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The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.

The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope. The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours. The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter. The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use. Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth.

This document describes the Xodus Medical Scope Antifogging System and its substantial equivalence to a predicate device, the Covidien Clearify Visualization System. The information provided focuses on performance testing to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting specific performance metrics for antifogging and other functions.

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

• Antifogging Validation (Bench): Not explicitly stated, but implies multiple applications and comparisons.
• Life Expectancy Validation: Not explicitly stated; "The Scope Antifogging System was activated and observed" implies at least one device, likely more for statistical relevance.
• Trocar Wiping Validation: "three test cases" were conducted.
• Antifogging Validation (Animal): "several instances" and "series of exploratory procedures with four different Storz laparoscope types" were used in "a live, anesthetized pig."
• Scope Lens Wiping of Debris (Animal): "all occasions" when matter was applied and wiped.
• Biocompatibility, Sterilization, Electrical Safety/EMC: Standardized tests typically use specific sample sizes dictated by the standards themselves.

Data Provenance: The studies were conducted internally ("Performance Testing - Bench" and "Performance Testing - Animal") by Xodus Medical, Inc. The data is prospective, generated specifically for this 510(k) submission. No information on country of origin of data beyond "Xodus Medical, Inc."

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

This document does not specify the number or qualifications of experts used to establish the ground truth for any of the performance tests. The conclusions for antifogging efficacy ("demonstrated the effectiveness... consistently, as with the predicate device") and wiping effectiveness ("successfully wiped away... no visible signs of any debris") appear to be based on direct observation during the tests.

4. Adjudication Method

Not applicable/not specified. The performance testing described suggests direct observation and comparison to the predicate device's performance, rather than an adjudication process involving multiple human reviewers to establish a consensus ground truth.

5. 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

Not applicable. This device is an antifogging system, not an AI-powered diagnostic or assistive tool for human readers/clinicians, therefore, no MRMC study or AI-related effect size data is presented.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As this device is a physical system for preventing fogging, the concept of a "standalone algorithm" is not relevant. The performance tests ("Bench" and "Animal") are essentially standalone evaluations of the device's physical function.

7. The Type of Ground Truth Used

• Antifogging: Direct observation of the presence or absence of fogging on the simulated equipment or laparoscope lens. The "ground truth" for effectiveness was the visual clear state of the lens, and the comparison was against the identical function of the predicate device.
• Warming Circuit Duration: Measurement of the duration the circuit remained activated and thermal characteristics were maintained.
• Wiping Effectiveness: Direct visual observation of the absence of debris (blood, tissue, bile, smudging) after wiping.
• Biocompatibility, Sterilization, Electrical Safety/EMC: Ground truth is established by adherence to and successful completion of specified international standards (ISO 10993-1, ISO 11137-2, IEC 60601-1-2, IEC 60601-1).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

As there is no training set for an algorithm, this question is not applicable.

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The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.

Indications: General, urologic, thoracic, plastic/reconstructive, gynecologic, laparoscopic and arthroscopic surgical procedures.

This device is used to activate the CUT and COAGULATE modes of an electrosurgical generator in order to cut soft tissue via a handheld push button or rocker switch controlled electrosurgical pencil. The body of the device has a molded plastic housing with either two buttons (one for cut and one for coagulate) or a rocker switch located at the distal end of the pencil. A ten foot cable exiting the housing features a universal three prong plug allowing the pencil to be connected to the monopolar side of a standard electrosurgical generator. A PTFE coated electrode or an uncoated stainless steel electrode will be packaged with this device with the option of including an insulated holster.

The Holster serves as an insulated container to store the pencil while it is inactive in order to avoid accidental activation when not in use. The holster conveniently attaches to a surgical drape.

The uncoated stainless steel electrode is used to cut and coagulate soft tissue. The PTFE coated electrode is a stainless steel electrode coated with a non-stick material (PTFE), which is also used to cut and coagulate soft tissue. The PTFE coating reduces the build up of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup.

This device is a single use, disposable device which will be sold sterile and bulk nonsterile to be sterilized by the customer. Electrode tips are also single use, disposable devices which may be sold individually sterile or bulk non-sterile to be sterilized by the customer.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for an electrosurgical pencil, primarily focusing on its equivalence to a predicate device and its intended use. There are no details regarding specific performance metrics, test methods, sample sizes, or expert involvement in a study.

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Anti-Fog is intended to be used to prevent "fogging" caused by condensation on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.

The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (

This 510(k) submission (K063587) for the Xodus Medical, Inc. Anti-Fog Solution is based on substantial equivalence to a predicate device, the Clear it Anti-Fog (K022826) by Preservation Solutions, Inc. It does not contain a study with explicitly defined acceptance criteria and device performance metrics in the typical sense of a novel medical device.

Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device. This means the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

Here's how to break down the information based on your request, even though it's not a performance study in the traditional sense:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not involve a "test set" in the context of clinical or performance data collection for the new device. The "testing" was primarily analytical comparison to the predicate device.

• Sample Size: Not applicable in the sense of patient or experimental samples. The comparison was based on deformulation of the predicate device and comparison of physical characteristics of the new device.
• Data Provenance: Deformulations of the predicate device (Clear it Anti-Fog) were performed presumably by Xodus Medical, Inc. This is an internal, analytical process rather than a clinical study with patients.

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

• Not Applicable: No "ground truth" in the sense of clinical expert assessment was established for a test set. The comparison was chemical and physical.

4. Adjudication Method for the Test Set

• Not Applicable: No adjudication method was used as there was no test set requiring multi-reader review or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This type of study (MRMC) was not performed. The device is an anti-fog solution, not an interpretive diagnostic system where human reader performance is pertinent.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable: This is a physical solution, not an algorithm. Therefore, a standalone performance study in that context was not performed.

7. Type of Ground Truth Used

The "ground truth" in this context is the established physical and chemical characteristics and performance of the predicate device.

• This was determined through:
  • Deformulation (reverse engineering of chemical composition) of the predicate device.
  • Direct comparison of physical characteristics (e.g., clear/colorless, water-soluble, bottling, packaging) between the new device and the predicate.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of an algorithm or machine learning. The comparison is based on the characteristics of the predicate device.

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

• Not Applicable: As there's no training set, this question is not relevant. The basis for comparison ("ground truth" of predicate device characteristics) was established through deformulation and direct observation.

In summary, K063587 is a 510(k) submission based on substantial equivalence. The "study" demonstrating this involves analytical chemistry (deformulation) and direct comparison of physical and functional characteristics to a previously cleared predicate device, rather than a clinical trial or performance study with acceptance criteria for quantitative metrics like sensitivity or specificity.

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The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.

The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Light Guard Light Handle Cover) which focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for the specific points you've listed (sample size, experts, adjudication, MRMC, standalone, ground truth, training set size).

The document states: "Xodus Medical Inc.'s Light Guard Light Handle Cover has the same physical characteristics, material and design as the predicate device. They are both designed to slide over a surgical light handle. Both the predicate device and Xodus Medical's device are used to provide a sterile barrier between the sterile personnel and the non-sterile light handle." This indicates that the regulatory approval was based on substantial equivalence, implying that the new device performs similarly to the already approved predicate device, rather than requiring a new clinical study to establish performance against specific acceptance criteria.

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The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

The disposable Cautery Tip Cleaner is a small 2" x 2" square polyurethane foam pad which features a textile abrasive layer with an adhesive backing. A radiopaque strip within the adhesive makes the device x-ray detectable. The adhesive backing allows for universal placement as well as allowing the device to remain in place while the tip of the electrosurgical cauterization device is "scratched" on the abrasive surface to remove eschar buildup.

The provided text is a 510(k) summary for a Cautery Tip Cleaner and does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document focuses on the device description, intended use, technological characteristics comparison to a predicate device, and the FDA's determination of substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

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