(83 days)
Not Found
No
The summary describes a steam sterilizer with factory-programmed cycles and a new PLC and operating panel. There is no mention of AI or ML capabilities.
No
This device is a sterilizer designed to clean medical instruments and materials, not to provide therapy to patients. Its function is to prepare items for use in healthcare, not to treat a medical condition.
No
This device is a sterilizer, designed to inactivate microorganisms on medical instruments. It does not perform any diagnostic function, which typically involves identifying or characterizing diseases or conditions.
No
The device is a steam sterilizer, which is a piece of hardware with integrated software for controlling sterilization cycles. The description clearly details physical components like doors, chambers, and mentions hardware modifications.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the sterilization of materials used in healthcare facilities (non-porous and porous heat and moisture-stable materials). This is a process to render medical devices and materials sterile, not to perform tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the steam sterilizer, its cycles, and its function in sterilizing materials. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies evaluate the sterilizer's ability to achieve a certain sterility assurance level (SAL) and meet standards for sterilization cycles. These studies are related to the effectiveness of the sterilization process, not the accuracy of a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to sterilize instruments and materials, which is a crucial step in preventing the spread of infection in healthcare settings, but it does not perform diagnostic testing.
N/A
Intended Use / Indications for Use
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are all equipped with the same factory-programmed Sterilization cycles and cycle parameters (Table 1).
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door (VS1) prevacuum/gravity or double door (VS2) prevacuum/gravity version.
Product codes
FLE
Device Description
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities.
Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 at least 106 reduction. Belimed 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, Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 were validated to meet the requirements of ANSI/AAMI ST8:2008.
The results of the Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 verification studies demonstrate that the sterilizers perform as intended and are summarized as follows:
- Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Flash and Gravity 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 requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.
- All Prevac cycles verified using the fabric test pack, as described in Section 5.5.2. ANSI/AAMI ST8:2008 were qualified according to section 5.5.2.5 ANSI/AAMI 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 minutes by half cycle, moisture retention of less than 3 % increase in pre-sterilization test pack weight, and exhibited no wet spots.
- All Prevac, and Gravity cycles verified using full load instruments trays were qualified according to section 5.5.4 of ANSI/AAMI ST8:2008. 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 minutes by half cycle, moisture retention of less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
- All Prevac Flash cycles verified using the unwrapped instrument trays were qualified according to section 5,5,5,2 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
- All Gravity cycles verified using the unwrapped instrument tray were qualified according to section 5.5.5.1 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
- The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6 of ANSI/AAMI ST8, and demonstrated a uniform color change throughout the test sneet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
- 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)".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
| Date: | February 21, 2011 | MAR 15 2011 | |
|---|---|---|---|
| Submitter's Name / Address: | Belimed Sauter AG | ||
| Zelgstrasse 8 | |||
| CH- 8583 Sulgen / Switzerland | K103841 | ||
| Contact Person: | Hans Stadler, Head of R&D | ||
| Email: hans.stadler@belimed-sauter.ch | |||
| Phone: +41 71 644 85 97 | |||
| Fax: +41 71 644 85 11 | |||
| Trade Name: | Belimed Steam Sterilizer MST-V | ||
| Models: | 6-0-6, 6-0-9, and 6-0-12 | ||
| Classification: | Steam Sterilizer – Class II, as listed per 21 CFR | ||
| 880.6880 | |||
| Product Code 80 FLE | |||
| Predicate Device: | Belimed Steam Sterilizer TOP 5000 | ||
| Series 4-8 (K033538) |
DEVICE DESCRIPTION:
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8.
NONCLINICAL COMPARISON TO THE PREDICATE DEVICE:
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are very similar to the predicate device.
Modifications made from the predicate device include:
- · Additional Gravity cycles
- · Increase of recommended load capacity.
- · New version of Programmable Logic control (PLC) and new operating panel (MMI)
CLINICAL DATA:
17
No clinical data is required for this device classification submission.
INDICATIONS FOR USE:
The Belimed Steam Sterilizers MST-V, models 6-0-6, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).
Release 1.3 February 21, 2011 Page 1 of 6
1
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version.
| CYCLE | PRE-TREATMENT | STERILIZE
TEMP /
PRESSURE | STERILIZE
TIME | DRY
TIME 1) | RECOMMENDED LOAD
3) |
|-------------------------------|------------------------------------------------------------------------|---------------------------------|-------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| PreVac 270
4S / 30Dry | 3 vacuum pulses:
80/100/100mbar
2 steam pulses:
1500/1500mbar | 270 °F
2880mbar | 4 min | 30 min | Double wrapped instrument trays,
max. weight of 25 lbs per tray
Fabric packs 2) |
| PreVac 270
4S / 5Dry | 3 vacuum pulses:
80/100/100mbar
2 steam pulses:
1500/1500mbar | 270 °F
2880mbar | 4 min | 5 min | Fabric packs 2) |
| PreVac Flash
270 3S / 1Dry | 3 vacuum pulses:
80/100/100mbar
2 steam pulses:
1500/1500mbar | 270 °F
2880mbar | 3 min | 1 min | Unwrapped non-porous single
instrument or
unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray |
| PreVac Flash
270 4S / 1Dry | 3 vacuum pulses:
80/100/100mbar
2 steam pulses:
1500/1500mbar | 270 °F
2880mbar | 4 min | 1 min | Unwrapped porous or non-porous
single instrument or
unwrapped mixed porous and non-
porous instrument trays, max. weight
of 25 lbs per tray |
| Gravity 270
15S / 30Dry | Purge time 4min | 270 °F
2880mbar | 15 min | 30 min | Wrapped instrument trays, max.
weight of 25 lbs per tray |
| Gravity 270
3S / 1Dry | Purge time 4min | 270 °F
2880mbar | 3 min | 1 min | Unwrapped non-porous single
instrument
or unwrapped non-porous
instrument trays, max. weight of 25
lbs per tray |
| Gravity 270
10S / 1Dry | Purge time 4min | 270 °F
2880mbar | 10 min | 1 min | Unwrapped porous or non-porous
single instrument or
unwrapped mixed porous and non-
porous instrument trays, max. weight
of 25 lbs per tray |
| Bowie-Dick
Test | 3 vacuum pulses:
80/100/100mbar
2 steam pulses:
1500/1500mbar | 273 °F
3030mbar | 3.5 min | 1 min | One DART or Bowie-Dick-Test-Pack |
| Leak Test | Vacuum: 65mbar
Test time: 15 min | | | | Empty chamber |
| Warm up &
leak test | Vacuum: 65mbar
Test time: 15 min | 270 °F
2880mbar | 3 min | 3 min | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Notes on Table 1:
2
r. Factory set ury time is recommended. Extenced ary time may on required depending on local conations and wraps.
-
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
-
Recommended load: Refer to table 3 and 4.
The Belimed Steam Sterilizer MST-V is offered in the following configurations:
Table 2: Dimensions
| Model
single door
double door | Configuration | Chamber size
(Volume)
(L) | Chamber size
(H x W x D)
(inch) | Chamber size
(H x W x D)
(mm) | Overall Dimensions
(H x W x D)
(inch) | Overall Dimensions
(H x W x D)
(mm) |
|-------------------------------------|---------------|---------------------------------|---------------------------------------|-------------------------------------|---------------------------------------------|-------------------------------------------|
| 6-0-6 VS1 | 1 door | 305 | 26"x 26"x
27.5" | 660 x
660 x 700 | 77.5"x 39"x
43" | 1970 x
990 x 1095 |
| 6-0-6 VS2 | 2 door | 305 | 26"x 26"x
27.5" | 660 x
660 x 700 | 77.5"x 39"x
44" | 1970 x
990 x 1120 |
| 6-0-9 VS1 | 1 door | 440 | 26"x 26"x
39.5" | 660 x
660 x 1000 | 77.5"x 39"x
55" | 1970 x
990 x 1395 |
| 6-0-9 VS2 | 2 door | 440 | 26"x 26"x
39.5" | 660 x
660 x 1000 | 77.5"x 39"x
56" | 1970 x
990 x 1420 |
| 6-0-12 VS1 | 1 door | 595 | 26"x 26"x 53" | 660 x
660 x 1350 | 77.5"x 39"x
69" | 1970 x
990 x 1750 |
| 6-0-12 VS2 | 2 door | 595 | 26"x 26"x 53" | 660 x
660 x 1350 | 77.5"x 39"x
70" | 1970 x
990 x 1775 |
The following table (Table 3) is Belimed Sauter AG's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:
Table 3: Recommended Loads
| Model
single door
double door | Wrapped
instrument trays,
max. 25 lbs each | Unwrapped tray
with single
instrument | Unwrapped
instrument tray,
max. 25 lbs each | Fabric Packs,
max. 6.6 lbs each | Fabric Packs,
max. 9 lbs each |
|-------------------------------------|--------------------------------------------------|---------------------------------------------|---------------------------------------------------|------------------------------------|----------------------------------|
| 6-0-6 VS1
6-0-6 VS2 | 6 | 1 | 2 | 12 | 8 |
| 6-0-9 VS1
6-0-9 VS2 | 9 | 1 | 2 | 18 | 12 |
| 6-0-12 VS1
6-0-12 VS2 | 12 | 1 | 2 | 24 | 16 |
3
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities.
Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.
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 at least 106 reduction. Belimed 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, Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 were validated to meet the requirements of ANSI/AAMI ST8:2008.
The results of the Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 verification studies demonstrate that the sterilizers perform as intended and are summarized as follows:
- . Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Flash and Gravity 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 requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.
- All Prevac cycles verified using the fabric test pack, as described in Section 5.5.2 . ANSI/AAMI ST8:2008 were qualified according to section 5.5.2.5 ANSI/AAMI 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 minutes by half cycle, moisture retention of less than 3 % increase in pre-sterilization test pack weight, and exhibited no wet spots.
- All Prevac, and Gravity cycles verified using full load instruments trays were qualified . according to section 5.5.4 of ANSI/AAMI ST8:2008. 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 minutes by half cycle, moisture retention of less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
- All Prevac Flash cycles verified using the unwrapped instrument trays were qualified . according to section 5,5,5,2 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
- All Gravity cycles verified using the unwrapped instrument tray were qualified according . to section 5.5.5.1 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
- . The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6 of ANSI/AAMI ST8, and demonstrated a uniform color change
4
througnout the test sneet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
- 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)".
SAFETY:
Belimed Sauter AG's sterilizers including the Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 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-V complies with the following safety standards:
- ANSI/AAMI ST8:2008 1.
-
- ANSI/AAMI ST79:2006+A1:2008 .
-
- IEC EN 62304:2006
-
- EN ISO 14971:2007
-
- ISO 13485:2007 Medical Devices - Quality management systems. Requirements for regulatory purposes
- IEC EN 60601-1-2:2007 റ.
-
- UL 61010-1:2004
-
- IEC EN 61010-2-040:2005
-
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2008)
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 MST-V provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
5
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 User's Manual and other labeling. Belimed 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.
CONCLUSION
The Belimed Steam Sterilizers MST-V, models 6-0-6, and 6-0-12 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 4-8 (K033538). This steam sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 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 and is safe and effective when used as intended.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sauter AG C/O Mr. Olaf Teichert Responsible Third Party Official TÜV SUD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
MAR 15 201
Re: K103841
Trade/Device Name: Belimed Steam Sterilizer MST-V, Models 6-0-6, 6-0-9, 6-0-12 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 25, 2011 Received: February 28, 2011
Dear Mr. Teichert:
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.
7
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K103841
Device Name: Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, 6-0-12
Indications for Use:
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are all equipped with the same factory-programmed Sterilization cycles and cycle parameters (Table 1).
The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door (VS1) prevacuum/gravity or double door (VS2) prevacuum/gravity version.
9
| CYCLE | PRE-TREATMENT | STERILIZE | STERILIZE | DRY | RECOMMENDED LOAD |
|---|---|---|---|---|---|
| TEMP / | |||||
| PRESSURE | TIME | TIME 1) | 3) | ||
| PreVac 270 | |||||
| 4S / 30Dry | 3 vacuum pulses: | ||||
| 80/100/100mbar | |||||
| 2 steam pulses: | |||||
| 1500/1500mbar | 270 °F | ||||
| 2880mbar | 4 min | 30 min | Double wrapped instrument trays, | ||
| max. weight of 25 lbs per tray | |||||
| Fabric packs 2) | |||||
| PreVac 270 | |||||
| 4S / 5Dry | 3 vacuum pulses: | ||||
| 80/100/100mbar | |||||
| 2 steam pulses: | |||||
| 1500/1500mbar | 270 °F | ||||
| 2880mbar | 4 min | 5 min | Fabric packs 2) | ||
| PreVac Flash | |||||
| 270 3S / 1Dry | 3 vacuum pulses: | ||||
| 80/100/100mbar | |||||
| 2 steam pulses: | |||||
| 1500/1500mbar | 270 °F | ||||
| 2880mbar | 3 min | 1 min | Unwrapped non-porous single | ||
| instrument or | |||||
| unwrapped non-porous instrument | |||||
| trays, max. weight of 25 Ibs per tray | |||||
| PreVac Flash | |||||
| 270 4S / 1Dry | 3 vacuum pulses: | ||||
| 80/100/100mbar | |||||
| 2 steam pulses: | |||||
| 1500/1500mbar | 270 °F | ||||
| 2880mbar | 4 min | 1 min | Unwrapped porous or non-porous | ||
| single instrument or | |||||
| unwrapped mixed porous and non- | |||||
| porous instrument trays, max. weight | |||||
| of 25 lbs per tray | |||||
| Gravity 270 | |||||
| 15S / 30Dry | Purge time 4min | 270 °F | |||
| 2880mbar | 15 min | 30 min | Wrapped instrument trays, max. | ||
| weight of 25 Ibs per tray | |||||
| Gravity 270 | |||||
| 3S / 1Dry | Purge time 4min | 270 °F | |||
| 2880mbar | 3 min | 1 min | Unwrapped non-porous single | ||
| instrument | |||||
| or unwrapped non-porous | |||||
| instrument trays, max. weight of 25 | |||||
| lbs per tray | |||||
| Gravity 270 | |||||
| 10S / 1Dry | Purge time 4min | 270 °F | |||
| 2880mbar | 10 min | 1 min | Unwrapped porous or non-porous | ||
| single instrument or | |||||
| unwrapped mixed porous and non- | |||||
| porous instrument trays, max. weight | |||||
| of 25 lbs per tray | |||||
| Bowie-Dick | |||||
| Test | 3 vacuum pulses: | ||||
| 80/100/100mbar | |||||
| 2 steam pulses: | |||||
| 1500/1500mbar | 273 °F | ||||
| 3030mbar | 3.5 min | 1 min | One DART or Bowie-Dick-Test-Pack | ||
| Leak Test | Vacuum: 65mbar | ||||
| Test time: 15 min | Empty chamber | ||||
| Warm up & | Vacuum: 65mbar | 270 °F | 3 min | 3 min | Empty chamber |
| CYCLE | PRE-TREATMENT | STERILIZE TEMP/ | |||
| PRESSURE | STERILIZE TIME | DRY TIME 1) | RECOMMENDED LOAD 3) | ||
| leak test | Test time: 15 min | 2880mbar |
Table 1: Factory programmed Sterilization cycles
10
Notes on Table 1:
-
Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps.
-
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
-
Recommended load: Refer to table 3 and 4.
The Belimed Steam Sterilizer MST-V is offered in the following configurations:
Table 2: Dimensions
| Model | Configuration | Chamber size | Chamber size | Overall Dimensions | ||
|---|---|---|---|---|---|---|
| single door | ||||||
| double door | (Volume) | |||||
| (L) | (H x W x D) | |||||
| (inch) | (mm) | (H x W x D) | ||||
| (inch) | (mm) | |||||
| 6-0-6 VS1 | 1 door | 305 | 26"x 26"x 27.5" | 660 x | ||
| 660 x 700 | 77.5"x 39"x 43" | 1970 x | ||||
| 990 x 1095 | ||||||
| 6-0-6 VS2 | 2 door | 305 | 26"x 26"x 27.5" | 660 x | ||
| 660 x 700 | 77.5"x 39"x 44" | 1970 x | ||||
| 990 x 1120 | ||||||
| 6-0-9 VS1 | 1 door | 440 | 26"x 26"x 39.5" | 660 x | ||
| 660 x 1000 | 77.5"x 39"x 55" | 1970 x | ||||
| 990 x 1395 | ||||||
| 6-0-9 VS2 | 2 door | 440 | 26"x 26"x 39.5" | 660 x | ||
| 660 x 1000 | 77.5"x 39"x 56" | 1970 x | ||||
| 990 x 1420 | ||||||
| 6-0-12 VS1 | 1 door | 595 | 26"x 26"x 53" | 660 x | ||
| 660 x 1350 | 77.5"x 39"x 69" | 1970 x | ||||
| 990 x 1750 | ||||||
| 6-0-12 VS2 | 2 door | 595 | 26"x 26"x 53" | 660 x | ||
| 660 x 1350 | 77.5"x 39"x 70" | 1970 x | ||||
| 990 x 1775 |
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The following table (Table 3) is Belimed Sauter AG's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:
| Model
single door
double door | Wrapped
instrument trays,
max. 25 lbs each | Unwrapped tray
with single
instrument | Unwrapped
instrument tray,
max. 25 lbs each | Fabric Packs,
max. 6.6 lbs
each | Fabric Packs,
max. 9 lbs each |
|-------------------------------------|--------------------------------------------------|---------------------------------------------|---------------------------------------------------|---------------------------------------|----------------------------------|
| 6-0-6 VS1 | 6 | 1 | 2 | 12 | 8 |
| 6-0-6 VS2 | | | | | |
| 6-0-9 VS1 | 9 | 1 | 2 | 18 | 12 |
| 6-0-9 VS2 | | | | | |
| 6-0-12 VS1 | 12 | 1 | 2 | 24 | 16 |
| 6-0-12 VS2 | | | | | |
Table 3: Recommended Loads
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x OTC (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Claine-Will
(Print) Sign
(Division Sign-Off) Division of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K103841