MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

• K Number: K050263
• Device Name: MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
• Manufacturer: M.O.C.O.M. SRL
• Date Cleared: 2006-11-21 ( 655 days)
• Product Code: FLE
• Regulation Number: 880.6880

Intended Use

The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

Device Description

MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles. The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions. MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load. An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result. The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one. The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.

Predicate Devices

K022816, K023348

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a steam sterilizer with advanced control systems and vacuum technology, but there is no mention of AI or ML capabilities.

Therapeutic

No
This device is a sterilizer for re-usable surgical and medical instruments, not a device used for treating patients.

Diagnostic

No

This device is a sterilizer, intended for use in sterilizing re-usable surgical instruments and medical materials, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical sterilizer with a sterilization chamber, vacuum system, and steam generation system, indicating it is a hardware 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 to sterilize re-usable surgical instruments and medical materials. This is a process performed on medical devices and materials, not a test performed on biological samples to diagnose or monitor a medical condition.
• Device Description: The description focuses on the sterilization process, including vacuum systems, steam generation, and sterilization cycles. These are all related to the physical process of sterilization, not diagnostic testing.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is entirely different.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

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

FLE

Device Description

MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.

The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.

MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.

An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.

The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.

The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.

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

medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities. Typical users of this system are trained professionals including, but not limited to, dentists, nurses and other specific medical professionals.

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)

Not Found

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.

K022816, K023348

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

0

Image /page/0/Picture/1 description: The image shows the text "K050263" in a handwritten style on the top line. Below that is the logo for "mocom" in a bold, sans-serif font. Underneath the logo is the text "Sistemi innovativi di sterilizzazione" in a smaller font size.

The information required by 21 CFR § 807.92 is listed below.

| Submitter: | M.O.COM. s.r.l.
1, Via delle Azalee
20090 Buccinasco (MI) - Italy | NOV 21 200 | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| Contact Person: | Daniele Tosi
Technical Manager
Phone: [phone]
Fax: [phone] | | |
| Date of Submission: | 2005, February 1st | | |
| Device Name: | Proprietary: MILLENNIUM series (B, B+, B2, Bμ)
Common: Steam Sterilizer (or Autoclave)
Classification: 880.6880 FLE: Sterilizer, Steam | | |
| Devices to which the
Millennium series
claims equivalence: | W&H Lisa (510(k) number K022816)
Midmark M9 UltraClave (510(k) number K023348) | | |

Device Description

MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.

The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.

MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.

1

Image /page/1/Picture/1 description: The image shows the logo for "mocom," with the "m" in a bold, stylized font and the rest of the letters in a simpler font. Below the logo, there is text that reads "Sistemi innovativi di sterilizzazione." The logo is in black and white.

An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.

The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.

The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.

Considering a standard program (i.c. program at 273 °F – 4' for porous load), after arranged the material in the chamber, closed the door, selected the program, started the cycle by the START key (with activation of the door locking device), the following sequence will run:

• 1. Pre-heating of the steam gencrator and sterilization chamber;
• 2. Chamber air removal and steam penctration inside the load through a series of vacuum stages and pressure phases;
• 3. Pressure rise-up, with consequent steam temperature increasing up to the preset sterilization conditions (for the example, 273 %F);
• 4. Stabilization of the pressure and temperature conditions inside the sterilization chamber;
• 5. Run of the sterilization process for the preset time (for the example, 4 minutes);
• 6. Chamber pressure decreasing through steam discharge;
• 7. Vacuum drying phase;
• 8. Venting phase through sterile air:
• 9. Chamber pressure leveling up to atmospheric value.

As reached this last phase the door locking mechanism will be released and the door can be opened to recovery the load from the sterilization chamber paying attention to use proper precautions.

Intended Use

The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental hand-pieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

• NOTE: make reference to the Table of the Available Programs on the following pages for detailed information on each model.

2

Image /page/2/Picture/1 description: The image shows the logo for MOCOM, a company that specializes in innovative sterilization systems. The logo consists of the letter "m" in a bold, stylized font, followed by the letters "ocom" in a similar font. Below the logo is the text "Sistemi innovativi di sterilizzazione", which translates to "Innovative sterilization systems" in English.

Table of the Available Programs (Millennium B)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F = fract.; S = single) | Standard drying (2)
(L = long; S = short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|--------------------------------------------|----------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 41' | 525 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 56' | 550 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 31' | 525 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 45' | 550 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 34' | 300 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 48' | 325 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 26' | 300 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 40' | 325 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 16' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | >4
or

20 | F/S | L/S | 56'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 6.00
(max) | 1.20
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 22' | - | - | Test pack only (without any other load) | | | |
| VACUUM TEST | - | -0.80 | - | - | - | 22' | - | - | Empty chamber | | | |

Image /page/2/Picture/4 description: The image shows a front view of a laboratory autoclave. The autoclave is white and has a digital display and several buttons on the right side. The door of the autoclave is round and has a handle on the left side.

3

Image /page/3/Picture/1 description: The image shows the logo for Mocom, a company that specializes in innovative sterilization systems. The logo features the word "mocom" in a stylized font, with the "m" in a solid black box. Below the logo is the text "Sistemi innovativi di sterilizzazione", which translates to "Innovative sterilization systems" in English.

Table of the Available Programs (Millennium B+)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L= long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|--------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|-----------------------------------------------|------------------------|---------------------------|------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 33' | 525 | 0.8 | Unpackaged porous material | 1.00 | 0.30 | 0.30 |
| | | | | | | | | | Porous material in single package | 0.75 | 0.25 | 0.25 |
| | | | | | | | | | Porous material in double package | 0.60 | 0.20 | 0.20 |
| | | | | | | | | | Solid material / handpieces in single package | 3.00 | 1.00 | 0.25 |
| | | | | | | | | | Solid material / handpieces in double package | 1.50 | 0.50 | 0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 48' | 550 | 0.8 | Unpackaged porous material | 1.00 | 0.30 | 0.30 |
| | | | | | | | | | Porous material in single package | 0.75 | 0.25 | 0.25 |
| | | | | | | | | | Porous material in double package | 0.60 | 0.20 | 0.20 |
| | | | | | | | | | Solid material / handpieces in single package | 3.00 | 1.00 | 0.25 |
| | | | | | | | | | Solid material / handpieces in double package | 1.50 | 0.50 | 0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 25' | 525 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 39' | 550 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 25' | 300 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 39' | 325 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 18' | 300 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 32' | 325 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 12' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | >4
or

20 | F/S | L/S | 48'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 6.00
(max) | 1.20
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 20' | - | - | Test pack only (without any other load) | | | |
| VACUUM TEST | - | -0.80 | - | - | - | 18' | - | - | Empty chamber | | | |

Image /page/3/Picture/4 description: The image shows a front view of a medical autoclave. The autoclave has a round door on the left side and a control panel on the right side. The control panel has a digital display and four buttons.

4

Image /page/4/Picture/1 description: The image shows the logo for "mocom Sistemi innovativi di sterilizzazione". The logo features a stylized lowercase "m" in a black box, followed by the text "ocom" in a simple sans-serif font. Below the logo is the text "Sistemi innovativi di sterilizzazione" in a smaller font size.

Table of the Available Programs (Millennium B2)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L=long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|----------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|-------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | I. | 43' | 525 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.25
1.00
0.75
4.00
2.00 | 0.40
0.30
0.25
1.25
0.60 | 0.30
0.25
0.20
0.25
0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | I. | 58' | 550 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.25
1.00
0.75
4.00
2.00 | 0.40
0.30
0.25
1.25
0.60 | 0.30
0.25
0.20
0.25
0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 35' | 525 | 0.7 | Unpackaged handpieces | 7.50 | 1.50 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 50' | 550 | 0.7 | Unpackaged handpieces | 7.50 | 1.50 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | I. | 32' | 300 | 0.6 | Solid material in single package | 4.00 | 1.25 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 46' | 325 | 0.6 | Solid material in single package | 4.00 | 1.25 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 25' | 300 | 0.5 | Unpackaged solid material | 7.50 | 1.50 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 39' | 325 | 0.5 | Unpackaged solid material | 7.50 | 1.50 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 14' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4) (5) | 134
or
121 | 2.10
or
1.10 | > 4
or

20 | F/S | L/S | 58'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 7.50
(max) | 1.50
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 24' | - | - | Test pack only (without any other load) | - | - | - |
| VACUUM TEST | - | -0.80 | - | - | - | 18' | - | - | Empty chamber | - | - | - |

Image /page/4/Picture/4 description: The image shows a front-facing view of a white dryer. The dryer has a round door on the left side and a control panel on the right side. The control panel has a digital display and four buttons.

5

Image /page/5/Picture/1 description: The image shows the logo for Mocom, a company that specializes in innovative sterilization systems. The logo features the word "mocom" in a stylized font, with the "m" in a bold, blocky style and the rest of the letters in a thinner, more rounded font. Below the logo is the tagline "Sistemi innovativi di sterilizzazione," which translates to "Innovative sterilization systems" in English. The logo is simple and modern, and the tagline clearly communicates the company's focus.

Table of the Available Programs (Millennium Bu)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L=long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|-------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|-----------------------------------------------|------------------------|---------------------------|------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 19' | 200 | 0.6 | Unpackaged porous material | 0.30 | 0.30 | 0.30 |
| | | | | | | | | | Porous material in single package | 0.30 | 0.30 | 0.25 |
| | | | | | | | | | Porous material in double package | 0.30 | 0.30 | 0.20 |
| | | | | | | | | | Solid material / handpieces in single package | 1.00 | 0.50 | 0.25 |
| | | | | | | | | | Solid material / handpieces in double package | 0.50 | 0.25 | 0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 34' | 210 | 0.6 | Unpackaged porous material | 0.30 | 0.30 | 0.30 |
| | | | | | | | | | Porous material in single package | 0.30 | 0.30 | 0.25 |
| | | | | | | | | | Porous material in double package | 0.30 | 0.30 | 0.20 |
| | | | | | | | | | Solid material / handpieces in single package | 1.00 | 0.50 | 0.25 |
| | | | | | | | | | Solid material / handpieces in double package | 0.50 | 0.25 | 0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 17' | 200 | 0.6 | Unpackaged handpieces | 1.80 | 0.90 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 32' | 210 | 0.6 | Unpackaged handpieces | 1.80 | 0.90 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 16' | 125 | 0.5 | Solid material in single package | 1.00 | 0.50 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 31' | 130 | 0.5 | Solid material in single package | 1.00 | 0.50 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 13' | 125 | 0.4 | Unpackaged solid material | 1.80 | 0.90 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 28' | 130 | 0.4 | Unpackaged solid material | 1.80 | 0.90 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 9' | 125 | 0.4 | Unpackaged solid material | 0.20 | 0.20 | 0.20 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | >4
or

20 | F/S | L/S | 34'
(max) | 210
(max) | 0.7
(max) | Unpackaged solid material | 1.80
(max) | 0.90
(max) | 0.25
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 16' | - | - | Test pack only (without any other load) | | | |
| VACUUM TEST | - | -0.80 | - | - | - | 16' | - | - | Empty chamber | | | |

Image /page/5/Picture/4 description: The image shows a white device with a digital display and several buttons on the top right. The device has a boxy shape with a slightly curved front. The display shows some text, but it is not clear enough to read. There are four buttons below the display, arranged in a row. The device appears to be some kind of electronic instrument or appliance.

Page 6 of 8 pages

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Image /page/6/Picture/1 description: The image shows the logo for "Mocom". The logo has a stylized "m" in a black box, followed by the letters "ocom" in a simple font. Below the logo, the text "Sistemi innovativi di sterilizzazione" is written in a smaller font.

GENERAL NOTES (for the Tables of the Available Programs above)

• FRACTIONATED = Pre-vacuum stage made by a sequence of 3 vacuum pulses + 3 pressure pulses. (1) "Fractionated vacuum cycles" are dedicated to the sterilization of porous materials or hand-pieces.
  SINGLE = Pre-vacuum stage made by 1 vacuum + 1 pressure pulse. "Single vacuum cycles" are dedicated to the sterilization of solid materials

• (2) LONG = Drying stage for porous material and/or hand-pieces and/or soltd material in single/double package. The validated LONG drying times (STANDARD option) are 16.5 min for Millemium B, 12.5 min for B+, 16.5 min for B' and 6 min for Bu
  The EXTRA and INTELLIGENT options have not been validated.

SHORT = Drying stage for unpackaged solid instruments and/or unpackaged hand-pieces. The validated "SHORT drying" times (STANDARD option) are 7 min for Millennium B, 6 min for B+, 8 min for B+ and 4 min for Bu.

The FAST option, having drying times of 2.5 min for Millennium B (up to a load of 1.0 kg max), 2 min for B+ (up to a load of 1.0 kg max), 2.5 min for B2 (up to a load of 1.0 kg max) and 1.5 min for Bp (up to a load of 0.4 kg max) has not been validated.

• (3) The Total Cycle Time is only indicative. It represents the time required for the entire program, from the cycle START to the cycle END and is calculated with a half-load within the chamber
• The 134°C / 12°C CUSTOM program has holding times of 4 minutes (or greater) and 20 minutes (or greater) respectively at (4) 134℃ and 121℃

Pre-vacuum type and Drying type settable according to the indications given in the notes (1) and (2) above.

The 134°C / 121°C CUSTOM program has not been validated

7

Image /page/7/Picture/1 description: The image shows the logo for MOCOM, a company that specializes in innovative sterilization systems. The logo features the word "mocom" in a bold, sans-serif font, with the "m" in a black box. Below the logo is the tagline "Sistemi innovativi di sterilizzazione", which translates to "Innovative sterilization systems" in English.

Technological Characteristics Comparison

The comparison shows that the new devices (M.O.COM. s.r.l. Millennium series Steam Sterilizers), which are intended to market, and the predicate devices:

• 1. Have the same intended use, principles of opcration and energy sources.
• 2. Have the same target population (user group).
• 3. Have the same (or better) technological characteristics, safeguards and performances.

The physical design, control system, materials of construction and method of manufacture differ slightly from the predicate devices.

There are not any new questions about safety and effectiveness and the new device is safe and effective as the predicate devices.

The M.O.COM. s.r.l. Millennium series Steam Sterilizers are substantially equivalent to the W&H Lisa Steam Sterilizer and Midmark M9 UltraClave Steam Sterilizer.

8

Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniele Tosi Technical Manager M.O.C.O.M S.r.l. VIA Delle Azalee 1 Buccinasco (MI), ITALY 20090

NOV 2 1 2006

Re: K050263

Trade/Device Name: MILLENNIUM Series Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: November 6, 2006 Received: November 8, 2006

Dear Mr. Tosi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

9

Page 2 - Mr. Tosi

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Cacey Wilson for

Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

510(k) Number: K050263 (if known)

Applicant: M.O.COM. S.r.l.

Device Name: MILLENNIUM series (including Millennium B, Millennium B+, Millennium B2 and Millennium Bu)

Indication For Use:

The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

Typical users of this system are trained professionals including, but not limited to, dentists, nurses and other specific medical professionals.

• NOTE: The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
  Also see the "Table of the Available Programs", one for each model, on the next pages.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shila H. Murphy, MD

താവിടേത്തിയും, General Hospital, Control, Dental Devices

057263

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Table of the Available Programs MILLENNIUM B (temperature in °C and pressure in bar)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L= long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|--------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 41' | 525 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 56' | 550 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 31' | 525 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 45' | 550 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 34' | 300 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 48' | 325 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 26' | 300 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 40' | 325 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 16' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | >4
or

20 | F/S | L/S | 56'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 6.00
(max) | 1.20
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3.5 | F | S | 22' | - | - | Test pack only (without any other load) | - | - | - |
| VACUUM TEST | | -0.80 | - | | | 22' | - | - | Empty chamber | - | - | - |

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: 上一

Concurrence of CDRH, Office of Device Evaluation (ODE)

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12

Table of the Available Programs MILLENNIUM B+ (temperature in ℃ and pressure in bar)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L= long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|--------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 33' | 525 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 48' | 550 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.00
0.75
0.60
3.00
1.50 | 0.30
0.25
0.20
1.00
0.50 | 0.30
0.25
0.20
0.25
0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 25' | 525 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 39' | 550 | 0.7 | Unpackaged handpieces | 6.00 | 1.20 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 25' | 300 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 39' | 325 | 0.6 | Solid material in single package | 3.00 | 1.00 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 18' | 300 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 32' | 325 | 0.5 | Unpackaged solid material | 6.00 | 1.20 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 12' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | > 4
or

20 | F/S | L/S | 48'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 6.00
(max) | 1.20
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 20' | | | Test pack only (without any other load) | | | |
| VACUUM TEST | | -0.80 | | | | 18' | | | Empty chamber | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

13

Table of the Available Programs MILLENNIUM B2 (temperature in ℃ and pressure in bar)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum(1)
(F= fract.; S= single) | Standard drying (2)
(L= long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|---------------------------------|---------------------|----------------------------|-----------------------|-----------------------------------------|--------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 43' | 525 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.25
1.00
0.75
4.00
2.00 | 0.40
0.30
0.25
1.25
0.60 | 0.30
0.25
0.20
0.25
0.25 |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 58' | 550 | 0.8 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 1.25
1.00
0.75
4.00
2.00 | 0.40
0.30
0.25
1.25
0.60 | 0.30
0.25
0.20
0.25
0.25 |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 35' | 525 | 0.7 | Unpackaged handpieces | 7.50 | 1.50 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 50' | 550 | 0.7 | Unpackaged handpieces | 7.50 | 1.50 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 32' | 300 | 0.6 | Solid material in single package | 4.00 | 1.25 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 46' | 325 | 0.6 | Solid material in single package | 4.00 | 1.25 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 25' | 300 | 0.5 | Unpackaged solid material | 7.50 | 1.50 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 39' | 325 | 0.5 | Unpackaged solid material | 7.50 | 1.50 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 14' | 300 | 0.45 | Unpackaged solid material | 0.50 | 0.50 | 0.50 |
| 134°C or 121°C
CUSTOM (4)(5) | 134
or
121 | 2.10
or
1.10 | > 4
or

20 | F/S | L/S | 58'
(max) | 550
(max) | 0.9
(max) | Unpackaged solid material | 7.50
(max) | 1.50
(max) | 0.50
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 24' | | - | Test pack only (without any other load) | | | |
| VACUUM TEST | - | -0.80 | - | - | - | 18' | | - | Empty chamber | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

: ্রাম্

:

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Table of the Available Programs MILLENNIUM Bu (temperature in °C and pressure in bar)

| PROGRAM
DESCRIPTION | Temperature
(°C) | Pressure
(bar relative) | Holding time
(min) | Pre-vacuum (1)
(F= fract.; S= single) | Standard drying (2)
(L= long; S= short) | Total cycle time (3)
(approx.) | Average H2O
consumption
(ml/cycle) | Average energy
consumption
(kWh/cycle) | TYPE OF LOAD | MAX TOTAL
MASS (kg) | MAX MASS
PER TRAY (kg) | MAX MASS
PER ARTICLE (kg) |
|------------------------------|---------------------|----------------------------|-----------------------|------------------------------------------|--------------------------------------------|-----------------------------------|------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------|------------------------------|
| 134°C POROUS | 134 | 2.10 | 4 | F | L | 19' | 200 | 0.6 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 0.30 | 0.30 | 0.30 |
| | | | | | | | | | 0.30 | 0.30 | 0.25 | |
| | | | | | | | | | 0.30 | 0.30 | 0.20 | |
| | | | | | | | | | 1.00 | 0.50 | 0.25 | |
| | | | | | | | | | 0.50 | 0.25 | 0.25 | |
| 121°C POROUS | 121 | 1.10 | 20 | F | L | 34' | 210 | 0.6 | Unpackaged porous material
Porous material in single package
Porous material in double package
Solid material / handpieces in single package
Solid material / handpieces in double package | 0.30 | 0.30 | 0.30 |
| | | | | | | | | | 0.30 | 0.30 | 0.25 | |
| | | | | | | | | | 0.30 | 0.30 | 0.20 | |
| | | | | | | | | | 1.00 | 0.50 | 0.25 | |
| | | | | | | | | | 0.50 | 0.25 | 0.25 | |
| 134°C HOLLOW | 134 | 2.10 | 4 | F | S | 17' | 200 | 0.6 | Unpackaged handpieces | 1.80 | 0.90 | 0.50 |
| 121°C HOLLOW | 121 | 1.10 | 20 | F | S | 32' | 210 | 0.6 | Unpackaged handpieces | 1.80 | 0.90 | 0.50 |
| 134°C WRAPPED | 134 | 2.10 | 4 | S | L | 16' | 125 | 0.5 | Solid material in single package | 1.00 | 0.50 | 0.25 |
| 121°C WRAPPED | 121 | 1.10 | 20 | S | L | 31' | 130 | 0.5 | Solid material in single package | 1.00 | 0.50 | 0.25 |
| 134°C SOLID | 134 | 2.10 | 4 | S | S | 13' | 125 | 0.4 | Unpackaged solid material | 1.80 | 0.90 | 0.50 |
| 121°C SOLID | 121 | 1.10 | 20 | S | S | 28' | 130 | 0.4 | Unpackaged solid material | 1.80 | 0.90 | 0.50 |
| 134°C EMERGENCY | 134 | 2.10 | 3 | S | S | 9' | 125 | 0.4 | Unpackaged solid material | 0.20 | 0.20 | 0.20 |
| 134°C or 121°C
CUSTOM (4) | 134
or
121 | 2.10
or
1.10 | >4
or

20 | F/S | L/S | 34'
(max) | 210
(max) | 0.7
(max) | Unpackaged solid material | 1.80
(max) | 0.90
(max) | 0.25
(max) |
| BOWIE & DICK TEST | 273 | 2.10 | 3,5 | F | S | 16' | - | - | Test pack only (without any other load) | - | - | - |
| VACUUM TEST | - | -0.80 | - | - | - | 16' | - | - | Empty chamber | - | - | - |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

15

GENERAL NOTES

• (1) FRACTIONATED = Pre-vacuum stage made by a sequence of 3 vacuum pulses + 3 pressure pulses. "Fractionated vacuum cycles" are dedicated to the sterilization of porous materials or hand-pieces.
  SINGLE = Pre-vacuum stage made by 1 vacuum + 1 pressure pulse. "Single vacuum cycles" are dedicated to the sterilization of solid materials.

• (2) LONG = Drying stage for porous material and/or hand-pieces and/or solid material in single/double package, The validated LONG drying times (STANDARD option) are 16.5 min for Millennium B, 12.5 min for B+, 16.5 min for B' and 6 min for Bu
  The EXTRA and INTELLIGENT options have not been validated.

SHORT = Drying stage for unpackaged solid instruments and/or unpackaged hand-pieces, The validated "SIIORT drying" times (STANDARD option) are 7 min for Millennium B, 6 min for B+ and 4 min for Bu.

The FAST option, having drying times of 2.5 min for Millennium B (up to a load of 1.0 kg max), 2 min for B+ (up to a load of 1.0 kg max), 2.5 min for B2 (up to a load of 1.0 kg max) and 1.5 min for Bp (up to a load of 0.4 kg max) has not been validated.

• The Total Cycle Time is only indicative. (3) It represents the time required for the entire program, from the cycle START to the cycle END and is calculated with a half-load within the chamber.
• (4) The 134°C / 121°C CUSTOM program has holding times of 4 minutes (or greater) and 20 minutes (or greater) respectively at 134°C and 121°C.

Pre-vacuum type and Drying type settable according to the indications given in the notes (1) and (2) above.

The 134℃ / 121℃ CUSTOM program has not been validated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)