Search Results

The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.

Optional instrument organizers are accessories to the trays and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.

Optional sterilization mats are accessories to the trays and are intended to be used in conjunction with the V-PRO Sterilization Trays to cushion and stabilize instruments within the trays.

The V-PRO Sterilization Tray is available in various sizes, 10"x 10" x 27" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with clamping mechanisms for securing to the trav. There are numerous holes in the tray and larger holes in the lids for sterilant penetration. The purpose of this premarket submission is to modify the trays by adding a longer tray to the existing product line (10' x 27"), to increase the vent area of the tray lid, and to extend indications for use of the tray to include the V-PRO 60 Low Temperature Sterilization System.

Optional instrument organizers are provided as accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attaches to the V-PRO Sterilization Trav. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device that requires stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock. The organizers are identical to those previously cleared under K070769.

Sterilization mats are provided as optional accessories to the trav and are identical to those previously cleared under K103226 for use in V-PRO Low Temperature Sterilizers' Lumen, Non Lumen and Flexible Cycles. A larger mat sized to fit into the new 10" x 27" tray has been added to the existing product line. The sterilization mats are intended to cushion and stabilize devices placed into the V-PRO. Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Sterilization Trays.

Here's a breakdown of the acceptance criteria and study information for the STERIS V-PRO Sterilization Tray, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for the test set used in the performance studies. It refers to "worst case test article" and "multiple worst case sterilization cycles" but doesn't provide numerical details.

The data provenance is not explicitly stated in terms of country of origin. The document is a 510(k) summary submitted to the FDA in the USA, implying testing was conducted to meet US regulatory requirements. The studies appear to be prospective, specifically designed to demonstrate the device's performance for this submission.

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 studies are performance tests related to sterilization efficacy and material compatibility, not studies involving expert interpretation of medical images or diagnoses.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided. The studies are laboratory-based performance tests, not clinical evaluations requiring adjudication of expert opinions.

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 and therefore not provided. This is a medical device for sterilization, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. This is a physical medical device, not an algorithm. The "standalone" performance here would refer to the device's ability to sterilize effectively by itself, which is what the "Demonstration of Effective Sterilant Penetration" test addresses. The study confirms that the device, in conjunction with the sterilizer, achieves sterilization.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance studies would be based on sterility assurance levels and material integrity measurements.

• For "Demonstration of Effective Sterilant Penetration": The ground truth is the absence of viable microorganisms after sterilization, typically confirmed using biological indicators (BIs) or other microbiological assays. The "reproducibly sterilized" criterion implies a defined sterility assurance level (SAL).
• For "Demonstration of Biocompatibility": The ground truth is confirmed absence of cytotoxicity (e.g., cell viability assays) and acceptable levels of chemical residues (e.g., hydrogen peroxide concentration measurements).
• For "Demonstration of Sterilant Compatibility": The ground truth is the continued functionality of the trays and accessories (e.g., visual inspection, mechanical performance tests) after exposure to sterilization cycles.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle].

The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four V-PRO Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Trays.

The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.

This document describes the acceptance criteria and study proving the STERIS Sterilization Mats meet these criteria for use in V-PRO Sterilizers.

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 specific sample size for each test category. However, it does provide details about the validation loads used in the sterilization efficacy tests for the various V-PRO cycles:

• Lumen Cycle: Validation load consisted of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. This testing used a maximum of twenty (20) lumens per load.
• Non Lumen Cycle: Validation load consisted of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
• Flexible Cycle (Configuration 1 - Two endoscopes): Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. Each endoscope was packaged into a tray with a silicone mat, 20 instrument organizers, and a light cord.
• Flexible Cycle (Configuration 2 - One endoscope + non-lumened instruments): One flexible endoscope in a tray with a silicone mat, 20 instrument organizers, and a light cord. Also included was an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective performance tests conducted by the manufacturer, STERIS Corporation, to demonstrate the device's efficacy and safety.

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

This type of submission (510(k) for sterilization accessories) typically relies on standardized test methods and quantitative measurements (e.g., microbial lethality assays, chemical analysis for residuals, visual inspection for material compatibility). Therefore, the "ground truth" is established through objective scientific measurements and established protocols, rather than expert consensus on diagnostic images or clinical outcomes. The document does not mention the involvement of external experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Given the nature of the tests (sterilization efficacy, biocompatibility, material compatibility, cleaning evaluation), an adjudication method like 2+1 or 3+1 typically used for subjective diagnostic assessments is not applicable. The results are based on direct measurements and qualitative observations against predefined scientific criteria. A "PASS" or "FAIL" determination is likely made based on whether the measured outcomes meet the quantitative or qualitative acceptance criteria.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The STERIS Sterilization Mats are a sterilization accessory, and their performance is assessed through objective physical and biological tests, not through human interpretation of diagnostic output.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (i.e., algorithm only without human-in-the-loop performance). The tests evaluate the performance of the sterilization mats themselves within the context of the V-PRO sterilization cycles, independent of human operators assisting an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by reproducible sterilization of worst-case test articles under worst-case ½ cycle conditions. This implies the use of biological indicators or similar methods to confirm microbial kill, which is an objective outcome measure.
• Biocompatibility: Measured by assessing cytotoxicity and residual hydrogen peroxide levels. These are objective laboratory tests.
• Material Compatibility: Assessed by observing the absence of incompatibilities (e.g., degradation, discoloration) after exposure to multiple cleaning and sterilization cycles. This is based on qualitative visual assessment against established standards for material integrity.
• Cleaning Evaluation: Assessed by the ease of cleaning, likely through standardized cleaning protocols and visual inspection for cleanliness.

In summary, the ground truth is primarily based on objective scientific measurements, established chemical and biological testing protocols, and qualitative assessments of physical and material integrity.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning components. This device is a physical accessory evaluated through traditional engineering and biological performance testing, not an AI-powered device. Therefore, the concept of a "training set" is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI component, the ground truth for a training set was not applicable and therefore not established.

Ask a specific question about this device