(135 days)
No
The device description and performance studies focus on the chemical composition and mechanical action of the irrigation solution, with no mention of AI or ML.
Yes
Explanation: The device is described as an "aqueous solution for irrigation and debridement of wounds" and is indicated for "cleansing and removal of debris, including microorganisms, from wounds." This indicates a direct therapeutic action on the wound, fitting the definition of a therapeutic device.
No
The device is an irrigation solution used for cleansing and debridement of wounds through mechanical action, not for diagnosing a condition.
No
The device description clearly states it is an "aqueous solution" provided in a "polypropylene plastic container," indicating it is a physical product (a liquid solution and its packaging) and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cleansing and removal of debris, including microorganisms, from wounds." This is a direct application to the body (a wound) for therapeutic or cleansing purposes, not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description details an "aqueous solution for irrigation and debridement of wounds." It describes a physical action (mechanical action of fluid) to remove debris. This aligns with a topical or irrigation solution, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, urine, tissue, etc.), detecting specific biomarkers, or providing information for diagnosis.
- Predicate and Reference Devices: The predicate and reference devices listed (Prontosan Wound Irrigation Solution and Atteris Antimicrobial Skin & Wound Cleanser) are also wound irrigation/cleansing solutions, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to clean a wound, which is a therapeutic or supportive action, not a diagnostic one.
N/A
Intended Use / Indications for Use
Next Science™ Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.
Product codes
FQH, FRO
Device Description
Next Science™ Irrigation Solution is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds.
The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds.
Next Science™ Irrigation Solution will be provided in a 1000 mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged with six (6) containers per case. The formulation for Next Science™ Irrigation Solution is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wounds
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
Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, and included the following:
- ISO Intracutaneous Reactivity Test to determine if the solution was capable of causing local dermal irritation.
- ISO Guinea Pig Maximization Sensitization Test (GLP Method for Liquid Test Article) to evaluate the solution's allergenic potential or sensitizing capacity.
Animal testing:
A Porcine Dermal Full-Thickness Wound Wash Study was conducted to evaluate the effect of the Irrigation Solution components on the wound healing process.
In the animal study conducted, eight Yorkshire pigs were used each receiving eight wounds, four on either side of the dorsal midline. The four wounds were treated with the same control or test solution, or an empty control (no treatment). The empty control article was included to serve as a baseline.
Under the conditions of the porcine wound healing study, Next Science Irrigation Solution resulted in normal wound healing and was comparable to wounds that received the control article and wounds without treatment over 24 days in this porcine full-thickness dermal wound model.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Next Science, LLC Matthew Myntti, Ph.D. President 8130 Baymeadows Way West, Suite 200 Jacksonville, FL 33256
Re: K161165
Trade/Device Name: Next Science Irrigation Solution Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: Class II Product Code: FQH Dated: August 9, 2016 Received: August 9, 2016
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
1
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.
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,
David Krause -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
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| Indications for Use (Describe) | ||
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| Device Name | ||
| 510(k) Number (if known | ||
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3
510(k) Summary: K161165
Next Science™ Irrigation Solution
| Submitter: | Next Science TM, LLC
8130 Baymeadows Way West
Suite 200
Jacksonville, Florida 32256 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matthew Myntti, Ph.D.
President, Next Science TM, LLC
855-564-2762 ext. 1004 |
| Date Prepared: | September 2, 2016 |
| Device Trade Name: | Next Science TM Irrigation Solution |
| Device Common Name: | Irrigation Solution |
| Classification Name: | Dressing, Wound, Drug |
| Product Code: | FRO and FQH |
| Classification: | Unclassified |
| Predicate Device: | Prontosan Wound Irrigation Solution (K072876) |
| Reference Device: | Atteris Antimicrobial Skin & Wound Cleanser
(K160192). This device is referenced because, like
the proposed device, it is intended for cleansing and
removal of debris, including microorganisms, from
wounds. |
| Device Description: | Next Science TM Irrigation Solution is an aqueous
solution for irrigation and debridement of wounds.
The solution is a clear, colorless, low-odor aqueous
solution that is used to remove debris, including
microorganisms, from wounds.
The mechanical action of fluid moving across the
wound provides the mechanism of action and aids in
the removal of debris, including microorganisms, from
wounds.
Next Science TM Irrigation Solution will be provided in
a 1000 mL polypropylene plastic container with a |
4
single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged with six (6) containers per case. The formulation for Next Science™ Irrigation Solution is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.
- Indications For Use: Next Science™ Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.
- The proposed device and the predicate device are Substantial Equivalence: intended for use in the irrigation of wounds. Although the proposed device and the predicate device consist of different ingredients, these differences do not raise different questions of safety or effectiveness. The safety and effectiveness of the Next Science™ Irrigation Solution is supported by biocompatibility testing, functional performance testing, animal testing, and shelf-life testing conducted on the proposed device.
| Product | Next Science™ Irrigation
Solution | Prontosan Wound Irrigation
Solution (K072876) |
|----------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Company | Next Science, LLC | B. Braun |
| 510(k) Number | K161165 | K072876 |
| Classification | FQH, Jet Lavage
FRO, Dressing, Wound,
Drug | FRO, Dressing, Wound, Drug |
| Composition | Ethanol, 100g/L
Acetic acid, 50g/L
Sodium acetate, 30g/L
Benzalkonium chloride,
1.3g/L
Purified water | 0.1% Undecylenamidopropyl
betaine
0.1% Polyaminopropyl
biguanide
Sodium hydroxide
Purified water |
| Description | Next Science™ Irrigation
Solution is a clear, colorless
liquid containing ethanol,
acetic acid, sodium acetate, | Prontosan Wound Irrigation
Solution is a clear, colorless
liquid containing
undecylenamidopropyl betaine, |
5
| Product | Next Science™ Irrigation
Solution | Prontosan Wound Irrigation
Solution (K072876) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | and benzalkonium chloride. | polyaminopropyl biguanide,
sodium hydroxide and purified
water. |
| Indications | Next Science Irrigation
Solution is to be used with a
jet lavage system and is
indicated for use in
cleansing and removal of
debris, including
microorganisms, from
wounds. | Prontosan Wound Irrigation
Solution is intended for cleaning
wounds and for moistening and
lubricating absorbent wound
dressings for ulcers, burns,
post-surgical wounds and
abrasions. |
| Mechanism(s)
of Action | Mechanical removal of
debris via hydrodynamic
shear.
The mechanical action of
moving across the wound
aids in the removal of
foreign material such as dirt
and debris. | Mechanical removal of debris
via hydrodynamic shear.
The mechanical action of
moving across the wound aids
in the removal of foreign
material such as dirt and debris. |
6
Performance testing:
Next Science™ Irrigation Solution is categorized as a surface device with limited contact per ISO10993-1:2007, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and FDA's Draft Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (April 23, 2013).
Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, and included the following:
-
ISO Intracutaneous Reactivity Test to determine if the solution was capable of causing local dermal irritation.
-
ISO Guinea Pig Maximization Sensitization Test (GLP Method for Liquid Test Article) to evaluate the solution's allergenic potential or sensitizing capacity.
Animal testing:
A Porcine Dermal Full-Thickness Wound Wash Study was conducted to evaluate the effect of the Irrigation Solution components on the wound healing process.
In the animal study conducted, eight Yorkshire pigs were used each receiving eight wounds, four on either side of the dorsal midline. The four wounds were treated with the same control or test solution, or an empty control (no treatment). The empty control article was included to serve as a baseline.
Under the conditions of the porcine wound healing study, Next Science Irrigation Solution resulted in normal wound healing and was comparable to wounds that received the control article and wounds without treatment over 24 days in this porcine full-thickness dermal wound model.
Substantial Equivalence Conclusions:
The Indications for Use statement for Next Science™ Irrigation Solution is similar to that for the predicate device, and the differences in ingredients do not raise different questions of safety or effectiveness. The performance testing and animal testing demonstrate that Next Science™ Irrigation Solution is at least as safe and effective as the predicate device. Therefore, the information in this submission demonstrates that Next Science™ Irrigation Solution is substantially equivalent to the predicate device.