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
PREVAC270° 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.
PREVAC270° F (132°C)	270° F(132°C)	4 minutes	5 minutes	Fabric Packs.
LIQUID250° F (121°C)	250° F(121°C)	45 minutes	0 minute	Refer to Table 3 for Guidelines
EXPRESS270° F (132°C)	270° F(132°C)	4 minutes	3 minutes	Single Wrapped Instrument Tray with non porous single instrument
FLASH270° F (132°C)	270° F(132°C)	3 minutes	1 minute	Unwrapped Instrument Tray with a single Instrument
FLASH270° 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:

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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K021223

JUN 2 6 2002

510(k) SUMMARY

Submitter Information.

Hans Stadler SAUTER AG Head of product development Zelgstrasse 8 CH-8583 Sulgen/ Switzerland +41 71 644 85 97 Date Summary Prepared: July 9, 2001

Introduction

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 substantially equivalent to the predicate devices, the Amsco Century Medium Steam Sterilizer, K0110865 and Amsco Steam Sterilizer K964332.

The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities.

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

CYCLES	STERILIZETEMP	STERILIZETIME	DRY TIME	RECOMMENDED LOAD
PREVAC270° 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.
PREVAC270° F (132°C)	270° F(132°C)	4 minutes	5 minutes	Fabric Packs.Refer to Table 2 for recommended quantities.
LIQUID250° F (121°C)	250° F(121°C)	45 minutes	-	Refer to Table 3 for Guidelines
EXPRESS270° F (132°C)	270° F(132°C)	4 minutes	3 minutes	Single Wrapped Instrument Tray with nonporous single instrument
FLASH270° F (132°C)	270° F(132°C)	3 minutes	1 minute	Unwrapped Instrument Tray with a singleInstrument
FLASH270° F (132°C)	270° F(132°C)	10 minutes	1 minute	Unwrapped Instrument Tray with non porousmultiple instruments (max. weight of 17 lbs)

Table 1: Factory programmed sterilization cycles

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Table 2 : Recommended Loads
Sterilizer Chamber Size	(mm) Wrapped InstrumentTrays 20"x10"max. 17lb each	Fabric Packs11"x11"x9"max. 6.6lb each	Fabric Packs23"x11"x11"max. 17lb each
26"x 42.5"x 41" (660 x 1080 x 1040)	9	18	9
26"x 42.5"x 55" (660 x 1080 x 1400)	12	30	12
26"x 42.5"x 67" (660 x 1080 x 1700)	15	36	15
26"x 42.5"x 79" (660 x 1080 x 2000)	18	42	18
26"x 48.5"x 43" (660 x 1230 x 1100)	9	18	9
26"x 48.5"x 55" (660 x 1230 x 1400)	12	30	12
26"x 48.5"x 67" (660 x 1230 x 1700)	15	36	15
26"x 48.5"x 79" (660 x 1230 x 2000)	18	42	18

The following table (Table 2) is SAUTER's recommended loads by sterilizer chamber size:

The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing: Table 3: Guidelines for liquid 250°F cycle processing

Sterilizer Chamber Size	Volume of Liquid in One Container	Number of containers
26"x 42.5"x 41" (660 x 1080 x 1040)	1000 ml	126
26"x 42.5"x 55" (660 x 1080 x 1400)	1000 ml	168
26"x 42.5"x 67" (660 x 1080 x 1700)	1000 ml	210
26"x 42.5"x 79" (660 x 1080 x 2000)	1000 ml	252
26"x 48.5"x 43" (660 x 1230 x 1100)	1000 ml	126
26"x 48.5"x 55" (660 x 1230 x 1400)	1000 ml	168
26"x 48.5"x 67" (660 x 1230 x 1700)	1000 ml	210
26"x 48.5"x 79" (660 x 1230 x 2000)	1000 ml	252

Effectiveness

Efficacy of sterilizer function and exposure time recommendations ate ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° reduction. SAUTER AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer TOP 5000 will be validated to meet the requirements of AAMI/ANSI-ST8, Third Edition, January 1994.

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The results of the Belimed Sterilizer TOP 5000 verification studies demonstrate that the sterilizer performs as intended and are summarized as follows:

All PREVAC cycles verified using the fabric test pack, as described in Section 5.5.1 AAMI/ANSI-. ST8 were qualified according to section 5.5.1 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10* through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
All PREVAC cycles verified using full load instruments trays were qualified according to section . 5.5.3 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1½ cycle, a moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
All FLASH cycles verified using the unwrapped instrument tray were qualified according to section t 7.7.3 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle and exhibited no wet spots.
All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.2.1 of . AAMI/ANSI-ST8, were qualified according to section 5.5.2 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-attemperature sufficient to produce an FO of at least 12 by ½ cycle, a 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.
The BD cycle was verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8, and demonstrated a uniform color change throughout the test sheet.
. The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)".

Safety

SAUTER AG sterilizers including the Belimed Steam Sterilizer TOP 5000 have been designed. constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer TOP 5000 will comply with the following requirements:

ينهنجي جي Underwriter Laboratory (UL) Code 3101-1
1. Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC1010-1)

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American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 3. pressure vessels

Hazards-Failure of Performances

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed., that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide spread use of steam sterilizers. Further, there are no known reports in the literature of patient infection that have resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer TOP 5000 provides microprocessor controller safequards that aborts the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

User information

SAUTER AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed Operator's Manual and other labeling. SAUTER AG also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three parallel, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Sauter AG C/O Mr. Mark Job Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K021223

Trade/Device Name: Belimed Steam Sterilizer, Model Top 5000 Regulation Number: 880.6880 Regulation Name: Stream Sterilizer Regulatory Class: II Product Code: FLE Dated: May 10, 2002 Received: June 12, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Tin othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT DEVICE NAME: BELIMED STEAM STERILIZER TOP 5000

INDICATIONS FOR 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
PREVAC270° 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.
PREVAC270° F (132°C)	270° F(132°C)	4 minutes	5 minutes	Fabric Packs.
LIQUID250° F (121°C)	250° F(121°C)	45 minutes	0 minute	Refer to Table 3 for Guidelines
EXPRESS270° F (132°C)	270° F(132°C)	4 minutes	3 minutes	Single Wrapped Instrument Tray with non porous single instrument
FLASH270° F (132°C)	270° F(132°C)	3 minutes	1 minute	Unwrapped Instrument Tray with a single Instrument
FLASH270° 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

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Table 2: Recommended Loads
Sterilizer Chamber Size(mm)	Wrapped InstrumentTrays 20"x10"max. 17lb each	Fabric Packs11"x11"x9"max. 6.6lb each	Fabric Packs23"x11"x11"max. 17lb each
26"x 42.5"x 41" (660 x 1080 x 1040)	9	18	9
26"x 42.5"x 55" (660 x 1080 x 1400)	12	30	12
26"x 42.5"x 67" (660 x 1080 x 1700)	15	36	15
26"x 42.5"x 79" (660 x 1080 x 2000)	18	42	18
26"x 48.5"x 43" (660 x 1230 x 1100)	9	18	9
26"x 48.5"x 55" (660 x 1230 x 1400)	12	30	12
26"x 48.5"x 67" (660 x 1230 x 1700)	15	36	15
26"x 48.5"x 79" (660 x 1230 x 2000)	18	42	18

· The following table (Table 2) is SAUTER's recommended loads by sterilizer size:

The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing:

Sterilizer Chamber Size	Volume of Liquid in OneContainer	Number of containers
26"x 42.5"x 41" (660 x 1080 x 1040)	1000 ml	126
26"x 42.5"x 55" (660 x 1080 x 1400)	1000 ml	168
26"x 42.5"x 67" (660 x 1080 x 1700)	1000 ml	210
26"x 42.5"x 79" (660 x 1080 x 2000)	1000 ml	252
26"x 48.5"x 43" (660 x 1230 x 1100)	1000 ml	126
26"x 48.5"x 55" (660 x 1230 x 1400)	1000 ml	168
26"x 48.5"x 67" (660 x 1230 x 1700)	1000 ml	210
26"x 48.5"x 79" (660 x 1230 x 2000)	1000 ml	252

Table 3: Guidelines for liquid cycle processing

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The Belimed Steam Sterilizer TOP 5000 is offered in the following medium-size configurations:

26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26"x 42.5″x 55″ (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 55" (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 79″ (660 mm x 1080 mm x 2000mm) 26"x 42.5″x 79″ (660 mm x 1080 mm x 2000mm) 26"x 48.5"x 43" (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 43″ (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm)

Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door. Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum

(Division Sign-Off)
Division of D

on Control eral Hospital Device

510(k) Number K02122

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).