Family of Steam Sterilizers B 28 series

K151597 · Cefla S.C. · FLE · Mar 4, 2016 · General Hospital

Device Facts

• Record ID: K151597
• Device Name: Family of Steam Sterilizers B 28 series
• Applicant: Cefla S.C.
• Product Code: FLE · General Hospital
• Decision Date: Mar 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers 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. The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2. The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2. The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below). The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Device Story

Table-top steam sterilizers (B Classic-28, B Futura-28) for medical/dental facilities. Uses saturated steam generated from demineralized water to sterilize heat/moisture-resistant instruments. Features fractionated vacuum system for air removal from hollow/porous loads and vacuum drying phase. Operated by healthcare professionals. Input: user-selected sterilization cycle (C1, C2, C4, C5). Device monitors chamber temperature, pressure, and time via internal probes/sensors. Output: sterilized instruments and cycle report (PDF/USB/optional printer). Affects clinical decision-making by ensuring instrument sterility for reuse. Benefits: provides validated sterilization for complex loads (lumens, textiles) in point-of-care settings.

Clinical Evidence

Bench testing only. Validation performed per AAMI ST55:2010. Biological indicators confirmed SAL of 10^-6 for textiles and 10^-9 for wrapped instruments/lumen devices. Moisture retention, air leak, and Bowie-Dick tests met acceptance criteria. Chamber temperature verified within -0°C to +3°C of set point.

Technological Characteristics

Austenitic stainless steel chamber (28L). Heating foil for preheating/temperature maintenance. Membrane vacuum pump (38 L/min or 20 L/min). 0.027 µm air filter (99.999% efficiency). Saturated steam sterilization at 121°C/134°C. Connectivity: USB, Ethernet, Wi-Fi. Software validated per IEC 62304. Electrical safety: IEC 61010-1, IEC 61010-2-040. EMC: IEC 61326-1.

Indications for Use

Indicated for sterilization of reusable surgical instruments, dental handpieces, medical materials, fabric packs/textiles, and lumen devices in medical/dental practices, hospitals, clinics, and laboratories. Contraindicated for fluids, liquids, or pharmaceutical products.

Regulatory Classification

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.

Predicate Devices

• MILLENNIUM series (B² model) (K050263)
• Tuttnauer Pre-Vacuum Tabletop Autoclave (Model ELARA-11) (K143311)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

March 4, 2016

CEFLA S.C. c/o Mr. Maurizio Pantaleoni CEO ISEMED srl Via Altobelli Bonetti 3/a IMOLA (BO), ITALY 40026

Re: K151597

Trade/Device Name: Family of Steam Sterilizer B28 series Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 1. 2016 Received: February 4, 2016

Dear Mr. Pantaleoni,

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.

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K151597

Device Name Family of Steam sterilizers B28 series

#### Indications for Use (Describe)

The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, and other facilities to sterilize reusable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

The Family of Steam Sterilizers B 28 series is validation of fabric packs/textiles for sterilization programs C1 and C2.

The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.

The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below)

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

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| The Statist Stelling of a arangally in the rollowing finances / Unificiallys . | | | | | |
|--------------------------------------------------------------------------------|-------|--------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|--|
| B Classic-28 model - 120 VOLT | MOCOM | ANTHOS | STERNWEBER | CASTELLINI | |
| | | | commercial brand commercial brand commercial brand commercial brand | | |
| B Futura-28 model -120 VOLT | MOCOM | ANTHOS | STERNWEBER | CASTELLINI | |
| | | | | commercial brand commercial brand commercial brand commercial brand | |
| Table 1 - Different models available for Steam sterilizers | | | | | |

The steam sterilizers are available in the following models / brandnames :

The full list of codes included in this submission is listed in the table 2 below:

| Code | Model | Commercial Brand Name |
|-----------|--------------------------|--------------------------|
| M7A730010 | B Classic-28<br>120 Volt | MOCOM - B Classic-28 |
| M7A770010 | B Futura-28<br>120 Volt | MOCOM - B Futura-28 |
| 7A173010 | B Classic-28<br>120 Volt | STERN WEBER - SW-28 |
| 7A177010 | B Futura-28<br>120 Volt | STERN WEBER - SW-28 PLUS |
| 7A073010 | B Classic-28<br>120 Volt | ANTHOS - A-28 |
| 7A077010 | B Futura-28<br>120 Volt | ANTHOS - A-28 PLUS |
| C7A730010 | B Classic-28<br>120 Volt | CASTELLINI - C-28 |
| C7A770010 | B Futura-28<br>120 Volt | CASTELLINI - C-28 PLUS |

Table 2 – List of codes of steam sterilizers and relation with the commercial brand name

Program description, cycle times, temperature and dry time for each model are described in the tables below:

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#### B CLASSIC-28 model (B Classic-28; A-28; SW-28; C-28)

Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27.7 litres)

| PROGRAM<br>NAME | CYCLE TYPE | STERILIZATION<br>TEMPERATURE<br>and TIME | DRYING<br>TIME (*) | MAXIMUM LOAD (**) (***) |
|-------------------------------------|-----------------------------------------------|------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C1)<br>UNIVERSAL<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9 kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C2)<br>UNIVERSAL<br>121 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 121°C / 250°F<br>20 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C4) SOLID<br>134 | PREVACUUM<br>(1 step; -0.8<br>bar) | 134°C / 273°F<br>4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments<br>(max 0.9kg per tray) |
| (C5)<br>HOLLOW<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray) |
| HELIX/BD<br>TEST | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>3.5 minutes | 1.5 min | Test device only (without another load) |
| VACUUM<br>TEST | Vacuum<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST (****) | | / | | / |

Table 3 - B-CLASSIC 28 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

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### B Futura-28 model (B Futura-28; A-28 PLUS; SW-28 PLUS; C-28 PLUS)

| PROGRAM<br>NAME | CYCLE TYPE | STERILIZATION<br>TEMPERATURE<br>and TIME | DRYING<br>TIME (*) | MAXIMUM LOAD (**) (***) |
|-------------------------------------|-----------------------------------------------|------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C1)<br>UNIVERSAL<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9 kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C2)<br>UNIVERSAL<br>121 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 121°C / 250°F<br>20 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C4) SOLID<br>134 | PREVACUUM<br>(1 step; -0.8<br>bar) | 134°C / 273°F<br>4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments<br>(max 0.9kg per tray) |
| (C5)<br>HOLLOW<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray) |
| HELIX/BD<br>TEST | PREVACUUM<br>(3 steps: -0.8<br>bar each step) | 134°C / 273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUM<br>TEST | Vacuum<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST (****) | | | | |

Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27.7 litres)

Table 4 - B-FUTURA 28 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

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Type of Use (Select one or both, as applicable)

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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FAMILY OF STEAM STERILIZERS B 28 SERIES

CEFLA SC 510(K) NOTIFICATION

# 510(k) Summary - K151597

## Family of steam sterilizers B 28 series

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 2.1. General Information

Submitter:

CEFLA SC Via Selice Provinciale, 23/A 40026 - IMOLA (BO) ITALY

Establishment Registration Number: 3006610845

Contact Person in Italy:

Maurizio Pantaleoni ISEMED srl Via Altobelli Bonetti 3/a 40026 Imola (BO) Italy Mob.phone: [phone] Telephone: [phone] Fax: [phone] Email: [e-mail]

February 01, 2016 Summary Preparation Date: 2.2. Names Family of Steam sterilizer B28 series Device Name: Classification Name: Steam Sterilizer Product Code: FLE Regulation number: 880.6880 Class: II

#### 2.3. Predicate Devices

The Family of steam sterilizers B 28 series is substantially equivalent to the following legally marketed predicate device:

| Applicant | Device name | 510(k) Number |
|--------------------------|-------------------------------------------------------------|---------------|
| M.O.COM. s.r I | MILLENNIUM series (B² model) | K050263 |
| Tuttnauer USA Co.<br>Ltd | Tuttnauer Pre-Vacuum Tabletop<br>Autoclave (Model ELARA-11) | K143311 |

#### 2.4. Intended Use

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The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers 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.

The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2.

The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.

The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below).

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

#### 2.5. Device Description

The Family of steam sterilizers B 28 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The B Classic-28 and B Futura-28 models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection

The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.

| The steam sterilizers are available in the following models / brandnames : | | | | |
|----------------------------------------------------------------------------|---------------------------|----------------------------|--------------------------------|--------------------------------|
| B Classic-28 model - 120 VOLT | MOCOM<br>commercial brand | ANTHOS<br>commercial brand | STERNWEBER<br>commercial brand | CASTELLINI<br>commercial brand |
| B Futura-28 model -120 VOLT | MOCOM<br>commercial brand | ANTHOS<br>commercial brand | STERNWEBER<br>commercial brand | CASTELLINI<br>commercial brand |
| Table 1 – Different models available for Steam sterilizers | | | | |

The full list of codes included in this submission is listed in the table 2 below:

| Code | Model | Commercial Brand Name |
|-----------|--------------|--------------------------|
| M7A730010 | B Classic-28 | MOCOM - B Classic-28 |
| M7A770010 | B Futura-28 | MOCOM - B Futura-28 |
| 7A173010 | B Classic-28 | STERN WEBER - SW-28 |
| 7A177010 | B Futura-28 | STERN WEBER - SW-28 PLUS |
| 7A073010 | B Classic-28 | ANTHOS - A-28 |
| 7A077010 | B Futura-28 | ANTHOS - A-28 PLUS |
| C7A730010 | B Classic-28 | CASTELLINI - C-28 |
| C7A770010 | B Futura-28 | CASTELLINI - C-28 PLUS |

Table 2 - List of codes of steam sterilizers and relation with the commercial brand name

Program description, cycle times, temperature and dry time for each model are described in the tables below:

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| Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27,7 litres) | | | | |
|------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PROGRAM<br>NAME | CYCLE TYPE | STERILIZATION<br>TEMPERATURE<br>and TIME | DRYING<br>TIME (*) | MAXIMUM LOAD (**) (***) |
| (C1)<br>UNIVERSAL<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9 kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C2)<br>UNIVERSAL<br>121 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 121°C / 250°F<br>20 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C4) SOLID<br>134 | PREVACUUM<br>(1 step; -0.8<br>bar) | 134°C / 273°F<br>4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments<br>(max 0.9kg per tray) |
| (C5)<br>HOLLOW<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray) |
| HELIX/BD<br>TEST | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>3.5 minutes | 1.5 min | Test device only (without another load) |
| VACUUM<br>TEST | Vacuum<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | / | / |

#### B Classic-28 model (B Classic-28; A-28; SW-28; C-28)

Table 3 - B-CLASSIC 28 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

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| Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27,7 litres) | | | | |
|------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PROGRAM<br>NAME | CYCLE TYPE | STERILIZATION<br>TEMPERATURE<br>and TIME | DRYING<br>TIME (*) | MAXIMUM LOAD (**) (***) |
| (C1)<br>UNIVERSAL<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9 kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9 kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C2)<br>UNIVERSAL<br>121 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 121°C / 250°F<br>20 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments and<br>dental handpieces (max 0.9kg per tray)<br>1.5kg double package metal or polymer instruments<br>and dental handpieces (max 0.9kg per tray)<br>1 kg unwrapped porous and fabric textiles<br>0.75 kg single package porous and fabric textiles<br>0.6kg double package porous and fabric textiles |
| (C4) SOLID<br>134 | PREVACUUM<br>(1 step; -0.8<br>bar) | 134°C / 273°F<br>4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray)<br>2.5kg single package metal or polymer instruments<br>(max 0.9kg per tray) |
| (C5)<br>HOLLOW<br>134 | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments<br>(max 0.9kg per tray) |
| HELIX/BD<br>TEST | PREVACUUM<br>(3 steps; -0.8<br>bar each step) | 134°C / 273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUM<br>TEST | Vacuum<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST(****) | / | / | / | |

### B Futura-28 model (B Futura-28; A-28 PLUS; SW-28 PLUS; C-28 PLUS)

Table 4 - B-FUTURA 28 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

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| Features | Subject Device | | Predicate Devices | | Substantially<br>Equivalent |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|
| | B FUTURA-28<br>B CLASSIC-28 | MOCOM - Millennium<br>Series B² model<br>K050263 | Tuttnauer Pre-Vacuum<br>Tabletop Autoclave<br>ELARA-11 K143311 | | |
| CFR code | 880.6880 - Steam Sterilizers | 880.6880 - Steam Sterilizers | 880.6880 - Steam Sterilizers | | same |
| Class | II | II | II | | same |
| Product<br>code | FLE | FLE | FLE | | same |
| Indication<br>for use | The Family of steam<br>Sterilizers B 28 series B<br>CLASSIC-28 and B<br>FUTURA-28 models are table<br>top steam sterilizers to be<br>used in medical and dental<br>practices, hospitals, clinics,<br>nursing homes, laboratories<br>and other facilities to sterilize<br>re-usable surgical instruments<br>(including dental handpieces)<br>and medical materials, heat<br>and moisture resistant and<br>compatible with steam<br>sterilization process.<br>The Family of Steam<br>Sterilizers B 28 series is<br>validated for sterilization of<br>fabric packs/textiles for<br>sterilization programs C1 and<br>C2<br>The Family of Steam<br>Sterilizers B 28 series is<br>validated for sterilization up<br>to 9 dental handpieces for<br>sterilization programs C1 and<br>C2.<br>The Family of Steam<br>Sterilizers B 28 series is<br>validated for sterilization up<br>to 6 lumen devices<br>The device shall not be used<br>for the sterilization of fluids,<br>liquids or pharmaceutical<br>products | The device is intended to be<br>used in medical and dental<br>practices, hospitals, clinics,<br>nursing homes, laboratories<br>and other facilities to sterilize<br>re-usable surgical instruments<br>(including dental handpieces)<br>and medical materials, heat<br>and moisture resistant and<br>compatible with steam<br>sterilization process.<br>Typical users of this system<br>are trained professionals<br>including, but not limited to,<br>dentists, nurses and other<br>specific medical<br>professionals.<br>NOTE: The device shall not<br>be used for the sterilization of<br>fluids, liquids or<br>pharmaceutical products. | The ELARA-11 is a table-top<br>autoclave designed for<br>sterilizing medical and<br>surgical goods, including both<br>wrapped and unwrapped,<br>solid, hollow, and porous<br>products and goods defined as<br>hollow A (e.g., dental hand<br>pieces; suction pipes) in<br>ophthalmic, dental, medical<br>clinics; and in first aid rooms.<br>The ELARA-11 is validated<br>for use in sterilizing lumened<br>device if no longer than 230<br>mm and no smaller than 3.4<br>mm for sterilization programs<br>2 and 4.<br>The ELARA-11 is validated<br>for use in sterilizing fabric<br>packs/textiles for sterilization<br>programs 2 and 4.<br>The ELARA-11 is validated<br>for use in sterilizing up to six<br>dental handpieces for<br>sterilization programs 2 and 4 | | equivalent |
| Construction | | | | | |
| Chamber<br>Volume<br>usable | 28 litres<br>(19 litres with tray supports<br>inserted) | 21 litres<br>(13 litres with tray supports<br>inserted) | 28.5 litres | | equivalent |
| Sterilization<br>Chamber<br>dimensions<br>(Φ x H) | 280 x 450 mm | 250 x 450 mm | 220 x 502mm | | equivalent |
| | Subject Device | Predicate Devices | | | Substantially<br>Equivalent |
| Features | B FUTURA-28<br>B CLASSIC-28 | MOCOM – Millennium<br>Series B² model<br>K050263 | Tuttnauer Pre-Vacuum<br>Tabletop Autoclave<br>ELARA-11 K143311 | | |
| Design | | | | | |
| Operating<br>principle | The sterilizing agent is steam<br>made from demineralized<br>water. Steam is commonly<br>used to sterilize porous and<br>non porous heat resistant<br>materials / textiles for more<br>than 100 years.<br>Sterilization temperatures are<br>121°C / 250 °F and 134°C /<br>273 °F. | The sterilizing agent is steam<br>made from demineralized<br>water. Steam is commonly<br>used to sterilize porous and<br>non porous heat resistant<br>materials / textiles for more<br>than 100 years.<br>Sterilization temperatures are<br>121°C / 250 °F and 134°C /<br>273 °F. | Sterilization using steam as<br>the sterilizing agent | same | |
| Mechanism<br>of action<br>for steam<br>sterilization | Saturated steam contacts the<br>surface of the device and is<br>able to sterilize it, since<br>saturated steam is able to<br>denature the membrane and<br>the proteins of<br>microorganisms and spores.<br>In case of packaged devices<br>or of devices with lumens<br>(e.g. dental handpieces), the<br>steam penetrates through the<br>packaging and into the<br>lumens, by means of the air<br>removal due to the vacuum<br>pump, and is able to sterilize<br>the devices | Saturated steam contacts the<br>surface of the device and is<br>able to sterilize it, since<br>saturated steam is able to<br>denature the membrane and<br>the proteins of<br>microorganisms and spores.<br>In case of packaged devices<br>or of devices with lumens<br>(e.g. dental handpieces), the<br>steam penetrates through the<br>packaging and into the<br>lumens, by means of the air<br>removal due to the vacuum<br>pump, and is able to sterilize<br>the devices | Saturated steam contacts the<br>surface of the device and is<br>able to sterilize it, since<br>saturated steam is able to<br>denature the membrane and<br>the proteins of<br>microorganisms and spores.<br>In case of packaged devices<br>or of devices with lumens<br>(e.g. dental handpieces), the<br>steam penetrates through the<br>packaging and into the<br>lumens, by means of the air<br>removal due to the vacuum<br>pump, and is able to sterilize<br>the devices | same | |
| Sterilization<br>cycle type | All cycles are pre-vacuum<br>with post vacuum drying | All cycles are pre-vacuum<br>with post vacuum drying | All cycles are pre-vacuum<br>with post vacuum drying…