(112 days)
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.
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-top opening. Lot number and expiration dating will be embossed on the printed tube.
The provided text describes a 510(k) premarket notification for a medical device called "Next Science Wound Gel (Rx)". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.
Therefore, many of the requested details, such as:
- A table of acceptance criteria and reported device performance (in the context of AI)
- Sample sizes for test sets (for AI)
- Number of experts and their qualifications (for AI ground truth)
- Adjudication method (for AI ground truth)
- MRMC comparative effectiveness study results (AI assistance)
- Standalone performance (AI algorithm only)
- Type of ground truth used (for AI)
- Sample size for training set (for AI)
- How ground truth for training set was established (for AI)
are not applicable or available in this document. The document concerns a physical medical device (wound gel) and its biological and functional performance, not an AI/software device.
However, I can extract the information relevant to the device's performance testing and the grounds for its substantial equivalence.
Here's what can be extracted:
1. Acceptance Criteria and Reported Device Performance (as related to the physical device properties):
The document doesn't present a table of quantitative acceptance criteria for biological or clinical performance in the typical sense of an AI/diagnostic study, but rather demonstrates compliance with safety and effectiveness standards through various tests and comparison to predicates.
| Acceptance Criteria Category | Reported Device Performance / Support |
|---|---|
| Biocompatibility | Compliant with the requirements of ISO 10993. These studies demonstrated that Next Science™ Wound Gel is safe for the indicated use. |
| Functional Performance | The gel's ability to aid in the management of wounds has been demonstrated by a full thickness wound study. (No specific quantitative performance metrics from this study are provided in the summary, just that it was conducted and demonstrated ability). The product description states it "helps to maintain a moist wound environment that is conducive to healing." |
| Preservative Efficacy / Microbial Inhibition | Demonstrated through USP Antimicrobial Effectiveness Testing <51> and <61> to demonstrate that the Wound Gel will not introduce bacteria to the application site. The antimicrobial agent, benzalkonium chloride, "inhibits the growth of microorganisms in the hydrogel." (No specific microbial inhibition rates or spectrum are provided in this summary, other than the general statement and the tests confirming efficacy). For comparison, the predicate Anasept Antimicrobial Skin and Wound Gel is stated to inhibit specific bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, MRSA, VRE) and fungi (Candida albicans and Aspergillus niger). While not directly an acceptance criterion for the Next Science gel, it provides context for the expected performance in this category. |
| Shelf-life | Testing was conducted to support substantial equivalence. (No specific duration or stability metrics are provided). |
| Substantial Equivalence | The device has the same indications for use as the predicate device (Anasept Antimicrobial Skin and Wound Gel) and the same technological characteristics as another predicate device (Next Science Wound Gel (OTC)). Performance testing demonstrates it is at least as safe and effective as the predicate devices. |
2. Sample Sample(s) Used for the Test Set and Data Provenance:
- Test Set (for the gel's performance): The document mentions a "full thickness wound study" and "biocompatibility studies" and "USP Antimicrobial Effectiveness Testing <51> and <61>".
- Sample Size: Not specified for any of these studies.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory or preclinical studies demonstrating functional and safety aspects of the gel, not clinical trials with human patient data. These would be considered prospective data generation for the purpose of demonstrating device characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable: This document describes a physical medical device (wound gel) and its chemical/biological properties and performance studies (biocompatibility, antimicrobial effectiveness, wound healing observation), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or similar.
4. Adjudication Method for the Test Set:
- Not applicable: As above, this is not an AI/diagnostic study scenario where human adjudication of interpretations is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No: This is not relevant to the presented device approval (wound gel). There is no AI component mentioned in this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- No: This is not relevant to the presented device approval (wound gel). There is no AI component mentioned in this document.
7. The Type of Ground Truth Used:
- For the physical properties and performance of the gel:
- Biocompatibility: Likely based on established ISO 10993 standards and assays, with "ground truth" being the measured biological reaction (e.g., cytotoxicity, irritation) against control limits.
- Functional Performance (Wound Study): Likely observational data on wound healing, potentially compared to controls or predicate devices.
- Preservative Efficacy: Based on quantitative microbial reduction/inhibition as defined by USP standards.
8. The Sample Size for the Training Set:
- Not applicable: This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable: This is a physical medical device, not an AI/machine learning model that requires a training set.
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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.
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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/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
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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)
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510(k) Summary K163188
Next Science™ Wound Gel (Rx)
| Submitter: | Next ScienceTM, LLC8130 Baymeadows Way WestSuite 200Jacksonville, Florida 32256 |
|---|---|
| Contact Person: | Matthew Myntti, Ph.D.President, Next ScienceTM, LLC855-564-2762 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 tomaintain a moist wound environment that isconducive to healing. The antimicrobial agent,benzalkonium chloride, inhibits the growth ofmicroorganisms in the hydrogel.The Wound Gel is applied directly to the wound andthen covered with an appropriate dressing. The useof the hydrogel on a wound creates a moistenvironment that is conducive to healing by eitherabsorbing wound exudate or donating moisture.The Wound Gel will be supplied in both 1 ounce and4-ounce low-density polyethylene tubes with a screw- |
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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 WoundGel™(Rx)K163188 | Next Science WoundGel™ (OTC)K150792 | Anasept AntimicrobialSkin and Wound GelK073547 |
|---|---|---|---|
| Company | Next Science™, LLC | Next Science™, LLC | Anacapa Technologies |
| Composition | Benzalkonium chloride0.13%, polyethyleneglycol 400, polyethyleneglycol 3350, sodiumcitrate, citric acid andwater | Benzalkonium chloride0.13%, polyethyleneglycol 400, polyethyleneglycol 3350, sodiumcitrate, citric acid andwater | Isotonic hydrogel andantimicrobial sodiumhypochlorite and water |
| Product Code | FRO (Dressing, Wound,Drug) | FRO (Dressing, Wound,Drug) | FRO (Dressing, Wound,Drug) |
| ProductDescription andCharacteristics | A hydrogel that helps tomaintain a moist woundenvironment that isconducive to healing.The antimicrobial agent,benzalkonium chloride,inhibits the growth ofmicroorganisms in thehydrogel. | A hydrogel that helps tomaintain a moist woundenvironment that isconducive to healing.The antimicrobial agent,benzalkonium chloride,inhibit the growth ofmicroorganisms in thehydrogel. | A hydrogel that helpsmaintain a moist woundenvironment that isconducive to healing.The antimicrobial agentinhibits the growth ofbacteria such as:Staphlyococcus aureus,Psuedomonasaeruginosa, Escherichiacoli, Proteus mirabilis,Serratia marcescens,Acinetobacter baumannii,antibiotic resistantMethicillin ResistantStaphylococcus aureus(MRSA), and VancomycinresistantEnterococcusfaecalis(VRE) that are commonlyfound in the wound bed, |
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| Product/510k # | Next Science WoundGel™(Rx)K163188 | Next Science WoundGel™ (OTC)K150792 | Anasept AntimicrobialSkin and Wound GelK073547 |
|---|---|---|---|
| as well as, fungi such asCandida albicans andAspergillus niger. | |||
| Indications | Rx: Management ofwounds such as Stage I-IV pressure ulcers,partial and full thicknesswounds, diabetic footand leg ulcers, post-surgical wounds, firstand second degreeburns, grafted and donorsites. | OTC: Management ofskin abrasions,lacerations, minorirritations, cuts, exitsites, and intact skin. | Rx: Management ofwounds such as Stage I-IV pressure ulcers, partialand full thicknesswounds, diabetic foot andleg ulcers, post-surgicalwounds, first and seconddegree burns, grafted anddonor sites.OTC: Management ofskin abrasions andlacerations, minorirritations, cuts, exit sitesand intact skin. |
| Mechanism ofAction | Provides a moist woundenvironment that isconducive to healing. | Provides a moist woundenvironment that isconducive to healing. | Provides a moist woundenvironment that isconducive 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.
N/A