The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.

Device Description

The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)

AI/ML Overview

The provided text describes the Minimally Invasive Devices Defogging and Cleaning Solution (Flo-X) and its equivalence to predicate devices. It includes a summary of performance testing, which serves as the data to prove the device meets certain criteria.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table like sensitivity/specificity. Instead, it describes performance goals as "effectiveness" and "equivalence" to predicate devices. Since specific criteria are not quantified, I will present the test title as the implicit criterion and the summarized results as the reported performance.

Acceptance Criteria (Implicit from Test Title)	Reported Device Performance
Biocompatibility:
- Syringe Extractable Study	Testing in compliance with ISO 10993-18 was performed to demonstrate that the container did not have any extractable compound that would leach into the Defogging and Cleaning solution.
- Evaluation of acute systemic toxicity (single intra-peritoneal injection into mice)	There was no mortality or evidence of systemic toxicity from the test article injected into mice.
Defogging Effectiveness:
- Effectiveness in defogging a laparoscope lens	This testing demonstrated that the Defogging and Cleaning Solution was effective as a defogging agent when the solution was applied to the laparoscope lens with no mechanical action such as blotting or use of a saturated sponge.
- Ability to Defog the Laparoscope Lens: Comparison with a Predicate Device	The Defogging and Cleaning Solution and the predicate device both demonstrated that they were effective and equivalent in defogging the laparoscope lens.
- Animal Testing: Effectiveness in keeping laparoscope lens defogged (Porcine Peritoneal Cavity)	The Defogging and Cleaning Solution was effective in keeping the laparoscope lens defogged when applied externally and was found to be equivalent to the predicate devices in keeping the laparoscope lens defogged when applied externally. The Minimally Invasive Device Defogging and Cleaning Solution did not interfere with the function of the FloShield™ Plus System, worked in conjunction with the FloShield™ Plus System and was effective in removing/cleaning debris/blood/fat from the lens in situ when applied in 1-2 cc aliquots through the FloShield™ Plus System.
Cleaning Effectiveness:
- Ability to Clean the Laparoscope Lens: Comparison with Water and Saline	The results demonstrate that the Defogging and Cleaning Solution effectively removed the grease from the laparoscope lens when applied with flushing via the FloShield™ Plus System. In comparison with water and saline, the water was the least effective at cleaning the lens, saline was slightly better, but the Defogging and Cleaning Solution was superior to water and saline in clearing grease from the lens. The Minimally Invasive Device Defogging and Cleaning Solution did not interfere with the function of the FloShield™ Plus System, worked in conjunction with the FloShield™ Plus System and was effective in removing/cleaning debris/blood/fat from the lens in situ when applied in 1-2 cc aliquots through the FloShield™ Plus System. (This benefit is also mentioned in the animal testing result).
Stability/Sterilization Compatibility:
- Effects of Irradiation on the Defogging and Cleaning Solution (E-Beam 25-40 kGy)	Analysis of the Defogging and Cleaning Solution pre and post E-Beam irradiation to 25-40 kiloGray (kGy) demonstrates that the solution is not affected by irradiation. The Docusate component is stable and the solution properties are unchanged. pH, concentration and analysis by HPLC were used to make the assessments.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify exact numerical sample sizes for most tests.
- For the acute systemic toxicity test, it mentions "mice" but not the number of mice.
- For other bench and animal (porcine peritoneal cavity) studies, the sample sizes are not explicitly stated.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but the descriptions of "testing performed" and "studies" imply these were prospective studies designed to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The tests seem to be primarily objective (e.g., measuring defogging, cleaning efficacy against a known contaminant like grease, stability analysis) rather than relying on expert subjective evaluation for "ground truth."

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (bench and animal, with objective metrics like clearing grease or defogging), it's unlikely that a human adjudication method in the context of clinical image assessment would be relevant or used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC study is not applicable and was not done. The device is a "Defogging and Cleaning Solution" for a laparoscope lens, not an AI or diagnostic imaging tool that would assist human readers interpreting medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is a physical solution, not an algorithm. Its performance is inherent to its physical and chemical properties and is evaluated in its intended use environment.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests appears to be:

Objective measures of function: E.g., the visible absence of fog, the visible removal of grease, the stability of chemical properties (pH, concentration, HPLC).
Comparison to controls/predicates: Water, saline, and legally marketed predicate defogging devices serve as benchmarks for effectiveness and equivalence.
Biological outcomes: For the toxicity study, "no mortality or evidence of systemic toxicity" in mice served as the outcome/ground truth for safety.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an abstract human figure or a symbol representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Minimally Invasive Devices, LLC % MM & A Consulting, LLC Mark L. Friedman, Ph.D. 6329 SW 81st Road Lake Butler, FL 32054

JUL 2 7 2015

Re: K102452

Trade/Device Name: Minimally Invasive Devices Defogging and Cleaning Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT Dated (Date on orig SE ltr): December 16, 2010 Received (Date on orig SE ltr): December 20, 2010

Dear Dr. Friedman,

This letter corrects our substantially equivalent letter of December 23, 2010.

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. Iisting 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (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/Safetw/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 Small Manufacturers, International and Consumer Assistance 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEC 2 3 2010

Indications for Use

510(k) Number (if known): _ K 102452

Device Name: Minimally Invasive Devices Defogging and Cleaning Solution

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rs. Rha 1 no 17
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102412

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Minimally Invasive Devices, Inc.

510(k) Summary

KIO 24.52

DEC 2 3 2010 Applicant Name Minimally Invasive Devices, Inc. and Address 1275 Kinnear Road Columbus, Ohio 43212 Contact Person: Caroline Crisafulli Date of Summary: December 16, 2010 Name of Device: Trade/Proprietary Name: Flo-X Common Name: Defogging and Cleaning Solution Establishment Name: Minimally Invasive Devices, Inc. 1275 Kinnear Road Columbus, Ohio 43212 3007362639 Establishment Number: Proposed Classification: KOG Class II 21 CFR Part 876.1500, Endoscope and/or Accessories. General and Plastic Surgery Panel: Predicate Devices:

K944249	Covidien Auto-Suture Anti-Fog Solution (Dexide FRED)
K982465	DeRoyal Industries, Inc. DeFogger
K080613	Minimally Invasive Devices, Inc. FloShieldTM System

Intended Use:

Device Description:

Summary of Technological Characteristics:

The Defogging and Cleaning Solution is comprised of a surfactant that provides the same physical characteristics as the listed predicate devices. The Defogging and Cleaning Solution is a clear/colorless, water soluble solution that is packaged in a syringe or bottle for easy use. The

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product is irradiated to ensure sterility. The defogging (anti-fogging) action of the Minimally Invasive Devices Defogging and Cleaning Solution works as a defogger in the same fashion of the predicate devices. Typically anti-fog treatments work by minimizing surface tension. resulting in a non-scattering film of water instead of single droplets, an effect called welting. Surfactants are one compound that are used in the predicate devices to "wet" the surface of the lens

Summary of Performance Testing:

Animal and bench studies (in simulated peritoneal cavity environments) have shown that the Minimally Invasive Devices Defogging and Cleaning Solution effectively washes debris and any oil, including lipid-based debris from the lens that saline or water will are unable to wash away. The cleaning action is a simple flush across the lens (no mechanical mechanism such as wiping is needed) when needed, the surfactant properties effectively rinse/wash the debris from the lens. The surfactant will then easily flow off the lens resulting in a refreshed and clear view of the operative site without interrupting the procedure. The testing performed included the following:

Test Title	Summarized Results
Syringe Extractable Study	Testing in compliance with ISO 10993-18 was performed to demonstrate thatthe container did not have any extractable compound that would leach into theDefogging and Cleaning solution.
Evaluation of acute systemic toxicity of theDefogging and Cleaning Solution following asingle intra-peritoneal injection into mice.	There was no mortality or evidence of systemic toxicity from the test articleinjected into mice.
Verification that the Minimally InvasiveDevices Defogging and Cleaning Solution iseffective in defogging a laparoscope lens.	This testing demonstrated that the Defogging and Cleaning Solution waseffective as a defogging agent when the solution was applied to thelaparoscope lens with no mechanical action such as blotting or use of asaturated sponge
Ability to Defog the Laparoscope Lens:Comparison between the Minimally InvasiveDevices Defogging and Cleaning Solutionand a Predicate Device	The Defogging and Cleaning Solution and the predicate device bothdemonstrated that they were effective and equivalent in defogging thelaparoscope lens.
Ability to Clean the Laparoscope Lens:Comparison between the Minimally InvasiveDevices Defogging and Cleaning Solution,Water and Saline	The results demonstrate that the Defogging and Cleaning Solution effectivelyremoved the grease from the laparoscope lens when applied with flushing viathe FloShield™ Plus System. In comparison with water and saline, the waterwas the least effective at cleaning the lens, saline was slightly better, but theDefogging and Cleaning Solution was superior to water and saline in clearinggrease from the lens.
Effects of Irradiation on the Defogging andCleaning Solution	Analysis of the Defogging and Cleaning Solution pre and post E-Beamirradiation to 25-40 kiloGray (kGy) demonstrates that the solution is notaffected by irradiation. The Docusate component is stable and the solutionproperties are unchanged. pH, concentration and analysis by HPLC wereused to make the assessments.
Animal Testing of the Defogging and	The Defogging and Cleaning Solution was effective in keeping thelaparoscope lens defogged when applied externally and was found to beequivalent to the predicate devices in keeping the laparoscope lens defoggedwhen applied externally.
Cleaning Solution (Porcine Peritoneal Cavity)	The Minimally Invasive Device Defogging and Cleaning Solution did notinterfere with the function of the FloShield™ Plus System, worked inconjunction with the FloShield™ Plus System and was effective inremoving/cleaning debris/blood/fat from the lens in situ when applied in 1-2 ccaliquots through the FloShield™ Plus System.

Conclusion:

The Minimally Invasive Devices Defogging and Cleaning Solution (Flo-X) is equivalent to the predicate devices in its ability to defog and keep a laparoscope lens defog during minimally invasive surgery and additionally aids in cleaning the laparoscope lens of debris that might otherwise accumulate on the lens during the course of the surgery. The Defogging and Cleaning Solution is at least as safe and effective as predicate devices.

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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.