(135 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Next Science Irrigation Solution:
I. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a structured table. Instead, it relies on a qualitative comparison to the predicate device regarding safety and effectiveness, supported by various tests. The core acceptance criterion is "Substantial Equivalence" to the predicate device, Prontosan Wound Irrigation Solution (K072876).
Since no numerical performance metrics are provided in the document, I cannot create a table with specific acceptance criteria and reported device performance. The information focuses on whether the device is at least as safe and effective as the predicate.
II. Study Details
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Sample Size used for the test set and data provenance:
- Test Set Description: The core "test set" for the critical animal study involved eight Yorkshire pigs.
- Data Provenance: The document does not specify the country of origin for the animal study. It was a prospective study designed to evaluate the effect of the irrigation solution.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish a "ground truth" for the animal study in the typical sense of expert annotation for AI algorithms. The assessment of wound healing was likely conducted by the study investigators based on observable physiological responses and histological analysis (though not explicitly detailed beyond "normal wound healing").
- Therefore, information on the number and qualifications of experts for ground truth establishment is not provided.
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Adjudication method for the test set:
- The document describes that "The four wounds were treated with the same control or test solution, or an empty control (no treatment)." This indicates a controlled experimental design where different treatments (test solution, control article, no treatment) were applied to wounds on the same animals.
- However, it does not describe an adjudication method for establishing ground truth, as it's not a human-reader interpretation study. The assessment of wound healing would be based on scientific observation and measurement.
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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 MRMC study was done. This device is a medical solution (irrigation solution), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical solution, not an algorithm. Therefore, no standalone algorithm-only performance study was conducted.
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The type of ground truth used:
- For the animal study, the "ground truth" was based on biological outcomes or physiological response, specifically "normal wound healing." This would have been assessed through direct observation and potentially histological analysis of the wound sites over the 24-day study period.
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The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there's no ground truth to establish for it.
In summary, the provided document describes a medical device (an irrigation solution) and its substantial equivalence determination based on biocompatibility, functional performance, and animal testing, rather than an AI/software device requiring a test set for algorithm performance evaluation, human reader studies, or training sets.
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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
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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
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| O | (D heading 108 973 12 heat 21 CFR 800 Support D | Type of Use (Select one or both, as applicable) |
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| Nort Secience Irrigation SolutionDevice Name | ||
| 510(k) Number (if knownK1616165 | ||
| sing the statement belowiration Date: January 31, 2017 | Food animbA Quog Aministrationdications for Us | |
| Form Approved: OMB No. 0910-0120 | гээгдэг иамин ома нттаан то тиэмтяачээ |
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510(k) Summary: K161165
Next Science™ Irrigation Solution
| Submitter: | Next Science TM, LLC8130 Baymeadows Way WestSuite 200Jacksonville, Florida 32256 |
|---|---|
| Contact Person: | Matthew Myntti, Ph.D.President, Next Science TM, LLC855-564-2762 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, likethe proposed device, it is intended for cleansing andremoval of debris, including microorganisms, fromwounds. |
| Device Description: | Next Science TM Irrigation Solution is an aqueoussolution for irrigation and debridement of wounds.The solution is a clear, colorless, low-odor aqueoussolution that is used to remove debris, includingmicroorganisms, from wounds.The mechanical action of fluid moving across thewound provides the mechanism of action and aids inthe removal of debris, including microorganisms, fromwounds.Next Science TM Irrigation Solution will be provided ina 1000 mL polypropylene plastic container with a |
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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™ IrrigationSolution | Prontosan Wound IrrigationSolution (K072876) |
|---|---|---|
| Company | Next Science, LLC | B. Braun |
| 510(k) Number | K161165 | K072876 |
| Classification | FQH, Jet LavageFRO, Dressing, Wound,Drug | FRO, Dressing, Wound, Drug |
| Composition | Ethanol, 100g/LAcetic acid, 50g/LSodium acetate, 30g/LBenzalkonium chloride,1.3g/LPurified water | 0.1% Undecylenamidopropylbetaine0.1% PolyaminopropylbiguanideSodium hydroxidePurified water |
| Description | Next Science™ IrrigationSolution is a clear, colorlessliquid containing ethanol,acetic acid, sodium acetate, | Prontosan Wound IrrigationSolution is a clear, colorlessliquid containingundecylenamidopropyl betaine, |
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| Product | Next Science™ IrrigationSolution | Prontosan Wound IrrigationSolution (K072876) |
|---|---|---|
| and benzalkonium chloride. | polyaminopropyl biguanide,sodium hydroxide and purifiedwater. | |
| Indications | Next Science IrrigationSolution is to be used with ajet lavage system and isindicated for use incleansing and removal ofdebris, includingmicroorganisms, fromwounds. | Prontosan Wound IrrigationSolution is intended for cleaningwounds and for moistening andlubricating absorbent wounddressings for ulcers, burns,post-surgical wounds andabrasions. |
| Mechanism(s)of Action | Mechanical removal ofdebris via hydrodynamicshear.The mechanical action ofmoving across the woundaids in the removal offoreign material such as dirtand debris. | Mechanical removal of debrisvia hydrodynamic shear.The mechanical action ofmoving across the wound aidsin the removal of foreignmaterial such as dirt and debris. |
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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.
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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.
§ 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.