Search Results

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two 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 that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
  • Or two lumens with:

• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length

• And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• 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. ++ The flexible endoscope may contain either:

· A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:
  • One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
  • And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

** 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 weight of 24 lbs (11 kg).

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: *

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
• · Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or

2.8 mm ID and 1 mm (~3/64") ID and 1.8 mm (~5/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, using VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required following completion of the cycle.

The V-PRO 1, V-PRO 1 Plus, and the V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycles, respectively.

The provided text describes the acceptance criteria and supporting studies for the STERIS Amsco V-PRO Low Temperature Sterilization Systems.

Here's the breakdown:

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

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

The document primarily describes validation studies for the V-PRO sterilization systems, which are typically performed in a prospective manner.

• Determination of Worst Case Material for VHP: This refers to previous submissions, but the current document specifically highlights Kraton as the "most resistant material." No specific sample size is given for how many materials were evaluated to determine Kraton as the worst case in previous studies.
• Medical Device Material Compatibility: "20 materials" were tested.
• Cytotoxicity Evaluation of Medical Devices: "various medical devices containing [unspecified material components]" were tested.
• Hydrogen Peroxide Residual Analysis of Processed Medical Devices: "19 proposed compatible materials" were tested across "three (3), worst case, back-to-back Lumen Cycles" in the V-PRO 60 Sterilizer.

The provenance of the data (country of origin) is not explicitly stated, but as this is an FDA submission for a U.S. company (STERIS Corporation, Mentor, OH), it's highly probable the studies were conducted in the U.S. or at facilities compliant with U.S. regulatory standards.

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 type of information is not applicable to the studies described. The studies are engineering and chemical validation tests for a sterilization system, not diagnostic device studies that would require expert human review or interpretation of medical images or patient data to establish ground truth.

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

This information is not applicable as the studies are not diagnostic assessments requiring adjudication of human reader interpretations. The acceptance criteria are based on measurable physical and chemical properties and biological effects (sterilization efficacy, material integrity, cytotoxicity, residuals).

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 is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool used by human readers. Therefore, no MRMC study or AI assistance improvement metrics are relevant.

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

This is not applicable. The device is a sterilization system and there is no algorithm or AI component involved in its operation or performance evaluation.

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

The "ground truth" in these validation studies is established by objective scientific and engineering measurements and standards:

• Sterilization effectiveness: Implicit in the "Worst Case Material" determination, where the goal is sterilization. Sterilization is typically confirmed by biological indicators demonstrating the inactivation of a specific resistant microorganism (e.g., Geobacillus stearothermophilus) to a defined sterility assurance level (SAL). While not explicitly detailed here, this is a standard method for sterilization validation.
• Material compatibility: Visual inspection for defects (crazing, cracks, chipping) and functional testing of devices after processing.
• Cytotoxicity: In vitro assays to assess cellular toxicity, with controls to ensure assay validity.
• Hydrogen peroxide residual analysis: Chemical analytical methods to quantify residual hydrogen peroxide, compared against established biological tolerance limits for mucosal and internal tissue contact.

8. The sample size for the training set

This is not applicable. The device is a sterilization system, not a machine learning model. There is no concept of a "training set."

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

This is not applicable as there is no training set.

Ask a specific question about this device

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

• Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
  • o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
  • o triple channeled devices with stainless steel lumens that are
    • ≥ 1.2 mm ID and ≤ 275 mm in length
    • ≥ 1.8 mm ID and ≤ 310 mm in length
    • or

    • 2.8 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm (~3/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required following completion of the cycle.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) cycles, respectively.

The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried 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 STERIS V-PRO Low Temperature Sterilization Systems were studied to verify two modifications: the removal of eye-contacting limitations and the addition of polyurethane as a compatible material for the Lumen Cycle.

Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact "sample size for the test set" in terms of number of unique devices or materials for each specific test. However, it indicates:

• For residual hydrogen peroxide and cytotoxicity comparison: "materials" were processed.
• For in-device cytotoxicity and tissue residue: "medical devices" were processed.
• For ocular irritation: "Materials coupons" were processed.
• For polyurethane compatibility: "polyurethane-containing device" and "polyurethane material" were evaluated.

Data Provenance: The studies were conducted by STERIS Corporation for a 510(k) premarket notification. This implies the data is prospective for the purpose of demonstrating the safety and effectiveness of the proposed changes. The country of origin of the data is not specified but is presumably the USA, where STERIS Corporation is based.

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

This information is not provided in the document. The tests described are primarily laboratory-based evaluations of chemical residues, cytotoxicity, material compatibility, and biological irritation, rather than assessments requiring interpretation by clinical experts. For biocompatibility tests like ocular irritation per ISO 10993-10, trained toxicologists or evaluators would interpret the results.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are laboratory-based experimental validations, not clinical studies requiring independent interpretation or adjudication of outcomes by multiple experts.

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

A MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance to human readers. The STERIS V-PRO System is a sterilizer, and its performance is evaluated through physical, chemical, and biological efficacy studies, not reader interpretation.

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

A standalone study was not done because the device itself is a sterilizer, not an algorithm. Its performance is inherent in its operation (sterilization efficacy, material compatibility, residue levels), not in an algorithmic output.

7. Type of Ground Truth Used

The ground truth used in these studies is based on:

• Quantitative measurements: Residual hydrogen peroxide levels (chemical analysis).
• Biological assays: Cytotoxicity tests (e.g., using live cells to detect toxic effects), ocular irritation tests (per ISO 10993-10 guidelines, likely involving animal models or in vitro alternatives).
• Visual assessment: Material degradation or cosmetic changes.
• Sterilization efficacy: Implied to be based on inactivation of biological indicators with a known sterility assurance level (SAL).

8. Sample Size for the Training Set

This information is not applicable as the V-PRO Sterilization System is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device type.

Ask a specific question about this device

The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and can sterilize: *

• Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors
• Medical devices with a single stainless steel lumen with: .
  • an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o
  • an insider diameter of 2 mm or larger and a length of 250 mm or shorter o
  • an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
  • • 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 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K.083097 and can sterilize: **

Non-lumened instruments including non-luments 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 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.

The provided text describes the acceptance criteria and the study conducted for the STERIS Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems. The changes to the device described in this submission are an update to the device Operator Manual to include polyether ether ketone (PEEK) as a compatible material for the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles; and polyurethane as a compatible material for the V-PRO 1 Plus Non Lumen Cycle.

Here's a breakdown of the requested information:

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 a separate "test set" sample size in the context of typical AI/ML studies (i.e., a dataset used for final model evaluation). Instead, the listed "tests" appear to be validation activities for the material compatibility claims.

• Sample Size: The document mentions that the Biocompatibility, Material Compatibility, ½ Cycle Sterilization Efficacy, Simulated Use Evaluation, and In Use Evaluation tests were completed for both polyurethane and PEEK.
  • For the V-PRO 1 Cycle / V-PRO 1 Plus Lumen Cycle, validation testing for lumen sizes used a maximum of twenty (20) lumens per load. 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. This was for the original K062297 clearance.
  • For the V-PRO 1 Plus Non Lumen Cycle, validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. This was for the original K083097 clearance.
  • The current submission adds PEEK and polyurethane, and these materials were subjected to the tests mentioned in the table. The exact number of PEEK/polyurethane items tested for each specific test is not detailed beyond "all polyurethane and PEEK containing devices" for the In Use evaluation.
• Data Provenance: The document does not specify the country of origin. Given it's a STERIS Corporation submission (located in Mentor, OH, USA) to the FDA, it is highly likely the studies were conducted in the USA or under US regulatory guidelines. The studies appear to be prospective validation studies rather than retrospective data analysis, as they involve performing specific tests to demonstrate safety and effectiveness for the new material claims.

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

This information is not directly applicable in the context of this device and study. The "ground truth" for a sterilizer device typically involves established scientific and regulatory standards for sterility (e.g., no microbial survivors). The validation studies involve laboratory testing and biological indicator challenges, not expert interpretation of outputs in the same way an AI diagnostic imaging system would. Therefore, there's no mention of "experts" establishing ground truth in terms of clinical image interpretation or similar tasks.

4. Adjudication Method for the Test Set

Not applicable. The study is based on laboratory and performance testing of a physical device and its sterilization efficacy, not on human interpretation or adjudication of data.

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, but a sterilization system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used in these studies is based on established sterilization principles and methods, primarily:

• Absence of Microbial Survivors: Demonstrated through biological indicators (e.g., spore strips) or direct microbial culture methods, particularly for "½ Cycle sterilization efficacy" and "Simulated Use evaluation."
• Biocompatibility Standards: Referring to established methods (e.g., ISO standards for cytotoxicity and residue analysis).
• Material Functionality: Assessed through engineering and functional tests to ensure the device maintains its intended performance after sterilization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no "training set." The studies are validation efforts for material compatibility of a physical sterilization system.

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

Not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device

The Amsco V-PRO 1 Plus Low Temperature Sterilization System, with VAPROX 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 two pre-programmed sterilization cycles; the Lumen and the Non Lumen Cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO 1 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) can sterilize *:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices with a single stainless steel lumen with:
  • an inside diameter of 1 mm or larger and a length of a 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 Ibs.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) can sterilize**:
Non-lumened instruments including non-luments 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 1 Plus Low Temperature Sterilizer is a self-contained standalone device using vaporized hydrogen peroxide. This device is intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizer operates at low pressure and low temperature and is therefore suitable for processing medical devices sensitive to heat and moisture.

The provided document is a 510(k) Summary for the Amsco V-PRO 1 Plus Low Temperature Sterilization System, focusing on the addition of a Non Lumen Cycle. It describes the device's validation against established criteria for sterilization effectiveness and safety.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The document describes "Performance Testing - Bench" and "Effectiveness" studies.

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

• Test Set Sample Size: The document does not explicitly state a numerical sample size for the test set in terms of number of instruments or specific configurations beyond the validation load. For the Non Lumen Cycle, it states: "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." This load represents the challenge in the sterility effectiveness tests. The number of biological indicators (BIs) used is not specified.
• Data Provenance: The studies are described as "Performance Testing - Bench" and "verification studies." There is no mention of country of origin of the data or whether the studies were retrospective or prospective, but given the nature of a 510(k) submission for a sterilizer, these would typically be prospective, controlled bench studies and laboratory tests conducted by the manufacturer (STERIS Corporation, USA).

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods demonstrating the complete kill of highly resistant biological indicators, rather than human expert interpretation of device performance.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging diagnostics) where there might be disagreement among readers. For sterilization efficacy, the outcome (kill/no kill of BIs) is objectively measured in a laboratory setting, not subject to human adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is not relevant for a sterilizer's performance evaluation. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) is affected by AI assistance, which is not applicable here as the device is a sterilization system, not a diagnostic tool that involves human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, effectively. The performance testing described (complete kill of biological indicators, verifying SAL, meeting FDA guidance) evaluates the sterilizer system's ability to achieve sterility on its own without human intervention influencing the sterilization outcome. While human operators load the device and select cycles, the performance of the sterilization process itself is measured as a standalone function of the device.

7. The Type of Ground Truth Used

• The primary ground truth for sterilization effectiveness is the complete kill of biological indicators (BIs) which are highly resistant microorganisms (spores) placed in challenging locations. This is an objective, laboratory-based physical/biological measure, designed to demonstrate a high Sterility Assurance Level (SAL) (at least 10⁻⁶). This is a direct measure of microbial inactivation.

8. The Sample Size for the Training Set

• Not applicable. The Amsco V-PRO 1 Plus Low Temperature Sterilization System is a physical sterilization device, not an AI software/algorithm that requires a "training set" in the machine learning sense. Its design and operation are based on validated physical and chemical principles, not learned patterns from data.

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

• Not applicable. As explained above, there is no "training set" for this type of medical device. The device's performance is established through rigorous validation studies based on scientific and regulatory standards.

Ask a specific question about this device