(239 days)
The Getinge 400HC-E/500HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The Getinge 400HC-E/500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The model designations provided in the 400HC-E/500HC-E Series Steam Sterilizer are 422HC-E. 433HC-E. 522HC-E and 533HC-E.
400HC-E/500HC-E Steam Sterilizer employs both gravity/downward The displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 24 cycles can be easily accessed and custom cvcle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
This is a 510(k) premarket notification for a Class II medical device, specifically a steam sterilizer. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove efficacy and safety in the same way a PMA (Pre-Market Approval) does. Therefore, typical "acceptance criteria" and "study results" related to diagnostic performance metrics (like sensitivity, specificity, AUC) from a multi-reader, multi-case study are not applicable here.
Instead, the acceptance criteria for this device are based on performance testing to demonstrate that the sterilizer effectively sterilizes various loads according to established industry standards and guidelines. The "study" here refers to validation testing against these standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Sterilization Efficacy (General): Complete kill of biological indicators (BI) and achievement of a sterility assurance level (SAL) of at least 10⁻⁶ (for PREVAC and GRAVITY cycles) or 10⁻³ (implied, as F₀ value of at least 12 is sufficient for 10⁻⁶ SAL, this is the main metric). | Demonstrated by complete kill of biological indicators and achievement of a Sterility Assurance Level (SAL) of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12 (for PREVAC and GRAVITY cycles). |
| Empty Chamber Testing: Capable of providing steady-state thermal conditions within the chamber consistent with the predicated SAL. | The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load. |
| Moisture Retention (Fabric Packs - PREVAC & GRAVITY): Less than 3% increase in pre-sterilization test pack weight, including no visible wet spots. | Demonstrated moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots for PREVAC and GRAVITY cycles using fabric process challenge packs. |
| Moisture Retention (Wrapped Instruments - PREVAC & GRAVITY): Less than 20% increase in pre-sterilization weight of the towel, including no visible wet spots on the outer wrapper. | Demonstrated moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper for PREVAC (excluding PREVAC 2 & 5 with shortened drying times) and GRAVITY cycles using wrapped instrument process challenge devices. |
| Immediate Use Cycles (Flash Sterilization): Achievement of a sterility assurance level of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12 and complete BI kill. | The results demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of time at temperature sufficient to produce an F₀ value of at least 12 and complete BI kill, using unwrapped non-porous process challenge devices. |
| Liquid Loads Cycles: Achievement of a sterility assurance level of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and water loss not exceeding 50ml. | The results demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill and water loss not exceeding 50ml, using 3 one-liter flasks. |
| Bowie Dick Cycle: Proper operation for air removal and steam penetration. | Bowie Dick cycle was validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2008 section 5.6.1.1. (The text implies successful validation without detailing specific pass/fail criteria from the standard, but acceptance is based on meeting the standard's requirements for the test pack indicator). |
| Software Validation: Compliance with FDA guidance for software in medical devices. | The software validation for the cycle operation was performed according to FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)". (Acceptance is based on adherence to the guidance, implying successful validation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of sterilization runs or individual items tested for each cycle type. Instead, it refers to using "fabric process challenge packs," "wrapped instrument process challenge devices," "unwrapped non-porous process challenge device," "3 one liter flasks," and "Bowie-Dick test pack." The number of items per chamber for each load configuration is specified in the tables (e.g., 2 double-wrapped instrument trays for 433HC-E, 12 fabric packs for 533HC-E), indicating various representative loads were tested.
- Data Provenance: This was "Factory recommended cycles were tested," implying prospective testing performed by the manufacturer, Getinge Sourcing LLC, located in Rochester, NY, USA. The testing was conducted according to US (ANSI/AAMI) standards.
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)
Not applicable. For a steam sterilizer, "ground truth" for sterilization efficacy is established through objective biological and physical indicators (e.g., biological indicators (BI) demonstrating complete kill of spores, F₀ value measurements, moisture retention measurements, Bowie-Dick test pack color changes). This is not a diagnostic device relying on expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device involving expert interpretation or adjudication of subjective outcomes. The outcomes are objective measurements of sterilization efficacy.
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 standalone medical device (steam sterilizer), not an AI-powered diagnostic tool, and involves no human "readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described is for the standalone device (the sterilizer itself) without direct human intervention in the sterilization process once the cycle is initiated. The "algorithm" here would refer to the control system and its programmed cycles. The testing demonstrates the sterilizer's ability to achieve sterilization based on its internal programming and physical processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for sterilization efficacy is defined by objective biological and physical endpoints:
- Complete kill of biological indicators (BI): Absence of viable spores after sterilization.
- Sterility Assurance Level (SAL) of at least 10⁻⁶: A statistical measure of the probability of a single viable microorganism occurring on an item after sterilization (achieved through F₀ values).
- F₀ value of at least 12: A measure of thermal lethality, indicating the equivalent time in minutes at 121.1°C (250°F) delivered to the load.
- Moisture retention percentages: Quantitative measurement of water absorbed by or remaining on sterilized items.
- Bowie-Dick test pack results: Visual indicator change confirming adequate air removal and steam penetration (a physical/chemical indicator).
- Water loss not exceeding 50ml: For liquid loads.
These are objective, scientifically measurable ground truths defined by industry standards (ANSI/AAMI ST8:2008).
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a "training set." Its effectiveness is based on physical and chemical principles of steam sterilization, validated by performance testing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).