(233 days)
Not Found
No
The document describes a standard steam sterilizer and its validation against established sterilization standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a steam sterilizer intended for sterilizing medical products, not for treating patients.
No
Explanation: This device is explicitly described as a "steam sterilizer" intended to sterilize reusable medical products, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "table-top steam sterilizer" that uses "saturated steam at high pressures and temperatures" and includes physical components like a "steam generator," "sterilization chamber," and "electric heating element." While it mentions software validation, the core function and components are hardware-based.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a steam sterilizer for re-usable medical products. It is used to kill infectious bio-organisms on these products.
- Device Description: The description details the physical process of steam sterilization using high pressure and temperature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (or animals) to provide information for diagnosis, monitoring, or treatment. The device's function is to sterilize medical instruments, not to analyze biological samples.
Therefore, the device falls under the category of a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
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 B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura 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
heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes)
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 10-6.
- 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.
- 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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines extending from the bottom profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Cefla S.C. c/o Maurizio Pantaleoni ISEMED srl Via Altobelli Bonetti 3/A Imola, Bologna 40026 ITALY
Re: K161848
Trade/Device Name: Family of Steam Sterilizers B17 B22 Series Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 15, 2017 Received: January 18, 2017
Dear Maurizio 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161848
Device Name Family of Steam sterilizers B17 B22 series
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Program description, cycle times, temperature and dry time are described in the table below:
3
B CLASSIC-17 model
| MODEL NAME | CYCLE NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-17 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps; -0.8 bar
each step) | 121°C / 250°F
20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C4) SOLID 134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5) HOLLOW
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
35 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| | VACUUM +
HELIX/BD
TEST (****) | / | / | / |
B CLASSIC-17 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
4
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Indications for Use
510(k) Number (if known) K161848
Device Name Family of Steam sterilizers B17 B22 series
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Program description, cycle times, temperature and dry time are described in the table below:
6
B CLASSIC-22 model
| Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters) | ||||
|---|---|---|---|---|
| -- | -- | -- | ---------------------------------------------------------------------------- | -- |
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-22 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps; -0.8 bar
each step) | 121°C / 250°F
20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 14.5 min | 4.50 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5)
HOLLOW 134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
3.5 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM
TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| | VACUUM +
HELIX/BD
TEST (****) | / | / | / |
B CLASSIC-22 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
7
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
Indications for Use
510(k) Number (if known) K161848
Device Name Family of Steam sterilizers B17 B22 series
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Program description, cycle times, temperature and dry time are described in the table below:
9
B FUTURA-17 model
Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-17 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps: -0.8 bar
each step) | 121°C / 250°F
20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5)
HOLLOW 134
(3 prevacuum
steps: -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps: -0.8 bar
each step) | 134°C / 273°F
3.5 minutes | 1.33 min | Test device only (without another load) |
| | VACUUM
TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| | VACUUM +
HELIX/BD
TEST (****) | / | / | |
B FUTURA-17 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
10
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
11
Indications for Use
510(k) Number (if known) K161848
Device Name Family of Steam sterilizers B17 B22 series
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Program description, cycle times, temperature and dry time are described in the table below:
12
B FUTURA-22 model
Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-22 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps: -0.8 bar
each step) | 121°C / 250°F
20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 11.5 min | 4.50 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5)
HOLLOW 134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
3.5 minutes | 1.33 min | Test device only (without another load) |
| | VACUUM
TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| | VACUUM +
HELIX/BD
TEST | / | / | / |
B FUTURA-22 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
13
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
14
510(k) Summary
Family of Steam sterilizers B17 B22 series
K161848
2.1. General Information
Submitter:
CEFLA S.C. 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 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation Date: | February 15, 2017 |
2.2. Names
| Device Name: | Family of Steam sterilizer B17 B22 series |
|---|---|
| Classification Name: | Steam Sterilizer |
| Product Code: | FLE |
| Regulation number: | 880.6880 |
| Class: | II |
Predicate Devices 2.3.
The Family of steam sterilizers B17 B22 series is substantially equivalent to the following legally marketed predicate device:
| Applicant | Carlos Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of
Device name | 510(k) Number |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| CEFLA S.C. | Family of steam sterilizers B28 series | K151597 |
15
2.4. Indications for Use
B CLASSIC-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B CLASSIC-17 model
Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)
| MODEL NAME | CYCLE NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-17 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps; -0.8 bar
each step) | 121°C / 250°F
20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C4) SOLID 134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5) HOLLOW
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
3.5 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| | VACUUM +
HELIX/BD
TEST | / | / | / |
Table 1 - B CLASSIC-17 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
16
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(***) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
B CLASSIC-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B CLASSIC-22 model
Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| B Classic-22 | (C2)
UNIVERSAL
121
(3 prevacuum
steps; -0.8 bar
each step) | 121°C / 250°F
20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 14.5 min | 4.50 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| | (C5)
HOLLOW 134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar | 134°C / 273°F
3.5 minutes | 1.5 min | Test device only (without another load) |
17
| each step) | ||
|---|---|---|
| VACUUM | ||
| TEST | ||
| (-0.8 bar) | / | Empty chamber |
| Vacuum -0.8 bar | ||
| Test Time: 27 min | ||
| VACUUM + | ||
| HELIX/BD | ||
| TEST (****) | / | / |
Table 3 - B CLASSIC-22 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
B FUTURA-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-17 model
Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-17 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121
(3 prevacuum
steps; -0.8 bar
each step) | 121°C / 250°F
20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.6 kg unwrapped porous and fabric textiles
0.5 kg single package porous and fabric textiles
0.4 kg double package porous and fabric textiles |
| | (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
18
| (C5)
HOLLOW 134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C/273°F
4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and dental handpieces (max 1.33 kg per tray) |
|---------------------------------------------------------------------|----------------------------|----------|------------------------------------------------------------------------------------------|
| HELIX/BD
TEST
(3 prevacuum
steps; -0.8 bar
each step) | 134°C/273°F
3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUM
TEST
(-0.8 bar) | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| VACUUM +
HELIX/BD
TEST (****) | / | / | / |
Table 2 - B FUTURA-17 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
B FUTURA-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-22 model
Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)
| MODEL NAME | CYCLE
NAME | STERILIZATION
TEMPERATURE /
EXPOSURE TIME | DRYING
TIME () | DESCRIPTION OF MAXIMUM LOAD AND TYPE
() () |
|--------------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-22 | (C1)
UNIVERSAL
134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
| | (C2)
UNIVERSAL
121 | 121°C / 250°F
20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments |
19
| (3 prevacuum
steps; -0.8 bar
each step) | | | and dental handpieces (max 1.33 kg per tray)
1.25 kg double package metal or polymer instruments
and dental handpieces (max 1.33 kg per tray)
0.75 kg unwrapped porous and fabric textiles
0.60 kg single package porous and fabric textiles
0.50 kg double package porous and fabric textiles |
|---------------------------------------------------------------------|------------------------------|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C4) SOLID
134
(1 prevacuum
step; -0.8 bar) | 134°C / 273°F
4 minutes | 11.5 min | 4.50 kg unwrapped metal or polymer instruments
(max 1.33 kg per tray)
2.25 kg single package metal or polymer instruments
(max 1.33 kg per tray) |
| (C5)
HOLLOW 134
(3 prevacuum
steps; -0.8 bar
each step) | 134°C / 273°F
4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and
dental handpieces (max 1.33 kg per tray) |
| (3 prevacuum
steps; -0.8 bar
each step)
HELIX/BD
TEST | 134°C / 273°F
3.5 minutes | 1.33 min | Test device only (without another load) |
| (3 prevacuum
steps; -0.8 bar
each step)
VACUUM
TEST | / | / | Empty chamber
Vacuum -0.8 bar
Test Time: 27 min |
| (-0.8 bar)
VACUUM +
HELIX/BD
TEST (****) | / | / | / |
Table 4 - B FUTURA-22 Factory programmed sterilization cycles and parameters (*) Default drying time, but the drving time can be manually increased
(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 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 with inner diameter/length of the lumen: ≥10 mm / ≤115 mm
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)
2.5. Device Description
The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura 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.
20
| Features | Subject Device | | Predicate Device
(K151597) | Substantially
Equivalent |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | B FUTURA-17
B CLASSIC-17 | B FUTURA-22
B CLASSIC-22 | B FUTURA-28
B CLASSIC-28 | |
| Regulation
number | 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 | B CLASSIC-17 is a steam
sterilizer that is intended for
use by a heath care provider
(i.e. hospitals, medical and
dental practices, clinics, and
nursing homes) to sterilize re-
usable medical products that
are heat and moisture resistant
and compatible with the steam
sterilization process.
The device shall not be used
for the sterilization of fluids,
liquids or pharmaceutical
products.
B FUTURA-17 is a steam
sterilizer that is intended for
use by a heath care provider
(i.e. hospitals, medical and
dental practices, clinics, and
nursing homes) to sterilize re-
usable medical products that
are heat and moisture resistant
and compatible with the steam
sterilization process.
The device shall not be used
for the sterilization of fluids,
liquids or pharmaceutical
products. | B CLASSIC-22 is a steam
sterilizer that is intended for
use by a heath care provider
(i.e. hospitals, medical and
dental practices, clinics, and
nursing homes) to sterilize re-
usable medical products that
are heat and moisture resistant
and compatible with the steam
sterilization process.
The device shall not be used
for the sterilization of fluids,
liquids or pharmaceutical
products.
B FUTURA-22 is a steam
sterilizer that is intended for
use by a heath care provider
(i.e. hospitals, medical and
dental practices, clinics, and
nursing homes) to sterilize re-
usable medical products that
are heat and moisture resistant
and compatible with the steam
sterilization process.
The device shall not be used
for the sterilization of fluids,
liquids or pharmaceutical
products. | 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 | Equivalent |
| Construction | | | | |
| Chamber
Volume
usable | 17 litres
(10 litres with tray supports
inserted) | 22 litres
(13 litres with tray supports
inserted) | 28 litres
(19 litres with tray supports
inserted) | Same |
| Sterilization
Chamber
dimensions
(Ø x H) | 250 x 350 mm | 250 x 450 mm | 280 x 450 mm | Same |
| Features | Subject Device | | Predicate Device
(K151597) | Substantially |
| | B FUTURA-17
B CLASSIC-17 | B FUTURA-22
B CLASSIC-22 | B FUTURA-28
B CLASSIC-28 | Equivalent |
| 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. | 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. | 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 | Same |
| Device SW
controlled | Yes | Yes | Yes | Same |
| Built
according to
standard | ANSI/AAMI ST55:2010
Table-top steam sterilizers | ANSI/AAMI ST55:2010
Table-top steam sterilizers | ANSI/AAMI ST55:2010
Table-top steam sterilizers | Same |
| 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 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 61010-2-040: 2005
(edition 1) for use in
conjunction with IEC 61010-
1:2001 (ed. 2) | Same |
| EMC
conformity | IEC 61326-1:2012 | IEC 61326-1:2012 | IEC 61326-1:2012 | Same |
| 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 | An heating foil pre heats the
sterilization chamber and
maintains the temperature for
the sterilization and drying
processes | Same |
| Steam
Generator | An external steam generator
produces steam through a
dedicated heater | An external steam generator
produces steam through a
dedicated heater | An external steam generator
produces steam through a
dedicated heater | Same |
| Vacuum
Device | FUTURA: Membrane vacuum
pump with max free air flow of
20 litres per minute.
CLASSIC: Membrane vacuum
pump with max free air flow of
7 litres per minute. | FUTURA: Membrane vacuum
pump with max free air flow of
38 litres per minute.
CLASSIC: Membrane vacuum
pump with max free air flow of
20 litres per minute. | FUTURA: Membrane vacuum
pump with max free air flow of
38 litres per minute.
CLASSIC: Membrane vacuum
pump with max free air flow of
20 litres per minute. | Equivalent |
| Features | Subject Device | | Predicate Device (K151597) | Substantially Equivalent |
| | B FUTURA-17
B CLASSIC-17 | B FUTURA-22
B CLASSIC-22 | B FUTURA-28
B CLASSIC-28 | |
| 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 | 0.027 μm,
efficiency: 99.999%
efficiency: 99.97% for 0.3-
micron particles | Same |
| Chamber
construction
material | Austenitic (304 grade)
Stainless Steel
or
Austenitic (316L grade)
Stainless Steel | Austenitic (304 grade)
Stainless Steel
or
Austenitic (316L grade)
Stainless Steel | Austenitic (304 grade)
Stainless Steel | Equivalent |
| Chamber
design
pressure | 2.4 bar / 34.8 psi (relative
pressure) | 2.4 bar / 34.8 psi (relative
pressure) | 2.4 bar / 34.8 psi (relative
pressure) | Same |
| Chamber
design
standard | Conforming to ASME BPVC
Section 8,Division 2 | Conforming to ASME BPVC
Section 8, Division 2 | Conforming to ASME BPVC
Section 8,Division 2 | Same |
| 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 | Same |
| 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:
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:
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 | Same |
| Process
Monitors | ✓ 1temperature 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 | ✓ 1temperature 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 prove 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 conductivity sensor
(water quality)
✓ 1 temperature prove in
the reservoir | Same |
| Performances | | | | |
| 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 ST55:2010) | SAL of 10-6 reduction
(no growth at half cycle with
validation loads according to
AAMI ST55:2010) | Same |
| Features | Subject Device | | Predicate Device
(K151597) | Substantially
Equivalent |
| | B FUTURA-17
B CLASSIC-17 | B FUTURA-22
B CLASSIC-22 | B FUTURA-28
B CLASSIC-28 | |
| 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 washer-disinfectors 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
2.7.Conclusions
In conclusion, the subject Family of Steam Sterilizers B17 B22 series is substantially equivalent to predicate device K151597. 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.