(238 days)
No
The summary describes a hydrogel dressing with antimicrobial properties, focusing on its chemical composition and physical properties for wound care. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
Yes
The device is intended to treat and manage various skin and wound conditions, facilitating healing and providing relief from pain and itch, which are characteristics of a therapeutic device.
No
This device is a hydrogel dressing intended for wound care, providing pain relief, moisture, and facilitating healing, rather than diagnosing conditions.
No
The device description clearly states it is a topically applied hydrogel dressing, which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a topical hydrogel applied to skin and wound areas for purposes like relieving itch and pain, moistening wounds, and facilitating healing. This is a direct application to the body surface for therapeutic and wound management purposes.
- Device Description: The description reinforces that it's a topically applied hydrogel dressing.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely focused on the management and healing of wounds and skin irritations through direct application.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and wound areas (dermal lesions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (lay user) and healthcare professionals
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)
The following studies have been performed to support the safety and effectiveness of the product:
- Stability Studies
- Biocompatibility studies in accordance with ISO 10993-1
- Antimicrobial/Preservative Effectiveness Testing per modified USP
Key results: 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 ISO 10093-1, hydrogels are biologically safe.
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.
K093585, K073547, K141863, K102945
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.
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/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) |
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3
3. 510(k) Summary
| Manufacturer Name: | Innovacyn, Inc. |
|---|---|
| Address: | 3546 N. Riverside Avenue |
| Rialto, 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 & Skin
Hydrogel;
Puracyn® Plus Antimicrobial Hydrogel Professional
Formula |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 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™ Antimicrobial
Wound & Skin
Hydrogel;
Puracyn® Plus
Antimicrobial
Hydrogel
Professional Formula | Microcyn™ Skin and
Wound HydroGel
(K093585) | Anasept™
Antimicrobial Skin
and Wound Gel
(K073547) | Puricore Wound
Hydrogel
(K141863) | Epicyn™ HydroGel
(K102945) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Technology | Aqueous based topical
hydrogel maintaining a
moist wound
environment and
encouraging autolytic
debridement | Topical Hydrogel
encouraging autolytic
debridement | Topical Hydrogel | Aqueous based topical
hydrogel maintaining a
moist wound
environment and
encouraging autolytic
debridement | Aqueous based topical
hydrogel maintaining a
moist wound
environment and
encouraging autolytic
debridement |
| Preservatives | Hypochlorous acid
Sodium hypochlorite | Hypochlorous acid
Sodium hypochlorite | Sodium hypochlorite | Hypochlorous acid
Sodium hypochlorite | Hypochlorous acid
Sodium hypochlorite |
| Antimicrobial
Effectiveness | Yes | Yes | Yes | Yes | Yes |
| Viscosity
Increasing
Ingredient | Magnesium lithium
sodium silicate
(nanoclay) | Magnesium lithium
fluorosilicate
(nanoclay) | Sodium magnesium
silicate (nanoclay) | Sodium magnesium
fluorosilicate
(nanoclay) | Magnesium lithium
sodium 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 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 ●
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.
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