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. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Next Science™ Wound Gel. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods for an AI/CAD/software device as requested in the prompt. The "performance testing" mentioned is chemical/biological for a wound gel, not algorithm performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility (ISO 10993 requirements)	Compliant with ISO 10993
Wound Management Effectiveness	Demonstrated by a full thickness wound study
Preservative Efficacy (USP <51> and <61>)	Demonstrated; will not introduce bacteria to application site

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified in the document. The studies mentioned are a "full thickness wound study" and "USP Antimicrobial Effectiveness Testing prototypes/samples."
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This relates to diagnostic interpretation, which is not the function of this wound gel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This relates to diagnostic interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a wound gel, not an AI/CAD device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is a wound gel, not an AI/CAD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility: Adherence to ISO standards, implying laboratory testing against specific metrics.
For wound management: Results from a "full thickness wound study," which would likely involve direct observation of healing, possibly histological assessment, or other direct biological measurements.
For preservative efficacy: Results against USP <51> and <61> standards, which are laboratory microbiological tests.

8. The sample size for the training set:

Not applicable/Not specified. This product is a wound gel, not a machine learning model.

9. How the ground truth for the training set was established:

Not applicable/Not specified. This product is a wound gel, not a machine learning model.

Summary

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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.

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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

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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)

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K150792 Page 1 of 4

3. 510(k) Summary

Next Science™ Wound Gel

Submitter:	Next Science ™, LLC8130 Baymeadows Way WestSuite 200Jacksonville, Florida 32256
Contact Person:	Matthew Myntti, Ph.D.President, Next Science™, LLC855-564-2762 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, virtuallyodorless hydrogel. The Wound Gel providesmanagement of skin abrasions, lacerations, minorirritations, cuts, exit sites, and intact skin by maintaining amoist wound environment that is conducive to woundhealing while inhibiting the growth of microorganisms inthe hydrogel

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	The Wound Gel is applied directly to the wound and thencovered with an appropriate dressing. The use of thehydrogel on a wound creates a moist environment that isconducive to wound healing.
	The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-topopening. Lot number and expiration dating will beembossed on the printed tube.
Intended Use:	Next Science™ Wound Gel is indicated for themanagement of skin abrasions, lacerations, minorirritations, cuts, exit sites, and intact skin.
Substantial Equivalence:	The proposed device and the primary predicate device,Anasept Antimicrobial Skin and Wound Gel, have theidentical indications for use. The proposed device alsohas the same technological characteristics as the primarypredicate device, in that they are both hydrogels intendedto create a moist wound environment conducive tohealing. The minor differences in composition do notraise new questions of safety or effectiveness. Thesafety and effectiveness of the Next Science™ WoundGel is supported by biocompatibility testing, functionalperformance testing, and shelf-life testing conducted withthe proposed device.

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Product/510k #	Next ScienceWound Gel™	SciVolutionsAntibacterialBandages(K020318)	AnaseptAntimicrobial Skinand Wound Gel(K073547)	Amerigel WoundDressingPLUS(K092086)
Company	Next Science™,LLC	Sci Volutions, Inc.	Anacapa Technologies	Amerx Health CareCorp.
Composition	Benzalkoniumchloride 0.13%,polyethyleneglycol 400,polyethyleneglycol 3350,sodium citrate,citric acid, andwater.	Benzalkoniumchloride 1%.	Isotonic hydrogel andantimicrobial sodiumhypochlorite.	Oak Extract (Oakin),MeadowsweetExtract, Zinc Acetate,polyethylene 400,polyethylene glycol3350, and Lidocaine4%.
Classification	FRO, Dressing,Wound, Drug.	MXE, MedicalAdhesive Tapeand Bandage withDisinfectant.	FRO, Dressing,Wound, Drug.	FRO, Dressing,Wound, Drug.
ProductDescriptionandCharacteristics	Hydrogel thathelps tomaintain a moistwoundenvironment thatis conducive tohealing. Theantimicrobialagent,benzalkoniumchloride, inhibitsthe growth ofmicroorganismsin the hydrogel.	Antimicrobialadhesive bandagecontaining 1%benzalkoniumchloride whichcreates a humidenvironment.	The product helps tomaintain a moist woundenvironment that isconducive to healing.The antimicrobial agentinhibits the growth ofmicroorganisms. It alsoinhibits the growth ofbacteria that arecommonly found in thewound bed.	The product helps tomaintain a moistwound environmentthat supports woundhealing. Lidocainehelps to reduce thediscomfort associatedwith painful wounds.
Indications	OTC:Management ofskin abrasions,lacerations,minor irritations,cuts, exit sites,and intact skin.	OTC: For topicalapplication toprovide anantibacterialbarrier for minorcuts and scrapes.	Rx: Management ofwounds such as StageI-IV pressure ulcers,partial and fullthickness wounds,diabetic foot and legulcers, post-surgicalwounds, first andsecond degree burns,grafted and donor sites.OTC: Management ofskin abrasions andlacerations, minorirritations, cuts, exitsites and intact skin.	Rx: Management ofwounds, such asStage I - IV Pressureulcers, venous stasisulcers, ulcerationscaused by mixedvascular etiologies,diabetic skin ulcers,first and seconddegree burns, post-surgical incisions,cuts, and abrasions.
Mechanism ofAction	Provides a moistwoundenvironment thatis conducive tohealing.	Physicalprotection andantibacterialbarrier for woundor cut.	Provides a moist woundenvironment that isconducive to healing,while delivering theantimicrobial agent,sodium hypochlorite.	Provides a moistwound environmentthat is conducive tohealing.

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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.

Regulation Number and Section

N/A