(195 days)
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.
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
The medical device in question is the Iodofoam® Iodophor Foam Dressing. The study provided focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific performance acceptance criteria for a novel device.
The 510(k) summary provided indicates that the primary approach to establishing substantial equivalence for the Iodofoam® Iodophor Foam Dressing was through comparison to legally marketed predicate devices: Iodoflex® Pads (K940414) and Iodosorb® Gel (K905069).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a new device having to meet specific performance thresholds. Instead, it demonstrates that the Iodofoam® device's characteristics are "substantially equivalent" to two predicate devices. The study aimed to show that the new device's performance falls within the range or is comparable to existing, legally marketed devices for key characteristics.
The table below presents the comparative data points used to demonstrate substantial equivalence, which effectively serve as the "acceptance criteria" through a bracketing or comparability approach.
| Feature / Characteristic | Acceptance Criteria (Predicate Range/Comparability) | Reported Device Performance (Iodofoam®) |
|---|---|---|
| Cumulative Iodine Release (in vitro at 12 hours) | Bracketed by Iodoflex (377 ppm) and Iodosorb (200 ppm) | 255 ppm |
| Iodine Dose (per cm² wound area) | Comparable to Iodoflex (1.9 mg) and Iodosorb (3.0-6.0 mg) | 1.8 mg (per label) |
| Cytotoxicity (ISO 10993) | Fail (similar to both predicates) | Fail |
| In Vivo Histology (Porcine wound healing model) | No aberration (similar to Iodoflex and PVA controls) | No Aberration |
| Biocompatibility Testing (ISO 10993) | Safe for indications of use (demonstrated by non-reactivity and non-sensitizing) | Non-reactive and non-sensitizing |
| Wound Healing Delay (In vivo porcine model) | No significant delay compared to predicates/controls | Not found to delay wound healing |
2. Sample size used for the test set and the data provenance
Cumulative Iodine Release:
- Sample Size: "three independent lots of each device" (Iodofoam®, Iodosorb®, and Iodoflex®). The exact number of samples per lot is not specified but implies multiple measurements per lot to establish average and lot-specific profiles.
- Data Provenance: In vitro study, conducted in distilled water under agitation at 37°C. The country of origin of the data is not specified but is implied to be from an independent lab commissioned by Progressive WoundCare Technologies. The study is prospective in nature since it was conducted specifically for this 510(k) submission.
Biocompatibility Testing & In Vivo Histology/Wound Healing Model:
- Sample Size:
- Cytotoxicity (ISO): Not specified, typically uses cell cultures.
- Intracutaneous Reactivity (ISO): Not specified, typically involves animal subjects.
- Guinea Pig Maximization Testing (ISO): Not specified, typically involves animal subjects.
- In Vivo Porcine Wound Healing Model: Not specified, but involved comparing Iodofoam®, Iodoflex®, and "PVA controls."
- Data Provenance: The document states "an independent in vitro study" for iodine release and "Biocompatibility testing (per ISO 10993)" and "in vivo porcine wound healing model" for other aspects. The country of origin is not mentioned. These studies were prospective, conducted for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This inquiry is not directly applicable to the type of device and studies presented. The studies involve laboratory measurements (iodine release, cytotoxicity, histology) and animal models, not human interpretation requiring expert consensus on a test set. Therefore, there are no "experts used to establish ground truth" in the context of clinical interpretation, nor are qualifications mentioned. The ground truth is established through standardized laboratory procedures and measurement protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically relevant for studies where subjective human interpretation (e.g., radiology reads) requires reconciliation or consensus, which is not the case for these laboratory and animal model studies.
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. An MRMC study is relevant for evaluating diagnostic systems involving human readers and typically artificial intelligence. The Iodofoam® Iodophor Foam Dressing is a physical wound dressing, and its evaluation does not involve human readers or AI in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept applies to AI algorithms and is irrelevant for a physical wound dressing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the studies presented:
- Cumulative Iodine Release: The ground truth is objective quantitative measurement of iodine concentration (in ppm) over time through chemical analysis.
- Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Guinea Pig Maximization): The ground truth is derived from standardized in vitro and in vivo biological assays according to ISO 10993, which produce measurable endpoints (e.g., cell viability, erythema, edema).
- In Vivo Histology and Wound Healing Model: The ground truth is derived from histological examination of tissue samples and macroscopic observation/measurement of wound healing parameters in an animal model, often assessed by trained histopathologists or researchers.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The studies described are for direct characterization and comparison to predicate devices.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device evaluation.
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1122634
| Submitter:Progressive WoundCare Technologies | Iodofoam® Iodophor Foam DressingPremarket Notification: Traditional 510(k) |
|---|---|
| 510(k) Summary | |
| Submitter Name: | Progressive Wound Care Technologies, LLC |
| Submitter Address: | 125 Busbridge CovePooler, Georgia 31322 |
| Phone Number:Fax Number: | 912-201-8138877-329-0079 |
| Contact Person: | Mason Diamond, DDSTexel Fortis, LLC150 Levinberg LaneWayne, NJ 07470Phone: 508-333-0108Fax: 973-305-0213 |
| Date Prepared: | 7 March, 2013 |
| Device Trade Name: | Iodofoam® Iodophor Foam Dressing |
| Common Name | Hydrophilic wound dressing |
| Classification Name,Number andProduct Code:Subsequent ProductCode: | Dressing, Wound, DrugUnclassifiedFROKOZ |
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
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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.
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| Submitter: |
|---|
| Progressive WoundCare Technologies |
.
| SubstantialEquivalence | lodofoam ® lodophor Foam Dressing device is substantiallyequivalent to the predicates, lodosorb® Gel (K905069) andlodoflex® Pads (K940414), with respect to technical and designfeatures. The submitted device poses no new questions aboutsafety or effectiveness as compared to the predicate devices. |
|---|---|
| Conclusion | The information discussed above demonstrates that thelodofoam® lodophor Foam Dressing device is substantiallyequivalent to the predicate devices. |
| Declarations | • This summary includes only information that is also covered inthe body of the 510(k).• This summary does not contain any unsubstantiated labelingclaims.• This summary does not contain any raw data, i.e., containsonly summary data.• This summary does not contain any trade secret or confidentialcommercial information.• This summary does not contain any patient identificationinformation. |
.
ﻟﮯ
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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 forWound ExudateAbsorption | Bandage, Liquid |
| Regulation | Pre-Amendment | 878.4018 | 880.5090 |
| Product Code(s) | FROKOZ | KOZ | KMF |
| Intended Use | The Iodofoam® IodophorFoam Dressing is indicatedfor use in cleaning wet ulcersand wounds, includingdiabetic ulcers, pressureulcers, arterial ulcers, venousstasis ulcers, and infectedtraumatic or surgical woundsand burns. | IODOSORB® Gel - Foruse in cleaning wetulcers and wounds suchas venous stasis ulcers,pressure sores, diabeticfoot ulcers, and infectedtraumatic and surgicalwounds. | IODOFLEX® Pads - For usein cleaning wet ulcers andwounds such as venousstasis ulcers, pressuresores, diabetic foot ulcers,and infected traumatic andsurgical wounds. |
| Dressing Material | PVA polymer | Modified Starch polymer | Modified Starch polymer |
| AntimicrobialAgent | iodophor complex(8% w/w iodine) | iodophor complex(0.9% w/w iodine) | iodophor complex(0.9% w/w iodine) |
| Cumulative Iodinerelease(in vitro at 12hours) | 255 ppm | 200 ppm | 377 ppm |
| Iodine Dose(per cm² woundarea) | 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
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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.
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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
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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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