(112 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a hydrogel for wound management. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is indicated for the management of various types of wounds, demonstrating a therapeutic intent related to healing and wound care.
No
The device, Next Science Wound Gel, is a hydrogel designed to help manage wounds and promote healing by maintaining a moist environment and inhibiting microbial growth. Its intended use is for treatment and management of wounds, not for diagnosis.
No
The device description clearly states that the device is a hydrogel, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds, which is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a hydrogel applied directly to the wound to create a moist environment and inhibit microbial growth. This is a topical treatment, not a diagnostic test.
- No mention of in vitro testing: There is no indication that this device is used to test samples outside of the body.
The device is a wound care product intended for direct application to the wound for therapeutic purposes.
N/A
Intended Use / Indications for 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.
Product codes
FRO
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-top opening. Lot number and expiration dating will be embossed on the printed tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (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).
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
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 and to demonstrate that the Wound Gel will not introduce bacteria to the application site.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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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, 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 and 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.