Belimed Steam Sterilizer MST-H TOP 5000

• K Number: K170228
• Device Name: Belimed Steam Sterilizer MST-H TOP 5000
• Manufacturer: Belimed AG
• Date Cleared: 2017-05-12 ( 107 days)
• Product Code: FLE
• Regulation Number: 880.6880

Intended Use

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

Device Description

The Belimed Steam Sterilizers MST-H, 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 Bowie-Dick Test cycles. The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):

Predicate Devices

K021223

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a steam sterilizer with predefined cycles and validation based on established standards. There is no mention of AI, ML, or any features that would suggest the use of such technologies.

Therapeutic

No
This device is a steam sterilizer designed to sterilize medical instruments and materials, not for direct therapeutic treatment of patients.

Diagnostic

No

The device is a steam sterilizer, not a diagnostic device. Its purpose is to sterilize materials, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical steam sterilizer with various models and configurations, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

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.
• Device Description: The device is a steam sterilizer with various cycles for sterilization. This aligns with the function of sterilizing equipment, not performing diagnostic tests.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring analytes
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is clearly designed for the sterilization of medical instruments and materials, which falls under the category of medical devices used in healthcare settings, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Belimed Steam Sterilizer 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 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, 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 Bowie-Dick Test cycles.

The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):
PREVAC 270F 4S / 30Dry, PreVac 270F 4S / 5Dry, Immediate Use 270F - Single Ins, Immediate Use 270F - Multi Ins, Express 270F, Bowie-Dick Test, Leak Test, Warm up & Leak Test, Liquid 250F.

The Belimed Steam Sterilizers MST-H are offered in the following versions:
Model: 9-6-9 HS1, GR 9-6-9 HS1, 9-6-9 HS2, GR 9-6-9 HS2, 9-6-12 HS1, GR 9-6-12 HS1, 9-6-12 HS2, GR 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS1, 9-6-15 HS2, GR 9-6-15 HS2, 9-6-18 HS1, GR 9-6-18 HS1, 9-6-18 HS2, GR 9-6-18 HS2.

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

The Belimed Steam Sterilizer 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) Single Door, Floor Flush Design, Prevacuum
26"x 48.5"x 79" (660 mm x 1230 mm) Double Door, Floor Flush Design, Prevacuum

The Belimed Steam Sterilizers MST-H, 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.

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)

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 Steam Sterilizer MST-H were validated to meet the requirements of ANSI/AAMI ST8:2013.

The results of the Belimed Steam Sterilizer MST-H verification studies demonstrate that the sterilizer performs as intended and is summarized as follows:

• The Prevac cycle where the maximum tray capacity is changing to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.4. This cycle demonstrated a sterility assurance level of at least 10-6 through achievement of a time-at-temperature sufficient to produce an F0 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.
• The Immediate Use Gravity cycle where the maximum tray capacity is changing from 17 lbs. to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.5.1.

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.

K021223

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2017

Belimed AG Jay Upchurch Product Engineer, U.S. Agent Belimed. Inc. 2325 Charleston Regional Parkway Charleston, South Carolina 29412

Re: K170228

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: April 6, 2017 Received: April 12, 2017

Dear Jay 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: 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.

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

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170228

Device Name Belimed Steam Sterilizer MST-H TOP 5000

Indications for Use (Describe)

The Belimed Steam Sterilizer 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 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)	Over-The-Counter Use (21 CFR 801 Subpart C)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Table 1: Factory programmed sterilization cycles and cycle values.

| CYCLES | STERILIZE
TEMP | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|-----------------------------------------------|-------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC 270F
(132°C) | 270°F
(132°C) | 4 minutes | 30 minutes | Double-wrapped instrument trays.
Maximum weight of 25 lbs. 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, 9-6-12 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 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-15 HS2, GR 9-6-18 HS1.
Fabric Packs. |
| PreVac 270F 4S
/ 5Dry (132°C) | 270°F
(132°C) | 4 minutes | 5 minutes | Fabric Packs. |
| Liquid 250F
(121°C) | 250°F
(121°C) | 45 minutes | 0 minute | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass. |
| Express 270F
(132°C) | 270°F
(132°C) | 4 minutes | 3 minutes | Single wrapped instrument tray with non-porous single instrument. |
| Immediate Use
270F - Single Ins
(132°C) | 270°F
(132°C) | 3 minutes | 1 minute | Unwrapped instrument tray with a single instrument. |
| Immediate Use
270F - Multi Ins
(132°C) | 270°F
(132°C) | 10 minutes | 1 minute | Unwrapped instrument tray with non-porous multiple instruments.
Maximum weight of 25 lbs 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 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. |

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510(k) Summary

K170228

Date: May 5, 2017 Owner's Name / Address: Belimed AG Grienbachstrasse 11 CH-6300 Zug / Switzerland Preparer's Name / Address: Belimed, Inc. 2325 Charleston Regional Parkway Charleston, SC 29412 USA Contact Person: Jay Upchurch Email: [e-mail] Phone: [phone] x133 [phone] Fax: Trade Name: Belimed Steam Sterilizer MST-H TOP 5000 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-12 Models: 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. Classification: Steam Sterilizer - Class II, as listed per 21 CFR 880.6880 Product Code: FLE Predicate Device: Belimed Steam Sterilizer TOP 5000 Series 9-18 (K021223)

INTENDED USE:

The Belimed Steam Sterilizer 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 equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1.

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Table 1: Factory programmed sterilization cycles and cycle values.

| CYCLES | STERILIZE
TEMP | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|-----------------------------------------------|-------------------|-------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC 270F
(132°C) | 270°F
(132°C) | 4 minutes | 30
minutes | Double-wrapped instrument trays.
Maximum weight of 25 lbs. 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, 9-6-12 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 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS1, GR 9-6-
15 HS2, GR 9-6-18 HS1.
Fabric Packs. |
| PreVac 270F 4S
/ 5Dry (132ºC) | 270°F
(132°C) | 4 minutes | 5
minutes | Fabric Packs. |
| Liquid 250F
(121°C) | 250°F
(121°C) | 45 minutes | 0
minute | Max 1000 ml of Liquid per bottle. Use only vented bottles,
type I, borosilicate glass. |
| Express 270F
(132°C) | 270°F
(132°C) | 4 minutes | 3
minutes | Single wrapped instrument tray with non-porous single
instrument. |
| Immediate Use
270F - Single Ins
(132°C) | 270°F
(132°C) | 3 minutes | 1
minute | Unwrapped instrument tray with a single instrument. |
| Immediate Use
270F - Multi Ins
(132°C) | 270°F
(132°C) | 10 minutes | 1
minute | Unwrapped instrument tray with non-porous multiple
instruments.
Maximum weight of 25 lbs 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 HS1, GR 9-6-
15 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. |

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DESCRIPTION OF DEVICE:

The Belimed Steam Sterilizers MST-H, 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 Bowie-Dick Test cycles.

The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):

Table 2: Factory programmed sterilization and test cycles.

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| No. | CYCLE | PRE-
TREATMENT | STERILIZE
TEMP | STERILIZE
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 lbs 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,
9-6-12 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 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1.
Fabric Packs. |
| 2 | PreVac 270F
4S / 5Dry | 4 pulses | 270°F | 4 minutes | 5
minutes | Fabric Packs. |
| 3 | Immediate
Use 270F -
Single Ins | Purge | 270°F | 3 minutes | 1 minute | Unwrapped instrument tray with a single
instrument |
| 4 | Immediate
Use 270F -
Multi Ins | Purge | 270°F | 10 minutes | 1 minute | Unwrapped instrument tray with non
porous multiple instruments.
Maximum weight of 25 lbs 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 9-6-15 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 |
| 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 | |

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Notes on Table 2:

1. Factory set sterilize time is recommended.

2. Factory set dry time.

3. Recommended load: Refer to table 4 and 5.

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.

5. The liquid cycle is for non-patient contact use only.

The Belimed Steam Sterilizers MST-H are offered in the following versions:

| Model
Single Door

Double Door	Configuration	Chamber Size (H x W x D) (mm)	Overall Size (H x W x D) (mm)
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:

Sterilizer Chamber Size (mm)	Model	Wrapped Instrument Trays 20"x10" max. 17lb each	Fabric Packs 11"x11"x9" max 6.6lb each	Fabric Packs 23"x11"x11" max. 17lb each
26"x 42.5"x 41" (660 x 1080 x 1040)	9-6-9 HS1 and 9-6-9 HS2	9	18	9
26"x 42.5"x 55" (660 x 1080 x 1400)	9-6-12 HS1	12	30	12
26"x 42.5"x 67" (660 x 1080 x 1700)	9-6-15 HS2	15	36	15
26"x 42.5"x 79" (660 x 1080 x 2000)	9-6-18 HS1 and 9-6-18 HS2	18	42	18
26"x 48.5"x 43" (660 x 1230 x 1100)	GR 9-6-9 HS1 and GR 9-6-9 HS2	9	18	9
26"x 48.5"x 55" (660 x 1230 x 1400)	GR 9-6-12 HS1 and GR 9-6-12 HS2	12	30	12
26"x 48.5"x 67" (660 x 1230 x 1700)	GR 9-6-15 HS1 and GR 9-6-15 HS2	15	36	15
26"x 48.5"x 79" (660 x 1230 x 2000)	GR 9-6-18 HS1	18	42	18

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.

| Sterilizer Chamber Size
(mm) | Model | Wrapped
Instrument
Trays 20"x10"
max. 25 lb.
each | Fabric
Packs
11"x11"x9"
max 6.6lb
each | Fabric
Packs
23"x11"x11"
max. 17lb
each |
|----------------------------------------|---------------|---------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| 26"x 42.5"x 55" (660 x 1080
x 1400) | 9-6-12 HS2 | 12 | 30 | 12 |
| 26"x 42.5"x 67" (660 x 1080
x 1700) | 9-6-15 HS1 | 15 | 36 | 15 |
| 26"x 48.5"x 79" (660 x 1230
x 2000) | GR 9-6-18 HS2 | 18 | 42 | 18 |

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| Model | Volume of Liquid in One
Container | Number of Containers |
|-----------|--------------------------------------|----------------------|
| 9-6-9 | 1000 mL | 126 |
| GR 9-6-9 | 1000 mL | 126 |
| 9-6-12 | 1000 mL | 168 |
| GR 9-6-12 | 1000 mL | 168 |
| 9-6-15 | 1000 mL | 210 |
| GR 9-6-15 | 1000 mL | 210 |
| 9-6-18 | 1000 mL | 252 |
| GR 9-6-18 | 1000 mL | 252 |

Table 6. Recommended loads for liquid cycle 250F.

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

The Belimed Steam Sterilizer 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) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm) Double Door, Floor Flush Design, Prevacuum

The Belimed Steam Sterilizers MST-H, 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.

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NONCLINICAL COMPARISON TO THE PREDICATE DEVICE:

The Belimed Steam Sterilizers MST-H, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are very similar to the predicate device.

A summary of the differences to the predicate device is included in Table 7.

| General Sterilizer
Features | Belimed Steam Sterilizer
TOP 5000 Series 9-18
(K021223) | Belimed Steam
Sterilizer TOP 5000
Series 9-18 | 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 ST8:1994
Hospital Steam Sterilizers | ANSI/AAMI ST8:2013
Hospital Steam
Sterilizers | Same |
| Chamber sizes | (H x W x D) in mm: | (H x W x D) in mm: | Same |
| Model:
9-6-9 / 9-6-12 /
GR9-6-12
9-6-15 / GR9-6-
15
9-6-18 / GR9-6-
18 | 1080x660x1040
1080x660x1400 /
1230x660x1400
1080x660x1700 /
1230x660x1700
1080x660x2000 /
1230x660x2000 | 1080x660x1040
1080x660x1400 /
1230x660x1400
1080x660x1700 /
1230x660x1700
1080x660x2000 /
1230x660x2000 | Same |
| Sterilization
cycles | PreVac 270 °F
Gravity 270 °F
Liquid 250 °F
Bowie Dick Test
Air Leak Test | PreVac 270 °F
Gravity 270 °F
Liquid 250 °F
Bowie Dick Test
Air Leak Test | Same |
| Max. instrument
tray weight | 17 lbs. | 17 lbs. for 9-6-9 HS1
9-6-9 HS2, GR 9-6-9
HS1, GR 9-6-9 HS2,
9-6-12 HS1, GR 9-6-
12HS1,
9-6-15 HS2, GR 9-6-
15 HS1, GR 9-6-15
HS2, 9-6-18 HS1, 9- | Same |
| 6-18 HS2, GR 9-6-18
HS1 | | | |
| 25 lbs. for 9-6-12
HS2, 9-6-15 HS1,
and GR 9-6-18 HS2 | | | |
| Load capacity
instrument trays | | | |
| Model: | | | |
| 9-6-9 / 9-6-12 /
GR9-6-12 | 9 | 9 | Same |
| 9-6-15 / GR9-6- | 12 | 12 | |
| 15 | 15 | 15 | |
| 9-6-18 / GR9-6-
18 | 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 |

Table 7. A summary of the differences to the predicate device.

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13

CLINICAL DATA:

No clinical data is required for this device classification submission.

SUMMARY OF PERFORMANCE TESTING:

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 Steam Sterilizer MST-H were validated to meet the requirements of ANSI/AAMI ST8:2013.

The results of the Belimed Steam Sterilizer MST-H verification studies demonstrate that the sterilizer performs as intended and is summarized as follows:

• The Prevac cycle where the maximum tray capacity is changing to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.4. This cycle demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an F0 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.
• The Immediate Use Gravity cycle where the maximum tray capacity is changing from 17 lbs. to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.5.1.

STANDARDS USED:

Belimed's sterilizers, including the Belimed Steam Sterilizer MST-H, models 9-6-12, and 9-6-18, 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 complies with the following safety standards:

• 1. ANSI/AAMI ST8:2013
• 2. ANSI/AAMI ST79:2010+A1:2010
• 3. IEC EN 62304:2006
• 4. EN ISO 14971:2012
• ISO 13485:2012 Medical Devices Quality management systems. Requirements for 5. regulatory purposes
• 6. IEC EN 60601-1-2:2007
• American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 7. pressure vessels Ed. 2015.
• 8. UL 61010-1:2004 Safety requirements for electrical equipment for measurement, control and laboratory use -Part 1: General requirements.
• 9. 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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CONCLUSION

The Belimed Steam Sterilizer MST-H Top 5000 is substantially equivalent device to that of the predicate device (K021223).

The nonclinical tests and accompanying in this premarket notification demonstrate that this device is as safe, as effective, and performs as well or better than the predicate device series (K021223).