(308 days)
No
The device description and intended use focus on the chemical composition and physical properties of a hydrogel spray for wound management. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is intended for the management of wounds, including pain and itch relief, cleansing, and moistening the wound bed to promote healing, which are all therapeutic purposes.
No
Explanation: The device is a wound hydrogel spray dressing intended for the management, cleansing, moisturizing, and pain/itch relief of wounds and skin. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly states it is an "aqueous hydrogel" and is offered in a "4.0oz bottle with a manual spray pump configuration." This indicates a physical product (hydrogel and bottle/pump) and not a software-only device.
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 wound dressing and treatment for various skin conditions and wounds. It focuses on managing the wound environment, providing pain and itch relief, and aiding in the healing process. This is a therapeutic and wound care application, not a diagnostic one.
- Device Description: The description details the composition and function of the hydrogel as a topical application for wounds. It describes its physical properties and how it interacts with the wound bed. There is no mention of analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: The text does not mention any components or functions related to detecting, measuring, or analyzing substances from the human body (like blood, urine, tissue, etc.) for diagnostic purposes.
- Performance Studies: The performance studies described are related to biocompatibility, stability, and effectiveness as a wound treatment, not diagnostic accuracy.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to directly treat and manage wounds topically.
N/A
Intended Use / Indications for Use
Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.
OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.
Product codes
FRO
Device Description
PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.
The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.
The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).
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
Rx: Under the supervision of a healthcare professional
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)
Pre-Clinical Testing included pH, Free Available Chlorine, Shelf Life, Chemical Stability, Antimicrobial Preservative Effectiveness, Agar Overlay Cytotoxicity, Primary Skin Irritation, and Guinea Pig Maximization Sensitization.
Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially equivalent to the predicate devices as the product has been subjected to in-vitro biocompatibility testing per ISO-10993-1 standards and Preservative Effectiveness testing. These results demonstrate that the product is as safe, as effective, and performs as well as or better than the legally marketed devices identified as the predicate devices listed above and in the Substantial Equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123071, K101882, K073547, K093585
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2015
PuriCore Incorporated Mr. Art Morse Director of Quality Assurance and Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355
Re: K141863
Trade/Device Name: PuriCore Wound Hydrogel Spray Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 11, 2015 Received: April 14, 2015
Dear Mr. Morse:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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) K141863
Device Name PuriCore Wound Hydrogel Spray Dressing
Indications for Use (Describe)
Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.
OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.
| 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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K141863, Page 1 of 2
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. |
|---|---|
| Submitter | PuriCore Inc., 508 Lapp Road |
| Malvern, PA 19355 | |
| Contact Person | Art Morse; Director of Quality Assurance and Regulatory Affairs; PuriCore Inc. |
| 508 Lapp Road, Malvern, PA 19355 | |
| 484 321 2728 (O), 484 321 2704 (F), 610 306 2870 (C) | |
| Date Prepared | May 8, 2015 |
| Trade Names | Puricore Wound Hydrogel Spray Dressing |
| Common Name | Hydrogel Wound Dressing |
| Product Code | FRO (Dressing, Wound, Drug) |
| Predicate Devices | Predicates with substantially equivalent chemical composition, mechanical action, and labeling: |
| Primary Predicate: K123071: Vashe Skin Wound Hydrogel, January 24, 2013; Secondary Predicates: K101882: Prontosan Wound Gel, November 3, 2010 K073547: Anasept Antimicrobial Skin and Wound Gel, April 23, 2008 K093585: Microcyn Skin and Wound Hydrogel, March 8, 2010 | |
| Product Description | PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The- Counter use. |
The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.
The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%). |
| Intended Use Rx | Under the supervision of a healthcare professional, Puricore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings. |
| Intended Use OTC | PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn. |
| Summary of
Technological
Characteristics
Compared to the
Primary
Predicate
Devices | Puricore Wound Hydrogel Spray Dressing has the same or similar technical characteristics as the
predicates listed above:
• An aqueous based topical hydrogel which controls moisture and wound exudates. Hydrogel
characteristics are imparted by an inert viscosity controlling agent. Maintains a moist wound
environment that supports the wound healing process by encouraging autolytic debridement. The
hydrogel barrier manages pain and itch by protecting the wound from contamination and irritation
• The Intended Use Statement utilizes the same indications as previously cleared under these
predicate devices.
The closure system for this product is substantially equivalent to the predicates as it is packaged in a
PET bottle and a Polypropylene spray cap. |
| Substantial
Equivalence -
Effectiveness | Puricore Wound Hydrogel Spray Dressing utilizes the same fundamental scientific technology as the
predicate device (K123071).
Biocompatibility studies proved that the product is equivalent to the predicate products as it was
determined safe under the worst case scenario of the highest specified concentration of available free
chlorine and the lowest specified pH. |
| Pre-Clinical
Testing | Pre-Clinical Testing included pH, Free Available Chlorine, Shelf Life, Chemical Stability, Antimicrobial
Preservative Effectiveness, Agar Overlay Cytotoxicity, Primary Skin Irritation, and Guinea Pig
Maximization Sensitization. |
| Conclusion: | Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially
equivalent to the predicate devices as the product has been subjected to in-vitro biocompatibility
testing per ISO-10993-1 standards and Preservative Effectiveness testing. These results demonstrate
that the product is as safe, as effective, and performs as well as or better than the legally marketed
devices identified as the predicate devices listed above and in the Substantial Equivalence. |
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