(254 days)
The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture.
The HC 80TT Lumen Cycle can sterilize:
o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors;
O Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or
- · ≥ 1.33 mm ID and ≤ 430 mm long; and,
o Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: - ≥ 1.00 mm ID and ≤ 310 mm long.
The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using two (2) separate validation loads as described in the following table.
The HC 80TT Flexible Cycle can sterilize:
- · Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
- · Single channel flexible endoscopes with flexible lumens that are:
- · ≥ 1.00 mm ID and ≤ 1280 mm long; and,
- · Dual channel flexible endoscopes with flexible lumens that are:
- · ≥ 0.80 mm ID and ≤ 1000 mm long.
The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is a self-contained standalone device, using vaporized hydrogen peroxide as the sterilant. The HC 80TT is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.
This document is a 510(k) summary for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. It details the device's technical characteristics, indications for use, and a comparison to a predicate device (Sterilucent PSD-85 Hydrogen Peroxide Sterilizer). It extensively describes the performance testing conducted to demonstrate the device's safety and efficacy.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a discrete table of "acceptance criteria" with quantitative targets alongside the "reported device performance." Instead, it describes various performance tests and the positive outcomes, implying that successful completion of these tests serves as the acceptance criteria. The overarching acceptance criterion for a sterilizer is achieving a Sterility Assurance Level (SAL) of 10^-6.
Below is a table summarizing the performance claim and the evidence provided:
| Performance Claim / Acceptance Criteria (Implicit) | Reported Device Performance (Evidence) |
|---|---|
| Overall Sterilization Efficacy | Achieved an SAL of at least 10^-6 for medical device surface sterilization. |
| Material Compatibility & Sterilization | No spore survivors on any material tested (various representative materials) at concentrations lower than the standard exposure concentration for half-cycle conditions. |
| Dose-Response Relationship (Hydrogen Peroxide) | Demonstrated >6 Spore Log Reduction (SLR) for a half cycle exposure across various material coupons. |
| Mated Surface Sterilization | Achieved an SAL of at least 10^-6 for mated material sterilization. |
| Lumen Sterilization (Rigid Stainless Steel) | No spore survivors after multiple ½ cycle exposure tests for lumens meeting specified dimensions (e.g., ≥ 0.77 mm ID and ≤ 410 mm long). |
| Lumen Sterilization (Flexible) | No spore survivors after multiple ½ cycle exposure tests for flexible lumens meeting specified dimensions (e.g., ≥ 1.00 mm ID and ≤ 1280 mm long). |
| Simulated Use Sterilization | Results showed sterility of all tested devices (representative lumen and non-lumen devices inoculated with spores and organic challenge soil, then exposed to a full sterilization cycle). |
| In-Use Sterilization (Clinical Settings) | Successfully sterilizes surgical instruments used in clinical settings (devices soiled with clinical soils, manually cleaned/washed, packaged, and processed in applicable cycles). |
| Sporicidal Activity | None of the carriers demonstrated growth in accordance with AOAC Official Method 966.04. |
| Software Validation | Performed according to FDA's moderate level of concern recommendations. |
| Process Lethality Stability | Process lethality was unaffected over the range of tested process parameters (chamber wall temperature, vaporizer temperature, injection pressure, vaporized hydrogen peroxide concentration). |
2. Sample sizes used for the test set and the data provenance
- Sample Size: The document provides some detail on sample sizes indirectly through load descriptions.
- Lumen Cycle Validation Loads: Two separate validation loads were used. Load #1 contained 15 total lumens. Load #2 contained 10 lumens. The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load.
- Flexible Cycle Validation Loads: Four separate validation loads were used. No specific lumen counts are given for these, but Load #1 included one single-channel flexible angioscope and one single-channel flexible ureteroscope. Load #3 included one dual-channel flexible ureteroscope and one single-channel flexible angioscope.
- Surface Sterilization, Mated Surface Sterilization, Lumen Sterilization: Tests involved "a wide variety of material coupons" or "a variety of medical device materials" or placing "at least 10⁶ Geobacillus stearothermophilus spores in the center of the lumens." The exact number of samples (coupons, devices) used in each of these tests is not explicitly stated numerically, beyond the load descriptions for the overall cycle validation.
- Simulated Use Testing: "Representative lumen and non-lumen devices" were inoculated. The exact number is not quantified.
- In-Use Testing: "Devices representative of surface features and lumen claims for the HC 80TT were selected." The exact number is not quantified.
- Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission for a US-based company (Minneapolis, Minnesota), it's highly probable the testing was conducted in the United States, likely in a laboratory setting. The studies described are prospective in nature, as they involve actively setting up and running sterilization cycles under controlled conditions to observe outcomes, rather than analyzing existing, previously collected data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this device. The "ground truth" for sterilization devices is established by objective microbiological methods, specifically the inactivation of highly resistant bacterial spores (Geobacillus stearothermophilus) to a statistically defined Sterility Assurance Level (SAL). It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The "ground truth" (i.e., whether sterilization was achieved) is determined by the absence or presence of viable spores after exposure to the sterilization process, which is an objective laboratory measure (incubation of biological indicators) and does not require adjudication by multiple human experts.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The Sterilucent HC 80TT is a sterilizer, not an AI diagnostic device, and its performance is evaluated through its ability to inactivate microorganisms, not through human interpretation of results.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the device's performance as a sterilizer without human intervention in the sterilization process itself. The entire battery of tests described (Dose-Response, Surface, Mated Surface, Lumen, Simulated Use, In-Use, Sporicidal Activity) are essentially "standalone" performance evaluations of the device's ability to sterilize. The human role is in setting up the device, loading items, initiating cycles, and performing post-sterilization analysis (e.g., biological indicator incubation), not in assisting the sterilization process itself in real-time. The device operates automatically once a cycle is initiated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is microbiological proof of sterility, specifically the inactivation of a highly resistant biological indicator organism, Geobacillus stearothermophilus, to a demonstrated Sterility Assurance Level (SAL) of 10^-6. This is an objective and quantitative measure, not subjective like expert consensus or pathology in a diagnostic context. This is also supported by the AOAC Official Method 966.04 for Sporicidal Activity.
8. The sample size for the training set
The concept of a "training set" is not applicable here. This device is a traditional medical device (a sterilizer), not an AI/ML-based device that learns from data. Therefore, there is no training set in the machine learning sense. The testing described is verification and validation.
9. How the ground truth for the training set was established
As there is no training set for this traditional sterilizer, this question is not applicable.
§ 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).