(267 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the hydrogel and its ability to maintain a moist wound environment and inhibit microbial growth. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a wound gel used for the management of skin abrasions, minor irritations, cuts, and exit sites, creating a moist environment conducive to wound healing and inhibiting the growth of microorganisms, which directly relates to treating or mitigating a condition.
No
Explanation: The device is described as a wound gel for management and healing of skin conditions, not for diagnosing them. Its intended use is therapeutic, not diagnostic.
No
The device description clearly states it 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 skin abrasions, minor irritations, cuts, exit sites, and intact skin. This is a topical application for wound care.
- Device Description: The description details a hydrogel applied directly to the wound to create a moist environment and inhibit microbial growth. This is a physical and chemical interaction with the wound surface.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are used for diagnosis, monitoring, or screening.
The device is a wound care product applied externally, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Next Science™ Wound Gel is indicated for the management of skin abrasions, minor irritations, cuts, exit sites and intact skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and to demonstrate that the Wound Gel will not introduce bacteria to the application site.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Anasept Antimicrobial Skin and Wound Gel (K073547), SciVolutions Antibacterial Bandages (K020318), Amerigel Wound Dressing PLUS (K092086)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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)
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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 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 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.