(117 days)
The Amsco 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 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 ≤ 310 mm in length
or - ≥2.8 mm ID and ≤ 317 mm in length
- ≥ 1.2 mm ID and ≤ 310 mm in length
- The validation studies 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 Ibs.
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 lbs.
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:
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- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
- 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 1 mm ID and 1 mm and
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.
The provided document is a 510(k) Summary for the Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems. The submission's primary purpose is to modify the V-PRO Lumen Cycle's stainless steel lumen claims. The acceptance criteria and supporting studies are detailed for this specific modification.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for each test. However, the "Conclusion" column for each test serves as the acceptance criteria being met (i.e., "PASS"). The reported device performance is integrated within the "Result" column.
| Test Title | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| 1/2 Cycle Modified Total Kill Endpoint Verification | Modified total kill endpoint analysis is 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. |
| 1/2 Cycle Sterilization Verification of Lumen Claims | V-PRO Lumen Cycle reproducibly sterilizes lumen claims. | The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen 1/2 Cycle. |
| 1/2 Cycle Sterilization Verification of Double Pouched Lumens | V-PRO Lumen Cycle reproducibly sterilizes double pouched lumens. | The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen 1/2 Cycle in a double pouched configuration. |
| Simulated Use Test | V-PRO Lumen Cycle sterilizes lumen claims under simulated use. | 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 | V-PRO Lumen Cycle sterilizes clinically cleaned instruments. | 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 | Biocompatibility is demonstrated. | Residue analysis evaluation has demonstrated biocompatibility after processing in the V-PRO Lumen Cycle. |
| Validation of Accessories (V-PRO Sterilization Trays) | Modified lumen claims are sterilized in trays. | The modified stainless lumens claims were successfully sterilized in the V-PRO Sterilization Trays under Lumen ½ cycle worst case conditions. |
| Validation of Accessories (Vis-U-All Tyvek Pouches) | Modified lumen claims are sterilized in pouches. | The modified stainless lumens claims were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions. |
2. Sample Size Used for the Test Set and the Data Provenance
The document details the lumen configurations tested, which infer the "sample" being tested:
- Single channeled devices: Stainless lumen ≥ 0.77 mm ID and ≤ 500 mm in length.
- Dual channeled devices: Stainless steel lumens ≥ 0.77 mm ID and ≤ 527 mm in length.
- Triple channeled devices: Stainless steel lumens either ≥ 1.2 mm ID and ≤ 310 mm in length OR ≥ 2.8 mm ID and ≤ 317 mm in length.
The validation studies 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. for the Lumen Cycle (and Non Lumen Cycle). For the Flexible Cycle (which is not the primary focus of this submission, though mentioned for context), different configurations of flexible endoscopes and additional instruments were used.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for sterility claims, these would be prospective, laboratory-based validation studies conducted under controlled conditions to demonstrate effective sterilization. The "In Use Test" indicates some testing with "clinically cleaned, patient-soiled medical instruments," suggesting a component of real-world or simulated clinical conditions, but still likely a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information about the number of experts or their qualifications for establishing the ground truth. For sterilization studies, the "ground truth" is typically defined by the complete eradication of specified biological indicators (e.g., bacterial spores) under rigorous testing parameters, observed by trained microbiology and sterilization validation specialists according to recognized standards.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method with multiple reviewers (e.g., 2+1, 3+1). For sterilization efficacy testing, the outcome is generally a definitive "sterile" or "non-sterile" based on microbiological culturing, which doesn't typically involve human opinion-based adjudication in the same way, for example, a radiology study might.
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 requiring human reader interpretation. No MRMC comparative effectiveness study was performed.
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; it is not an algorithm for diagnosis or image interpretation. The device's performance is inherently "standalone" in its function as a sterilizer, meaning its efficacy is measured directly, not through human-in-the-loop performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for sterilization efficacy is the complete kill of microbial organisms, typically using highly resistant biological indicators (e.g., bacterial spores). The tests refer to "Total Kill Endpoint Verification," "Sterilization Verification," and "Simulated Use Test," all of which fundamentally rely on demonstrating the absence of viable microorganisms after processing. The "In Use Test" further corroborates this with "clinically cleaned, patient-soiled medical instruments."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable in the context of this device and study. This is a validation of a physical sterilization process using specific parameters and loads, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML model, this question is not applicable. For the validation studies, the efficacy (ground truth) was established through scientifically accepted microbiological testing methods to confirm sterility.
§ 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).