(238 days)
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. The hydrogel dressings will be supplied in various packaging configurations. Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel.
This document is a 510(k) premarket notification summary for the medical device Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and Puracyn® Plus Antimicrobial Hydrogel Professional Formula. It is a submission to the FDA seeking a determination of substantial equivalence to predicate devices, not primarily a report on a clinical study with detailed acceptance criteria and performance data in the context of an AI/human reader study.
As such, the document does not contain the specific information requested regarding acceptance criteria related to device performance in a clinical setting, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth establishment as would be found in a clinical study report for a diagnostic or AI-assisted device.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use/Indications for Use
- Technological Characteristics (e.g., active ingredients, formulation, mechanism of action)
- Non-Clinical Testing (e.g., stability, biocompatibility, antimicrobial effectiveness for product preservation).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study proving device meets those criteria because that detailed level of clinical performance data for a complex AI/diagnostic device is not present in this 510(k) summary for a wound hydrogel.
The "Non-Clinical Testing" section mentions "Antimicrobial/Preservative Effectiveness Testing per modified USP <51>". This refers to benchtop microbiological testing to ensure the product itself remains sterile or inhibits microbial growth within the product, not clinical effectiveness on a wound or a comparative study of a diagnostic/AI device.
For clarity, I will explain what is in the document regarding "acceptance criteria" in the context of a 510(k) for this type of device, which is primarily demonstrating similarity and safety/effectiveness through non-clinical means.
Understanding "Acceptance Criteria" in this Context:
In a 510(k) submission for a non-diagnostic, non-AI device like a wound hydrogel, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with:
- Technological Equivalence: The new device's technology, materials, and principle of operation are similar to legally marketed predicate devices.
- Performance Benchmarks (Non-Clinical): The device meets established standards for safety and basic function, such as:
- Stability: The product remains effective and safe over its shelf life (e.g., pH, viscosity, active ingredient concentration, sterility maintained).
- Biocompatibility: The materials used are not harmful to biological systems (e.g., ISO10993-1 testing results are within acceptable limits).
- Preservative Effectiveness: The preservative (hypochlorous acid) effectively inhibits microbial growth within the product for its intended shelf life (e.g., passing modified USP <51> criteria for specified microorganisms).
- Intended Use Equivalence: The proposed indications for use are the same as or very similar to predicate devices, and the differences do not raise new questions of safety or effectiveness.
Study Proving Device Meets Acceptance Criteria (as described in this document):
The studies mentioned are non-clinical and focus on product characteristics, not clinical outcomes on patients with wounds in a comparative study against standard care.
Here's how the provided information relates to the closest interpretation of your request, adjusted for the nature of the document:
1. Table of "Acceptance Criteria" (interpreted as non-clinical performance and equivalence to predicates) and Reported Device Performance
| "Acceptance Criteria" (for 510(k) Submission) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use Equivalence | "There are no differences between the subject and predicate devices with respect to intended use." (Page 6) |
| Technological Equivalence | "The subject devices are similar in technology to the predicate devices in that the products are topical hydrogels which encourage autolytic debridement and protect the wound against contamination. The products contain viscosity enhancing agents which impart hydrogel characteristics, as well as hypochlorous acid and/or sodium hypochlorite as preservatives." (Page 6) |
| Biocompatibility (e.g., meeting ISO10993-1 standards) | "As supported by biocompatibility testing according to ISO10093-1, hydrogels are biologically safe." (Page 6) |
| Antimicrobial/Preservative Effectiveness (e.g., USP <51>) | "Expanded testing consistent with USP <51> supports that the Free Available Chlorine (FAC) inhibits microbial contamination within the product." "Puracyn® Plus hydrogels contain hypochlorous acid, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Candida albicans, Aspergillus brasiliensis, acinetobacter albumin, Vancomycinresistant Enterococcus (VRE), Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Methicillin-resistant Staphylococcus aureus (MRSA) in the hydrogel." (Page 4, 6) |
| Stability (e.g., maintaining properties over shelf life) | "Stability Studies" were performed. (Page 6) Specific acceptance values not detailed in summary, but completion indicated passing. |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical laboratory testing and a submission for substantial equivalence, not a clinical trial with patient "test sets." The "data provenance" mentioned would be laboratory data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic test is not established for this type of device in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO10993-1 for biocompatibility, USP <51> for preservative effectiveness) which have defined criteria for "passing."
8. The sample size for the training set: Not applicable. This refers to laboratory and product characteristic data, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and connection. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2015
Innovacyn Incorporated % Ms. Roshana Ahmed, MA, RAC OptumInsight Incorporated 4 Innovative Drive Dundas. Ontario L9H 7P3 Canada
Re: K150799
Trade/Device Name: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel Puracyn® Plus Antimicrobial Hydrogel Professional Formula Regulatory Class: Unclassified Product Code: FRO Dated: October 21, 2015 Received: October 21, 2015
Dear Ms. Ahmed:
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. 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 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K150799
Device Name
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel Puracyn® Plus Antimicrobial Hydrogel Professional Formula
Indications for Use (Describe)
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
3. 510(k) Summary
| Manufacturer Name: | Innovacyn, Inc. |
|---|---|
| Address: | 3546 N. Riverside AvenueRialto, CA 92377 |
| Contact Name: | Victor Torcat |
| Title: | Vice President, Regulatory and Compliance |
| Phone Number: | 866-318-3116 |
| Fax Number: | 909-428-1947 |
| Date Prepared: | October 15, 2015 |
| Device Proprietary Names: | Puracyn® Plus Duo-Care™ Antimicrobial Wound & SkinHydrogel;Puracyn® Plus Antimicrobial Hydrogel ProfessionalFormula |
|---|---|
| Common or Usual Name: | Hydrogel Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Classification Code: | FRO |
| Regulation Number: | N/A |
| Device Classification | Unclassified |
Predicate Devices:
Substantial equivalence is claimed to the following devices as related to intended use, design, and material characteristics:
- Microcyn™ Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc., . K093585
- Anasept™ Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., . K073547
- Puricore Wound Hydrogel Spray Dressing, Puricore Inc., K141863 ●
- Epicyn™ HydroGel, Oculus Innovative Sciences, Inc., K102945 .
Innovacyn's Puracyn Plus Skin and Wound Care Solutions (K133542) is used as a reference device.
Description of the Device
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from
{4}------------------------------------------------
itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. The hydrogel dressings will be supplied in various packaging configurations. Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel.
Intended Use/Indications for Use
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations. minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Technological Characteristics
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. Puracyn® Plus hydrogels contain hypochlorous acid, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Candida albicans, Aspergillus brasiliensis, acinetobacter albumin, Vancomycinresistant Enterococcus (VRE), Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Methicillin-resistant Staphylococcus aureus (MRSA) in the hydrogel.
A comparison of technological characteristics between the subject and predicate devices is provided in the table below.
{5}------------------------------------------------
| Puracyn® Plus Duo-Care™ AntimicrobialWound & SkinHydrogel;Puracyn® PlusAntimicrobialHydrogelProfessional Formula | Microcyn™ Skin andWound HydroGel(K093585) | Anasept™Antimicrobial Skinand Wound Gel(K073547) | Puricore WoundHydrogel(K141863) | Epicyn™ HydroGel(K102945) | |
|---|---|---|---|---|---|
| Technology | Aqueous based topicalhydrogel maintaining amoist woundenvironment andencouraging autolyticdebridement | Topical Hydrogelencouraging autolyticdebridement | Topical Hydrogel | Aqueous based topicalhydrogel maintaining amoist woundenvironment andencouraging autolyticdebridement | Aqueous based topicalhydrogel maintaining amoist woundenvironment andencouraging autolyticdebridement |
| Preservatives | Hypochlorous acidSodium hypochlorite | Hypochlorous acidSodium hypochlorite | Sodium hypochlorite | Hypochlorous acidSodium hypochlorite | Hypochlorous acidSodium hypochlorite |
| AntimicrobialEffectiveness | Yes | Yes | Yes | Yes | Yes |
| ViscosityIncreasingIngredient | Magnesium lithiumsodium silicate(nanoclay) | Magnesium lithiumfluorosilicate(nanoclay) | Sodium magnesiumsilicate (nanoclay) | Sodium magnesiumfluorosilicate(nanoclay) | Magnesium lithiumsodium silicate(nanoclay) |
| Biocompatible | Yes | Yes | Yes | Yes | Yes |
{6}------------------------------------------------
There are no differences between the subject and predicate devices with respect to intended use.
The subject devices are similar in technology to the predicate devices in that the products are topical hydrogels which encourage autolytic debridement and protect the wound against contamination. The products contain viscosity enhancing agents which impart hydrogel characteristics, as well as hypochlorous acid and/or sodium hypochlorite as preservatives. Expanded testing consistent with USP <51> supports that the Free Available Chlorine (FAC) inhibits microbial contamination within the product. As supported by biocompatibility testing according to ISO10093-1, hydrogels are biologically safe.
Non-Clinical Testing
The following studies have been performed to support the safety and effectiveness of the product:
- . Stability Studies
- Biocompatibility studies in accordance with ISO10993-1 ●
- Antimicrobial/Preservative Effectiveness Testing per modified USP <51> ●
Conclusion
Based on the analysis presented above and the results of performance testing, the subject devices are as safe and effective as the predicate devices. Therefore, it is concluded that the subject devices are substantially equivalent to the identified predicate devices.
------------------This space intentionally left blank-------------------------------------------------------------------------------------------------------------------------
N/A