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The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.

The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).

The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.

The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).

The provided text describes the STERIZONE® CI+ Chemical Indicator and its assessment for substantial equivalence to a predicate device. It explicitly states that "Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010."

However, the document does not describe a study involving an AI device or algorithm. The "device" in question is a chemical indicator that changes color. Therefore, most of the requested information regarding AI device-specific criteria (like sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this text.

I will provide the acceptance criteria and performance as described for the chemical indicator, and note where the requested information is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance for Test Set:
The document does not specify specific sample sizes (e.g., number of indicators tested) for each non-clinical test.
Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests, which are laboratory-based functionality tests for a chemical indicator, not typically tied to patient data.

3. Number and Qualifications of Experts for Ground Truth (Test Set):
Not applicable. This device is a chemical indicator with a physical color change. Its performance is assessed by physical and chemical tests against a standard, not by human expert interpretation in the same way an AI diagnostic tool would be.

4. Adjudication Method for Test Set:
Not applicable for the reasons stated above. The "ground truth" for a chemical indicator is its physical response to sterilization parameters as defined by industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a chemical indicator, not an AI system. There are no "human readers" to improve with "AI assistance" in this context.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a passive chemical indicator, not an algorithm.

7. Type of Ground Truth Used:
The ground truth used for evaluating the STERIZONE® CI+ Chemical Indicator is based on industry standards and physical/chemical properties. Specifically, performance is assessed against the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010. The color change (red to peach or lighter) triggered by exposure to the STERIZONE® VP4 Sterilizer's Cycle 1 is the intended functional ground truth.

8. Sample Size for Training Set:
Not applicable. This is a manufactured chemical indicator, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable. As above, no training set or AI model is involved.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.

The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55 - 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the media ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60 ℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to vellow and/or if the media is turbid.

This document describes two devices, the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Biological Indicator Challenge Pack. Both submissions are focused on qualifying these devices for use with the new V-PRO 60 Low Temperature Sterilization System, demonstrating substantial equivalence to their respective predicate devices.

VERIFY® V24 Self-Contained Biological Indicator (SCBI)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 unit," implying prospective testing for this specific sterilizer. The K numbers (K073244, K090514) indicate prior clearances and associated data.

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

This information is not provided within the document. The "ground truth" for biological indicators is inherently based on the viability of Geobacillus stearothermophilus spores, which is determined by culturing and observing growth or no-growth.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail, or sterile/non-sterile) for biological indicators is typically a direct observation of microbial growth or lack thereof.

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

This type of study is not applicable as the device is a biological indicator, not an imaging or diagnostic AI tool that involves human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The device, a biological indicator, functions independently without a human in the loop for its direct performance, though human observation is required for interpreting its results (color change, turbidity).

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores. A successful sterilization cycle should kill all spores, resulting in no growth (sterile). If spores survive, they will grow, indicating a sterilization failure. This is effectively a biological assay for sterility.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator. All listed tests are performance evaluations for the device itself rather than training data for an algorithm.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth underpin the ground truth for biological indicators.

VERIFY® V24 Biological Indicator Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 Sterilizer," implying prospective testing for this specific sterilizer. K103331 is cited as the predicate.

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

This information is not provided within the document. Similar to the SCBI, the ground truth for the challenge pack relies on the biological viability of Geobacillus stearothermophilus spores and the visual change of the chemical indicator.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail) is based on the biological indicator's growth/no growth and the chemical indicator's color change.

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

This type of study is not applicable as the device is a biological indicator challenge pack.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The challenge pack, containing a biological indicator and a chemical indicator, functions independently in the sterilizer without a human in the loop for its direct performance. Human observation is required for interpreting the results of both indicators.

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores for the biological indicator component and the color change of the chemical indicator. Both are indicators of effective sterilization.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator challenge pack. All listed tests are performance evaluations for the device itself.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth, along with established chemical indicator responses to sterilization processes, underpin the ground truth.

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The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO maX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
  • an inside diameter of 1 mm or larger and a length of 125 mm or shorter
  • an insider diameter of 2 mm or larger and a length of 250 mm or shorter
  • an inside diameter of 3 mm or larger and a length of 400 mm or shorter
    The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
   The flexible endoscopes may contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
   The flexible endoscope can contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.

The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required.

The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.

The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.

The provided 510(k) summary (K112760) describes a modification to the Amsco V-PRO maX Low Temperature Sterilization System, involving minor software changes to enhance usability. The study submitted for this modification is a Software Validation.

Here's a breakdown of the requested information 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

The document does not explicitly state the sample size used for the software validation test set (e.g., number of test cases run, or specific inputs). It only indicates that "Software Validation" was performed.

Regarding data provenance, the document does not specify country of origin for the validation data. The nature of the study (software validation) suggests it would be conducted in a controlled environment, likely by the manufacturer (STERIS Corporation, based in Mentor, Ohio, USA). The study is retrospective in the sense that the software was already developed and then validated.

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the software validation. For a software validation, ground truth would typically be defined by the software requirements and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the software validation. For software validation, discrepancies (bugs) are typically identified and fixed, not adjudicated by independent parties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The Amsco V-PRO maX is a sterilizer, and its effectiveness is determined by its ability to reliably sterilize medical devices, not by human interpretation of its output in a clinical setting. Therefore, an MRMC study with human readers and AI assistance is not applicable to this device.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, a standalone study was performed. The "Software Validation" is an assessment of the algorithm (software)'s performance against its specifications and intended function without human intervention in its operation other than initiating the process and evaluating the outcome of the software's execution.

7. Type of Ground Truth Used

For the "Software Validation," the ground truth would be defined by the software requirements and specifications. The software's performance is validated against these pre-defined functional and non-functional requirements to ensure it operates as intended.

8. Sample Size for the Training Set

The document does not mention a "training set" because this is a software validation for a sterilizer. The software for a sterilizer is typically developed based on engineering principles and verified through testing against specifications, rather than being "trained" on a dataset like a machine learning algorithm.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

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