Who is the manufacturer of Next Science Wound Gel (Rx)?

Next Science, LLC filed the 510(k) submission for Next Science Wound Gel (Rx) (K163188).

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

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

What is the regulatory pathway for Next Science Wound Gel (Rx)?

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

What are the predicate devices for Next Science Wound Gel (Rx)?

Anasept Antimicrobial Skin and Wound Gel (K073547); Next Science Wound Gel (K150792).

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

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 (Rx)

K163188 · Next Science, LLC · FRO · Mar 6, 2017 · SU

Device Facts

Record ID	K163188
Device Name	Next Science Wound Gel (Rx)
Applicant	Next Science, LLC
Product Code	FRO · SU
Decision Date	Mar 6, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Next Science Wound Gel (Rx) is indicated for the 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.

Device Story

Next Science Wound Gel (Rx) is a hydrogel dressing containing 0.13% benzalkonium chloride as an antimicrobial agent. Applied topically to wounds by clinicians, it maintains a moist environment conducive to healing by absorbing exudate or donating moisture. The antimicrobial agent inhibits microbial growth within the gel. Supplied in low-density polyethylene tubes, it is intended for use in clinical settings for various wound types. The device benefits patients by providing a protective, moist environment that supports the natural healing process while preventing microbial proliferation within the dressing.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993. Functional performance demonstrated via full-thickness wound study. Preservative efficacy validated through USP Antimicrobial Effectiveness Testing <51> and <61>.

Technological Characteristics

Hydrogel dressing composed of benzalkonium chloride (0.13%), polyethylene glycol 400, polyethylene glycol 3350, sodium citrate, citric acid, and water. Supplied in low-density polyethylene tubes. Biocompatibility compliant with ISO 10993.

Indications for Use

Indicated for management of Stage I-IV pressure ulcers, partial/full thickness wounds, diabetic foot/leg ulcers, post-surgical wounds, first/second degree burns, and grafted/donor sites in patients requiring prescription wound care.

Predicate Devices

Anasept Antimicrobial Skin and Wound Gel (K073547)
Next Science Wound Gel (K150792)

Related Devices

K150792 — Next Science Wound Gel · Next Science, LLC · Dec 17, 2015
K252028 — LUOFUCON® Antimicrobial Wound Gel · Huizhou Foryou Medical Co., Ltd. · Mar 11, 2026
K130857 — PRONTOSAN WOUND GEL X · B.Braun Medical, Inc. · Oct 8, 2013
K062212 — SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S · Anacapa Technologies, Inc. · Nov 21, 2006
K073197 — SILVER ANTIMICROBIAL WOUND GEL · Advanced Medical Solutions Limited · Aug 28, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 6, 2017 Next Science, LLC Matthew Myntti, Ph.D. President 8130 Baymeadows Way W, Suite 200 Jacksonville, Florida 32256 Re: K163188 Trade/Device Name: Next Science Wound Gel (Rx) Regulatory Class: Unclassified Product Code: FRO Dated: February 10, 2017 Received: February 10, 2017 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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) Device Name Next Science Wound Gel (Rx) Indications for Use (Describe) Next Science Wound Gel (Rx) is indicated for the 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. 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 comblete 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ ## 510(k) Summary K163188 ## Next Science™ Wound Gel (Rx) | Submitter: | Next ScienceTM, LLC 8130 Baymeadows Way West Suite 200 Jacksonville, Florida 32256 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Matthew Myntti, Ph.D. President, Next ScienceTM, LLC 855-564-2762 ext. 1004 | | Date Prepared: | February 8, 2017 | | Device Trade Name: | Next ScienceTM Wound Gel (Rx) | | Device Common Name: | Wound Dressing | | Classification Name: | Dressing, Wound, Drug | | Product Code: | FRO | | Classification: | Unclassified | | Predicate Devices: | Anasept Antimicrobial Skin and Wound Gel (K073547) (primary predicate) Next Science Wound Gel (K150792) | | Device Description: | Next Science Wound Gel is a 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. 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 healing by either absorbing wound exudate or donating moisture. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw- | {4}------------------------------------------------ top opening. Lot number and expiration dating will be embossed on the printed tube. - Next Science™ Wound Gel is intended for use in the Intended Use: 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. - Substantial Equivalence: The proposed device has the same indications for use as the predicate device, Anasept Antimicrobial Skin and Wound Gel, and the same technological characteristics as the predicate device, Next Science Wound Gel (OTC), as shown in the following table. The safety and effectiveness of the Next Science™ Wound Gel (Rx) is supported by biocompatibility, functional performance, and shelf-life testing. | Product/ 510k # | Next Science Wound Gel™(Rx) K163188 | Next Science Wound Gel™ (OTC) K150792 | Anasept Antimicrobial Skin and Wound Gel K073547 | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Next Science™, LLC | Next Science™, LLC | Anacapa Technologies | | Composition | Benzalkonium chloride 0.13%, polyethylene glycol 400, polyethylene glycol 3350, sodium citrate, citric acid and water | Benzalkonium chloride 0.13%, polyethylene glycol 400, polyethylene glycol 3350, sodium citrate, citric acid and water | Isotonic hydrogel and antimicrobial sodium hypochlorite and water | | Product Code | FRO (Dressing, Wound, Drug) | FRO (Dressing, Wound, Drug) | FRO (Dressing, Wound, Drug) | | Product Description and Characteristics | A 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. | A hydrogel that helps to maintain a moist wound environment that is conducive to healing. The antimicrobial agent, benzalkonium chloride, inhibit the growth of microorganisms in the hydrogel. | A hydrogel that helps maintain a moist wound environment that is conducive to healing. The antimicrobial agent inhibits the growth of bacteria such as: Staphlyococcus aureus, Psuedomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and Vancomycin resistant Enterococcusfaecalis (VRE) that are commonly found in the wound bed, | {5}------------------------------------------------ | Product/ 510k # | Next Science Wound Gel™(Rx) K163188 | Next Science Wound Gel™ (OTC) K150792 | Anasept Antimicrobial Skin and Wound Gel K073547 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | as well as, fungi such as Candida albicans and Aspergillus niger. | | Indications | 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, lacerations, minor irritations, cuts, exit sites, and intact skin. | 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. | | Mechanism of Action | Provides a moist wound environment that is conducive to healing. | Provides a moist wound environment that is conducive to healing. | Provides a moist wound environment that is conducive to healing. | Performance Testing: Next Science™ Wound Gel (Rx) 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 (Rx) are identical to the predicate devices. The performance testing demonstrates that Next Science™ Wound Gel (Rx) 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.