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The V-PRO® s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
• ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length

• 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or

• ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length

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

• Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
  ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
• ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
• ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (21 5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and 1.8 mm (~5/64") ID and 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and

The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed cycles all utilize a conditioning phase, a sterilize 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 following completion of the cycle.

The information provided describes the acceptance criteria and a study proving the device meets these criteria for the V-PRO® 60 Low Temperature Sterilization Systems and V-PRO® s2 Low Temperature Sterilization Systems.

1. Table of Acceptance Criteria and Reported Device Performance

• Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.
• Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.
  Maximum of eight (8) lumens per load. Validation load of one pouched instrument tray and two pouched devices outside the tray with a total weight of 4.0 lbs (~1.8kg). | PASS: Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.) |
  | For V-PRO s2 Sterilizer Flexible Cycle:
  Sterilization of one surgical flexible endoscope (single or dual lumen, ≥ 1 mm ID and ≤ 990 mm length) or bronchoscope with light cord (if not integral).
  Additional load, up to 11 lb (5 kg), including stainless steel lumens with:
• ≥ 0.76 mm ID and ≤ 233 mm length
• ≥ 1.0 mm ID and ≤ 254 mm length
• ≥ 1.8 mm ID and ≤ 542 mm length.
  Validation load of two instrument trays (one with flexible endoscope, mat, organizers, light cord; second with additional load and twelve stainless steel lumens) for a total load weight of 11 lbs (5 kg). | PASS: Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated; previous 2mm ID x 400mm length removed as it falls within the new claim). |
  | For V-PRO s2 Sterilizer Lumen Cycle:
  Sterilization of medical devices including single, dual, and triple channeled rigid and semi-rigid endoscopes with specific lumen configurations:
• Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.
• Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.
  Maximum of twelve (12) stainless steel lumens per load. Validation load of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). | PASS: Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.) |
  | General Sterilization Effectiveness:
  Successful sterilization (achieving a Sterility Assurance Level, typically 10^-6, meaning a 1 in a million chance of a non-sterile unit) as demonstrated by biological indicators (BI) in ½ cycle total kill endpoint verification and simulated use tests. | PASS:
• ½ Cycle Modified Total Kill Endpoint Verification: Demonstrated for sterilizer cycles. Standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load. Partial positives or all survive results were seen at lower injection weights.
• Simulated Use Test: Verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. |

The tables for V-PRO 60 cycles are identical to the V-PRO s2 cycles for Non Lumen, Flexible, and Lumen cycles, indicating the same acceptance criteria and performance were met for V-PRO 60.

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

The document explicitly states:

• "Validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg)" for the Non Lumen Cycle.
• "Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load... using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg)" for the Fast Cycle.
• "Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope... and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg)" for the Flexible Cycle.
• "Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load... using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg)" for the Lumen Cycle.

The specific number of individual sterilization cycles performed for these validation studies (e.g., number of replicates for the biological indicator and simulated use tests) is not explicitly stated in the provided text.

Data Provenance: The document implies these studies were conducted by STERIS Corporation, the manufacturer, in support of their 510(k) submission to the FDA. The nature of these tests (validation studies, half-cycle kill, simulated use) strongly suggests they are prospective, experimentally designed studies within a controlled environment. The country of origin for the data is not specified beyond the fact that the company is located in Mentor, Ohio, USA, and is submitting to the U.S. FDA.

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

This is an electromechanical sterilization device, not an AI or imaging device that typically uses human experts for ground truth. The "ground truth" for sterilization devices is established by microbiological testing (biological indicators) and chemical indicators which show whether a Sterility Assurance Level (SAL) has been met. These are objective, quantitative measures of microbial inactivation.

Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists for image interpretation) does not apply here. The "experts" would be the microbiologists and engineers who design, execute, and interpret the standardized sterilization test methods.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI device requiring consensus from multiple readers. For sterilization devices, the results of biological indicator and chemical indicator tests (e.g., growth/no growth, color change) are objective and typically do not require adjudication.

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

Not applicable. This is a sterilization device, not an AI diagnostic tool. No human readers or AI assistance in a diagnostic context are involved.

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

Not applicable. This is a physical sterilization system, not an algorithm. The device performance itself is the "standalone" performance in its intended function.

7. Type of Ground Truth Used

The ground truth used is based on biological indicators (BIs) and simulated use testing.

• Biological Indicators: Viable spores of a highly resistant microorganism (e.g., Geobacillus stearothermophilus) are placed in challenging locations within the device or test load. After the sterilization cycle, these BIs are cultured. No growth indicates successful sterilization to a defined Sterility Assurance Level (SAL).
• Simulated Use Testing: Involves placing inoculated test devices (with the resistant microorganism) into the sterilizer and running the cycle to verify sterilization effectiveness under conditions simulating actual use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model that requires a training set. The "design" and "development" of such a system would involve engineering principles and iterative testing, not algorithmic training on a dataset.

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

Not applicable, as there is no training set for a device of this type.

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The V-PRO® s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
• ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length

• 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or

• ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length

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

• Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
  ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
• ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
• ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (21 5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and 1.8 mm (~5/64") ID and 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and

The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed cycles all utilize a conditioning phase, a sterilize 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 following completion of the cycle.

The document describes the V-PRO® 60 Low Temperature Sterilization System and V-PRO® s2 Low Temperature Sterilization System, which are intended for terminal sterilization of medical devices. The submission (K190917) is for modifications to the indications for use of these systems.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the sterilization effectiveness. However, the study concludes with "PASS" for both tests, indicating that a predefined, unstated acceptance criterion for sterilization efficacy was met.

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 provides details about validation loads used, which can be considered the test sets for device performance:

• V-PRO s2/60 Sterilizer Non Lumen Cycle: one instrument tray for a total weight of 25 lbs (11.3 kg).
• V-PRO s2 Sterilizer Fast Cycle: one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). Maximum of eight (8) lumens per load.
• V-PRO s2/60 Sterilizer Flexible Cycle: two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg).
• V-PRO s2/60 Sterilizer Lumen Cycle: one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). Maximum of twelve (12) stainless steel lumens per load.

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective or prospective. Given it's a 510(k) submission for device modification, the studies are typically prospective validation studies performed by the manufacturer (STERIS Corporation, based in Mentor, OH, USA).

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. The device is a sterilizer, and its performance (sterilization) is typically assessed through biological indicators (e.g., spore strips) or chemical indicators, not by human expert interpretation of an image or data. The "ground truth" for sterilization is the complete inactivation of microorganisms.

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

Not applicable, as the evaluation is based on objective biological and chemical indicator results, not expert 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

Not applicable. This is a medical device for sterilization, not an AI-assisted diagnostic or triaging tool.

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

Not applicable. The device is a physical sterilizer system.

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

The ground truth for sterilization studies is typically the complete kill of highly resistant bacterial spores (often Geobacillus stearothermophilus) in biological indicators. The ½ Cycle Modified Total Kill Endpoint Verification and Simulated Use Test rely on this concept to confirm sterility.

8. The sample size for the training set

Not applicable. The device is a physical sterilizer system, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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