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The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041. Thus, the device description for the CoaguChek XS Plus System remains the same as that presented and cleared in K071041. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Plus System housing and components.

The provided document describes a Special 510(k) submission for extending cleaning and disinfection claims for the CoaguChek XS Plus System to include "Super Sani-Cloth" wipes.

Here's an analysis of the acceptance criteria and study for the device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions that the CoaguChek XS Plus meters were subjected to 10,950 Cleaning and Disinfection (C&D) cycles. This number represents the simulated lifetime (three years at 10 tests/day) of the cleaning/disinfection robustness. The number of actual meters tested (i.e., the sample size of the devices themselves) is not explicitly stated. However, it implies testing was performed on at least one or more devices to generate this data.
• Data Provenance: Not specified, but the context is an FDA submission from Roche Diagnostics, implying internal testing conducted by the manufacturer. The document does not mention the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing carried out for this submission.

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

• Not Applicable. This study is focused on the robustness of the device itself to a cleaning and disinfection process, not on diagnostic performance where expert interpretation of results would be required to establish ground truth. The 'ground truth' here is the continued accurate function and performance of the instrument.

4. Adjudication Method for the Test Set:

• None. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. This study evaluates the objective performance (accuracy and functionality) of a medical device after a specific treatment (cleaning/disinfection).

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 is not an AI-assisted diagnostic device, nor is it a study involving human readers.

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

• Yes, in the sense that the device's performance was evaluated standalone. The study assessed the inherent accuracy and functionality of the CoaguChek XS Plus System after cleaning with Super Sani-Cloth wipes. There's no human-in-the-loop variable being tested here; it's about the device's physical and operational integrity.

7. The Type of Ground Truth Used:

• The ground truth used is the inherent accurate measurement capability and continued functionality of the CoaguChek XS Plus System before and after repeated cleaning and disinfection cycles. This is established by comparing the device's performance (specifically, meter accuracy) using venous blood measurements against established standards or baseline performance, and verifying that its functionality (e.g., ability to power on, display results, etc.) remains intact.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" for this type of robustness study. The study involves demonstrating that the already cleared device, K071041, maintains its performance after being subjected to a specific cleaning agent. It's not a machine learning or AI algorithm that requires training data.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460. Thus, the device description for the CoaguChek XS Pro System remains the same as that presented and cleared in K093460. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Pro System housing and components.

This document (K180693) describes a Special 510(k) Premarket Notification for the CoaguChek XS Pro System. The purpose of this submission is not to introduce a new device or change the core functionality of the existing CoaguChek XS Pro System (cleared under K093460). Instead, it's to add Super Sani-Cloth wipes to the approved cleaning and disinfection procedures for the device, replacing 10% sodium hypochlorite solution. Therefore, the acceptance criteria and study described focus on the device's robustness and continued performance after repeated exposure to the new cleaning agent.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for the Test Set: "CoaguChek XS Pro meters that had been subjected to 10,950 C&D cycles". This refers to the number of cleaning and disinfection cycles applied to the meters, not individual patient samples. The number of actual meters tested is not explicitly stated in this excerpt, but it implies a sufficient number were used to confirm the robustness over the simulated lifetime.
• Data Provenance: Not explicitly stated, but given this is a robustness study for cleaning chemicals, it would likely be laboratory-based testing conducted by the manufacturer (Roche Diagnostics). It is implicitly prospective testing as the devices were subjected to a defined number of cleaning cycles.

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

• Not applicable. This study is not a diagnostic performance study requiring expert interpretation of results to establish ground truth (e.g., radiologists reviewing images). Instead, it focuses on the physical and functional integrity of the device after exposure to cleaning agents. The "ground truth" here is the original, un-degraded performance of the CoaguChek XS Pro System, against which the post-cleaning performance is compared.

4. Adjudication Method for the Test Set

• Not applicable. This study does not involve expert adjudication of results. The assessment is based on objective measurements of meter accuracy and functionality compared to established performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. This is not an MRMC study. An MRMC study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a study validating a cleaning agent's compatibility with a medical device.

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

• Yes, effectively. The study implicitly evaluates the "standalone" performance of the CoaguChek XS Pro System itself after undergoing the cleaning process. The CoaguChek XS Pro System is a quantitative measurement device, and its accuracy and functionality are assessed intrinsically, not in conjunction with human interpretation in the way an AI diagnostic algorithm would be.

7. The Type of Ground Truth Used

• Established Performance Specifications / Reference Method. The "ground truth" is the expected accurate and functional performance of the CoaguChek XS Pro System when measuring prothrombin time using venous blood, against which the performance of the repeatedly cleaned meters is compared. The original clearance (K093460) would have established the accuracy of the device against a reference method.

8. The Sample Size for the Training Set

• Not applicable. This is a validation study for cleaning procedures, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As there is no training set, this question is not relevant.

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The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.

The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.

The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.

No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679.

Thus, the Device Description for the ACCU-CHEK Inform II System remains the same as that presented and cleared in K121679.

This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the ACCU-CHEK Inform II System housing and components.

Please note that we intend to modify the ACCU-CHEK Inform II System labeling by adding the Super Sani-Cloth for cleaning and disinfection of the system, in addition to the Clorox Germicidal Wipes, which were previously cleared for this purpose on K121679. The Super Sani-Cloth will not replace the current Clorox Germicidal Wipe. Both wipes will be included in the product labeling.

This 510(k) submission (K130138) is a "Special 510(k)" for a claim extension to the existing ACCU-CHEK® Inform II System. The purpose is to add another cleaning and disinfecting product, Super Sani-Cloth® wipes, for use with the device. Therefore, the acceptance criteria and study described focus on the effectiveness of the Super Sani-Cloth wipes for cleaning and disinfection, not on the glucose monitoring performance of the ACCU-CHEK Inform II System itself.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Meet performance requirements for intended use. | "All components passed the cleaning and disinfection test protocol, based on the defined criteria."
  "The corresponding test results demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device..." |
  | Substantial equivalence to the predicate device (ACCU-CHEK Inform II System with Clorox® Germicidal Wipes for cleaning and disinfection). | "The Super Sani-Cloth is substantially equivalent to the Clorox Germicidal Wipe when used on the ACCU-CHEK Inform II System."
  "Overall, the data demonstrate that the ACCU-CHEK Inform II System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes." |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document states the test was performed on "the same six distinct components of the ACCU-CHEK Inform II System," but it does not specify the number of individual devices or components tested, nor the number of cleaning/disinfection cycles.
• Data Provenance: The document implies this was a prospective study conducted by Roche Diagnostics Corporation, as they are submitting the results. The country of origin is not explicitly stated, but the company is based in Indianapolis, IN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" here would relate to the assessment of cleanliness and disinfection efficacy, which would typically be determined by laboratory methods (e.g., microbial cultures, visual inspection for cleanliness) rather than expert human interpretation in the context of device performance.

4. Adjudication method for the test set

This information is not provided in the document, as the evaluation likely involved quantitative laboratory measurements rather than human reader adjudication.

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

There was no MRMC comparative effectiveness study done. This submission is about the efficacy of a cleaning/disinfecting wipe, not an AI-assisted diagnostic tool.

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

A "standalone" study in the typical sense of algorithm performance was not done. The study evaluated the standalone performance of the Super Sani-Cloth wipes in cleaning and disinfecting the device components, according to a defined protocol. There is no algorithm involved.

7. The type of ground truth used

The ground truth used would be based on laboratory standards and measurements for cleaning efficacy (e.g., visual cleanliness, gravimetric analysis if applicable) and disinfection efficacy (e.g., reduction in microbial load according to established disinfectant testing standards). While the specific methods aren't detailed, "All components passed the cleaning and disinfection test protocol, based on the defined criteria" indicates adherence to such objective measures.

8. The sample size for the training set

There is no training set in the context of this submission. This is a validation study for a cleaning product, not a machine learning model.

9. How the ground truth for the training set was established

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

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Vapo Solution™ is an alcohol solution intended to be used only in Harvey Chemiclave sterilizers to sterilize medical and dental surgical instrument. Vapo Solution™ is intended to be a direct substitute for Vapo-Steril®. Vapo Solution™ is recommended for use in the following Chemiclave models: 4000, 5500, 6000 and models covered under K924380 and K943654.

Vapo Solution™ is compatible with Chemiclave cycle parameters as follows:

• Model 4000, 5000, 5500, 6000, EM5000, EM5500, and EM6000
• Operating pressure: 20-40 psi (1.41 2.82 kg/cm²)
• Operating Temperature: 132 +2 ℃ (270 + 5 0r)
• Maximum load: Bagged instruments:
  • 6" Chamber (models 4000, 5000, EM5000) 0.6 Kg (1.3 lbs)
  • 8" Chamber (models 5500, EM5500) 1.2 Kg (2.6 lbs)
  • 10" Chamber (models 6000, EM6000) 2.4 Kg (5.3 lbs)
• Maximum load: Unwrapped instruments:
  • 6" Chamber (models 4000, 5000, EM5000) 0.75 Kg (1.7 lbs)
  • 8" Chamber (models 5500, EM5500) 1.4 Kg (3.1 lbs)
  • 10" Chamber (models 6000, EM6000) 2.8 Kg (6.2 lbs)
• Model 7000 and 8000
• Operating pressure: approximately 25 psi
• Operating Temperature: 132 ± 2°C (270 ±5°F)
• Maximum load: Bagged instruments:
  • 8" Chamber (model 7000) 1.2 Kg (2.6 lbs)
  • 10" Chamber (model 8000) 2.4 Kg (5.3 lbs)
• Maximum load: Unwrapped instruments:
  • 8" Chamber (model 7000) 1.4 Kg (3.1 lbs)
  • 10" Chamber (model 8000) 2.8 Kg (6.2 lbs)

Vapo Solution™ is compatible with but not limited to the following instruments and material types:

• Surgical and cutting instruments, handpieces, and similar items.
• Plastics that can tolerate in excess of 132 °C. i.e. Polysulfone, Phenolic, Nylon, Teflon, Polyethylene, Polyacetal, Polypropylene. Note: Polycarbonate is not chemically compatible.
• Rubber components made of Silicone, Fluorosilicone

Vapo Solution™ is not compatible with the following materials:

• Linen, textiles or fabrics These are incompatible with the chemical vapor process.
• Liquids and agars These are incompatible with high temperature processing (132°C).
• Items contained in tightly woven packs or wraps, or sealed containers These cause poor vapor penetration.
• Plastics which cannot tolerate temperatures in excess of 132ºC.
• Polycarbonate - Chemically incompatible.
• Nylon tubing and bags Inhibits penetration of chemical vapors.

Vapo Solution™ is not recommended for use for "flash" sterilization cycles.

A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers.

The provided text describes a 510(k) submission for a sterilization solution, not a medical device in the typical sense of needing performance metrics like sensitivity or specificity. Therefore, the information requested in the prompt, which is geared towards diagnostic or AI-powered devices, is not directly applicable.

However, I can extract the relevant "acceptance criteria" and "performance data" as presented in the document, interpreting "acceptance criteria" as what the manufacturer aimed to demonstrate for substantial equivalence and "reported device performance" as the data provided to support that claim.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the claim of "substantial equivalence" to the predicate device, MDT Harvey Vapo-Steril® solution. Specifically, the device (Vapo Solution™) had to demonstrate comparable efficacy in killing spores.

"One-year old solution (600 additional tests): Same comparative results."

"Two-year old solution (600 tests): Same comparative results."

Conclusion: "From non-clinical tests, the Model 5000 shows no significant difference in survivors for the two solutions; the Models 5500 and 6000 show a significant difference in survivors at shorter cycle times (Vapo Solution™ has fewer survivors), but no significant difference at longer cycle times. The two solutions are substantially the same in efficacy." |
| Non-toxic performance. | "A study conducted in dental offices using an analogous alcohol solution containing 0.23% formaldehyde reported the following: 15 min STEL ave. 0.81 ppm (OSHA 2.0 ppm); 8-hour average 0.029 ppm (OSHA TWA 1.0 ppm). 29 CFR 1910.1048 >0.1 ppm considered a Health Hazard." (This indicates the levels were below OSHA hazardous thresholds.) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Efficacy Tests: "4,000 independent tests were performed using 'fresh' solutions; 600 additional tests using one-year old solutions; 600 tests using two-year old solutions." This totals 5,200 tests.
  • For the "fresh" solutions, the breakdown per model is: 680 tests (Vapo Solution™) + 670 tests (Vapo-Steril®) for Model 5000; 650 tests (Vapo Solution™) + 640 tests (Vapo-Steril®) for Model 5500; 680 tests (Vapo Solution™) + 680 tests (Vapo-Steril®) for Model 6000. These specific tests total 4,000.
  • Toxicology: "A study conducted in dental offices" – no specific sample size (number of offices or measurements) provided, but it implies real-world usage.
• Data Provenance: Not explicitly stated (e.g., country of origin). The efficacy tests are described as "independent tests," suggesting controlled laboratory conditions rather than clinical data from patients. The toxicology study was "conducted in dental offices," indicating a real-world, prospective measurement of air quality during use. The studies appear to be prospective as they involved performing tests with the solutions and measuring outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the ground truth for sterilization efficacy is typically established through direct microbiological culture results (presence/absence of Bacillus stearothermophilus growth), not expert consensus on interpretations of images or patient data. For toxicology, the ground truth is established by chemical measurement against OSHA standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of complex data (e.g., medical images) to establish a consensus ground truth. Here, the ground truth is based on objective scientific measurements (spore growth, chemical concentration).

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

This information is not applicable. MRMC studies are relevant for diagnostic devices that involve human interpretation, often assisted by AI. This submission is for a sterilization solution, which does not involve human "readers" or AI assistance in its direct function.

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

This information is not applicable. This is a chemical solution, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Efficacy Tests: The ground truth for efficacy was the direct measurement of Bacillus stearothermophilus spore growth on spore strips after sterilization cycles. The absence of growth indicates successful sterilization (killing of spores).
• Toxicology: The ground truth for toxicology was quantitative measurement of formaldehyde levels in the air of dental offices, compared against established OSHA safety standards.

8. The sample size for the training set

This information is not applicable. This is a chemical product, not a machine learning device that requires a training set. The performance data presented are for validation/testing, not training.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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