Who is the manufacturer of Next Science Wound Gel?

Next Science, LLC filed the 510(k) submission for Next Science Wound Gel (K150792).

What is the FDA product code for Next Science Wound Gel?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Next Science Wound Gel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Next Science Wound Gel?

SciVolutions Antibacterial Bandages (K020318); Amerigel Wound Dressing PLUS (K092086); Anasept Antimicrobial Skin and Wound Gel (K073547).

Who can help prepare an FDA 510(k) submission like Next Science Wound Gel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Next Science Wound Gel

K150792 · Next Science, LLC · FRO · Dec 17, 2015 · SU

Device Facts

Record ID	K150792
Device Name	Next Science Wound Gel
Applicant	Next Science, LLC
Product Code	FRO · SU
Decision Date	Dec 17, 2015
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Next Science™ Wound Gel is indicated for the management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin.

Device Story

Next Science™ Wound Gel is a white, odorless hydrogel dressing; applied topically to wounds to maintain a moist environment conducive to healing; inhibits microbial growth within the gel via benzalkonium chloride (0.13%). Supplied in 1 oz and 4 oz low-density polyethylene tubes. Used in clinical or home settings; applied by patients or healthcare providers directly to the wound site, then covered with an appropriate secondary dressing. Benefits include moisture maintenance and antimicrobial protection to support wound healing.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993. Full-thickness wound study demonstrated efficacy in wound management. Preservative efficacy confirmed via USP <51> and <61> antimicrobial effectiveness testing.

Technological Characteristics

Hydrogel dressing; composition includes benzalkonium chloride 0.13%, polyethylene glycol 400, polyethylene glycol 3350, sodium citrate, citric acid, and water. Packaged in low-density polyethylene tubes. Biocompatibility compliant with ISO 10993.

Indications for Use

Indicated for management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin in patients requiring a moist wound environment.

Predicate Devices

SciVolutions Antibacterial Bandages (K020318)
Amerigel Wound Dressing PLUS (K092086)
Anasept Antimicrobial Skin and Wound Gel (K073547)

Related Devices

K163188 — Next Science Wound Gel (Rx) · Next Science, LLC · Mar 6, 2017
K252028 — LUOFUCON® Antimicrobial Wound Gel · Huizhou Foryou Medical Co., Ltd. · Mar 11, 2026
K231057 — Antibacterial Gel Wound Dressing · Winner Medical Co., Ltd. · Dec 1, 2023
K130857 — PRONTOSAN WOUND GEL X · B.Braun Medical, Inc. · Oct 8, 2013
K092826 — ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL · American Biotech Labs · Nov 12, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like element above them, possibly representing an eagle or another bird of prey. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 17, 2015 Next Science™, LLC Matthew Myntti, Ph.D. President 8130 Baymeadows Way West, Suite 200 Jacksonville, Florida 32256 Re: K150792 Trade/Device Name: Next Science™ Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: November 12, 2015 Received: November 13, 2015 Dear Dr. Myntti: 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 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. {1}------------------------------------------------ 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, # Joshua C. Nipper -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) K150792 Device Name Next Science™ Wound Gel Indications for Use (Describe) Next Science™ Wound Gel is indicated for the management of skin abrasions, minor irritations, cuts, exit sites and intact skin. Prescription Use (Part 21 CFR 801 Subpart D) |X | 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}------------------------------------------------ K150792 Page 1 of 4 #### 3. 510(k) Summary ## Next Science™ Wound Gel | Submitter: | Next Science ™, LLC 8130 Baymeadows Way West Suite 200 Jacksonville, Florida 32256 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Matthew Myntti, Ph.D. President, Next Science™, LLC 855-564-2762 ext. 1004 | | Date Prepared: | March 25, 2015 | | Device Trade Name: | Next Science™ Wound Gel | | Device Common Name: | Wound Dressing | | Classification Name: | Dressing, Wound, Drug | | Product Code: | FRO | | Classification: | Unclassified | | Predicate Devices: | SciVolutions Antibacterial Bandages (K020318) Amerigel Wound Dressing PLUS (K092086) Anasept Antimicrobial Skin and Wound Gel (K073547) | | Device Description: | The Next Science™ Wound Gel is a white, virtually odorless hydrogel. The Wound Gel provides management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin by maintaining a moist wound environment that is conducive to wound healing while inhibiting the growth of microorganisms in the hydrogel | {4}------------------------------------------------ | | The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to wound healing. | | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | | The Wound Gel will be supplied in both 1 ounce and 4- ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube. | | | | Intended Use: | Next Science™ Wound Gel is indicated for the management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin. | | | | Substantial Equivalence: | The proposed device and the primary predicate device, Anasept Antimicrobial Skin and Wound Gel, have the identical indications for use. The proposed device also has the same technological characteristics as the primary predicate device, in that they are both hydrogels intended to create a moist wound environment conducive to healing. The minor differences in composition do not raise new questions of safety or effectiveness. The safety and effectiveness of the Next Science™ Wound Gel is supported by biocompatibility testing, functional performance testing, and shelf-life testing conducted with the proposed device. | | | {5}------------------------------------------------ | Product/ 510k # | Next Science Wound Gel™ | SciVolutions Antibacterial Bandages (K020318) | Anasept Antimicrobial Skin and Wound Gel (K073547) | Amerigel Wound Dressing PLUS (K092086) | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Next Science™, LLC | Sci Volutions, Inc. | Anacapa Technologies | Amerx Health Care Corp. | | Composition | Benzalkonium chloride 0.13%, polyethylene glycol 400, polyethylene glycol 3350, sodium citrate, citric acid, and water. | Benzalkonium chloride 1%. | Isotonic hydrogel and antimicrobial sodium hypochlorite. | Oak Extract (Oakin), Meadowsweet Extract, Zinc Acetate, polyethylene 400, polyethylene glycol 3350, and Lidocaine 4%. | | Classification | FRO, Dressing, Wound, Drug. | MXE, Medical Adhesive Tape and Bandage with Disinfectant. | FRO, Dressing, Wound, Drug. | FRO, Dressing, Wound, Drug. | | Product Description and Characteristics | Hydrogel that helps to maintain a moist wound environment that is conducive to healing. The antimicrobial agent, benzalkonium chloride, inhibits the growth of microorganisms in the hydrogel. | Antimicrobial adhesive bandage containing 1% benzalkonium chloride which creates a humid environment. | The product helps to maintain a moist wound environment that is conducive to healing. The antimicrobial agent inhibits the growth of microorganisms. It also inhibits the growth of bacteria that are commonly found in the wound bed. | The product helps to maintain a moist wound environment that supports wound healing. Lidocaine helps to reduce the discomfort associated with painful wounds. | | Indications | OTC: Management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin. | OTC: For topical application to provide an antibacterial barrier for minor cuts and scrapes. | Rx: Management of wounds such as 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. OTC: Management of skin abrasions and lacerations, minor irritations, cuts, exit sites and intact skin. | Rx: Management of wounds, such as Stage I - IV Pressure ulcers, venous stasis ulcers, ulcerations caused by mixed vascular etiologies, diabetic skin ulcers, first and second degree burns, post- surgical incisions, cuts, and abrasions. | | Mechanism of Action | Provides a moist wound environment that is conducive to healing. | Physical protection and antibacterial barrier for wound or cut. | Provides a moist wound environment that is conducive to healing, while delivering the antimicrobial agent, sodium hypochlorite. | Provides a moist wound environment that is conducive to healing. | {6}------------------------------------------------ Performance Testing: Next Science™ Wound Gel has been subjected to biocompatibility studies to demonstrate that the device is safe for the indicated use. These biocompatibility studies demonstrated that Next Science™ Wound Gel is compliant with the requirements of ISO 10993. > The gel's ability to aid in the management of wounds has been demonstrated by a full thickness wound study. Preservative efficacy has been demonstrated through USP Antimicrobial Effectiveness Testing <51> and <61> to demonstrate that the Wound Gel will not introduce bacteria to the application site. Substantial Equivalence Conclusions: The Indications for Use and technological characteristics for Next Science™ Wound Gel are similar to the referenced predicate devices. The performance testing demonstrates that Next Science™ Wound Gel is at least as safe and effective as the predicate devices. Therefore, the information in this submission demonstrates that Next Science™ Wound Gel is substantially equivalent to the predicate devices.