(341 days)
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.
The provided document describes the Belimed Steam Sterilizer MST-H, not an AI-powered device. Therefore, the questions related to AI-specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, training set information, or a multi-reader, multi-case study) are not applicable.
The document details the acceptance criteria (performance requirements) for the steam sterilizer and summarizes the studies proving it meets these criteria through non-clinical validation.
1. A table of acceptance criteria and the reported device performance
The document presents performance criteria and verified results implicitly throughout the "EFFECTIVENESS" and "NONCLINICAL COMPARISON TO PREDICATE DEVICE" sections by referencing compliance with ANSI/AAMI ST8:2013 and specific outcomes. Here's a structured table:
| Acceptance Criteria / Performance Requirement | Reported Device Performance (Belimed Steam Sterilizer MST-H) |
|---|---|
| Biological Performance (Sterility Assurance Level - SAL) | SAL of 10⁻⁶ reduction (through achievement of no growth at half cycle with validation loads), complying with AAMI ST8:2013. Verified for PreVac 270 cycles (fabric), PreVac and Gravity instrument cycles, and liquid cycle. |
| Moisture Retention (Fabrics) | <3% increase in pre-sterilization textiles test pack weight, and no wet spots. Complies with ANSI/AAMI ST8:2013 section 5.7.1.4. |
| Moisture Retention (Instruments) | <20% increase in pre-sterilization towel weight of the test load, and no wet spots on the outer wrapper. Complies with ANSI/AAMI ST8:2013 section 5.7.2.4. |
| Empty Chamber Testing (Thermal Conditions) | Demonstrated capability to provide steady-state thermal conditions within the chamber corresponding with the predicted SAL in the load. Meets temperature control requirements of ANSI/AAMI ST8:2013 Section 4.4.2.5 for PreVac, Gravity, and Liquid cycles. |
| Bowie-Dick Test Cycle Performance | Demonstrated a uniform color change throughout the test sheet, and load temperature devices attained exposure temperature within 10 seconds of progressing into the exposure phase. Qualified according to ANSI/AAMI ST8:2013 section 5.6.1. |
| Liquid Cycle Performance (Temperature & Loss) | Achieved sterility assurance level of 10⁻⁶ (no growth). Temperature above 121°C for at least 12 minutes. Loss of liquid did not exceed 70ml in a 1000ml bottle (unloading temperature 90°C), including with full load liquids. Verified according to ANSI/AAMI ST8:2013 section 5.5.3. Also note: Liquid cycle is not intended to sterilize liquids that are used for direct patient contact (stated in factory programmed cycle details, page 3). |
| Software Validation | Performed according to FDA's moderate level of concern recommendations in "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)". |
| Compliance with Standards | Designed, constructed, and tested to meet safety and performance requirements of standards including ANSI/AAMI ST8:2013, ANSI/AAMI ST79:2010 (+A1:2010 +A2:2011 +A3:2012 +A4:2013), IEC EN 62304:2006, EN ISO 14971:2012, EN ISO 13485:2003+AC2009, IEC EN 60601-1-2:2007, UL 61010-1:2004, IEC EN 61010-2-040:2005, and ASME Section VIII, Division 1 for unfired pressure vessels Ed. 2013. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The information provided does not specify a "test set" in the context of individual patient data or medical images, as this is a steam sterilizer for heat and moisture-stable materials, not a diagnostic or AI device.
Instead, the "test set" refers to the tested load configurations and biological indicator runs:
- Sample Size: Not explicitly quantified as a single number, but refers to "validation loads," "single fabric test pack," "full load fabrics," "full load instruments trays (25lbs each)," "Bowie-Dick Test Pack," and "liquids in 1000ml in vented containers" (including "3 bottles" and "full load liquids"). The number of cycles performed for each validation is not specified in detail (e.g., "All PreVac 270 cycles were verified...").
- Data Provenance: The studies were part of the device's premarket notification, implying they were conducted by or on behalf of the manufacturer (Belimed Sauter AG, based in Switzerland). The testing was done to meet U.S. FDA requirements and U.S. standards (ANSI/AAMI). The nature of the testing is prospective validation of the device's performance against established 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)
This question is not applicable. For a steam sterilizer, "ground truth" is established by direct measurement of physical parameters (temperature, pressure, time) and the observed biological outcome (kill of biological indicators) as defined by established standards (e.g., AAMI ST8:2013). There is no "expert consensus" on diagnostic interpretations or image analysis. The "experts" involved would be microbiologists, engineers, and quality assurance personnel following standardized protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human interpretive tasks (e.g., medical image reading) where disagreement among experts is possible. For a steam sterilizer, compliance is determined by objective physical and biological measurements against predefined criteria in standards.
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 question is not applicable. The device is a steam sterilizer and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a steam sterilizer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the steam sterilizer's performance is established by:
- Biological Indicators: Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ reduction, meaning no growth from biological indicators after exposure to the sterilization cycle. This is a direct measure of microbial inactivation.
- Physical Measurements: Verification of appropriate temperature and pressure profiles throughout the sterilization chamber during cycles, ensuring steady-state thermal conditions and proper air removal (Bowie-Dick test).
- Moisture Retention: Quantitative measurement of weight increase in test loads and visual inspection for wet spots to ensure adequate drying.
- Compliance with Standards: The ultimate "ground truth" is adherence to the specified performance requirements laid out in recognized national and international standards, primarily ANSI/AAMI ST8:2013.
8. The sample size for the training set
This question is not applicable. The device is a physical product (steam sterilizer), not a machine learning model; therefore, it does not have a "training set" in the AI sense. Its design and performance are based on engineering principles and validated through physical and biological testing.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Belimed Sauter AG Michael Hari Head of Medical Engineering Zelgstrasse 8 CH8583 Sulgen, Switzerland
Re: K141879
Trade/Device Name: Belimed Steam Sterilizer MST-H Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 18, 2015 Received: May 20, 2015
Dear Mr. Hari,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Hari
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number:
Device Name: Belimed Steam Sterilizer MST-H
Indications for Use
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H, models 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.
Type of Use (Select one or both, as applicable) □ Prescription Use (Part 21 CFR 801 Subpart D) 区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:
| Cycle | Pre-treatment | Sterilizing temperature | Sterilizing Time 1) | Drying time 2) | Recommended load 3) |
|---|---|---|---|---|---|
| PreVac 2704S/30D | 5 pulses | 270 °F | 4 min | 30 min | Double wrapped instrumenttrays, max. weight of 25 lbsper tray, Fabric packs |
| PreVac 2704S/5D | 5 pulses | 270 °F | 4 min | 5 min | Fabric packs4) |
| PreVac 2753S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrumenttrays, max. weight of 25 lbsper tray, Fabric packs |
| Bowie-DickTest | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 27015S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrumenttrays, with non-porousinstruments, max. weight of25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml invented or open containers 5) |
| Air leak Test | Vacuum: 65mbarTest time: 15 min | - | - | - | Empty chamber |
| Warm up & AirLeak Test | Vacuum: 65mbarTest time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270 °F | 3 min | 3 min | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Notes for Table 1:
-
- Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
-
- Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
-
- Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
-
- Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
-
- Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.
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| Model | Instrument trays,max. 25 Ibs each | Fabric Packs,max. 3.3 lbs each |
|---|---|---|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |
The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:
Table 2: Recommended loads for non-porous and porous load cycles
| Model | Volume of liquid in one container | Number of containers |
|---|---|---|
| 9-6-12 | 1000 ml | 168 |
| 9-6-15 | 1000 ml | 210 |
| 9-6-18 | 1000 ml | 252 |
Table 3: Recommended loads for liquid cycle 250 °F
The Belimed Steam Sterilizer MST-H is offered in the following models:
| Model | Configuration | Net loadingcapacity (L) | Chamber size(H x W x D) (mm) | Overall Dimensions(H x W x D) (mm) |
|---|---|---|---|---|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
Table 4: Models and dimensions
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510(k) Summary
| Date: | June 10, 2015 |
|---|---|
| Submitter's Name / Address: | Belimed Sauter AGZelgstrasse 8CH- 8583 Sulgen / Switzerland |
| Contact Person: | Michael HariEmail: michael.hari@belimed.chPhone: +41 71 644 86 37Fax: +41 71 644 85 11 |
| Trade Name: | Belimed Steam Sterilizer MST-H |
| Models: | 9-6-12, 9-6-15 and 9-6-18 |
| Classification: | Steam Sterilizer – Class II, as listed per 21 CFR 880.6880Product Code: FLE |
| Predicate Device: | Belimed Steam Sterilizer TOP 5000Series 9-18 (K021223) |
INTENDED USE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
DESCRIPTION OF DEVICE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.
The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.
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The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:
| Cycle | Pre-treatment | Sterilizingtemperature | SterilizingTime 1) | Dryingtime 2) | Recommended load3) |
|---|---|---|---|---|---|
| PreVac 2704S/30D | 5 pulses | 270 °F | 4 min | 30 min | Double wrapped instrumenttrays, max. weight of 25 lbsper tray, Fabric packs |
| PreVac 2704S/5D | 5 pulses | 270 °F | 4 min | 5 min | Fabric packs4) |
| PreVac 2753S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrumenttrays, max. weight of 25 lbsper tray, Fabric packs |
| Bowie-DickTest | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 27015S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrumenttrays, with non-porousinstruments, max. weight of25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml invented or open containers 5) |
| Air leak Test | Vacuum: 65mbarTest time: 15 min | - | - | - | Empty chamber |
| Warm up & AirLeak Test | Vacuum: 65mbarTest time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270°F | 3 min | 3 min | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Notes for Table 1:
-
- Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
-
- Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
-
- Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
-
- Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
-
- Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.
| Model | Instrument trays,max. 25 lbs each | Fabric Packs,max. 3.3 lbs each |
|---|---|---|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |
The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:
Table 2: Recommended loads for non-porous and porous load cycles
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| Model | Volume of liquid in onecontainer | Number of containers |
|---|---|---|
| 9-6-12 | 1000 ml | 168 |
| 9-6-15 | 1000 ml | 210 |
| 9-6-18 | 1000 ml | 252 |
Table 3: Recommended loads for liquid cycle 250 °F
The Belimed Steam Sterilizer MST-H is offered in the following models:
| Model | Configuration | Net loadingcapacity (L) | Chamber size(H x W x D) (mm) | Overall Dimensions(H x W x D) (mm) |
|---|---|---|---|---|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
Table 4: Models and dimensions
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NONCLINICAL COMPARISON TO PREDICATE DEVICE:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are very similar to the predicate device.
A summary of the differences to the predicate device is included in Table 5 :
| General SterilizerFeatures | Belimed Steam SterilizerTOP5000Series 9-18 (K021223) | Belimed Steam SterilizerMST-H | SubstantiallyEquivalent orDifferent |
|---|---|---|---|
| Intended Use | Terminal Sterilization of non-porous and porous heat andmoisture-stabile materials used inhealthcare facilities | Terminal Sterilization of non-porous and porous heat andmoisture-stabile materials usedin healthcare facilities | Same |
| Operating Principle | The sterilizing agent of theBelimed Sterilizers MST-H issteam. Steam is made fromdemineralized water and istherefore non-toxic. Steam is thepreferred method to sterilizeporous an non-porous heatresistant materials and textiles inhospitals for more than 100 years.Preferred sterilizationtemperatures are 250 °F, 270 °Fand 275 °F. | The sterilizing agent of theBelimed Sterilizers MST-H issteam. Steam is made fromdemineralized water and istherefore non-toxic. Steam is thepreferred method to sterilizeporous an non-porous heatresistant materials and textiles inhospitals for more than 100years. Preferred sterilizationtemperatures are 250 °F, 270 °Fand 275 °F. | Same |
| Product code | FLE | FLE | |
| C.F.R: code | 880.6880 Steam Sterilizer | 880.6880 Steam Sterilizer | |
| Class | II | II | |
| Built according toStandard | ANSI/AAMI ST8:1994Hospital Steam Sterilizers | ANSI/AAMI ST8:2013Hospital Steam Sterilizers | SubstantiallyEquivalent,(ST8:2013 usesheavier instrumentload and refers tonew standardversions) |
| Electrical safetystandard | UL 3101-1IEC 61010-1 ed1, am1IEC 61010-2-041 de1 | UL IEC 61010-1: 2004,IEC 61010-2-040:2005 | SubstantiallyEquivalent |
| EMC conformity | IEC / EN 61326:2001 / 2002 | IEC / EN 61326:2001 / 2002 | Same |
| Electrical supply | 3 Phase 208V, 60Hz | 3 Phase 208V, 60Hz | |
| 9-6-9 &9-6-12 | Max. current: 13A | Max. current: 13A | Same |
| 9-6-15 & 9-6-18 | Max. current: 20A | Max. current: 20A | |
| Utility supply pressurerequirementSteamWaterCompressed air | 2.5 - 3 bar g2 – 5 bar g5 - 7 bar g | 2.5 - 3.5 bar g2 – 5 bar g5 – 7 bar g | SubstantiallyEquivalent |
| Steam capacityrequirement:Model 9-6-9Model 9-6-12Model 9-6-15Model 9-6-18 | 120 kg/h160 kg/h200 kg/h240 kg/h | n/a100 kg/h120 kg/h170 kg/h | Lower,SubstantiallyEquivalent |
| Compressed aircapacity requirement: | 10 Nm³/h | 10 Nm³/h | Same |
| Cooling waterrequirement:Model 9-6-9Model 9-6-12Model 9-6-15Model 9-6-18 | 2 m³/h2.5 m³/h3 m³/h3.5 m³/h | n/a2.4 m³/h2.8 m³/h3.2 m³/h | Lower,SubstantiallyEquivalent |
| Control devices | |||
| Vacuum deviceModel 9-6-9, 9-6-12Model 9-6-15, 9-6-18 | Water-ring vacuum pump90 m³/h125 m³/h | Water-ring vacuum pump90 m³/h125 m³/h | Same |
| Additional gas ejector /sterilizer runs withmax. cooling watertemperatures | No/80 °F | Yes, if optional cooling waterloop is not installed90 °F | SubstantiallyEquivalent |
| Steam condenser | Shell-and-tube heat exchanger,stainless steel | Shell-and-tube heat exchanger,stainless steel | SubstantiallyEquivalent |
| Air Filtration | 0,2µm, efficiency >99.5%>99.97% for 0.3-micron particles | 0,2µm, efficiency >99.5%>99.97% for 0.3-micron particles | Same |
| Control valvesfor steam, vacuum andcondensate | Stainless steel grade 316 Lpneumatically driven piston-valves | Stainless steel grade 316 Lpneumatically driven piston-valves | SubstantiallyEquivalent |
| Control valves forcooling water | BrassElectric solenoid valves | Fiber-reinforced plastic materialElectric solenoid valves | SubstantiallyEquivalent |
| Piping material grade | AISI 316L | AISI 316L | Same |
| Pressure vessel | |||
| Chamber and jacketmaterial grade | AISI 316L | AISI 316L | Same |
| Chamber construction | Cubic welded structure with all-round heating ducts | Cubic welded structure with all-round heating ducts | Same |
| Chamber designpressure | 39psi | 40psi | SubstantiallyEquivalent |
| Safety valves | Bronce, ASME approved | Bronce, ASME approved | Same |
| Chamber designstandard | ASME Section VIII, Division 1, forunfired pressure vessels | ASME Section VIII, Division 1, forunfired pressure vessels | Same |
| Door material grade | AISI 321 | AISI 321 | Same |
| Door opening | Single or double doorHorizontal door operationMotor driven | Single or double doorHorizontal door operationMotor driven | SubstantiallyEquivalent |
| Door safety:Door safety barAdditional door lockingfixtureNumber of door limitswitches | YesNoTwo 'door closed' switches perdoor | YesYesone 'door closed' switch per doorand one 'door closed &mechanically locked' switch perdoor | SubstantiallyEquivalent |
| Door seal | Compressed air activated | Compressed air activated | Same |
| Chamber sizesModel:9-6-99-6-129-6-159-6-18Control | (H x W x D) in mm:1080x660x10401080x660x14001080x660x17001080x660x2000 | (H x W x D) in mm:Not available1080x660x13981080x660x17061080x660x2014 | SubstantiallyEquivalent |
| Control Technology | PLC | PLC | same |
| HMI Technologyloading side | LCD color / 5,7" | TFT color 10" | Different, largerdisplay |
| HMI Technologyunloading side | BT2-2004 LCD display /h x w = 35mm x 68mm | LSC display /h x w=27mmx100mm | SubstantiallyEquivalent |
| Printer Technology | Matrix Dot technology42 char /line, paper width 57mm | Thermal technology42 char /line, paper width 57mm | SubstantiallyEquivalent(same Informationon printout) |
| Process control | Automatic through all phases of acycle | Automatic through all phases of acycle | Same |
| Sterilization processcontrol | Pressure controlled by anabsolute pressure transmitter | Pressure controlled by anabsolute pressure transmitter | Same |
| Sterilization processrecording | Independent temperature andpressure sensors for recording | Independent temperature andpressure sensors for recording | Same |
| Sterilization processmonitoring | Temperature sensor for exposuretemperature monitoring | Temperature sensor for exposuretemperature monitoring | Same |
| Process alarms | Detected errors cause an acousticand visual alarm. Alarms arerecorded on the printer.At cycle end the door on theunloading side (double doormodels) can't be opened. Alarmsmust be manually acknowledgedon the load side operating panel. | Detected errors cause anacoustic and visual alarm. Alarms arerecorded on the printer.At cycle end the door on theunloading side (double doormodels) can't be opened. Alarmsmust be manually acknowledgedon the load side operating panel. | Same |
| Cycle phases | All cycle phases and sterilizer status are monitored on display. Display of:-Chamber temperature & pressure-Process status-Door status-Alarms, if pending | All cycle phases and sterilizer status are monitored on display. Display of:-Chamber temperature & pressure-Process status-Door status-Alarms, if pendingAdditional process status display for cycle state above the chamber (LED bar display) | SubstantiallyEquivalent(Additionalinformation) |
| Cycle end | Acoustic signal at cycle endCycle end Indication on operating panel display. | Acoustic signal at cycle endCycle end Indication on operating panel display. | Same |
| Performance: | |||
| Biological performance | SAL of 10-6 reduction | SAL of 10-6 reduction | |
| (half cycle) | Through achievement of no growth at half cycle with validation loads.AAMI ST8:1994 | Through achievement of no growth at half cycle withvalidation loads.AAMI ST8:2013 | Same |
| Comply with | |||
| Moisture retention | Fabrics:<3% increase in pre-sterilization textiles test pack weight | Fabrics:<3% increase in pre-sterilization textiles test pack weight | |
| Comply with | Instruments<20% increase in pre-sterilization towel weight of the test loadAAMI ST8: 1994 | Instruments<20% increase in pre-sterilization towel weight of the test loadAAMI ST8:2013 | Same |
| Factory predefinedcycles | |||
| Prevac 270°F | Yes | Yes | |
| Sterilize temperature | 132°C / 270°F | 132°C / 270°F | |
| Sterilize time | 4 minutes | 4 minutes | |
| Dry time | 20 minutes | 30 minutes | |
| No. of pre-vacuums | 4 | 5 (improved air removal) | |
| Qualified according to | AAMI ST8: 1994 | AAMI ST8:2013 | SubstantiallyEquivalent |
| Test Load | Instrument load in double wrapped trays, full load | Instrument load in double wrapped trays, full load | |
| 17lbs gross weight per tray | 25 lbs gross weight per tray | ||
| Load capacity (trays)model 9-6-9model 9-6-12model 9-6-15model 9-6-18 | 9121518 | n/a162024 | |
| Prevac 270°F | Yes | Yes | SubstantiallyEquivalent |
| Sterilize temperature | 132°C / 270°F | 132°C / 270°F | |
| Sterilize time | 4 minutes | 4 minutes | |
| Dry time | 5 minutes | 5 minutes | |
| No. of pre-vacuums | 4 | 5 (improved air removal) | |
| Qualified according to | AAMI ST8: 1994 | AAMI ST8:2013 | |
| Test Load | Single fabric pack | Single fabric pack and full load | |
| Load capacity (packs)model 9-6-9model 9-6-12model 9-6-15model 9-6-18 | 18303642 | n/a324048 | |
| Liquid 250°F | Yes | Yes | |
| Sterilize temperature | 121°C / 250°F | 121°C / 250°F | |
| Sterilize time | 45 minutes | 45 minutes | |
| Qualified according to | AAMI ST8:1994 | AAMI ST8:2013 | |
| Test Load | Liquids in 1000ml in ventedcontainers, 3 bottles | Liquids in 1000ml in ventedcontainers, 3 bottles and full load | |
| Load capacitymodel 9-6-9model 9-6-12model 9-6-15model 9-6-18 | Number of containers126168210252 | Number of containersn/a168210252 | |
| Prevac 275°F | n/a | Yes | Different |
| Sterilize temperature | 135°C / 275°F | ||
| Sterilize time | 3 minutes | ||
| Dry time | 30 minutes | ||
| No. of pre-vacuums | 5 (improved air removal) | ||
| Qualified according to | AAMI ST8:2013 | ||
| Test Load | Instrument load in doublewrapped, full load25 lbs gross weight per tray | ||
| Load capacitymodel 9-6-12model 9-6-15model 9-6-18 | 162024 | ||
| Gravity 270°F | n/a | Yes | |
| Sterilize temperature | 132°C / 270°F | ||
| Sterilize time | 15 minutes | ||
| Dry time | 30 minutes | ||
| Qualified according to | AAMI ST8:2013 | ||
| Test Load | Metal load in double wrappedtrays, 25 lbs gross weight pertray | Different | |
| Load capacitymodel 9-6-12model 9-6-15model 9-6-18 | 162024 | ||
| BOWIE-DICK Test | Yes | Yes | |
| Sterilize temperature | 134°C | 134°C | |
| Sterilize time | 3.5 minutes | 3.5 minutes | Substantially |
| Dry time | 3 minutes | 3 minutes | Equivalent |
| No. of pre-vacuums | 4 | 5 | |
| Qualified according to | AAMI ST8: 1994 | AAMI ST8:2013 | |
| Air leak test | |||
| Leak test | Yes | Yes | Same |
| Qualified according to | AAMI ST8: 1994 | AAMI ST8:2013 | |
| Warm-Up and leaktest | Yes | Yes | Same |
| Qualified according to | AAMI ST8: 1994 (air leak test) | AAMI ST8:2013 (air leak test) | |
| Express 270°F | Yes, Prevac cycle | n/a | |
| Sterilize temperature | 132°C / 270°F | ||
| Sterilize time | 4 minutes | ||
| Dry time | 3 minutes | Different | |
| Qualified according to | AAMI ST8:1994 | ||
| Test Load | Single wrapped instrument traywith a single instrument | ||
| Gravity 270°F | Yes Flash cycle | n/a | |
| Sterilize temperature | 132°C / 270°F | ||
| Sterilize time | 3 minutes | ||
| Dry time | 1 minute | Different | |
| Qualified according to | AAMI-ST37:1996 | ||
| Test Load | Unwrapped instrument tray with asingle instrument | ||
| Gravity 270°F | Yes Flash cycle | n/a | |
| Sterilize | 132°C / 270°F | ||
| temperature | 10 minutes | ||
| Sterilize time | minute | Different | |
| Dry time | AAMI-ST37-1996 | ||
| Qualifiedaccording to | Unwrapped instrument tray with anon-porous multiple instruments, | ||
| Test Load | max. weight of 17lbs |
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Table 5: Comparison to predicate device
CLINICAL DATA:
No clinical data is required for this device classification submission.
EFFECTIVENESS:
Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of 10° reduction. Belimed Sauter AG validates its sterilization cvcles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Steam Sterilizer MST-H, models 9-6-12, 9-6-15, and 9-6-18 were validated to meet the requirements of ANSI/AAMI ST8:2013.
The results of the Belimed Steam Sterilizer MST-H, models 9-6-12, 9-6-15, and 9-6-18 verification studies demonstrate that the sterilizers perform as intended and are summarized as follows:
- Empty chamber testing was performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2013, for the PreVac, Gravity and Liquid cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that are corresponding with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the temperature control requirements of Section 4.4.2.5 of ANSI/AAMI ST8.
- All PreVac 270 cycles were verified using a single fabric test pack for biological ● performance, as described in Section 5.5.2 ANSI/AAMI ST8:2013 were qualified according to section 5.5.2.5 of ANSI/AAMI ST8:2013. These cycles demonstrated a sterility assurance level (SAL) of 10th through achievement of no growth at half cycle with validation loads. Moisture retention of less than 3 % increase in pre-sterilization test pack weight was demonstrated with a single fabric pack and with full load fabrics, and no wet spots were examined, according to section 5.7.1.4 of ANSI/AAMI ST8:2013.
- . All PreVac and Gravity instrument cycles were qualified according to section 5.5.4 of ANSI/AAMI ST8:2013. The tests were performed with full load instruments travs. 25lbs each. Instead of cotton wrappers, FDA cleared wrappers (double wrapped) were used. These cycles demonstrated a sterility assurance level of 10° through achievement of no growth at half cycle with validation loads, moisture retention of less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper according to section 5.7.2.4 of ANSI/AAMI ST8:2013.
- . The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6.1 of ANSI/AAMI ST8:2013 and demonstrated a uniform color change throughout the test sheet (FDA cleared test indicator) and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
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- The liquid cycle was verified according to section 5.5.3 of ANSI/AAMI ST8:2013. . This cycle demonstrated a sterility assurance level of 10th through achievement of no growth with validation loads and the temperature was above 121°C for at least 12 minutes. The loss of liquid did not exceed 70ml in a 1000ml bottle (unloading temperature 90°C). Additional tests with full load liquids showed the same results.
- 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 Premarket Submissions for Software Contained in Medical Devices (May 2005)".
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Standards:
Belimed Sauter AG's sterilizers including the Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer MST-H complies with the following safety standards:
-
- ANSI/AAMI ST8:2013
-
- ANSI/AAMI ST79:2010 +A1:2010 +A2:2011 +A3:2012 +A4:2013
-
- IEC EN 62304:2006
-
- EN ISO 14971:2012
-
- EN ISO 13485:2003+AC2009 Medical Devices - Quality management systems. Requirements for requlatory purposes
- IEC EN 60601-1-2:2007 6.
- UL 61010-1:2004 7.
-
- IEC EN 61010-2-040:2005
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 9. pressure vessels Ed. 2013
USER INFORMATION:
Belimed Sauter AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed Operating Instructions, Technical Manual and other labeling. Belimed Sauter AG also recommends the use and periodic review of the AAM steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.
CONCLUSION:
The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are substantially equivalent devices to that of the predicate device. There have been no substantial changes in technology and intended use to the predicate device series 9-18 (K021223). This steam sterilizer MST-H, models 9-6-12, 9-6-15, and 9-6-18 meet the applicable requirements of the applicable standards.
Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate 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).