR FOAM DRESSING?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for IODOFOAM IODOPHOR FOAM DRESSING?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IODOFOAM IODOPHOR FOAM DRESSING?

Iodosorb® Gel (K905069); Iodoflex® Pads (K940414).

Who can help prepare an FDA 510(k) submission like IODOFOAM IODOPHOR FOAM DRESSING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IODOFOAM IODOPHOR FOAM DRESSING

K122634 · Progressive Wound Care Technologies, LLC · FRO · Mar 12, 2013 · SU

Device Facts

Record ID	K122634
Device Name	IODOFOAM IODOPHOR FOAM DRESSING
Applicant	Progressive Wound Care Technologies, LLC
Product Code	FRO · SU
Decision Date	Mar 12, 2013
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

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.

Device Story

Iodofoam® is a sterile, single-use, absorptive polyvinyl alcohol (PVA) foam dressing complexed with 8% (w/w) iodine. Used in clinical settings for wound management, the device is applied by a healthcare provider to the wound surface. It functions by absorbing wound exudate, debris, and loose slough while simultaneously releasing iodine to provide an antimicrobial effect. The dressing acts as a protective, moist environment for healing. As the foam absorbs fluid and the iodine is depleted, the dressing changes color from blue/black to off-white, signaling the need for a dressing change. The non-adherent nature of the PVA foam is intended to reduce pain and trauma during removal, potentially improving patient compliance.

Clinical Evidence

Bench testing only. In vitro study compared iodine release profiles of Iodofoam® to predicates in distilled water at 37°C over 12 hours; results showed reproducible release bracketed by predicate profiles. Biocompatibility testing (ISO 10993) showed cytotoxicity failure, consistent with predicate devices. Follow-up in vivo porcine wound healing model demonstrated no significant difference in healing time or incidence compared to predicates or PVA controls, and the device was non-reactive/non-sensitizing in ISO intracutaneous and guinea pig maximization tests.

Technological Characteristics

Hydrophilic PVA foam dressing; 8% (w/w) iodine complex; sterile, single-use. Dimensions/form factor not specified. Standalone device. Biocompatibility per ISO 10993. Mechanism: passive absorption of exudate and controlled release of iodine.

Indications for Use

Indicated for cleaning wet ulcers and wounds, including diabetic, pressure, arterial, and venous stasis ulcers, as well as infected traumatic or surgical wounds and burns.

Predicate Devices

Iodosorb® Gel (K905069)
Iodoflex® Pads (K940414)

Related Devices

K140954 — LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING · Huizhou Foryou Medical Devices Co., Ltd. · Mar 23, 2015
K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING · Hydrofera, LLC · Jan 2, 2014
K190819 — Silicone PHMB Foam Wound Dressing · Advanced Medical Solutions, Ltd. · Jul 25, 2019
K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE · Convatec, Inc. · Jun 6, 2013
K190730 — IODOSORB · Smith & Nephew Medical, Ltd. · Dec 20, 2019

Submission Summary (Full Text)

{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 Page 1 of 1