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):

AI/ML Overview

The provided text describes the Belimed Steam Sterilizer MST-H TOP 5000 and its equivalency to a predicate device, focusing on non-clinical performance and a summary of performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the sterilizer are demonstrated by meeting the requirements of ANSI/AAMI ST8:2013. The reported device performance is described for specific cycles.

Acceptance Criteria (Set by ANSI/AAMI ST8:2013)	Reported Device Performance (Belimed Steam Sterilizer MST-H)
Sterility Assurance Level (SAL) of at least 10^-6	Achieved an SAL 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 (for Prevac cycle with 25 lbs tray capacity).
Moisture retention of less than 20% increase in pre-sterilization weight of the towel	Demonstrated moisture retention of less than 20% increase in pre-sterilization weight of the towel (for Prevac cycle with 25 lbs tray capacity).
No wet spots on the outer wrapper	Exhibited no wet spots on the outer wrapper (for Prevac cycle with 25 lbs tray capacity).
Qualified according to AAMI ST8:2013 section 5.5.4	Prevac cycle with maximum tray capacity changing to 25 lbs was qualified according to AAMI ST8:2013 section 5.5.4.
Qualified according to AAMI ST8:2013 section 5.5.5.1	Immediate Use Gravity cycle with maximum tray capacity changing from 17 lbs. to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.5.1.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of sterilization cycles or tests performed for the verification studies. It mentions that the sterilizer was "validated to meet the requirements of ANSI/AAMI ST8:2013." The data provenance is implied to be from the manufacturer's own internal testing ("Belimed validates its sterilization cycles... Prior to release, Belimed Steam Sterilizer MST-H were validated..."). It is a retrospective summary of testing that has already occurred. The country of origin of the data is not specified directly, but the manufacturer (Belimed AG) is based in Switzerland and has a U.S. agent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The "ground truth" for a steam sterilizer's performance is typically established through adherence to recognized consensus standards like ANSI/AAMI ST8:2013, which outline methodologies for testing and defining effective sterilization. The document does not describe a process involving human expert review of test results for ground truth establishment beyond meeting the standard's requirements.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the testing is for steam sterilizer efficacy, it's unlikely to involve traditional adjudication methods like 2+1 or 3+1 typically used for diagnostic AI devices. The "adjudication" would be based on whether the physical and biological indicators used in the validation tests meet the pass criteria defined by the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The performance described is inherently standalone in terms of the device's function. The "device performance" refers to the sterilizer's ability to sterilize materials according to pre-programmed cycles and validated parameters, without human intervention in the sterilization process itself (beyond loading and selecting the cycle). The validation studies assess the sterilizer's function alone against the defined standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for assessing the sterilizer's performance is based on scientific and engineering principles, and adherence to recognized consensus standards. Specifically, the ground truth for sterilization efficacy is established by:

Sterility Assurance Level (SAL) of at least 10^-6: A microbiological standard indicating a probability of one in a million chance of a non-sterile unit.
Time-at-temperature sufficient to produce an F0 of at least 12 minutes: A measure of the lethality of the steam sterilization process.
Moisture retention of less than 20% increase in pre-sterilization weight of the towel: A physical parameter indicating effective drying.
Absence of wet spots on the outer wrapper: A visual indicator of effective drying.

These are objective, measurable criteria defined by standards like ANSI/AAMI ST8:2013 and verified through physical and biological indicator testing.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional medical device (steam sterilizer), not an AI/ML-based device that requires a "training set" in the context of machine learning. The "training" for such a device would refer to its design and engineering to meet specific operational parameters, not data-driven learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, this device does not utilize a training set in the AI/ML sense.

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

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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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 (800) 638-2041 or (301) 796-7100 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	STERILIZETEMP	STERILIZETIME	DRYTIME	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 Use270F - Single Ins(132°C)	270°F(132°C)	3 minutes	1 minute	Unwrapped instrument tray with a single instrument.
Immediate Use270F - 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: Jay.Upchurch@Belimed.com Phone: (843) 216-7424 x133 (843) 216-7707 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	STERILIZETEMP	STERILIZETIME	DRYTIME	RECOMMENDED LOAD
PREVAC 270F(132°C)	270°F(132°C)	4 minutes	30minutes	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	5minutes	Fabric Packs.
Liquid 250F(121°C)	250°F(121°C)	45 minutes	0minute	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	3minutes	Single wrapped instrument tray with non-porous singleinstrument.
Immediate Use270F - Single Ins(132°C)	270°F(132°C)	3 minutes	1minute	Unwrapped instrument tray with a single instrument.
Immediate Use270F - Multi Ins(132°C)	270°F(132°C)	10 minutes	1minute	Unwrapped instrument tray with non-porous multipleinstruments.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 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	STERILIZETEMP	STERILIZETIME	DRYTIME	RECOMMENDED LOAD
1	PreVac 270F4S / 30Dry	4 pulses	270°F	4 minutes	30minutes	Double-wrapped instrument trays.Maximum weight of 25 lbs each for thefollowing models: 9-6-12 HS2, 9-6-15HS1, and GR 9-6-18 HS2.Maximum weight of 17 lbs. 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 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1.Fabric Packs.
2	PreVac 270F4S / 5Dry	4 pulses	270°F	4 minutes	5minutes	Fabric Packs.
3	ImmediateUse 270F -Single Ins	Purge	270°F	3 minutes	1 minute	Unwrapped instrument tray with a singleinstrument
4	ImmediateUse 270F -Multi Ins	Purge	270°F	10 minutes	1 minute	Unwrapped instrument tray with nonporous multiple instruments.Maximum weight of 25 lbs each for thefollowing models: 9-6-12 HS2, 9-6-15HS1, and GR 9-6-18 HS2.Maximum weight of 17 lbs. 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 9-6-15 HS2,GR 9-6-18 HS1. Maximum of 4instrument trays.
5	Express 270F	2 pulses	270°F	4 minutes	3minutes	Single wrapped instrument tray with nonporous single instrument
6	Bowie-DickTest	4 pulses	273°F	3.5 minutes	1 minute	One DART or Bowie-Dick-Test-Pack
7	Leak Test	Vacuum:65 mbarTest time:15 min	-	-	-	Empty chamber
8	Warm up &Leak Test	Vacuum:65 mbarTest time:15 min	270°F	4 minutes	3minutes	Empty chamber
10	Liquid 250F	Purge	250°F	45 minutes	Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glassCycle disabled

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Notes on Table 2:

Factory set sterilize time is recommended.
Factory set dry time.
Recommended load: Refer to table 4 and 5.
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.

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

ModelSingle DoorDouble 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	WrappedInstrumentTrays 20"x10"max. 25 lb.each	FabricPacks11"x11"x9"max 6.6lbeach	FabricPacks23"x11"x11"max. 17lbeach
26"x 42.5"x 55" (660 x 1080x 1400)	9-6-12 HS2	12	30	12
26"x 42.5"x 67" (660 x 1080x 1700)	9-6-15 HS1	15	36	15
26"x 48.5"x 79" (660 x 1230x 2000)	GR 9-6-18 HS2	18	42	18

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Model	Volume of Liquid in OneContainer	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 SterilizerFeatures	Belimed Steam SterilizerTOP 5000 Series 9-18(K021223)	Belimed SteamSterilizer TOP 5000Series 9-18	Comparison
Intended Use	Terminal Sterilization of non-porous and porous heat andmoisture-stable materialsused in healthcare facilities	Terminal Sterilizationof non-porous andporous heat andmoisture-stablematerials used inhealthcare facilities	Same
Operatingprinciple	The sterilizing agent issteam.	The sterilizing agentis steam.	Same
Built according tostandard	ANSI/AAMI ST8:1994Hospital Steam Sterilizers	ANSI/AAMI ST8:2013Hospital SteamSterilizers	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 /GR9-6-129-6-15 / GR9-6-159-6-18 / GR9-6-18	1080x660x10401080x660x1400 /1230x660x14001080x660x1700 /1230x660x17001080x660x2000 /1230x660x2000	1080x660x10401080x660x1400 /1230x660x14001080x660x1700 /1230x660x17001080x660x2000 /1230x660x2000	Same
Sterilizationcycles	PreVac 270 °FGravity 270 °FLiquid 250 °FBowie Dick TestAir Leak Test	PreVac 270 °FGravity 270 °FLiquid 250 °FBowie Dick TestAir Leak Test	Same
Max. instrumenttray weight	17 lbs.	17 lbs. for 9-6-9 HS19-6-9 HS2, GR 9-6-9HS1, GR 9-6-9 HS2,9-6-12 HS1, GR 9-6-12HS1,9-6-15 HS2, GR 9-6-15 HS1, GR 9-6-15HS2, 9-6-18 HS1, 9-	Same
6-18 HS2, GR 9-6-18HS1
25 lbs. for 9-6-12HS2, 9-6-15 HS1,and GR 9-6-18 HS2
Load capacityinstrument 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
Chambermaterial	Stainless steel 316L	Stainless steel 316L	Same
Chamber designpressure	39 psi	39 psi	Same
Door construction	Automated horizontal slidingdoor(s)	Automated horizontalsliding door(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 DotTechnology	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

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

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

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).