(108 days)
Not Found
No
The document describes a steam sterilizer with predefined cycles and standard performance testing, with no mention of AI or ML.
No
The device is a steam sterilizer designed to sterilize materials used in healthcare, not to provide therapy directly to patients.
No
Explanation: The device is a steam sterilizer designed to sterilize medical materials. Its function is to process items, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly indicates it is a physical steam sterilizer with various models and configurations (single/double door, carriage/ground loader). The performance studies also focus on the physical sterilization process and chamber temperature, not software performance.
Based on the provided information, 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. This is a process applied to medical devices and materials, not a test performed on biological samples to diagnose a condition or provide information about a patient's health.
- Device Description: The description details a steam sterilizer with various cycles for sterilization. This aligns with a device used for reprocessing medical equipment.
- Performance Studies: The performance studies focus on sterilization efficacy and physical performance (temperature profiling), which are relevant to ensuring the device effectively sterilizes materials. They do not involve testing biological samples or generating diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results.
Therefore, the Belimed Steam Sterilizer MST-H TOP 5000 is a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
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):
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
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
healthcare 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)
Biological Performance Tests: Sterilization Efficacy Validation
PreVac 132°C (270°F) for 4 minutes Exposure and 30 min. Dry 25 lbs wrapped instrument PCD
Device Sample Size: MST-H TOP 5000 GR 9-6-15 HS2
Test Method: ANSI AAMI ST8:2013 5.5.4. Biological performance with wrapped instrument PCD; BI's used in testing comply with ANSI/AAMI/ISO 11138-3
Acceptance Criteria: 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; ANSI/AAMI ST8:2013 5.5.4.5; ANSI/AAMI/ISO 14161
Results: Pass
Sterilization Efficacy Validation
PreVac 132°C (270°F) for 4 minutes Exposure 25 lbs wrapped instrument PCD
1: Full cycle / 3 runs
2: Half cycle 2 minutes / 3 runs
Device Sample Size: MST-H TOP 5000 GR 9-6-15 HS2
Test Method: ANSI AAMI ST8:2013 5.5.4. Biological performance with wrapped instrument PCD; BI's used in testing comply with ANSI/AAMI/ISO 11138-3
Acceptance Criteria: Sterility assurance level (SAL) 10-6; time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle; ANSI/AAMI ST8:2013 5.5.4.5; ANSI/AAMI/ISO 14161
Results: Pass
Physical Performance Test: Chamber temperature profile
Device Sample Size: MST-H TOP 5000 GR 9-6-15 HS2
Test Method: ANSI AAMI ST8:2013 5.4.2.5 with empty chamber
Acceptance Criteria: +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature
Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Table 1: Factory programmed sterilization cycles and cycle values.
.
:
.
:
:
:
| CYCLES | STERILIZE
TEMP | STERI
LIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|-------------------------------------|-------------------|-----------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PreVac
270F 4S /
30Dry | 270°F | 4
minutes | 30
minutes | Double-wrapped instrument trays.
Maximum weight of 25 Ib each for the following
models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and
GR 9-6-18 HS2.
Maximum weight of 17 Ib each for the following
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 GR 9-
6-18 HS1.
Fabric Packs. |
| PreVac
270F 4S /
5Dry | 270°F | 4
minutes | 5
minutes | Fabric Packs. |
| Liquid 250F | 250°F | 45
minutes | | Max 1000 ml of Liquid per bottle. Use only vented
bottles, type I, borosilicate glass
Cycle disabled |
| Express
270F | 270°F | 4
minutes | 3
minutes | Single wrapped instrument tray with non porous single
instrument |
| Immediate
Use 270F
Single Ins | 270°F | 4
minutes | 3
minutes | Unwrapped instrument tray with non porous single
instrument |
| Immediate
Use 270F
Multi Ins | 270°F | 10
minutes | 1
minute | Unwrapped instrument tray with non porous multiple
instruments.
Maximum weight of 25 lb each for the following
models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18
HS2.
Maximum weight of 17 lbs. each for the following
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. |
.
:
.
:
.
4
510(k) Summary
| K191896 | |
|---|---|
| Date: | October 25, 2019 |
| Owner's Name / Address: | Belimed AG |
| Grienbachstrasse 11 | |
| CH-6300 Zug / Switzerland | |
| Preparer's Name / Address: | Belimed AG |
| Grienbachstrasse 11 | |
| CH-6300 Zug / Switzerland | |
| Contact Person: | Marc Lüthi |
| Email: marc.luethi@belimed.com | |
| Phone: +41 71 644 87 80 | |
| Fax: +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 per |
| 21 CFR 880.6880 | |
| Product Code: FLE | |
| Predicate Device: | Belimed Steam Sterilizer MST-H TOP 5000 |
| (K170228) |
5
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 | STERILIZE
TEMP | STERI
LIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|-------------------------------------|-------------------|-----------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PreVac
270F 4S /
30Dry | 270°F | 4
minutes | 30
minutes | Double-wrapped instrument trays.
Maximum weight of 25 lb each for the following
models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and
GR 9-6-18 HS2.
Maximum weight of 17 lb each for the following
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 GR 9-
6-18 HS1.
Fabric Packs. |
| PreVac
270F 4S /
5Dry | 270°F | 4
minutes | 5
minutes | Fabric Packs. |
| Liquid 250F | 250°F | 45
minutes | - | Max 1000 ml of Liquid per bottle. Use only vented
bottles, type I, borosilicate glass
Cycle disabled |
| Express
270F | 270°F | 4
minutes | 3
minutes | Single wrapped instrument tray with non porous single
instrument |
| Immediate
Use 270F
Single Ins | 270°F | 4
minutes | 3
minutes | Unwrapped instrument tray with non porous single
instrument |
| Immediate
Use 270F
Multi Ins | 270°F | 10
minutes | 1
minute | Unwrapped instrument tray with non porous multiple
instruments.
Maximum weight of 25 lb each for the following
models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18
HS2.
Maximum weight of 17 lb each for the following
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. |
Table 1: Factory programmed sterilization cycles and cycle values.
6
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):
7
| No | CYCLE | PRE-
TREATM
ENT | STERILIZE
TEMP | STERI
LIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|----|-------------------------------|--------------------------------------------|-------------------|-----------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | PreVac
270F 4S /
30Dry | 4 pulses | 270°F | 4
minutes | 30
minutes | Double-wrapped instrument trays.
Maximum weight of 25 lb each for the
following models: 9-6-12 HS2, 9-6-15
HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2.
Maximum weight of 17 lb each for the
following 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 GR
9-6-18 HS1.
Fabric Packs. |
| 2 | PreVac
270F 4S /
5Dry | 4 pulses | 270°F | 4
minutes | 5
minutes | Fabric Packs. |
| 3 | Flash
270F -
Single Ins | Purge | 270°F | 3
minutes | 1 minute | Unwrapped instrument tray with a single
instrument |
| 4 | Flash
270F -
Multi Ins | Purge | 270°F | 10
minutes | 1 minute | Unwrapped instrument tray with non
porous multiple instruments.
Maximum weight of 25 Ib each for the
following models: 9-6-12 HS2, 9-6-15
HS1, and GR 9-6-18 HS2.
Maximum weight of 17 Ib each for the
following 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 | Express
270F | 2 pulses | 270°F | 4
minutes | 3
minutes | Single wrapped instrument tray with non
porous single instrument |
| 6 | Bowie-
Dick Test | 4 pulses | 273°F | 3.5
minutes | 1 minute | One DART or Bowie-Dick-Test-Pack |
| 7 | Leak Test | Vacuum:
65 mbar
Test time:
15 min | - | - | - | Empty chamber |
| 8 | Warm up
& Leak
Test | Vacuum:
65 mbar
Test time:
15 min | 270°F | 4
minutes | 3
minutes | Empty chamber |
| 9 | - | - | - | - | - | - |
| 10 | Liquid
250F | Purge | 250°F | 45
minutes | - | Max 1000 ml of Liquid per bottle. Use only
vented bottles, type I, borosilicate glass
Cycle 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.
8
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.
9
The following tables show the recommended loads for the Belimed Steam Sterilizers MST-H TOP 5000:
| Model
single door
double door | Wrapped
instrument
trays, max. 17
lb each | Fabric Packs
11"*x11"x9"
max.6.6 lb each | Fabric Packs
23"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.
| Model
single door
double door | Wrapped
instrument
trays, max. 25
lb each | Fabric Packs
11*x11"x9"
max.6.6 lb each | Fabric Packs
23"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 |
10
| Model | Volume of Liquid in One
Container | Number of Containers |
|---------------------|--------------------------------------|----------------------|
| 9-6-9
GR 9-6-9 | 1000 mL | 126 |
| 9-6-12
GR 9-6-12 | 1000 mL | 168 |
| 9-6-15
GR 9-6-15 | 1000 mL | 210 |
| 9-6-18
GR 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
11
Technological Characteristics Table:
| Shown below is a comparison of the subject device versus the predicate device: | |||
|---|---|---|---|
| General Sterilizer
Features | Belimed Steam Sterilizer
MST-H TOP 5000 (K170228) | Belimed Steam Sterilizer
MST-H TOP 5000 (K191896) | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Terminal Sterilization of non-
porous and porous heat and
moisture-stable materials
used in healthcare facilities | Terminal Sterilization of non-
porous and porous heat and
moisture-stable materials
used in healthcare facilities | Same |
| Operating
principle | The sterilizing agent is steam. | The sterilizing agent is steam. | Same |
| Built according to
standard | ANSI/AAMI ST8:2013
Hospital Steam Sterilizers | ANSI/AAMI ST8:2013
Hospital Steam Sterilizers | Same |
| Chamber sizes
Model: | (H x W x D) in mm: | (H x W x D) in mm: | Same |
| 9-6-9
9-6-12
GR9-6-12 | 1080x660x1040
1080x660x1400
1230x660x1400 | 1080x660x1040
1080x660x1400
1230x660x1400 | |
| 9-6-15
GR9-6-15 | 1080x660x1700
1230x660x1700 | 1080x660x1700
1230x660x1700 | |
| 9-6-18
GR9-6-18 | 1080x660x2000
1230x660x2000 | 1080x660x2000
1230x660x2000 | |
| Sterilization
cycles | 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. instrument
tray weight | Double-wrapped instrument
trays.
Maximum weight of 25 lb each
for the following models: 9-6-12
HS2, 9-6-15 HS1 and
GR 9-6-18 HS2.
Maximum weight of 17 lb each
for the following 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, GR 9-6-15 HS2 and
GR 9-6-18 HS1.
Fabric Packs | Double-wrapped instrument
trays.
Maximum weight of 25 lb each
for the following models: 9-6-12
HS2, 9-6-15 HS1, GR 9-6-15
HS2 and GR 9-6-18 HS2.
Maximum weight of 17 lb each
for the following 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 GR 9-6-18 HS1.
Fabric Packs | Similar |
| General Sterilizer
Features | Belimed Steam Sterilizer
MST-H TOP 5000 (K170228) | Belimed Steam Sterilizer
MST-H TOP 5000 (K191896) | Comparison |
| Load capacity
instrument 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 | |
| Chamber
material | Stainless steel 316L | Stainless steel 316L | same |
| Chamber design
pressure | 39 psi | 39 psi | same |
| Door construction | Automated horizontal sliding
door(s) | Automated horizontal sliding
door(s) | same |
| Safety (pressure
relief) 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 |
| Control
Technology | PLC | PLC | Same |
| Printer
Technology | Matrix Dot Technology | Matrix Dot Technology | Same |
| Vacuum pump | 9-6-9 / GR 9-6-9: 95m3/h
9-6-12 / GR 9-6-12: 95m3/h
9-6-15 / GR 9-6-15: 130m3/h
9-6-18 / GR 9-6-18: 130m3/h | 9-6-9 / GR 9-6-9: 95m3/h
9-6-12 / GR 9-6-12: 95m3/h
9-6-15 / GR 9-6-15: 130m3/h
9-6-18 / GR 9-6-18: 130m3/h | Same |
| Air filter | 0.3 microns | 0.3 microns | Same |
12
Based on the comparison above the subject device and the predicate device demonstrate many of the same technological characteristics.
13
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 | Device
Describtion/
Sample Size | Test Method/
Applicable
Standards | Acceptance
Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Biological Performance Tests: | | | | |
| Sterilization Efficacy
Validation
PreVac 132°C (270°F)
for 4 minutes Exposure
and 30 min. Dry 25 lbs
wrapped instrument
PCD
1: Full cycle / 3 runs | MST-H
TOP 5000
GR 9-6-15
HS2 | ANSI AAMI
ST8:2013
5.5.4. Biological
performance with
wrapped instrument
PCD
BI's used in testing
comply with
ANSI/AAMI/ISO
11138-3 | 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
ANSI/AAMI ST8:2013
5.5.4.5
ANSI/AAMI/ISO 14161 | Pass |
| Sterilization Efficacy
Validation
PreVac 132°C (270°F)
for 4 minutes Exposure
25 lbs wrapped
instrument PCD
1:
Full cycle / 3 runs
2:
Half cycle 2 minutes /
3 runs | MST-H
TOP 5000
GR 9-6-15
HS2 | ANSI AAMI
ST8:2013
5.5.4. Biological
performance with
wrapped instrument
PCD
BI's used in testing
comply with
ANSI/AAMI/ISO
11138-3 | Sterility assurance level
(SAL) 10-6
time-at-temperature
sufficient to produce an
F0 of at least 12 minutes
by half cycle
ANSI/AAMI ST8:2013
5.5.4.5
ANSI/AAMI/ISO 14161 | Pass |
| Physical Performance Test: | | | | |
| Chamber temperature
profile | MST-H
TOP 5000
GR 9-6-15
HS2 | ANSI AAMI
ST8:2013
5.4.2.5 with empty
chamber | +3°C (or +6°F) and
-0°C (or -0°F) of the
selected sterilization
exposure temperature | Pass |
14
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:
-
- ANSI/AAMI ST8:2013
-
- ANSI/AAMI ST79:2017
-
- IEC EN 62304:2006
-
- EN ISO 14971:2012
-
- ISO 13485:2016 Medical Devices - Quality management systems. Requirements for regulatory purposes
-
- 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.
-
- 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.
-
- 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).