(108 days)
The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H TOP 5000, models 9-6-9, 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 available in a carriage loader and a ground loader (GR) version.
The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and BowieDick Test cycles.
The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):
Here's a breakdown of the acceptance criteria and study information for the Belimed Steam Sterilizer MST-H TOP 5000, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Performance Tests: | ||
| Sterilization Efficacy Validation (PreVac 270F 4S / 30Dry, 25 lbs wrapped instrument PCD) | Sterility assurance level (SAL) 10-6, time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle, moisture retention of less than 20% increase | Pass |
| Sterilization Efficacy Validation (PreVac 270F 4S / 25 lbs wrapped instrument PCD) | Sterility assurance level (SAL) 10-6, time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle | Pass |
| Physical Performance Test: | ||
| Chamber temperature profile | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Biological Performance Tests: For the "PreVac 270F 4S / 30Dry, 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs." For the "PreVac 270F 4S / 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs" and "Half cycle 2 minutes / 3 runs." This indicates a total of 9 runs for the biological performance tests (3 for the 30Dry full cycle, 3 for the 25lb full cycle, and 3 for the 25lb half cycle).
- Physical Performance Test: The "Chamber temperature profile" test mentions "with empty chamber," but does not explicitly state the number of runs or specific sample size beyond that.
- Data Provenance: Not explicitly stated. The document refers to "non-clinical testing" and the standards it complies with (ANSI AAMI ST8:2013, ANSI/AAMI/ISO 11138-3, ANSI/AAMI/ISO 14161). This suggests the data was generated through laboratory testing, likely by the manufacturer, in accordance with these U.S. and international standards. It does not provide information about country of origin of the data beyond "Belimed AG" being in Switzerland, or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are objective, performance-based tests against established standards for sterilization efficacy and temperature profiles. The "ground truth" here is the pass/fail criteria defined by these standards, not expert evaluation of subjective data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of these objective, performance-based tests. Adjudication methods like "2+1" or "3+1" are typically used for subjective evaluations (e.g., medical image interpretation) where multiple experts assess the same data and discrepancies need to be resolved. For device performance testing against defined metrics, the results are direct measurements compared to acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and would assess the impact of AI assistance on human performance. The device described is a steam sterilizer, which does not involve human interpretation in its operational performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The performance tests ("Biological Performance Tests" and "Physical Performance Test") evaluate the sterilizer's function itself (algorithm only, if one considers the sterilizer's programmed cycles as an algorithm). There is no "human-in-the-loop" aspect to the sterilizer's core function of sterilization during these tests.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on defined performance standards and scientific parameters for sterilization efficacy and physical characteristics.
- For biological performance, the ground truth involves achieving a Sterility Assurance Level (SAL) of 10^-6 and a time-at-temperature (F0) of at least 12 minutes by half cycle, along with specific moisture retention percentages. These are objective, measurable outcomes derived from scientific principles of sterilization.
- For physical performance, the ground truth is the chamber temperature profile being within a specific range (+3°C / +6°F and -0°C / -0°F of the target temperature).
These are not based on expert consensus, pathology, or outcomes data in the typical medical diagnostic sense, but rather on engineering and microbiological performance standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a steam sterilizer, a medical device with pre-programmed cycles and physical components, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves its design, engineering, and adherence to established manufacturing and performance standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for the development of such a device stems from engineering specifications, regulatory standards (e.g., ANSI/AAMI ST8:2013), and validated sterilization principles rather than a labeled dataset used to train an AI model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2019
Belimed AG Marc Lüthi Head of R&D Sustaining Grienbachstrasse 11 CH-6300 Zug / Switzerland
Re: K191896
Trade/Device Name: Belimed Steam Sterilizer MST-H TOP 5000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 20, 2019 Received: September 25, 2019
Dear Marc Lüthi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191896
Device Name
Belimed Steam Sterilizer MST-H TOP 5000
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-H TOP 5000 is equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Z Over-The-Counter Use (21 CFR 801 Subpart C)
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Table 1: Factory programmed sterilization cycles and cycle values.
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:
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:
:
:
| CYCLES | STERILIZETEMP | STERILIZETIME | DRYTIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| PreVac270F 4S /30Dry | 270°F | 4minutes | 30minutes | Double-wrapped instrument trays.Maximum weight of 25 Ib each for the followingmodels: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 andGR 9-6-18 HS2.Maximum weight of 17 Ib each for the followingmodels: 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-15 HS1 and GR 9-6-18 HS1.Fabric Packs. |
| PreVac270F 4S /5Dry | 270°F | 4minutes | 5minutes | Fabric Packs. |
| Liquid 250F | 250°F | 45minutes | Max 1000 ml of Liquid per bottle. Use only ventedbottles, type I, borosilicate glassCycle disabled | |
| Express270F | 270°F | 4minutes | 3minutes | Single wrapped instrument tray with non porous singleinstrument |
| ImmediateUse 270FSingle Ins | 270°F | 4minutes | 3minutes | Unwrapped instrument tray with non porous singleinstrument |
| ImmediateUse 270FMulti Ins | 270°F | 10minutes | 1minute | Unwrapped instrument tray with non porous multipleinstruments.Maximum weight of 25 lb each for the followingmodels: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18HS2.Maximum weight of 17 lbs. each for the followingmodels: 9-6-9 HS1, 9-6-9 HS2, 9-6-12HS1, 9-6-15HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15HS1, GR 9-6-15 HS2, GR 9-6-18 HS1. Maximum of4 instrument trays. |
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:
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:
.
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510(k) Summary
| K191896 | |
|---|---|
| Date: | October 25, 2019 |
| Owner's Name / Address: | Belimed AGGrienbachstrasse 11CH-6300 Zug / Switzerland |
| Preparer's Name / Address: | Belimed AGGrienbachstrasse 11CH-6300 Zug / Switzerland |
| Contact Person: | Marc LüthiEmail: marc.luethi@belimed.comPhone: +41 71 644 87 80Fax: +41 41 449 78 89 |
| Trade Name: | Belimed Steam Sterilizer MST-H TOP 5000 |
| Models: | 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1,9-6-12 HS2, 9-6-15 HS1, 9-6-15 HS2,9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1,GR 9-6-9 HS2, GR 9-6-12 HS1,GR 9-6-12 HS2, GR 9-6-15 HS1,GR 9-6-15 HS2, GR 9-6-18 HS1,GR 9-6-18 HS2 |
| Classification: | Steam Sterilizer - Class II, as listed per21 CFR 880.6880Product Code: FLE |
| Predicate Device: | Belimed Steam Sterilizer MST-H TOP 5000(K170228) |
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Intended Use:
The Belimed Steam Sterilizers MST-H TOP 5000, models 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-12 HS2, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1 and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-H TOP 5000 is equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1.
| CYCLES | STERILIZETEMP | STERILIZETIME | DRYTIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| PreVac270F 4S /30Dry | 270°F | 4minutes | 30minutes | Double-wrapped instrument trays.Maximum weight of 25 lb each for the followingmodels: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 andGR 9-6-18 HS2.Maximum weight of 17 lb each for the followingmodels: 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-15 HS1 and GR 9-6-18 HS1.Fabric Packs. |
| PreVac270F 4S /5Dry | 270°F | 4minutes | 5minutes | Fabric Packs. |
| Liquid 250F | 250°F | 45minutes | - | Max 1000 ml of Liquid per bottle. Use only ventedbottles, type I, borosilicate glassCycle disabled |
| Express270F | 270°F | 4minutes | 3minutes | Single wrapped instrument tray with non porous singleinstrument |
| ImmediateUse 270FSingle Ins | 270°F | 4minutes | 3minutes | Unwrapped instrument tray with non porous singleinstrument |
| ImmediateUse 270FMulti Ins | 270°F | 10minutes | 1minute | Unwrapped instrument tray with non porous multipleinstruments.Maximum weight of 25 lb each for the followingmodels: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18HS2.Maximum weight of 17 lb each for the followingmodels: 9-6-9 HS1, 9-6-9 HS2, 9-6-12HS1, 9-6-15HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15HS1, GR 9-6-15 HS2, GR 9-6-18 HS1. Maximum of4 instrument trays. |
Table 1: Factory programmed sterilization cycles and cycle values.
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Description of Device:
The Belimed Steam Sterilizers MST-H TOP 5000, models 9-6-9, 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 available in a carriage loader and a ground loader (GR) version.
The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and BowieDick Test cycles.
The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles
(Table 2):
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| No | CYCLE | PRE-TREATMENT | STERILIZETEMP | STERILIZETIME | DRYTIME | RECOMMENDED LOAD |
|---|---|---|---|---|---|---|
| 1 | PreVac270F 4S /30Dry | 4 pulses | 270°F | 4minutes | 30minutes | Double-wrapped instrument trays.Maximum weight of 25 lb each for thefollowing models: 9-6-12 HS2, 9-6-15HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2.Maximum weight of 17 lb each for thefollowing models: 9-6-9 HS1, 9-6-9 HS2,9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2,GR 9-6-12 HS1, GR 9-6-15 HS1 and GR9-6-18 HS1.Fabric Packs. |
| 2 | PreVac270F 4S /5Dry | 4 pulses | 270°F | 4minutes | 5minutes | Fabric Packs. |
| 3 | Flash270F -Single Ins | Purge | 270°F | 3minutes | 1 minute | Unwrapped instrument tray with a singleinstrument |
| 4 | Flash270F -Multi Ins | Purge | 270°F | 10minutes | 1 minute | Unwrapped instrument tray with nonporous multiple instruments.Maximum weight of 25 Ib each for thefollowing models: 9-6-12 HS2, 9-6-15HS1, and GR 9-6-18 HS2.Maximum weight of 17 Ib each for thefollowing models: 9-6-9 HS1, 9-6-9 HS2,9-6-12HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2,GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1.Maximum of 4 instrument trays. |
| 5 | Express270F | 2 pulses | 270°F | 4minutes | 3minutes | Single wrapped instrument tray with nonporous single instrument |
| 6 | Bowie-Dick Test | 4 pulses | 273°F | 3.5minutes | 1 minute | One DART or Bowie-Dick-Test-Pack |
| 7 | Leak Test | Vacuum:65 mbarTest time:15 min | - | - | - | Empty chamber |
| 8 | Warm up& LeakTest | Vacuum:65 mbarTest time:15 min | 270°F | 4minutes | 3minutes | Empty chamber |
| 9 | - | - | - | - | - | - |
| 10 | Liquid250F | Purge | 250°F | 45minutes | - | Max 1000 ml of Liquid per bottle. Use onlyvented bottles, type I, borosilicate glassCycle disabled |
Table 2: Factory programmed Sterilization cycles
Notes on Table 2:
-
- Factory set sterilize time is recommended.
-
- Factory set dry time.
-
- Recommended load: Refer to table 3 and 4.
-
- Fabric load should be preconditioned between 68°F and 75°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
-
- The liquid cycle is for non-patient contact use only.
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The Belimed Steam Sterilizers MST-H TOP 5000 are offered in the following versions:
| Model | Configuration | Chamber Size (H x W x D) (mm) | Overall Size (H x W x D) (mm) |
|---|---|---|---|
| Single Door | |||
| Double Door | |||
| 9-6-9 HS1 | 1 door | 1080 x 660 x 1040 | 2000 x 1700 x 1280 |
| GR 9-6-9 HS1 | 1230 x 660 x 1100 | 2000 x 1900 x 1600 | |
| 9-6-9 HS2 | 2 door | 1080 x 660 x 1040 | 2000 x 1700 x 1300 |
| GR 9-6-9 HS2 | 1230 x 660 x 1100 | 2000 x 1900 x 1600 | |
| 9-6-12 HS1 | 1 door | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| GR 9-6-12 HS1 | 1230 x 660 x 1400 | 2000 x 1900 x 1900 | |
| 9-6-12 HS2 | 2 door | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| GR 9-6-12 HS2 | 1230 x 660 x 1400 | 2000 x 1900 x 1900 | |
| 9-6-15 HS1 | 1 door | 1080 x 660 x 1700 | 1970 x 1700 x 2022 |
| GR 9-6-15 HS1 | 1230 x 660 x 1706 | 2000 x 1900 x 2200 | |
| 9-6-15 HS2 | 2 door | 1080 x 660 x 1700 | 1970 x 1700 x 2022 |
| GR 9-6-15 HS2 | 1230 x 660 x 1706 | 2000 x 1900 x 2200 | |
| 9-6-18 HS1 | 1 door | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| GR 9-6-18 HS1 | 1230 x 660 x 2000 | 2000 x 1900 x 2500 | |
| 9-6-18 HS2 | 2 door | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| GR 9-6-18 HS2 | 1230 x 660 x 2000 | 2000 x 1900 x 2500 |
Table 3. Versions and dimensions.
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The following tables show the recommended loads for the Belimed Steam Sterilizers MST-H TOP 5000:
| Modelsingle doordouble door | Wrappedinstrumenttrays, max. 17lb each | Fabric Packs11"*x11"x9"max.6.6 lb each | Fabric Packs23"x11"x11" max.17 lb each |
|---|---|---|---|
| 9-6-9 HS1 | 9 | 18 | 9 |
| 9-6-9 HS2 | |||
| GR 9-6-9 HS1 | |||
| GR 9-6-9 HS2 | |||
| 9-6-12 HS1 | 12 | 30 | 12 |
| GR 9-6-12HS1 | |||
| GR 9-6-12HS2 | |||
| 9-6-15 HS2 | 15 | 36 | 15 |
| GR 9-6-15 HS1 | |||
| 9-6-18 HS1 | 18 | 42 | 18 |
| 9-6-18 HS2 | |||
| GR 9-6-18 HS1 |
Table 4: Recommended loads by sterilizer for 17 lb. instrument trays and fabric packs.
Table 5: Recommended loads by sterilizer for 25 lb. instrument trays and fabric packs.
| Modelsingle doordouble door | Wrappedinstrumenttrays, max. 25lb each | Fabric Packs11*x11"x9"max.6.6 lb each | Fabric Packs23"x11"x11" max.17 lb each |
|---|---|---|---|
| 9-6-12 HS2 | 12 | 30 | 12 |
| 9-6-15 HS1 | 15 | 36 | 15 |
| GR 9-6-15 HS2 | |||
| GR 9-6-18 HS2 | 18 | 42 | 18 |
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| Model | Volume of Liquid in OneContainer | Number of Containers |
|---|---|---|
| 9-6-9GR 9-6-9 | 1000 mL | 126 |
| 9-6-12GR 9-6-12 | 1000 mL | 168 |
| 9-6-15GR 9-6-15 | 1000 mL | 210 |
| 9-6-18GR 9-6-18 | 1000 mL | 252 |
Table 6. Recommended loads for liquid cycle 250F.
The Belimed Steam Sterilizer MST-H TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-H TOP 5000 is offered in the following medium-size configurations: 26"x 42.5"x 41" (660 mm x 1080 mm x 1040 mm) Single Door, Prevacuum 26"x 42.5"x 41" (660 mm x 1080 mm x 1040 mm) Double Door, Prevacuum 26"x 42.5"x 55" (660 mm x 1080 mm x 1400 mm) Single Door, Prevacuum 26"x 42.5"x 55" (660 mm x 1080 mm x 1400 mm) Double Door, Prevacuum 26"x 42.5"x 67" (660 mm x 1080 mm x 1700 mm) Single Door, Prevacuum 26"x 42.5"x 67" (660 mm x 1080 mm x 1700 mm) Double Door, Prevacuum 26"x 42.5"x 79" (660 mm x 1080 mm x 2000 mm) Single Door, Prevacuum 26"x 42.5"x 79" (660 mm x 1080 mm x 2000 mm) Double Door, Prevacuum 26"x 48.5"x 43" (660 mm x 1230 mm x 1100 mm) Single Door. Floor Flush Design. Prevacuum 26"x 48.5"x 43" (660 mm x 1230 mm x 1100 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 55" (660 mm x 1230 mm x 1400 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 55" (660 mm x 1230 mm x 1400 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 67" (660 mm x 1230 mm x 1700 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 67" (660 mm x 1230 mm x 1700 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm x 2000 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm x 2000 mm) Double Door, Floor Flush Design, Prevacuum
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Technological Characteristics Table:
| Shown below is a comparison of the subject device versus the predicate device: | |||
|---|---|---|---|
| General SterilizerFeatures | Belimed Steam SterilizerMST-H TOP 5000 (K170228) | Belimed Steam SterilizerMST-H TOP 5000 (K191896) | Comparison |
|---|---|---|---|
| Intended Use | Terminal Sterilization of non-porous and porous heat andmoisture-stable materialsused in healthcare facilities | Terminal Sterilization of non-porous and porous heat andmoisture-stable materialsused in healthcare facilities | Same |
| Operatingprinciple | The sterilizing agent is steam. | The sterilizing agent is steam. | Same |
| Built according tostandard | ANSI/AAMI ST8:2013Hospital Steam Sterilizers | ANSI/AAMI ST8:2013Hospital Steam Sterilizers | Same |
| Chamber sizesModel: | (H x W x D) in mm: | (H x W x D) in mm: | Same |
| 9-6-99-6-12GR9-6-12 | 1080x660x10401080x660x14001230x660x1400 | 1080x660x10401080x660x14001230x660x1400 | |
| 9-6-15GR9-6-15 | 1080x660x17001230x660x1700 | 1080x660x17001230x660x1700 | |
| 9-6-18GR9-6-18 | 1080x660x20001230x660x2000 | 1080x660x20001230x660x2000 | |
| Sterilizationcycles | PreVac 270 °F | PreVac 270 °F | Same |
| Gravity 270 °F | Gravity 270 °F | ||
| Liquid 250 °F | Liquid 250 °F | ||
| Bowie Dick Test | Bowie Dick Test | ||
| Air Leak Test | Air Leak Test | ||
| Max. instrumenttray weight | Double-wrapped instrumenttrays.Maximum weight of 25 lb eachfor the following models: 9-6-12HS2, 9-6-15 HS1 andGR 9-6-18 HS2.Maximum weight of 17 lb eachfor the following models: 9-6-9HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18HS2, GR 9-6-9 HS1, GR 9-6-9HS2, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2 andGR 9-6-18 HS1.Fabric Packs | Double-wrapped instrumenttrays.Maximum weight of 25 lb eachfor the following models: 9-6-12HS2, 9-6-15 HS1, GR 9-6-15HS2 and GR 9-6-18 HS2.Maximum weight of 17 lb eachfor the following models: 9-6-9HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18HS2, GR 9-6-9 HS1, GR 9-6-9HS2, GR 9-6-12 HS1, GR 9-6-15 HS1 and GR 9-6-18 HS1.Fabric Packs | Similar |
| General SterilizerFeatures | Belimed Steam SterilizerMST-H TOP 5000 (K170228) | Belimed Steam SterilizerMST-H TOP 5000 (K191896) | Comparison |
| Load capacityinstrument trays | |||
| Model: | |||
| 9-6-9 / 9-6-12 /GR9-6-12 | 9 | 9 | same |
| 9-6-15 / GR9-6-15 | 12 | 12 | |
| 9-6-18 / GR9-6-18 | 15 | 15 | |
| 18 | 18 | ||
| Chambermaterial | Stainless steel 316L | Stainless steel 316L | same |
| Chamber designpressure | 39 psi | 39 psi | same |
| Door construction | Automated horizontal slidingdoor(s) | Automated horizontal slidingdoor(s) | same |
| Safety (pressurerelief) valves | ASME approved | ASME approved | same |
| Piping | Stainless steel 316 L | Stainless steel 316 L | same |
| Electrical | 3 phase 208V 60Hz | 3 phase 208V 60Hz | same |
| HMI Technology | LCD color / 5.7" | LCD color / 5.7" | same |
| ControlTechnology | PLC | PLC | Same |
| PrinterTechnology | Matrix Dot Technology | Matrix Dot Technology | Same |
| Vacuum pump | 9-6-9 / GR 9-6-9: 95m3/h9-6-12 / GR 9-6-12: 95m3/h9-6-15 / GR 9-6-15: 130m3/h9-6-18 / GR 9-6-18: 130m3/h | 9-6-9 / GR 9-6-9: 95m3/h9-6-12 / GR 9-6-12: 95m3/h9-6-15 / GR 9-6-15: 130m3/h9-6-18 / GR 9-6-18: 130m3/h | Same |
| Air filter | 0.3 microns | 0.3 microns | Same |
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Based on the comparison above the subject device and the predicate device demonstrate many of the same technological characteristics.
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Clinical Data:
No clinical data is required for this device classification submission.
Summary of Performance Testing:
Show below is a summary of the non-clinical testing that was performed with this device.
| Test Performed | DeviceDescribtion/Sample Size | Test Method/ApplicableStandards | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Biological Performance Tests: | ||||
| Sterilization EfficacyValidationPreVac 132°C (270°F)for 4 minutes Exposureand 30 min. Dry 25 lbswrapped instrumentPCD1: Full cycle / 3 runs | MST-HTOP 5000GR 9-6-15HS2 | ANSI AAMIST8:20135.5.4. Biologicalperformance withwrapped instrumentPCDBI's used in testingcomply withANSI/AAMI/ISO11138-3 | Sterility assurance level(SAL) 10-6time-at-temperaturesufficient to produce anF0 of at least 12 minutesby half cycle, moistureretention of less than 20%increaseANSI/AAMI ST8:20135.5.4.5ANSI/AAMI/ISO 14161 | Pass |
| Sterilization EfficacyValidationPreVac 132°C (270°F)for 4 minutes Exposure25 lbs wrappedinstrument PCD1:Full cycle / 3 runs2:Half cycle 2 minutes /3 runs | MST-HTOP 5000GR 9-6-15HS2 | ANSI AAMIST8:20135.5.4. Biologicalperformance withwrapped instrumentPCDBI's used in testingcomply withANSI/AAMI/ISO11138-3 | Sterility assurance level(SAL) 10-6time-at-temperaturesufficient to produce anF0 of at least 12 minutesby half cycleANSI/AAMI ST8:20135.5.4.5ANSI/AAMI/ISO 14161 | Pass |
| Physical Performance Test: | ||||
| Chamber temperatureprofile | MST-HTOP 5000GR 9-6-15HS2 | ANSI AAMIST8:20135.4.2.5 with emptychamber | +3°C (or +6°F) and-0°C (or -0°F) of theselected sterilizationexposure temperature | Pass |
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Standards Used:
Belimed's sterilizers, including the Belimed Steam Sterilizer MST-H TOP 5000 series have been designed and constructed to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer MST-H TOP 5000 complies with the following standards:
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- ANSI/AAMI ST8:2013
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- ANSI/AAMI ST79:2017
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- IEC EN 62304:2006
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- EN ISO 14971:2012
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- ISO 13485:2016 Medical Devices - Quality management systems. Requirements for regulatory purposes
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- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2017.
- UL 61010-1:2004 Safety requirements for electrical equipment for measurement, control 7. and laboratory use -Part 1: General requirements.
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- IEC 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and laboratory use -Part 2: Particular requirements for sterilizers and washerdisinfectors used to treat medical materials.
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- IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
Conclusion:
The nonclinical tests in this premarket notification demonstrate that this device is as safe, as effective, and performs as well or better than the predicate device series (K170228).
§ 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).