Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard steam sterilizer with validated sterilization cycles and safety features, with no mention of AI or ML in the device description, performance studies, or key metrics.

Therapeutic

No.
The device is a sterilizer for medical and dental instruments, not a therapeutic device used to treat or cure a disease or condition.

Diagnostic

No.
The device is a steam sterilizer, used for sterilizing surgical instruments and medical materials, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a table-top steam sterilizer that uses saturated steam at high pressures and temperatures, indicating it is a physical hardware device. While it mentions software validation, the core function and description are of a hardware sterilizer.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a steam sterilizer used to sterilize reusable surgical instruments and medical materials. This is a process performed on medical devices to make them safe for reuse, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
Device Description: The description details how the device uses steam, pressure, and temperature to kill microorganisms. This aligns with sterilization, not in vitro diagnostic testing.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
- Using reagents or test kits

The device is a medical device used for sterilization, which is a critical process in healthcare settings, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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, 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.

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

FLE

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.

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, and other facilities, laboratories. Typical users 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)

The design and sterilization process have been validated according to the requirements of AAMI ST55:2010. Especially the performed tests include Biological tests that show that the sterilization cycles are able to kill biological indicators assuring a sterility assurance level (SAL) of 10⁻⁶ reduction.

The results of the tests performed are summarized below:

The chamber temperature during sterilization has been verified according to AAMI ST55 (points 4.4.3 / 5.4.3) using worst case loads. Chamber temperatures are always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. The results are in compliance with the acceptance criteria defined.
The biological performances with a textile PCD have been verified according to AAMI ST55 (point 5.5.2). All the biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁹.
The biological performances with wrapped instruments and lumen devices (double package) have been verified according to AAMI ST55 (point 5.5.4). All the biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁹.
The biological performances with dental handpieces (double package) have been verified according to AAMI ST55 (point 5.5.5). All the biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁹.
The Bowie Dick Test cycle has been verified using a FDA cleared Bowie-Dick test pack according to AAMI ST55 (point 5.6.1.1). After the test run, the Bowie-Dick test indicator showed a uniform color change.
The Air Leak test has been performed according to AAMI ST55 (point 5.6.2). After the test run, the average leak rate is

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

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.

1

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/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 (800) 638-2041 or (301) 796-7100 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

2

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.

3

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
120 Volt	MOCOM - B Classic-28
M7A770010	B Futura-28
120 Volt	MOCOM - B Futura-28
7A173010	B Classic-28
120 Volt	STERN WEBER - SW-28
7A177010	B Futura-28
120 Volt	STERN WEBER - SW-28 PLUS
7A073010	B Classic-28
120 Volt	ANTHOS - A-28
7A077010	B Futura-28
120 Volt	ANTHOS - A-28 PLUS
C7A730010	B Classic-28
120 Volt	CASTELLINI - C-28
C7A770010	B Futura-28
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:

4

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

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

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

5

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

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

6

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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7

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: +39-348 4435155 Telephone: +39-542 683803 Fax: +39-542 698456 Email: regulatory@isemed.eu

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.
Ltd	Tuttnauer Pre-Vacuum Tabletop
Autoclave (Model ELARA-11)	K143311

2.4. Intended Use

8

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
commercial brand	ANTHOS
commercial brand	STERNWEBER
commercial brand	CASTELLINI
commercial brand
B Futura-28 model -120 VOLT	MOCOM
commercial brand	ANTHOS
commercial brand	STERNWEBER
commercial brand	CASTELLINI
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:

9

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

10

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

11

| Features | Subject Device | | Predicate Devices | | Substantially
Equivalent |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|
| | B FUTURA-28
B CLASSIC-28 | MOCOM - Millennium
Series B² model
K050263 | Tuttnauer Pre-Vacuum
Tabletop Autoclave
ELARA-11 K143311 | | |
| CFR code | 880.6880 - Steam Sterilizers | 880.6880 - Steam Sterilizers | 880.6880 - Steam Sterilizers | | same |
| Class | II | II | II | | same |
| Product
code | FLE | FLE | FLE | | same |
| Indication
for 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
The device shall not be used
for the sterilization of fluids,
liquids or pharmaceutical
products | 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. | The ELARA-11 is a table-top
autoclave designed for
sterilizing medical and
surgical goods, including both
wrapped and unwrapped,
solid, hollow, and porous
products and goods defined as
hollow A (e.g., dental hand
pieces; suction pipes) in
ophthalmic, dental, medical
clinics; and in first aid rooms.
The ELARA-11 is validated
for use in sterilizing lumened
device if no longer than 230
mm and no smaller than 3.4
mm for sterilization programs
2 and 4.
The ELARA-11 is validated
for use in sterilizing fabric
packs/textiles for sterilization
programs 2 and 4.
The ELARA-11 is validated
for use in sterilizing up to six
dental handpieces for
sterilization programs 2 and 4 | | equivalent |
| Construction | | | | | |
| Chamber
Volume
usable | 28 litres
(19 litres with tray supports
inserted) | 21 litres
(13 litres with tray supports
inserted) | 28.5 litres | | equivalent |
| Sterilization
Chamber
dimensions
(Φ x H) | 280 x 450 mm | 250 x 450 mm | 220 x 502mm | | equivalent |
| | Subject Device | Predicate Devices | | | Substantially
Equivalent |
| Features | B FUTURA-28
B CLASSIC-28 | MOCOM – Millennium
Series B² model
K050263 | Tuttnauer Pre-Vacuum
Tabletop Autoclave
ELARA-11 K143311 | | |
| Design | | | | | |
| Operating
principle | The sterilizing agent is steam
made from demineralized
water. Steam is commonly
used to sterilize porous and
non porous heat resistant
materials / textiles for more
than 100 years.
Sterilization temperatures are
121°C / 250 °F and 134°C /
273 °F. | The sterilizing agent is steam
made from demineralized
water. Steam is commonly
used to sterilize porous and
non porous heat resistant
materials / textiles for more
than 100 years.
Sterilization temperatures are
121°C / 250 °F and 134°C /
273 °F. | Sterilization using steam as
the sterilizing agent | same | |
| Mechanism
of action
for steam
sterilization | Saturated steam contacts the
surface of the device and is
able to sterilize it, since
saturated steam is able to
denature the membrane and
the proteins of
microorganisms and spores.
In case of packaged devices
or of devices with lumens
(e.g. dental handpieces), the
steam penetrates through the
packaging and into the
lumens, by means of the air
removal due to the vacuum
pump, and is able to sterilize
the devices | Saturated steam contacts the
surface of the device and is
able to sterilize it, since
saturated steam is able to
denature the membrane and
the proteins of
microorganisms and spores.
In case of packaged devices
or of devices with lumens
(e.g. dental handpieces), the
steam penetrates through the
packaging and into the
lumens, by means of the air
removal due to the vacuum
pump, and is able to sterilize
the devices | Saturated steam contacts the
surface of the device and is
able to sterilize it, since
saturated steam is able to
denature the membrane and
the proteins of
microorganisms and spores.
In case of packaged devices
or of devices with lumens
(e.g. dental handpieces), the
steam penetrates through the
packaging and into the
lumens, by means of the air
removal due to the vacuum
pump, and is able to sterilize
the devices | same | |
| Sterilization
cycle type | All cycles are pre-vacuum
with post vacuum drying | All cycles are pre-vacuum
with post vacuum drying | All cycles are pre-vacuum
with post vacuum drying | equivalent | |
| Device SW
controlled | Yes | Yes | Yes | same | |
| Built
according
to standard | ANSI/AAMI ST55:2010
Table-top steam sterilizers | ANSI/AAMI ST55:2003
Table-top steam sterilizers | ANSI/AAMI ST55:2010
Table-top steam sterilizers | equivalent | |
| Electrical
safety
standard | IEC 61010-1:2001 (edition 2)
/ UL 61010-1 2nd edition
IEC 61010-2-040: 2005
(edition 1) for use in
conjunction with IEC 61010-
1:2001 (ed. 2) | IEC 61010-1:2001 (edition 2)
/ UL 61010-1 2nd edition
IEC 1010-2-041: 1995 (1st
Edition) | IEC 61010-1:2001 (edition 2)
/ UL 61010-1 2nd edition
IEC 61010-2-040: 2005
(edition 1) for use in
conjunction with IEC 61010-
1:2001 (ed. 2) | equivalent | |
| EMC
conformity | IEC 61326-1:2012 | IEC 61326-1:2006 | Unknown | equivalent | |
| Heaters | An heating foil pre heats the
sterilization chamber and
maintains the temperature for
the sterilization and drying
processes | An heating foil pre heats the
sterilization chamber and
maintains the temperature for
the sterilization and drying
processes | pre-heating of the sterilization
chamber | equivalent | |
| Steam
Generator | An external steam generator
produces steam through a
dedicated heater | An external steam generator
produces steam through a
dedicated heater | steam generator produces
steam through a dedicated
heater | equivalent | |
| | Subject Device | Predicate Devices | Substant | | |
| Features | B FUTURA-28
B CLASSIC-28 | MOCOM - Millennium
Series B² model
K050263 | Tuttnauer Pre-Vacuum
Tabletop Autoclave
ELARA-11 K143311 | ially
Equivale
nt | |
| Vacuum
Device | Membrane vacuum pump
with max free air flow of 38
litres per minute (B Futura) or
20 litres per minute (B
Classic) | Membrane vacuum pump with
max free air flow of 20 litres
per minute | Vacuum pump | equivalent | |
| Air
filtration | 0.027 µm,
efficiency: 99.999%
efficiency: 99.97% for 0.3-
micron particles | 0.027 µm,
efficiency: 99.999%
efficiency: 99.97% for 0.3-
micron particles | 0.2 µm filter | equivalent | |
| Chamber: | Construction material:
Austenitic Stainless Steel.
Design Pressure: 2.4 bar /
34.8 psi (relative pressure)
Design Standard: Conforming
to ASME BPVC Section 8,
Division 2 | Construction material:
Austenitic Stainless Steel.
Design Pressure: 2.4 bar /
34.8 psi (relative pressure)
Design Standard: Conforming
to ASME BPVC Section 8,
Division 1 | Construction material:
Austenitic Stainless Steel.
Design Pressure: 2.8 bar / 40
psi
Design Standard: Conforming
to ASME BPVC Section 8,
Division 1 | equivalent | |
| Process
parameters /
Process
Control | Sterilization cycle is
controlled by time,
temperature and pressure and
are recorded on printout. The
process is controlled
automatically through all the
phases of the cycle | Sterilization cycle is controlled
by time, temperature and
pressure and are recorded on
printout. The process is
controlled automatically
through all the phases of the
cycle | Sterilization cycle is
controlled by time,
temperature and pressure and
are recorded on printout. The
process is controlled
automatically through all the
phases of the cycle | equivalent | |
| Process
parameters
displayed
on control
panel: | At cycle start:
total number of cycles
set Sterilization temperature
set Holding time
During the cycle:
cycle time countdown
real time temperature
real time pressure.
At the end of the cycle:
Cycle outcome (positive or
negative)
min/max temperature during
sterilization phase
min/max pressure during
sterilization phase | At cycle start:
total number of cycles
set Sterilization temperature
set Holding time
During the cycle:
real time temperature
real time pressure.
At the end of the cycle:
Cycle outcome (positive or
negative)
min/max temperature during
sterilization phase
min/max pressure during
sterilization phase | At cycle start:
total number of cycles
During the cycle:
Sterilization temperature
Sterilization time
Dry time
Chamber temperature
Chamber pressure
Steam generator pressure
Time display: Clock &
Time countdown
At the end of the cycle:
Cycle outcome (positive or
negative) | equivalent | |
| Process
Monitors | ✓
1 temperature probe in the
chamber
✓
1 temperature probe in
the heating element
✓
1 temperature probe in
the steam generator
✓
1 pressure sensor for
sterilization chamber
✓
1 conductivity sensor
(water quality)
✓
1 temperature probe in
the reservoir | ✓
1 temperature probe in
the chamber
✓
1 temperature probe in
the heating element
✓
1 temperature probe in
the steam generator
✓
1 pressure sensor for
sterilization chamber | ✓
1 temperature probe in the
chamber
✓
1 temperature probe in
the heating element
✓
1 temperature probe in the
steam generator
✓
1 pressure sensor for
sterilization chamber | equivalent | |
| Features | Subject Device
B FUTURA-28
B CLASSIC-28 | Predicate Devices | | Substantially
Equivalent | |
| Performances | | MOCOM – Millennium
Series B² model
K050263 | Tuttnauer Pre-Vacuum
Tabletop Autoclave
ELARA-11 K143311 | | |
| Biological
performance | SAL of 10⁻⁶ reduction
(no growth at half cycle with
validation loads
according to AAMI
ST55:2010) | SAL of 10⁻⁶ reduction
(no growth at half cycle with
validation loads
according to AAMI
ST55:2003) | SAL of 10⁻⁶ reduction
(no growth at half cycle with
validation loads according to
AAMI ST55:2010) | same | |
| Moisture
retention | IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

IEC 61010-2-040 Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-040: Particular requirements for sterilizers and washerdisinfectors used to treat medical materials

. Electromagnetic compatibility tests have been performed according to the following standards demonstrating the conformity of the subject device:

IEC 61326-1 Electrical equipment for measurement, control and laboratory use -EMC requirements - Part 1: General requirements

18

FAMILY OF STEAM STERILIZERS B 28 SERIES

2.8.Conclusions

In conclusion, the subject Family of Steam Sterilizers B28 series is substantially equivalent to predicate devices K050263 and K143311. Based on the intended use, technological characteristics, and performance data, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device.