BELIMED STEAM STERILIZER, MODEL TOP 5000

• K Number: K021223
• Device Name: BELIMED STEAM STERILIZER, MODEL TOP 5000
• Manufacturer: SAUTER AG
• Date Cleared: 2002-06-26 ( 69 days)
• Product Code: FLE
• Regulation Number: 880.6880
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K964332
• Predicate For: K072087 , K141879 , K170228

Intended Use

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)

CYCLES	STERILIZE TEMP	STERILIZE TIME	DRY TIME	RECOMMENDED LOAD
PREVAC
270° F (132°C)	270° F
(132°C)	4 minutes	20 minutes	Double-wrapped Instrument Trays, max.
weight of 17 lbs (7.7 kg) each. Fabric packs.
Refer to Table 2 for recommended quantities.
PREVAC
270° F (132°C)	270° F
(132°C)	4 minutes	5 minutes	Fabric Packs.
LIQUID
250° F (121°C)	250° F
(121°C)	45 minutes	0 minute	Refer to Table 3 for Guidelines
EXPRESS
270° F (132°C)	270° F
(132°C)	4 minutes	3 minutes	Single Wrapped Instrument Tray with non porous single instrument
FLASH
270° F (132°C)	270° F
(132°C)	3 minutes	1 minute	Unwrapped Instrument Tray with a single Instrument
FLASH
270° F (132°C)	270° F
(132°C)	10 minutes	1 minute	Unwrapped Instrument Tray with non porous multiple instruments (max. weight of 17 lbs)

Table 1: Factory programmed Sterilization Cycles

Device Description

The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities. The device is equipped with factory-programmed sterilization cycles. It is offered in various medium-size configurations with single or double doors and prevacuum or floor flush designs. The device includes microprocessor controller safeguards that abort the cycle and provide signals, alerts, and warnings when required conditions are not met or a malfunction occurs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Belimed Steam Sterilizer TOP 5000 meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The sterilizer is designed to achieve a Sterility Assurance Level (SAL) of at least 10^-6, meaning a one-in-a-million chance of a non-sterile item. The F0 value of at least 12 represents heat delivered equivalent to 12 minutes at 121°C (250°F) for microbial kill.

Criteria Category	Specific Acceptance Criteria	Reported Device Performance (as summarized in the submission)
Sterility Assurance	Achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶ (through complete kill of biological indicators and an appropriate safety factor). This is demonstrated by achieving a time-at-temperature sufficient to produce an F0 of at least 12 by 1/2 cycle.	All PREVAC, FLASH, and LIQUID cycles demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by ½ cycle.
Moisture Retention (PREVAC - Fabric Test Pack)	Moisture retention of less than 3% increase in pre-sterilization test pack weight, and no wet spots.	All PREVAC cycles (fabric test pack) exhibited moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots.
Moisture Retention (PREVAC - Full Load Instruments)	Moisture retention of less than 20% increase in pre-sterilization weight of the towel, and no wet spots on the outer wrapper.	All PREVAC cycles (full load instrument trays) exhibited moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
Wet Spots (FLASH cycles)	No wet spots.	All FLASH cycles (unwrapped instrument tray) exhibited no wet spots.
LIQUID Cycle Specifics	For 1000 ml flasks: water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes.	All LIQUID cycles (three 1000 ml flasks) exhibited water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes.
Bowie-Dick (BD) Cycle	Uniform color change throughout the test sheet.	The BD cycle demonstrated a uniform color change throughout the test sheet.
Software Validation	Compliance with FDA's moderate level of concern recommendations in "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)".	The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations.
Safety and Performance	Designed, constructed, and tested to meet safety and performance requirements of national safety codes and standards, specifically UL Code 3101-1, CSA Standard C22.2 No. 1010-1 (IEC1010-1), and ASME Section VIII, Division 1 for unfired pressure vessels.	The device will comply with UL Code 3101-1, CSA Standard C22.2 No. 1010-1, and ASME Section VIII, Division 1. (This is a forward-looking statement of intent to comply, rather than a direct report of a study result in the same vein as the efficacy tests).

The Study Proving Acceptance Criteria

The studies demonstrating the device meets the acceptance criteria are referred to as "verification studies." These studies were conducted internally by SAUTER AG prior to the device's release.

Key Details of the Study:

1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not explicitly state the numerical sample size (e.g., number of test cycles performed for each type). However, it refers to using specific configurations for testing:
     • "fabric test pack, as described in Section 5.5.1 AAMI/ANSI-ST8"
     • "full load instruments trays"
     • "unwrapped instrument tray"
     • "three 1'000 ml flasks, as described in section 5.5.2.1 of AAMI/ANSI-ST8"
     • "Bowie-Dick Test Pack"
   • Data Provenance: The studies were conducted by SAUTER AG, a Swiss company. The exact country where the tests took place is not specified but is presumably Switzerland. The studies were prospective as they were conducted to validate the device prior to release.

2. 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 provided. The ground truth (sterility, F0 value, moisture retention, etc.) was established through scientific measurements and biological indicator testing against and according to AAMI/ANSI-ST8 standards. These are objective measures rather than expert consensus based on subjective assessment.

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

   • Not applicable. The "ground truth" for sterilizers is determined by adherence to established sterilization standards and objective measurements (e.g., temperature probes, biological indicator kill, weight measurements, visual inspection for wetness or color change), not by human adjudication of an output.

4. 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 device is a steam sterilizer, not an AI-powered diagnostic or assistive tool for human readers. Its effectiveness is based on its ability to sterilize, not on improving human interpretation.

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

   • Yes, in a sense. The "performance" of the sterilizer is its standalone ability to achieve sterilization parameters and kill biological indicators. The testing described (e.g., F0 value, moisture retention, biological indicator kill) evaluates the device's intrinsic function without direct human intervention in the sterilization process itself (though humans operate and monitor the device). The software validation was also standalone, verifying the algorithm's control of the cycle.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth relied on standards-based objective measurements and biological indicators.
     • Biological Indicators: Used to confirm the complete kill of spores, providing direct evidence of sterility.
     • Physical Measurements: Time-at-temperature measurement to calculate F0 values; weight measurements for moisture retention; temperature probes for liquid cycles (achieving 121°C for 12 minutes); visual inspection for wet spots and Bowie-Dick test pack color change.
     • Standard Reference: All validations were performed "according to AAMI/ANSI-ST8" (Association for Advancement of Medical Instrumentation / American National Standards Institute - Sterilization of Health Care Products - Steam). This standard defines accepted methods and criteria for validating steam sterilizers.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" of the device is its engineering design and manufacturing to specification.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the AI/ML context. The operational parameters and control logic were designed based on established principles of steam sterilization thermodynamics and microbiology, codified in standards like AAMI/ANSI-ST8.

Regulation Number and Section

§ 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).