(242 days)
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.
The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.
Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.
The provided documentation describes the Belimed Steam Sterilizer MST-V, model 4-4-6. This is a medical device intended for sterilization, not an AI/ML device, and therefore the acceptance criteria and study detailed in the document are related to the physical performance of the sterilizer, not to the performance of an algorithm.
As a result, some of the requested information regarding AI/ML device evaluation (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or available in this document.
Here's an analysis based on the provided text for a steam sterilizer:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its performance is evaluated against the requirements of ANSI/AAMI ST8:2008, a standard for hospital steam sterilizers. The "acceptance criteria" can be inferred from the requirements of this standard and the "reported device performance" is the statement that the device meets these requirements.
| Acceptance Criteria (from ANSI/AAMI ST8:2008) | Reported Device Performance (Belimed Steam Sterilizer MST-V, model 4-4-6) |
|---|---|
| Empty Chamber Testing (Section 5.4.2.5): Capability to provide steady state thermal conditions corresponding to predicted sterility assurance level (SAL). Meets requirements of Sections 4.4.2.2 and 4.4.2.5. | Demonstrated capability to provide steady state thermal conditions within the chamber that correspond with the predicted SAL in the load for PreVac, PreVac Immediate Use, and Gravity cycles. Meets the requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8. |
| Fabric Test Pack (Section 5.5.2): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle, moisture retention < 3% increase in pre-sterilization test pack weight, no wet spots. | All PreVac cycles demonstrated a sterility assurance level of at least 10^-6^ 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. |
| Full Load Instrument Trays (Section 5.5.4): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle, moisture retention < 20% increase in pre-sterilization towel weight, no wet spots on outer wrapper. | All PreVac and Gravity cycles demonstrated a sterility assurance level of at least 10^-6^ 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. |
| Unwrapped Instrument Trays (PreVac Immediate Use - Section 5.5.5.2): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle. | All PreVac Immediate Use cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle. |
| Unwrapped Instrument Trays (Gravity Immediate Use - Section 5.5.5.1): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle. | All Gravity Immediate Use cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time at temperature sufficient to produce an Fo of at least 12 minutes by half cycle. |
| Bowie-Dick Test Pack (Section 5.6): Uniform color change throughout the test sheet, load temperature devices attain exposure temperature within 10 seconds of exposure phase. | The Bowie-Dick Test cycle demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase. |
| Software Validation: Compliance with FDA's moderate level of concern recommendations (Guidance for Premarket Submissions for Software Contained in Medical Devices (May 2005)). | Software validation for 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)". |
2. Sample size used for the test set and the data provenance
The document does not specify a quantitative "sample size" in terms of number of runs for each test. Instead, it states that "Belimed 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)." It refers to "verification studies" and "qualified according to section" of ANSI/AAMI ST8.
- Sample Size: Not explicitly stated as a number of cycles/runs per test. The typical validation for sterilizers involves multiple runs (often three replicate runs) under worst-case conditions for each specified cycle and load configuration according to standards like AAMI ST8. The document implies these standard practices were followed ("All Prevac cycles verified...", "All Gravity Immediate Use cycles were verified...").
- Data Provenance: The studies were "verification studies" performed by the manufacturer, Belimed, or a contracted lab on their behalf. The country of origin for the data is not specified, but the submission is to the FDA (USA). The nature of the studies is prospective, as they are conducted specifically to validate the performance of the new device before its market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a steam sterilizer, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for a sterilizer's performance is biological (kill of biological indicators) and physical (temperature, pressure, dry conditions) measurements, established through scientific laboratory testing and adherence to recognized standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers in AI/ML performance evaluation. For a sterilizer, the performance is measured objectively against defined physical and biological criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a sterilizer, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a sterilizer, not an algorithm. Its performance is measured as a standalone system (the sterilizer operating independently) based on its ability to meet sterilization parameters and kill microorganisms.
7. The type of ground truth used
The ground truth used for sterilizer validation is a combination of:
- Biological Efficacy: Complete kill of biological indicators to demonstrate a sterility assurance level (SAL) of at least 10^-6^. This is the primary measure of sterilization effectiveness.
- Physical Parameters: Achievement of specified time-at-temperature (Fo value), pressure, and appropriate dry conditions (e.g., moisture retention within limits, no wet spots). These physical parameters ensure the conditions for sterilization were met.
These are objective, measurable outcomes, not subjective expert consensus or pathology in the context of an AI/ML device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is engineered and tested against established physical and biological principles.
9. How the ground truth for the training set was established
Not applicable as there is no training set for an AI/ML model. The "ground truth" for the sterilizer's function is established by adherence to recognized sterilization standards (like ANSI/AAMI ST8) which define what constitutes effective sterilization based on decades of scientific and medical knowledge in microbiology and engineering.
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KI30172
510(k) Summary
| Date: | February 28, 2013 |
|---|---|
| Submitter's Name / Address: | Belimed, Inc.2284 Clements Ferry RoadCharleston, SC 29492 |
| Contact Person: | Jay Upchurch, Product Engineer/Quality Assurance ManagerEmail: jay.upchurch@belimed.usPhone: (843) 216-7424Fax: (843) 216-7707 |
| Trade Name: | Belimed Steam Sterilizer MST-V |
| Model: | 4-4-6 |
| Classification: | Steam Sterilizer – Class II, as listed per 21 CFR 880.6880Product Code FLE |
| Predicate Device: | Belimed Steam Sterilizer MST-VSeries 3-3-6 (K100662)SEP 2 3 2013 |
DEVICE DESCRIPTION:
The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6.
NONCLINICAL COMPARISON TO THE PREDICATE DEVICE:
The Belimed Steam Sterilizer MST-V, model 4-4-6 is very similar to the predicate device. Modifications made from the predicate device include:
- · Larger chamber size
- · Control system and HMI (operating panel)
- · Modification of gravity cycle parameters (exposure and dry times)
- Change in manufacturing location
CLINICAL DATA:
No clinical data is required for this device classification submission.
INDICATIONS FOR USE:
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO
Release 1.1 / February 28, 2013 Page 1 of 7
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The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.
| No. | CYCLE | PRE-TREATMENT | STERILIZETEMP /PRESSURE | STERILIZETIME | DRYTIME 1 | RECOMMENDED LOAD2 |
|---|---|---|---|---|---|---|
| 1 | PreVac 2704S / 30Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 4 min | 30 min | Double wrapped instrument trays,max. weight of 25 lbs per trayFabric packs3 |
| 2 | PreVacImmediateUse 2704S / 1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 4 min | 1 min | Unwrapped porous or non-poroussingle instrument orUnwrapped mixed porous and non-porous instrument trays, max.weight of 25 lbs per tray |
| 3 | PreVacImmediateUse 270 3S /1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 3 min | 1 min | Unwrapped non-porous singleinstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 4 | PreVacImmediateUse 270 10S/ 1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 10 min | 1 min | Unwrapped porous or non-poroussingle instrument orUnwrapped mixed porous and non-porous instrument trays, max.weight of 25 lbs per tray |
| 5 | GravityImmediateUse 2703S / 1Dry | Purge time 3 min | 270 °F2880mbar | 3 min | 1 min | Unwrapped non-porous singleinstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 6 | GravityImmediateUse 27010S / 1Dry | Purge time 3 min | 270 °F2880mbar | 10 min | 1 min | Unwrapped non-porous singleinstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 7 | Gravity 27015S / 30Dry | Purge time 3 min | 270 °F2880mbar | 15 min | 30 min | Double wrapped non-porousinstrument trays, max. weight of 25Ibs per tray |
| 8 | Gravity 25030S / 30Dry | Purge time 3 min | 250 °F2040mbar | 30 min | 30 min | Double wrapped non-porousinstrument trays, max. weight of 25lbs per tray |
| 9 | Bowie-DickTest | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 273 °F3030mbar | 3.5 min | 1 min | One DART or Bowie-Dick-Test-Pack |
| No. | CYCLE | PRE-TREATMENT | STERILIZETEMP /PRESSURE | STERILIZETIME | DRYTIME1 | RECOMMENDED LOAD3 |
| 10 | Leak Test | Vacuum: 100mbarTest time: 15 min | - | - | - | Empty chamber |
Table 1: Factory programmed Sterilization cycles
Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO
Release 1.1 / February 28, 2013 Page 2 of 7
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Notes on Table 1:
-
Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps.
-
Recommended load: Refer to table 3 and 4.
-
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
The Belimed Steam Sterilizer MST-V is offered in the following configuration:
Table 2: Dimensions
| Modelsingle doordouble door | Configuration | Chamber size(Volume)(L) | Chamber size(H x W x D) | Overall Dimensions(H x W x D) | ||
|---|---|---|---|---|---|---|
| 4-4-6 | 1 door | 110 | (inch)16"x 16"x 26" | (mm)406 x406 x 660 | (inch)74.75" x26" x 35.5" | (mm)1900 x660 x 900 |
Table 3 indicates Belimed's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:
Table 3: Recommended Loads
| Modelsingle doordouble door | Wrappedinstrument trays,max. 25 lbs each | Unwrapped traywith singleinstrument | Unwrappedinstrument traymax. 25 lbs each | Fabric Packs,max. 6.6 lbs each | Fabric Packs,max. 9 lbs each |
|---|---|---|---|---|---|
| 14-4-6 |
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.
Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.
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Comparison to Predicate Device
.
| Feature | Belimed MST-V 4-4-6 | Belimed MST-V 3-3-6 | ||
|---|---|---|---|---|
| (Predicate) | ||||
| Intended Use | Terminal sterilization of non porous andporous heat and moisture-stabilematerials. This includes rigid deviceswith lumens processed in accordancewith AAMI ST8. | Terminal Sterilization of non porousand porous heat and moisture-stabilematerials. This includes rigid deviceswith lumens processed in accordancewith AAMI ST8. | ||
| Designed for | Steam sterilization in health carefacilities | Steam sterilization in health carefacilities | ||
| Design,Construction,Components | Stainless Steel 316L16" x 16" x 26" (110 l)Design Pressure 40PSIASME Certified Chamber and JacketCubic welded structure with completejacket (except door and back wall) | Stainless Steel 316L13" x 13" x 25" (73 I)Design Pressure 40PSIASME Certified Chamber and JacketCubic welded structure with all-roundheating ducts | ||
| Process monitoring& control devices: | Interactive Touch Panel with 5.7" colordisplayPrinter (24 Char/ Line)Pressure Gauges: chamber, jacket,door seal (digital)compressed air, steam supply, chamberpressure, jacket pressure (analog) | Interactive Operating Panel with 5.7"color display (TFT)Printer (42 Char/ Line)Pressure Gauges: chamber, jacket(digital)compressed air, steam supply, doorseal (analog) | ||
| Safety Devices | Safety Relief ValvesEmergency Stop SwitchDoor safety pressure relief valve | Safety Relief ValvesEmergency Stop Switch | ||
| Standard Cycles | PreVac 270 4S / 30DryPreVac Immediate Use 270 4S / 1DryPreVac Immediate Use 270 3S / 1DryPreVac Immediate Use 270 10S / 1DryGravity Immediate Use 270 3S / 1DryGravity Immediate Use 270 10S / 1DryGravity 270 15S / 30DryGravity 250 30S / 30DryBowie-Dick TestLeak Test | PreVac 270 Long Dry (4S, 30D)PreVac 270 Short Dry (4S, 5D)Prevac Flash 270 (4S, 1D)Gravity 250 (25S, 0D)PreVac 270 Long Dry (10S, 30D)PreVac Flash 270 (10S, 1D)Bowie-Dick TestLeak TestWarm up & leak test |
.
· .
.
·
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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 10° reduction. Belimed validates its sterilization cycles by recommended practices, standards and quidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Sterilizer MST-V, model 4-4-6 was validated to meet the requirements of ANSI/AAMI ST8:2008.
The results of the Belimed Steam Sterilizer MST-V, model 4-4-6 verification studies demonstrate that the sterilizer performs as intended and is summarized as follows:
- t Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Immediate Use, and Gravity cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that correspond 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 cvcles 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 10th 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 Immediate Use cycles were verified using unwrapped instrument trays and were . qualified according to section 5.5.5.2 ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle.
- . All Gravity Immediate Use cycles were verified using unwrapped instrument tray and 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 sheet 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)".
{5}------------------------------------------------
SAFETY:
Belimed's sterilizers, including the Belimed Steam Sterilizer MST-V model 4-4-6, have been designed and constructed 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
-
- ANSI/AAMI ST79:2010+A1:2010
-
- IEC EN 62304:2006
-
- EN ISO 14971:2007
-
- ISO 13485:2007 Medical Devices - Quality management systems. Requirements for regulatory purposes
- ర్. IEC EN 60601-1-2:2007
-
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2009
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 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.
Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO
Release 1.1 / February 28, 2013 Page 6 of 7
{6}------------------------------------------------
USER INFORMATION
Belimed provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed User's Manual and other labeling. Belimed 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 Sterilizer MST-V, model 4-4-6 is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and intended use to the predicate device series 3-3-6 (K100662). This steam sterilizer MST-V model 4-4-6 meets the applicable requirements of the applicable standards.
Based on the provided information in this premarket notification, the subject device is substantially equivalent to the predicate device and is safe and effective when used as intended.
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/7/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers. The logo is black and white.
September 23, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
Belimed, Incorporated Mr. Jay Upchurch Quality Assurance Manager 2284 Clements Ferry Road CHARLESTON, SOUTH CAROLINA 29492
Re: K130172
Trade/Device Name: Belimed Steam Sterilizer MST-V, model 4-4-6 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Il Product Code: FLE Dated: August 26, 2013 Received: August 27, 2013
Dear Mr. Upchurch:
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: CDRFI 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.
{8}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Richard C. Chapman 2013.09.23 13:47:57 -04'00'
for
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Indications for Use
510(k) Number: K130172
Device Name: Belimed Steam Sterilizer MST-V, model 4-4-6
Indications for Use:
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.
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)
Sreekanth Gutala -S 2013.09.23 13:14:12 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number: K130172
Table 1: Factory programmed Sterilization cycles
Page 1 of 3
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| No. | CYCLE | PRE-TREATMENT | STERILIZETEMP /PRESSURE | STERILIZETIME | DRYTIME 1 | RECOMMENDED LOAD2 |
|---|---|---|---|---|---|---|
| 1 | PreVac 2704S / 30Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 4 min | 30 min | Double-wrapped instrument trays,max. weight of 25 lbs per tray orFabric packs3 |
| 2 | PreVacImmediateUse 2704S / 1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 4 min | 1 min | Unwrapped porous or non-poroussingle instrument orUnwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray |
| 3 | PreVacImmediateUse 270 3S /1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 3 min | 1 min | Unwrapped non-porous singleInstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 4 | PreVacImmediateUse 270 10S/ 1Dry | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 270 °F2880mbar | 10 min | 1 min | Unwrapped porous or non-poroussingle instrument orUnwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray |
| 5 | GravityImmediateUse 2703S / 1Dry | Purge time 3 min | 270 °F2880mbar | 3 min | 1 min | Unwrapped non-porous singleinstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 6 | GravityImmediateUse 27010S / 1Dry | Purge time 3 min | 270 °F2880mbar | 10 min | 1 min | Unwrapped non-porous singleinstrument orUnwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray |
| 7 | Gravity 27015S / 30Dry | Purge time 3 min | 270 °F2880mbar | 15 min | 30 min | Double wrapped instrument trays,max. weight of 25 lbs per tray |
| 8 | Gravity 25030S / 30Dry | Purge time 3 min | 250 °F2040mbar | 30 min | 30 min | Double wrapped instrument trays,max. weight of 25 lbs per tray |
| 9 | Bowie-DickTest | 3 vacuum pulses:100/100/100mbar2 steam pulses:1800/1800mbar | 273 °F3030mbar | 3.5 min | 1 min | One DART or Bowie-Dick Test Pack |
| 10 | Leak Test | Vacuum: 100mbarTest time: 15 min | Empty chamber |
{11}------------------------------------------------
Notes on Table 1:
1 Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps. 2 Recommended loads: Refer to table 3.
3 Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for al least 2 hours.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is offered in the following configuration:
Table 2: Dimensions
| Modelsingle doordouble door | Configuration | Chamber size(Volume)(L) | Chamber size(H x W x D) | Overall Dimensions(H x W x D) | ||
|---|---|---|---|---|---|---|
| (inch) | (mm) | (inch) | (mm) | |||
| 4-4-6 | 1 door | 110 | 16"x 16"x 26" | 406 x406 x 660 | 74.75" x26" x 35.5" | 1900 x660 x 900 |
The following table (Table 3) provides guidelines for recommended loads in the Belimed Steam Sterilizer MST-V, model 4-4-6:
Table 3: Recommended Loads
| Modelsingle door,double door | Wrappedinstrument trays,max. 25 lbs each | Unwrapped traywith singleinstrument | Unwrappedinstrument tray,max. 25 lbs each | Fabric Packs |
|---|---|---|---|---|
| 4-4-6 | 2 | 1 | 2 | 4 |
§ 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).