FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Amsco V-PRO I, V-PRO I 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 reusable 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 low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:

Lumened and non-lumened instruments 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:
- single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel 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 ≤ 317 mm in length
The validation studies for all channel/lumen configurations were 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 and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394 and K111810, can sterilize:
Non-lumened instruments including non-lumened rigid, semi-rigid and flexible 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 Ibs.
  The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, 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 that is ≥ 1 mm ID and ≤ 1050 mm in length
or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 998 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).
1. 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 that is ≥ 1 mm ID and ≤ 1050 mm in length
or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- and the other lumen that is > 1 mm 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 load weight of 24.0 Ibs.

Device Description

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed V-PRO 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.

AI/ML Overview

The provided text describes the 510(k) summary for the Amsco V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems. It focuses on updating the indications for use statement for the Lumen Cycle.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the successful demonstration of sterilization capability under various test conditions for the device's Lumen Cycle, especially for the modified stainless steel lumen claims. The "Conclusion" column in the table below explicitly states "PASS" for all tests, indicating that these criteria were met.

Test	Acceptance Criteria (Implied)	Reported Device Performance
½ Cycle Modified Total Kill Endpoint Verification	Demonstrate a modified total kill endpoint analysis, showing all sterile results for specified Lumen Cycle claims at standard and lower injection weights, and survival at the lowest weight.	Modified total kill endpoint analysis was demonstrated. The standard injection weight of 2.1 g and a lower injection weight of 1.457 g resulted in all sterile results for the Lumen Cycle modified stainless steel lumen claims. All survival results were shown at the lowest weight evaluated (0.121 g). Partial positives results were seen at the intermediate injection weights.
½ Cycle Sterilization Verification of Lumen Claims	Reproducibly sterilize the modified stainless steel lumen claims under worst-case conditions in a V-PRO Lumen ½ Cycle.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen ½ Cycle.
½ Cycle Sterilization Verification of Double Pouched Lumens	Reproducibly sterilize the modified stainless steel lumen claims under worst-case conditions in a V-PRO Lumen ½ Cycle in a double pouched configuration.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen ½ Cycle in a double pouched configuration.
Simulated Use Test	Verify the ability of the V-PRO Lumen Cycle to sterilize the modified stainless steel lumen claims under worst-case processing conditions.	Simulated use testing verified the ability of the V-PRO Lumen Cycle to sterilize the modified stainless steel lumen claims under worst case processing conditions.
In Use Test	Demonstrate the ability of the V-PRO Lumen Cycle to sterilize clinically cleaned, patient-soiled medical instruments representative of the modified stainless steel lumen claims.	The in use investigation demonstrated the ability of the V-PRO Lumen Cycle to sterilize clinically cleaned, patient-soiled medical instruments representative of the modified stainless steel lumen claims.
Biocompatibility	Demonstrate biocompatibility after processing in the V-PRO Lumen Cycle through residue analysis.	Residue analysis evaluation has demonstrated biocompatibility after processing in the V-PRO Lumen Cycle.
Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims (V-PRO Sterilization Trays)	Successfully sterilize the modified stainless lumens claims in V-PRO Sterilization Trays under Lumen ½ cycle worst-case conditions.	The modified stainless lumens claims were successfully sterilized in the V-PRO Sterilization Trays under Lumen ½ cycle worst case conditions.
Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims (Vis-U-All Tyvek Pouches)	Successfully sterilize the modified stainless lumens claims in Vis-U-All Tyvek Pouches under ½ cycle worst-case conditions.	The modified stainless lumens claims were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions.

Study Details

Based on the provided text, the document describes nonclinical tests primarily focused on verifying the sterilization efficacy of the device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of individual devices or lumens tested for each specific test is not explicitly stated in numerical form. However, for the "Lumen Cycle," the validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. The validation load consisted of two instrument trays and two pouches for a total weight of 19.65 lbs.
- Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements. The studies appear to be prospective validation studies conducted by the manufacturer, STERIS Corporation, for the purpose of demonstrating the device's efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts or their qualifications for establishing the ground truth. Sterilization efficacy studies like these typically rely on microbiological testing (e.g., spore-kill assays) to establish an objective "ground truth" of sterility, rather than expert human interpretation.
Adjudication method for the test set:
- Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or subjective assessments. This document describes objective performance testing (sterilization efficacy), so such adjudication methods are not applicable and therefore not mentioned.
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:
- No. This is a study on a sterilization device, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC study and related effect sizes are not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The tests described are "standalone" performance evaluations of the sterilization system's ability to achieve sterility without direct human intervention during the sterilization cycle itself. The device is an automated sterilizer, so its performance is inherently "algorithm-only" in its operation. However, no "algorithm" in the typical AI sense is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth in these sterilization studies is microbiological sterility. The "½ Cycle Modified Total Kill Endpoint Verification" and "½ Cycle Sterilization Verification" tests indicate the use of biological indicators (spores) to definitively determine if sterilization was achieved (total kill/survival results). The "In Use Test" also mentions sterilization of "patient-soiled medical instruments," implying a microbiological assessment of sterility. Biocompatibility is assessed by "residue analysis."
The sample size for the training set:
- This document describes validation and verification studies for a physical sterilization device, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable and not mentioned.
How the ground truth for the training set was established:
- As there is no training set for an AI algorithm, this information is not applicable.

Summary

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).