(181 days)
No
The device description and performance studies focus on the physical and chemical properties of a gel dressing, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of various types of wounds and burns, including surgically created wounds, ulcers, and partial thickness burns, which are conditions that require therapeutic intervention to promote healing.
No
The device description and indications for use clearly state it is a dressing for managing wounds and burns, not for diagnosing conditions.
No
The device description clearly states it is a "translucent, biocompatible, odorless, semisolid gel," which is a physical substance, not software. The performance studies also focus on biocompatibility, shelf life, and animal wound healing, all related to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that PluroGel is a topical dressing applied directly to wounds and burns. It is intended to maintain a moist wound environment and aid in debridement. It does not involve testing samples taken from the body.
The device is a wound dressing, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.
OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.
Product codes
FRO
Device Description
PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to provide and maintain a clean and moist wound environment that is conducive to healing. The dressing maintains moisture in the wound and protects the wound from desiccation to provide an optimal moist wound environment conducive to wound healing. PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is non-cytotoxic, contains a surfactant, and is water soluble to aid in the removal of wound debris in between dressing changes.
PluroGel® is provided non-sterile and contains phenoxyethanol and potassium sorbate as antimicrobial preservative agents to inhibit the growth of microorganisms within the product during shelf storage before and after opening.
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
Not Found
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
Non-Clinical Testing:
Biocompatibility Testing: Conducted in accordance with FDA guidance "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices - Part 1: Evaluation of Testing within a Risk Management Process.
Shelf Life and Sterilization: Stability testing performed on final finished product to support shelf life.
Period of Use after Opening: Testing conducted to ensure preservative effectiveness.
Performance Testing (Animal): A wound healing study was conducted following Good Laboratory Practice (GLP) as indicated in 21 CFR Part 58 and in accordance to established in vivo test systems.
Clinical Testing: Not applicable.
Key Metrics
Not Found
Predicate Device(s)
Sonafine Wound Dressing - K110172
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2024
Medline Industries, LP Dinah Rincones Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K233151
Trade/Device Name: PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
Regulatory Class: Unclassified Product Code: FRO Dated: September 26, 2023 Received: September 27, 2023
Dear Dinah Rincones:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Kathleen Young Kathleen Young =S =S =S = Digitally signed by Kathleen Your
=S =S =S =S =S =S =S =S =S =S =S =S =S =S =2024.03.26 10:17:51 -04'00' For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233151
Device Name
PluroGel® Antimicrobial Burn and Wound Dressing PluroGel® Burn and Wound Dressing (OTC)
Indications for Use (Describe)
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.
OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.
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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Page 1 of 4
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Dinah Rincones Sr. Regulatory Affairs Specialist Phone: 847-949-2687 Email: DRincones@medline.com
Summary Preparation Date
March 25th, 2024
Type of 510(k) Submission
Traditional
Device Information
Type of 510(k) Submission ●
- Traditional - Wound Dressing
- Device Common Name ●
- Trade Name ●
- Classification Name ●
- Regulatory Class ●
- Review Panel ●
- Product Code ●
- PluroGel® Antimicrobial Burn and Wound Dressing - PluroGel® Burn and Wound Dressing (OTC)
- Dressing, Wound, Drug
- Unclassified
- General & Plastic Surgery
- FRO
Predicate Device Information
Sonafine Wound Dressing - K110172 (Predicate)
Reference Device Information
Epiceram Skin Barrier Emulsion - K052643 (Reference device 1) Medline Burn and Wound Dressing - K173911 and Medline Burn and Wound Dressing (OTC) -K190224 (Reference device 2).
Device Description
PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to provide and maintain a clean and moist wound environment that is conducive to healing. The dressing maintains moisture in the wound and protects the wound from desiccation to provide an optimal moist wound environment conducive to wound
4
healing. PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is non-cytotoxic, contains a surfactant, and is water soluble to aid in the removal of wound debris in between dressing changes.
PluroGel® is provided non-sterile and contains phenoxyethanol and potassium sorbate as antimicrobial preservative agents to inhibit the growth of microorganisms within the product during shelf storage before and after opening.
Indications for Use
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.
OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.
Summary of Technological Characteristics
PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is substantially equivalent in function and intended use to the following legally marketed device: Sonafine Wound Dressing - K110172.
Refer to Table 1 for a comparison and discussion of similarities and differences between the subject device, predicate device, and reference devices.
| | Subject Device | Predicate Device
Sonafine | Comparison Analysis |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233151 | K110172 | N/A |
| Applicant | Medline Industries, LP | STRATUS PHARMACEUTICAL | N/A |
| Regulation
Number | Unclassified | Unclassified | Same as Predicate Device |
| Product Code | FRO | FRO | Same as Predicate Device |
| Rx Indications
for Use | PluroGel® Antimicrobial Burn and
Wound Dressing is indicated for the
management of full and partial
thickness wounds including
surgically created wounds, dermal
ulcers (pressure ulcers), leg ulcers
(diabetic foot ulcers), superficial
wounds, first degree burns, partial
thickness burns, and donor sites.
PluroGel® Antimicrobial Burn and
Wound Dressing maintains a moist
wound and skin environment that | Indicated for the management of full
and partial thickness wounds
including dermal ulcers, leg ulcers,
superficial wounds, first and second
degree burns and donor sites,
including:
-Radiation Dermatitis
-Various types of dermatoses
-Atopic dermatitis
-Allergic contact dermatitis
-Dry waxy skin | Similar to Predicate Device.
Note:
The subject device and the predicate device are
intended to maintain a moist wound and skin
environment and for the management of various
types of wounds and burns that would benefit
from a moist environment. Additional wound
type listed for the subject device do not result in
a new intended use.
Similar to Reference Device 2.
Note: |
| | Subject Device | Predicate Device
Sonafine | Comparison Analysis |
| | supports autolytic debridement of
necrotic tissue. | SONAFINE® Wound Dressing
maintains a moist wound and skin
environment. | The subject device and reference device 2
contain Poloxamer P-188 and are used for
maintaining a moist wound healing environment
that supports autolytic debridement of necrotic
tissue. |
| OTC Indications
for Use | PluroGel® Burn and Wound
Dressing (OTC) is indicated for the
management of minor cuts, minor
burns, and minor lacerations.
PluroGel® Burn and Wound
Dressing (OTC) maintains a moist
wound and skin environment. | SONAFINE® Wound Dressing is
indicated for the management of
minor cuts, minor burns, and minor
lacerations. SONAFINE® Wound
Dressing maintains a moist wound
and skin environment.
Contraindicated for individuals with
a known sensitivity to the
components contained in the
formulation. | Same as Predicate Device |
| Ingredients | Poloxamer, Purified Water,
Phenoxyethanol (antimicrobial
preservative), Sodium Phosphate
Dibasic, Potassium Sorbate
(antimicrobial preservative), Citric
Acid. | Avocado oil, cetyl palmitate,
ethylene glycol monostearate,
fragrance, liquid paraffin, methyl
paraben, paraffin wax, propylene
glycol, propyl paraben, purified
water, sodium alginate, sodium
hydroxide, sorbic acid (potassium
salt), squalene, stearic acid and
trolamine. | Similar to Predicate Device
Note:
The subject device and the predicate device
comprise ingredients that act as surfactants,
diluents, buffers, humectants and preservatives
(to inhibit the growth of microorganisms within
the product). The predicate device (K110172)
contains one of the same preservatives as the
subject device (Potassium Sorbate), and
reference device 1 (K052643) contains the other
preservative (Phenoxyethanol).
The subject device, the predicate device and
reference devices all meet biocompatibility
safety requirements in accordance with to ISO
10993-1. |
| Configurations | 50g jars | 28g, 45g and 90g tubes. | Different to Predicate Device
Note:
The predicate device is provided in 28g, 45g and
90g tubes while the proposed device is provided
in 50g jars. This difference does not affect the
subject device safety or effectiveness. In
addition, the FDA has cleared semisolid
dressings for the same intended use offered in
the same type and size of jars (K150985). |
| Overall Design | Semisolid burn and wound dressings
with the following features:
· Preserved formulation.
· Semisolid form.
· Water-soluble. | Semisolid burn and wound dressings
with the following features:
· Preserved formulation.
· Semisolid form.
· Water-soluble. | Same as Predicate Device |
| Sterile vs. Non-
sterile | Non-sterile | Non-sterile | Same as Predicate Device |
Table 1: Comparison of the Subject Device with the Predicate Device
5
K233151
6
Summary of Non-Clinical Testing
Biocompatibility Testing
PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is categorized as a surface device for breached or compromised skin with prolonged contact (>24 hours to 30 days). The biological evaluation of the PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices - Part 1: Evaluation of Testing within a Risk Management Process.
Shelf Life and Sterilization
The PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is a nonsterile device. Stability testing has been performed on the final finished product to support its shelf life.
Period of Use after Opening
Period of Use testing was conducted to ensure that preservative effectiveness is maintained throughout the intended use-life of the device.
Performance Testing (Animal)
A wound healing study was conducted following Good Laboratory Practice (GLP) as indicated in 21 CFR Part 58 and in accordance to established in vivo test systems.
Performance Testing (Clinical)
Not applicable.
Summary of Clinical Testing Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP. concludes that PluroGel® Antimicrobial Burn and Wound Dressing and PluroGel® Burn and Wound Dressing (OTC) is as safe and as effective for its intended use as the predicate device, Sonafine Wound Dressing cleared in K110172.