K Number

Device Name

BELIMED STEAM STERILIZER MST-V

Manufacturer

BELIMED, INC.

Date Cleared

2013-09-23

(242 days)

Product Code

FLE

Regulation Number

880.6880

Intended Use

The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.

Device Description

The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6. The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity. The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities. Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized. The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100662

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard steam sterilizer with factory-programmed cycles and validation based on established standards (ANSI/AAMI ST8). There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

No.
The device is a sterilizer, designed to sterilize medical instruments and materials, not to treat patients or medical conditions directly.

Diagnostic

No.

This device is a sterilizer, designed to decontaminate materials and instruments used in healthcare facilities, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a physical steam sterilizer (hardware) with factory-programmed cycles, not a software-only device. The mention of software validation refers to the software contained within the hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, the Belimed Steam Sterilizer MST-V, model 4-4-6 is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the sterilization of medical devices and materials used in healthcare facilities. This is a process applied to instruments and materials, not a test performed on biological samples to diagnose a condition.
Device Description: The description focuses on the physical characteristics and sterilization cycles of the device, not on analyzing biological samples.
Performance Studies: The performance studies described are focused on the efficacy of the sterilization process (killing microorganisms), not on the accuracy of a diagnostic test.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays

Therefore, the Belimed Steam Sterilizer MST-V, model 4-4-6 is a medical device used for sterilization, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.

Product codes (comma separated list FDA assigned to the subject device)

FLE

Device Description

The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.
The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.
Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.

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

hospital and health care 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)

Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° reduction. Belimed validates its sterilization cycles by recommended practices, standards and quidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Sterilizer MST-V, model 4-4-6 was validated to meet the requirements of ANSI/AAMI ST8:2008.
The results of the Belimed Steam Sterilizer MST-V, model 4-4-6 verification studies demonstrate that the sterilizer performs as intended and is summarized as follows:

t Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Immediate Use, and Gravity cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that correspond with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.
All Prevac cvcles verified using the fabric test pack, as described in Section 5.5.2 . ANSI/AAMI ST8:2008 were qualified according to section 5.5.2.5 ANSI/AAMI ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 3 % increase in pre-sterilization test pack weight, and exhibited no wet spots.
. All Prevac and Gravity cycles verified using full load instruments trays were qualified according to section 5.5.4 of ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
All Prevac Immediate Use cycles were verified using unwrapped instrument trays and were . qualified according to section 5.5.5.2 ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle.
. All Gravity Immediate Use cycles were verified using unwrapped instrument tray and were qualified according to section 5.5.5.1 ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time at temperature sufficient to produce an Fo of at least 12 minutes by half cycle.
. The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6 of ANSI/AAMI ST8, and demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
. The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)".

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.

K100662

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

KI30172

510(k) Summary

Date:	February 28, 2013
Submitter's Name / Address:	Belimed, Inc.
2284 Clements Ferry Road
Charleston, SC 29492
Contact Person:	Jay Upchurch, Product Engineer/Quality Assurance Manager
Email: jay.upchurch@belimed.us
Phone: (843) 216-7424
Fax: (843) 216-7707
Trade Name:	Belimed Steam Sterilizer MST-V
Model:	4-4-6
Classification:	Steam Sterilizer – Class II, as listed per 21 CFR 880.6880
Product Code FLE
Predicate Device:	Belimed Steam Sterilizer MST-V
Series 3-3-6 (K100662)
SEP 2 3 2013

DEVICE DESCRIPTION:

NONCLINICAL COMPARISON TO THE PREDICATE DEVICE:

The Belimed Steam Sterilizer MST-V, model 4-4-6 is very similar to the predicate device. Modifications made from the predicate device include:

· Larger chamber size
· Control system and HMI (operating panel)
· Modification of gravity cycle parameters (exposure and dry times)
Change in manufacturing location

CLINICAL DATA:

No clinical data is required for this device classification submission.

INDICATIONS FOR USE:

The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO

Release 1.1 / February 28, 2013 Page 1 of 7

The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.

| No. | CYCLE TEMP /
PRESSURE | STERILIZE
TIME | DRY
TIME 1 | RECOMMENDED LOAD2 |-----|----------------------- | 1 | PreVac 270
4S / 30Dry 100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 4 min max. weight of 25 lbs per tray
Fabric packs3 | 2 | PreVac
Immediate
Use 270
4S / 1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 4 min single instrument or
Unwrapped mixed porous and non-
porous instrument trays, max.
weight of 25 lbs per tray |
| 3 | PreVac
Immediate
Use 270 3S /
1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 3 min instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray | 4 | PreVac
Immediate
Use 270 10S
/ 1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 10 min single instrument or
Unwrapped mixed porous and non-
porous instrument trays, max.
weight of 25 lbs per tray |
| 5 | Gravity
Immediate
Use 270
3S / 1Dry | Purge time 3 min 2880mbar | 3 min instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray | 6 | Gravity
Immediate
Use 270
10S / 1Dry | Purge time 3 min 2880mbar | 10 min instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray | 7 | Gravity 270
15S / 30Dry 2880mbar | 15 min instrument trays, max. Ibs per tray | 8 | Gravity 250
30S / 30Dry 2040mbar | 30 min instrument trays, max. lbs per tray | 9 | Bowie-Dick
Test 100/100/100mbar
2 steam pulses:
1800/1800mbar | 273 °F
3030mbar | 3.5 min | No. | CYCLE TEMP /
PRESSURE | STERILIZE
TIME | DRY
TIME1 | RECOMMENDED LOAD3 | 10 | Leak Test Test time: 15 min | PRE-TREATMENT | STERILIZE
|
------------------------|-------------------------------------------------------------------------|---------------------------------|-------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3 vacuum pulses:
| 30 min | Double wrapped instrument trays,
|
| 1 min | Unwrapped porous or non-porous
| 1 min | Unwrapped non-porous single
|
| 1 min | Unwrapped porous or non-porous
| 270 °F
| 1 min | Unwrapped non-porous single
|
| 270 °F
| 1 min | Unwrapped non-porous single
|
| Purge time 3 min | 270 °F
| 30 min | Double wrapped non-porous
weight of 25
|
| Purge time 3 min | 250 °F
| 30 min | Double wrapped non-porous
weight of 25
|
| 3 vacuum pulses:
| 1 min | One DART or Bowie-Dick-Test-Pack |
| PRE-TREATMENT | STERILIZE
|
| Vacuum: 100mbar
| - | - | - | Empty chamber |

Table 1: Factory programmed Sterilization cycles

Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO

Release 1.1 / February 28, 2013 Page 2 of 7

Notes on Table 1:

Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps.
Recommended load: Refer to table 3 and 4.
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.

The Belimed Steam Sterilizer MST-V is offered in the following configuration:

Table 2: Dimensions

| Model
single door
double door | Configuration | Chamber size
(Volume)
(L) | Chamber size
(H x W x D) | | Overall Dimensions
(H x W x D) | |
|-------------------------------------|---------------|---------------------------------|-----------------------------|----------------------------|-----------------------------------|-----------------------------|
| 4-4-6 | 1 door | 110 | (inch)
16"x 16"x 26" | (mm)
406 x
406 x 660 | (inch)
74.75" x
26" x 35.5" | (mm)
1900 x
660 x 900 |

Table 3 indicates Belimed's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:

Table 3: Recommended Loads

| Model
single door
double door | Wrapped
instrument trays,
max. 25 lbs each | Unwrapped tray
with single
instrument | Unwrapped
instrument tray
max. 25 lbs each | Fabric Packs,
max. 6.6 lbs each | Fabric Packs,
max. 9 lbs each |
|-------------------------------------|--------------------------------------------------|---------------------------------------------|--------------------------------------------------|------------------------------------|----------------------------------|
| 14-4-6 | | | | | |

The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.

Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.

The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.

Comparison to Predicate Device

Feature	Belimed MST-V 4-4-6	Belimed MST-V 3-3-6
		(Predicate)
Intended Use	Terminal sterilization of non porous and
porous heat and moisture-stabile
materials. This includes rigid devices
with lumens processed in accordance
with AAMI ST8.	Terminal Sterilization of non porous
and porous heat and moisture-stabile
materials. This includes rigid devices
with lumens processed in accordance
with AAMI ST8.
Designed for	Steam sterilization in health care
facilities	Steam sterilization in health care
facilities
Design,
Construction,
Components	Stainless Steel 316L
16" x 16" x 26" (110 l)
Design Pressure 40PSI
ASME Certified Chamber and Jacket
Cubic welded structure with complete
jacket (except door and back wall)	Stainless Steel 316L
13" x 13" x 25" (73 I)
Design Pressure 40PSI
ASME Certified Chamber and Jacket
Cubic welded structure with all-round
heating ducts
Process monitoring
& control devices:	Interactive Touch Panel with 5.7" color
display
Printer (24 Char/ Line)
Pressure Gauges: chamber, jacket,
door seal (digital)
compressed air, steam supply, chamber
pressure, jacket pressure (analog)	Interactive Operating Panel with 5.7"
color display (TFT)
Printer (42 Char/ Line)
Pressure Gauges: chamber, jacket
(digital)
compressed air, steam supply, door
seal (analog)
Safety Devices	Safety Relief Valves
Emergency Stop Switch
Door safety pressure relief valve	Safety Relief Valves
Emergency Stop Switch
Standard Cycles	PreVac 270 4S / 30Dry
PreVac Immediate Use 270 4S / 1Dry
PreVac Immediate Use 270 3S / 1Dry
PreVac Immediate Use 270 10S / 1Dry
Gravity Immediate Use 270 3S / 1Dry
Gravity Immediate Use 270 10S / 1Dry
Gravity 270 15S / 30Dry
Gravity 250 30S / 30Dry
Bowie-Dick Test
Leak Test	PreVac 270 Long Dry (4S, 30D)
PreVac 270 Short Dry (4S, 5D)
Prevac Flash 270 (4S, 1D)
Gravity 250 (25S, 0D)
PreVac 270 Long Dry (10S, 30D)
PreVac Flash 270 (10S, 1D)
Bowie-Dick Test
Leak Test
Warm up & leak test

· .

EFFECTIVENESS:

The results of the Belimed Steam Sterilizer MST-V, model 4-4-6 verification studies demonstrate that the sterilizer performs as intended and is summarized as follows:

t Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Immediate Use, and Gravity cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that correspond with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.
All Prevac cvcles verified using the fabric test pack, as described in Section 5.5.2 . ANSI/AAMI ST8:2008 were qualified according to section 5.5.2.5 ANSI/AAMI ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 3 % increase in pre-sterilization test pack weight, and exhibited no wet spots.
. All Prevac and Gravity cycles verified using full load instruments trays were qualified according to section 5.5.4 of ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
All Prevac Immediate Use cycles were verified using unwrapped instrument trays and were . qualified according to section 5.5.5.2 ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle.
. All Gravity Immediate Use cycles were verified using unwrapped instrument tray and were qualified according to section 5.5.5.1 ANSI/AAMI ST8:2008. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time at temperature sufficient to produce an Fo of at least 12 minutes by half cycle.
. The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6 of ANSI/AAMI ST8, and demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
. The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)".

SAFETY:

Belimed's sterilizers, including the Belimed Steam Sterilizer MST-V model 4-4-6, have been designed and constructed to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer MST-V complies with the following safety standards:

1. ANSI/AAMI ST8:2008
1. ANSI/AAMI ST79:2010+A1:2010
1. IEC EN 62304:2006
1. EN ISO 14971:2007
1. ISO 13485:2007 Medical Devices - Quality management systems. Requirements for regulatory purposes
ర్. IEC EN 60601-1-2:2007
1. American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2009

HAZARDS-FAILURE OF PERFORMANCES

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another not otherwise infected prior to the incident.

To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed, that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide spread use of steam sterilizers. Further, there are no known reports in the literature of patient infection that have resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer MST-V provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

Belimed Steam Sterilizer MST-V FDA 510(K) Author: PKO

Release 1.1 / February 28, 2013 Page 6 of 7

USER INFORMATION

Belimed provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed User's Manual and other labeling. Belimed also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.

CONCLUSION

The Belimed Steam Sterilizer MST-V, model 4-4-6 is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and intended use to the predicate device series 3-3-6 (K100662). This steam sterilizer MST-V model 4-4-6 meets the applicable requirements of the applicable standards.

Based on the provided information in this premarket notification, the subject device is substantially equivalent to the predicate device and is safe and effective when used as intended.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers. The logo is black and white.

September 23, 2013

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

Belimed, Incorporated Mr. Jay Upchurch Quality Assurance Manager 2284 Clements Ferry Road CHARLESTON, SOUTH CAROLINA 29492

Re: K130172

Trade/Device Name: Belimed Steam Sterilizer MST-V, model 4-4-6 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Il Product Code: FLE Dated: August 26, 2013 Received: August 27, 2013

Dear Mr. Upchurch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard C. Chapman 2013.09.23 13:47:57 -04'00'

for

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number: K130172

Device Name: Belimed Steam Sterilizer MST-V, model 4-4-6

Indications for Use:

The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X OTC (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth Gutala -S 2013.09.23 13:14:12 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K130172

Table 1: Factory programmed Sterilization cycles

Page 1 of 3

| No. | CYCLE | PRE-TREATMENT | STERILIZE
TEMP /
PRESSURE | STERILIZE
TIME | DRY
TIME 1 | RECOMMENDED LOAD2 |
|-----|-----------------------------------------------|-------------------------------------------------------------------------|---------------------------------|-------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | PreVac 270
4S / 30Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 4 min | 30 min | Double-wrapped instrument trays,
max. weight of 25 lbs per tray or
Fabric packs3 |
| 2 | PreVac
Immediate
Use 270
4S / 1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 4 min | 1 min | Unwrapped porous or non-porous
single instrument or
Unwrapped mixed porous and non-
porous instrument trays, max. weight
of 25 lbs per tray |
| 3 | PreVac
Immediate
Use 270 3S /
1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 3 min | 1 min | Unwrapped non-porous single
Instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray |
| 4 | PreVac
Immediate
Use 270 10S
/ 1Dry | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 270 °F
2880mbar | 10 min | 1 min | Unwrapped porous or non-porous
single instrument or
Unwrapped mixed porous and non-
porous instrument trays, max. weight
of 25 lbs per tray |
| 5 | Gravity
Immediate
Use 270
3S / 1Dry | Purge time 3 min | 270 °F
2880mbar | 3 min | 1 min | Unwrapped non-porous single
instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray |
| 6 | Gravity
Immediate
Use 270
10S / 1Dry | Purge time 3 min | 270 °F
2880mbar | 10 min | 1 min | Unwrapped non-porous single
instrument or
Unwrapped non-porous instrument
trays, max. weight of 25 lbs per tray |
| 7 | Gravity 270
15S / 30Dry | Purge time 3 min | 270 °F
2880mbar | 15 min | 30 min | Double wrapped instrument trays,
max. weight of 25 lbs per tray |
| 8 | Gravity 250
30S / 30Dry | Purge time 3 min | 250 °F
2040mbar | 30 min | 30 min | Double wrapped instrument trays,
max. weight of 25 lbs per tray |
| 9 | Bowie-Dick
Test | 3 vacuum pulses:
100/100/100mbar
2 steam pulses:
1800/1800mbar | 273 °F
3030mbar | 3.5 min | 1 min | One DART or Bowie-Dick Test Pack |
| 10 | Leak Test | Vacuum: 100mbar
Test time: 15 min | | | | Empty chamber |

Notes on Table 1:

1 Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps. 2 Recommended loads: Refer to table 3.

3 Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for al least 2 hours.

The Belimed Steam Sterilizer MST-V, model 4-4-6 is offered in the following configuration:

Table 2: Dimensions

| Model
single door
double door | Configuration | Chamber size
(Volume)
(L) | Chamber size
(H x W x D) | | Overall Dimensions
(H x W x D) | |
|-------------------------------------|---------------|---------------------------------|-----------------------------|--------------------|-----------------------------------|---------------------|
| | | | (inch) | (mm) | (inch) | (mm) |
| 4-4-6 | 1 door | 110 | 16"x 16"x 26" | 406 x
406 x 660 | 74.75" x
26" x 35.5" | 1900 x
660 x 900 |

The following table (Table 3) provides guidelines for recommended loads in the Belimed Steam Sterilizer MST-V, model 4-4-6:

Table 3: Recommended Loads

| Model
single door,
double door | Wrapped
instrument trays,
max. 25 lbs each | Unwrapped tray
with single
instrument | Unwrapped
instrument tray,
max. 25 lbs each | Fabric Packs |
|--------------------------------------|--------------------------------------------------|---------------------------------------------|---------------------------------------------------|--------------|
| 4-4-6 | 2 | 1 | 2 | 4 |