(114 days)
MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
MIS Solution is a clear, colorless solution intended for cleansing and removal of 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 microorganism, from wounds. MIS Solution is provided in a soft polypropylene 500mL container with a spikeable port. MIS Solution is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.
This document is a 510(k) summary for the device "MIS Solution," a wound irrigation solution. It focuses on demonstrating substantial equivalence to a predicate device, Next Science® Irrigation Solution (K161165).
Based on the provided text, a conventional comparative effectiveness study (like an MRMC study for AI devices) was not conducted. The primary studies are bench tests and biocompatibility studies aimed at showing the new device functions similarly and is as safe as the predicate device, rather than improving human performance or providing standalone AI output.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria and reported device performance in a table format for the primary "efficacy" aspect of debris removal. Instead, it describes performance in qualitative terms and through comparison to a predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Functionality: Able to remove debris including microorganisms from wounds. | "Combined Dissolution Efficacy" Test: Demonstrated that MIS Solution and the predicate device are substantially equivalent at removing debris under static conditions. "Compatibility and Irrigation Force Comparison" Test: Verified that MIS Solution, with manual and powered irrigation devices, reached published pressures deemed adequate for wound irrigation. |
| Biocompatibility: Non-toxic, non-pyrogenic, non-sensitizing, non-irritating, does not inhibit wound healing. | Biocompatibility Studies (ISO 10993-1:2018 Compliant): - Material Mediated Pyrogenicity (USP <151>): Passed. - Guinea Pig Maximization Sensitization Test: Passed. - Porcine Wound Healing: Did not inhibit normal wound healing over 25 days. - Toxicological Risk Assessment (ISO 10993-17): Performed. - Chemical Characterization of Extractables and Leachables: Performed. - Irritation (Human): Determined to be a non-irritant. |
| Safety: No adverse events or complications. | Human Repeat Patch Test (Clinical Study): No adverse events or complications. |
2. Sample Size Used for the Test Set and Data Provenance
- Human Repeat Patch Test (Clinical Study):
- Sample Size: Not explicitly stated, but implies multiple human subjects ("Human Repeat Patch Test"). The number of patches applied is also not stated.
- Data Provenance: Prospective (clinical study), country of origin not specified but likely U.S. as FDA submission.
- Porcine Wound Healing Study (Animal Testing):
- Sample Size: 16 domestic pigs were used. Each pig had eight wounds (four on the left and four on the right side of the animal's back). Two or three wounds per animal were assigned to a treatment group (subject device, predicate device, or negative control).
- Data Provenance: Prospective animal study, country of origin not specified.
- Bench Tests (Compatibility and Irrigation Force Comparison, Combined Dissolution Efficacy): Sample size refers to the number of tests or runs; specific numbers are not provided. Data provenance is laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For biocompatibility and animal studies, "ground truth" is typically objective measurements (e.g., pyrogenicity, irritation scores, wound healing progression assessed by researchers). For the bench tests, the outcomes are based on measurable physical properties (pressure, dissolution efficacy). There is no mention of experts establishing a "ground truth" in the way it would be for an AI diagnostic device reviewing images.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1 consensus) are typically relevant for human interpretation of data, particularly subjective data, where multiple readers provide initial reads. This is not applicable to the types of studies described (biocompatibility, bench tests, animal healing, human patch test), which rely on objective measurements and predefined test protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI device on human reader performance (e.g., radiologists interpreting images). The "MIS Solution" is a wound irrigation solution, not a diagnostic AI device requiring human interpretation of output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a physical solution, not an algorithm. The "standalone" performance would be its inherent chemical and physical properties as measured in the bench tests (e.g., dissolution efficacy) or its biological impact as measured in animal/human studies (e.g., wound healing, irritation).
7. Type of Ground Truth Used
- Biocompatibility Studies: Objective laboratory measurements, standardized test results (e.g., USP <151> for pyrogenicity, ISO 10993 for irritation/sensitization).
- Animal Study (Porcine Wound Healing): Histological and macroscopic evaluation of wound healing progression, as measured by researchers using predefined assessment criteria.
- Human Repeat Patch Test (Clinical Study): Clinical assessment of skin irritation by qualified healthcare professionals based on visual inspection and patient reports, using standardized scoring.
- Performance Bench Testing: Quantitative physical measurements (e.g., pressure, dissolution rate) against established scientific benchmarks or the predicate device.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning algorithm, so there is no training set in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (as there is no training set).
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April 23, 2021
Next Science, LLC Courtney Narain Regulatory Affairs Specialist 10550 Deerwood Park Blvd Ste 300 Jacksonville, Florida 32256
Re: K203835
Trade/Device Name: MIS Solution Regulatory Class: Unclassified Product Code: FRO Dated: March 25, 2021 Received: March 26, 2021
Dear Courtney Narain:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu. Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MIS Solution
Indications for Use (Describe)
MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
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
MIS Solution
| Submitter: | Next Science®, LLC10550 Deerwood ParkSuite 300Jacksonville, Florida 32256 |
|---|---|
| Contact Person: | Courtney NarainRegulatory Affairs Specialist855-564-2762 ext. 6004855-564-2460 (fax) |
| Date Prepared: | April 23, 2021 |
| Device Trade Name: | MIS Solution |
| Device Common Name: | Wound Irrigation Solution |
| Classification Name: | Dressing, Wound, Drug |
| Product Code: | FRO |
| Classification: | Unclassified |
| Predicate Device: | Next Science® Irrigation Solution (K161165) |
| Indications For Use: | MIS Solution is indicated for use in cleansing and removal ofdebris, including microorganisms, from wounds. |
Device Description:
MIS Solution is a clear, colorless solution intended for cleansing and removal of 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 microorganism, from wounds. MIS Solution is provided in a soft polypropylene 500mL container with a spikeable port. MIS Solution is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.
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Technological Characteristics:
MIS Solution (subject device) and Next Science® Irrigation Solution (predicate device) consist of different ingredients. However, while the device technology is different between the subject and predicate device, the function of each ingredient is analogous. Both devices incorporate a surfactant to assist in the solubilization of debris, a buffer system to maintain the pH of the formulation and a vehicle to carry away debris from the wound.
The table below compares MIS Solution to the predicate device.
| Product | MIS Solution | Next Science® Irrigation Solution(Predicate) |
|---|---|---|
| Company | Next Science®, LLC | Next Science®, LLC |
| 510(k) Number | K203835 | K161165 |
| Indications | MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms, from wounds. | 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 micro-organisms, from wounds. |
| Composition | pH BufferSodium Citrate 31.33 g/LCitric Acid 32.50 g/LSurfactantSodium Lauryl Sulfate 1.00g/LVehicleWater | pH BufferSodium Acetate 30.00 g/LAcetic Acid 50.00 g/LSurfactantBenzalkonium Chloride 1.3 g/LVehicleEthanol 100 g/LWater |
| Sterility | Sterile | Sterile |
| 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, microorganisms, dirt and debris.The mechanical action can be provided by either a manual syringe or powered irrigation device. | 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.The mechanical action of the irrigation is provided by the Pulsavac Plus lavage systems |
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Biocompatibility
The biocompatibility of MIS Solution has been evaluated in accordance with ISO 10993-1:2018 and FDA guidance "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The battery of studies includes the following:
- Material Mediated Pyrogenicity using USP <151> ●
- . Guinea Pig Maximization Sensitization Test
- Porcine Wound Healing to address the cytotoxicity endpoint ●
- . Toxicological Risk Assessment per ISO 10993-17
- Chemical Characterization of Extractables and Leachables for device packaging ●
- . Irritation (Human)
Performance Bench Testing
The following bench tests were conducted to support the substantial equivalency of MIS Solution in removing debris from a surface and adequate irrigation:
- Compatibility and Irrigation Force Comparison the test verified that use of the subject ● device in manual and powered irrigation devices were able to reach published pressures deemed adequate for wound irrigation.
- Combined Dissolution Efficacy The test demonstrated that MIS Solution and the . predicate device are substantially equivalent at removing debris under static conditions.
Animal Testing
A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device components on the wound healing process.
In the animal study conducted, 16 domestic pigs were used, each receiving eight wounds, four on the left and right sides of the animal's back parallel to the spine line. Two or three of the animal's wounds were assigned to a treatment group of the subject device, the predicate device or a negative control.
Under the conditions of the study, MIS Solution did not inhibit normal wound healing over 25 days in this porcine wound healing study.
Clinical Study
MIS Solution was evaluated in a Human Repeat Patch Test to evaluate the irritation endpoint in humans. MIS Solution was determined to be a non-irritant. There were no adverse events or complications in this study.
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Conclusion:
The conclusions drawn from biocompatibility, performance tests and a clinical study demonstrate that MIS Solution is as safe and effective as the legally marketed device, Next Science® Irrigation Solution (K161165).
N/A