(233 days)
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.
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.
This document pertains to the FDA 510(k) premarket notification for a new family of steam sterilizers (B17 B22 Series) and compares them to a legally marketed predicate device (Family of Steam sterilizers B28 series, K151597). The information provided focuses on the physical and performance characteristics of mechanical steam sterilizers, not on AI/ML-driven diagnostic devices. Therefore, a direct response to the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth, etc.) cannot be extracted from this document.
However, I can extract the acceptance criteria for the steam sterilizer's performance and the reported device performance based on the provided text, as these are the "study" and "acceptance criteria" applicable to this specific type of medical device.
Key Findings for Steam Sterilizer Device Performance and Acceptance:
The document demonstrates substantial equivalence to a predicate device (CEFLA S.C. Family of Steam sterilizers B28 series, K151597) by meeting the requirements of ANSI/AAMI ST55:2010 for table-top steam sterilizers.
Here's a table of acceptance criteria and reported device performance for this steam sterilizer:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI ST55:2010, as implied by compliance statements) | Reported Device Performance (from "2.6. Performance Data") |
|---|---|
| Biological Performance (Sterility Assurance Level - SAL) | |
| SAL of 10⁻⁶ reduction (no growth at half cycle with validation loads) | Textile PCD: All biological indicators resulted sterile, ensuring a SAL of 10⁻⁹. |
| Wrapped instruments and lumen devices (double package): All biological indicators resulted sterile, ensuring a SAL of 10⁻⁶. | |
| Dental handpieces (double package): All biological indicators resulted sterile, ensuring a SAL of 10⁻⁶. | |
| Chamber Temperature Control | |
| Chamber temperatures always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. | Chamber temperatures always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. (In compliance with acceptance criteria defined). |
| Bowie-Dick Test | |
| Uniform color change on a FDA cleared Bowie-Dick test pack. | Uniform color change on a FDA cleared Bowie-Dick test pack. |
| Air Leak Test | |
| Average leak rate < 1mmHg (0.13kPa) | Average leak rate < 1mmHg (0.13kPa). (In compliance with acceptance criteria defined). |
| Moisture Retention Test | |
| <0.5% increase in wrapped instrument test tray | <0.5% increase in wrapped instrument test tray. (In compliance with ANSI/AAMI ST55 acceptance criteria). |
| <2% increase in textile test pack | <2% increase in textile test pack. (In compliance with ANSI/AAMI ST55 acceptance criteria). |
| Software Validation | |
| Compliance with IEC 62304 First Edition 2006-05. | Software validation performed according to IEC 62304 First Edition 2006-05. |
| Electrical Safety | |
| Conformity to IEC 61010-1 and IEC 61010-2-040. | Safety tests performed demonstrating conformity to IEC 61010-1 and IEC 61010-2-040. |
| Electromagnetic Compatibility (EMC) | |
| Conformity to IEC 61326-1. | EMC tests performed demonstrating conformity to IEC 61326-1. |
Regarding the AI/ML-specific questions, based only on the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable to a steam sterilizer. The "test set" here refers to specific loads and operational conditions for validating sterilization efficacy, not data for an AI model. Data provenance (country, retrospective/prospective) is not mentioned for the performance tests, as these are lab-based validations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for a sterilizer is established through universally accepted microbiological standards (e.g., SAL, biological indicators) and physical measurements (temperature, pressure, leak rates) according to standards like AAMI ST55. It does not involve human expert interpretation in the way AI/ML diagnostic tools do.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human interpretation outcomes, not for the objective readings of physical and biological indicators in a sterilizer.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable, as this is not an AI/ML diagnostic device with human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device. The device operates as a standalone sterilizer, and its performance is evaluated independently of human intervention during the cycle.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The ground truth for this device is based on microbiological sterility (absence of viable microorganisms, confirmed by biological indicators) and physical parameters (temperature, pressure, vacuum, moisture retention) measured against established industry standards (ANSI/AAMI ST55:2010).
- The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.
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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 | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Classic-17 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps; -0.8 bareach step) | 121°C / 250°F20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles | |
| (C4) SOLID 134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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) HOLLOW134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F35 minutes | 1.5 min | Test device only (without another load) | |
| VACUUM TEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min | |
| VACUUM +HELIX/BDTEST (****) | / | / | / |
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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Classic-22 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps; -0.8 bareach step) | 121°C / 250°F20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles | |
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F3.5 minutes | 1.5 min | Test device only (without another load) | |
| VACUUMTEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min | |
| VACUUM +HELIX/BDTEST (****) | / | / | / |
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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Futura-17 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps: -0.8 bareach step) | 121°C / 250°F20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles | |
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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 prevacuumsteps: -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps: -0.8 bareach step) | 134°C / 273°F3.5 minutes | 1.33 min | Test device only (without another load) | |
| VACUUMTEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min | |
| VACUUM +HELIX/BDTEST (****) | / | / |
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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Futura-22 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps: -0.8 bareach step) | 121°C / 250°F20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles | |
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F3.5 minutes | 1.33 min | Test device only (without another load) | |
| VACUUMTEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min | |
| VACUUM +HELIX/BDTEST | / | / | / |
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 PantaleoniISEMED srlVia Altobelli Bonetti 3/a40026 Imola (BO)ItalyMob.phone: +39-348 4435155Telephone: +39-542 683803Fax: +39-542 698456Email: 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 ofDevice name | 510(k) Number |
|---|---|---|
| CEFLA S.C. | Family of steam sterilizers B28 series | K151597 |
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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 | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Classic-17 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps; -0.8 bareach step) | 121°C / 250°F20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles | |
| (C4) SOLID 134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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) HOLLOW134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F3.5 minutes | 1.5 min | Test device only (without another load) | |
| VACUUM TEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min | |
| VACUUM +HELIX/BDTEST | / | / | / |
Table 1 - B CLASSIC-17 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
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(**) 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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles | |
| B Classic-22 | (C2)UNIVERSAL121(3 prevacuumsteps; -0.8 bareach step) | 121°C / 250°F20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles |
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) | |
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bar | 134°C / 273°F3.5 minutes | 1.5 min | Test device only (without another load) |
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| each step) | ||
|---|---|---|
| VACUUMTEST(-0.8 bar) | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST (****) | / | / |
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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Futura-17 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121(3 prevacuumsteps; -0.8 bareach step) | 121°C / 250°F20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.6 kg unwrapped porous and fabric textiles0.5 kg single package porous and fabric textiles0.4 kg double package porous and fabric textiles | |
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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) |
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| (C5)HOLLOW 134(3 prevacuumsteps; -0.8 bareach step) | 134°C/273°F4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and dental handpieces (max 1.33 kg per tray) |
|---|---|---|---|
| HELIX/BDTEST(3 prevacuumsteps; -0.8 bareach step) | 134°C/273°F3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUMTEST(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST (****) | / | / | / |
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 | CYCLENAME | STERILIZATIONTEMPERATURE /EXPOSURE TIME | DRYINGTIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE() (*) |
|---|---|---|---|---|
| B Futura-22 | (C1)UNIVERSAL134(3 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles |
| (C2)UNIVERSAL121 | 121°C / 250°F20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray)2.25 kg single package metal or polymer instruments |
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| (3 prevacuumsteps; -0.8 bareach step) | and dental handpieces (max 1.33 kg per tray)1.25 kg double package metal or polymer instrumentsand dental handpieces (max 1.33 kg per tray)0.75 kg unwrapped porous and fabric textiles0.60 kg single package porous and fabric textiles0.50 kg double package porous and fabric textiles | ||
|---|---|---|---|
| (C4) SOLID134(1 prevacuumstep; -0.8 bar) | 134°C / 273°F4 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 prevacuumsteps; -0.8 bareach step) | 134°C / 273°F4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments anddental handpieces (max 1.33 kg per tray) |
| (3 prevacuumsteps; -0.8 bareach step)HELIX/BDTEST | 134°C / 273°F3.5 minutes | 1.33 min | Test device only (without another load) |
| (3 prevacuumsteps; -0.8 bareach step)VACUUMTEST | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| (-0.8 bar)VACUUM +HELIX/BDTEST (****) | / | / | / |
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.
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| Features | Subject Device | Predicate Device(K151597) | SubstantiallyEquivalent | |
|---|---|---|---|---|
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | ||
| Regulationnumber | 880.6880 – Steam Sterilizers | 880.6880 – Steam Sterilizers | 880.6880 – Steam Sterilizers | Same |
| Class | II | II | II | Same |
| Productcode | FLE | FLE | FLE | same |
| Indicationfor use | B CLASSIC-17 is a steamsterilizer that is intended foruse by a heath care provider(i.e. hospitals, medical anddental practices, clinics, andnursing homes) to sterilize re-usable medical products thatare heat and moisture resistantand compatible with the steamsterilization process.The device shall not be usedfor the sterilization of fluids,liquids or pharmaceuticalproducts.B FUTURA-17 is a steamsterilizer that is intended foruse by a heath care provider(i.e. hospitals, medical anddental practices, clinics, andnursing homes) to sterilize re-usable medical products thatare heat and moisture resistantand compatible with the steamsterilization process.The device shall not be usedfor the sterilization of fluids,liquids or pharmaceuticalproducts. | B CLASSIC-22 is a steamsterilizer that is intended foruse by a heath care provider(i.e. hospitals, medical anddental practices, clinics, andnursing homes) to sterilize re-usable medical products thatare heat and moisture resistantand compatible with the steamsterilization process.The device shall not be usedfor the sterilization of fluids,liquids or pharmaceuticalproducts.B FUTURA-22 is a steamsterilizer that is intended foruse by a heath care provider(i.e. hospitals, medical anddental practices, clinics, andnursing homes) to sterilize re-usable medical products thatare heat and moisture resistantand compatible with the steamsterilization process.The device shall not be usedfor the sterilization of fluids,liquids or pharmaceuticalproducts. | The Family of SteamSterilizers B 28 series BCLASSIC-28 and BFUTURA-28 models are tabletop steam sterilizers to beused in medical and dentalpractices, hospitals, clinics,nursing homes, laboratoriesand other facilities to sterilizere-usable surgical instruments(including dental handpieces)and medical materials, heatand moisture resistant andcompatible with steamsterilization process.The Family of SteamSterilizers B 28 series isvalidated for sterilization offabric packs/textiles forsterilization programs C1 andC2.The Family of SteamSterilizers B 28 series isvalidated for sterilization upto 9 dental handpieces forsterilization programs C1 andC2.The Family of SteamSterilizers B 28 series isvalidated for sterilization upto 6 lumen devicesThe device shall not be usedfor the sterilization of fluids,liquids or pharmaceuticalproducts | Equivalent |
| Construction | ||||
| ChamberVolumeusable | 17 litres(10 litres with tray supportsinserted) | 22 litres(13 litres with tray supportsinserted) | 28 litres(19 litres with tray supportsinserted) | Same |
| SterilizationChamberdimensions(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-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | Equivalent | |
| Operatingprinciple | The sterilizing agent is steammade from demineralizedwater. Steam is commonlyused to sterilize porous andnon porous heat resistantmaterials / textiles for morethan 100 years.Sterilization temperatures are121°C / 250 °F and 134°C /273 °F. | The sterilizing agent is steammade from demineralizedwater. Steam is commonlyused to sterilize porous and nonporous heat resistant materials /textiles for more than 100years.Sterilization temperatures are121°C / 250 °F and 134°C /273 °F. | The sterilizing agent is steammade from demineralizedwater. Steam is commonlyused to sterilize porous andnon porous heat resistantmaterials / textiles for morethan 100 years.Sterilization temperatures are121°C / 250 °F and 134°C /273 °F. | Same |
| Mechanismof action forsteamsterilization | Saturated steam contacts thesurface of the device and isable to sterilize it, sincesaturated steam is able todenature the membrane andthe proteins ofmicroorganisms and spores. Incase of packaged devices or ofdevices with lumens (e.g.dental handpieces), the steampenetrates through thepackaging and into thelumens, by means of the airremoval due to the vacuumpump, and is able to sterilizethe devices | Saturated steam contacts thesurface of the device and isable to sterilize it, sincesaturated steam is able todenature the membrane and theproteins of microorganisms andspores. In case of packageddevices or of devices withlumens (e.g. dentalhandpieces), the steampenetrates through thepackaging and into the lumens,by means of the air removaldue to the vacuum pump, andis able to sterilize the devices | Saturated steam contacts thesurface of the device and isable to sterilize it, sincesaturated steam is able todenature the membrane andthe proteins ofmicroorganisms and spores.In case of packaged devicesor of devices with lumens(e.g. dental handpieces), thesteam penetrates through thepackaging and into thelumens, by means of the airremoval due to the vacuumpump, and is able to sterilizethe devices | Same |
| Sterilizationcycle type | All cycles are pre-vacuumwith post vacuum drying | All cycles are pre-vacuum withpost vacuum drying | All cycles are pre-vacuumwith post vacuum drying | Same |
| Device SWcontrolled | Yes | Yes | Yes | Same |
| Builtaccording tostandard | ANSI/AAMI ST55:2010Table-top steam sterilizers | ANSI/AAMI ST55:2010Table-top steam sterilizers | ANSI/AAMI ST55:2010Table-top steam sterilizers | Same |
| Electricalsafetystandard | IEC 61010-1:2001 (edition 2) /UL 61010-1 2nd editionIEC 61010-2-040: 2005(edition 1) for use inconjunction with IEC 61010-1:2001 (ed. 2) | IEC 61010-1:2001 (edition 2) /UL 61010-1 2nd editionIEC 61010-2-040: 2005(edition 1) for use inconjunction with IEC 61010-1:2001 (ed. 2) | IEC 61010-1:2001 (edition 2)/ UL 61010-1 2nd editionIEC 61010-2-040: 2005(edition 1) for use inconjunction with IEC 61010-1:2001 (ed. 2) | Same |
| EMCconformity | IEC 61326-1:2012 | IEC 61326-1:2012 | IEC 61326-1:2012 | Same |
| Heaters | An heating foil pre heats thesterilization chamber andmaintains the temperature forthe sterilization and dryingprocesses | An heating foil pre heats thesterilization chamber andmaintains the temperature forthe sterilization and dryingprocesses | An heating foil pre heats thesterilization chamber andmaintains the temperature forthe sterilization and dryingprocesses | Same |
| SteamGenerator | An external steam generatorproduces steam through adedicated heater | An external steam generatorproduces steam through adedicated heater | An external steam generatorproduces steam through adedicated heater | Same |
| VacuumDevice | FUTURA: Membrane vacuumpump with max free air flow of20 litres per minute.CLASSIC: Membrane vacuumpump with max free air flow of7 litres per minute. | FUTURA: Membrane vacuumpump with max free air flow of38 litres per minute.CLASSIC: Membrane vacuumpump with max free air flow of20 litres per minute. | FUTURA: Membrane vacuumpump with max free air flow of38 litres per minute.CLASSIC: Membrane vacuumpump with max free air flow of20 litres per minute. | Equivalent |
| Features | Subject Device | Predicate Device (K151597) | Substantially Equivalent | |
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B 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 |
| Chamberconstructionmaterial | Austenitic (304 grade)Stainless SteelorAustenitic (316L grade)Stainless Steel | Austenitic (304 grade)Stainless SteelorAustenitic (316L grade)Stainless Steel | Austenitic (304 grade)Stainless Steel | Equivalent |
| Chamberdesignpressure | 2.4 bar / 34.8 psi (relativepressure) | 2.4 bar / 34.8 psi (relativepressure) | 2.4 bar / 34.8 psi (relativepressure) | Same |
| Chamberdesignstandard | Conforming to ASME BPVCSection 8,Division 2 | Conforming to ASME BPVCSection 8, Division 2 | Conforming to ASME BPVCSection 8,Division 2 | Same |
| Processparameters /ProcessControl | Sterilization cycle iscontrolled by time,temperature and pressure andare recorded on printout. Theprocess is controlledautomatically through all thephases of the cycle | Sterilization cycle is controlledby time, temperature andpressure and are recorded onprintout. The process iscontrolled automaticallythrough all the phases of thecycle | Sterilization cycle is controlledby time, temperature andpressure and are recorded onprintout. The process iscontrolled automaticallythrough all the phases of thecycle | Same |
| Processparametersdisplayedon controlpanel: | At cycle start:total number of cyclesset Sterilization temperatureset Holding timeDuring the cycle:cycle time countdownreal time temperaturereal time pressure.At the end of the cycle:Cycle outcome (positive ornegative)min/max temperature duringsterilization phasemin/max pressure duringsterilization phase | At cycle start:total number of cyclesset Sterilization temperatureset Holding timeDuring the cycle:cycle time countdownreal time temperaturereal time pressure.At the end of the cycle:Cycle outcome (positive ornegative)min/max temperature duringsterilization phasemin/max pressure duringsterilization phase | At cycle start:total number of cyclesset Sterilization temperatureset Holding timeDuring the cycle:cycle time countdownreal time temperaturereal time pressure.At the end of the cycle:Cycle outcome (positive ornegative)min/max temperature duringsterilization phasemin/max pressure duringsterilization phase | Same |
| ProcessMonitors | ✓ 1temperature probe in thechamber✓ 1 temperature probe in theheating element✓ 1 temperature probe in thesteam generator✓ 1 pressure sensor forsterilization chamber✓ 1 conductivity sensor(water quality)✓ 1 temperature probe in thereservoir | ✓ 1temperature probe in thechamber✓ 1 temperature probe in theheating element✓ 1 temperature probe in thesteam generator✓ 1 pressure sensor forsterilization chamber✓ 1 conductivity sensor(water quality)✓ 1 temperature prove in thereservoir | ✓ 1 temperature probe in thechamber✓ 1 temperature probe inthe heating element✓ 1 temperature probe inthe steam generator✓ 1 pressure sensor forsterilization chamber✓ 1 conductivity sensor(water quality)✓ 1 temperature prove inthe reservoir | Same |
| Performances | ||||
| Biologicalperformance | SAL of 10-6 reduction(no growth at half cycle withvalidation loads according toAAMI ST55:2010) | SAL of 10-6 reduction(no growth at half cycle withvalidation loads according toAAMI ST55:2010) | SAL of 10-6 reduction(no growth at half cycle withvalidation loads according toAAMI ST55:2010) | Same |
| Features | Subject Device | Predicate Device(K151597) | SubstantiallyEquivalent | |
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | ||
| Moistureretention | <0.5% increase in wrappedinstrument test tray<2% increase in textile testpackaccording to AAMIST55:2010 | <0.5% increase in wrappedinstrument test tray<2% increase in textile testpackaccording to AAMI ST55:2010 | <0.5% increase in wrappedinstrument test tray<2% increase in textile testpackaccording to AAMIST55:2010 | Same |
| Processequivalenttime (F0) | FUTURA 17:30.14 (F0 at 121°C - worstcase condition)CLASSIC 1730.14 (F0 at 121°C - worstcase condition) | FUTURA 22:29.88 (F0 at 121°C - worstcase condition)CLASSIC 2229.88 (F0 at 121°C - worstcase condition) | FUTURA 28:28.62 (F0 at 121°C - worstcase condition)CLASSIC 2827.70 (F0 at 121°C - worstcase condition) | Equivalent |
| Cycle characteristics | ||||
| Cycle phasescomparison | The cycle is composed by 9phases that are:1) Preheating generator /chamber2) Vacuum / Steam pulses3) Temperature increasethrough pressure raise4) Temperature and pressurestabilization5) Sterilization6) Depressurization ofsterilization chamber(STEAM DISCHARGE)7) Vacuum-drying phase8) Load ventilation withsterile air9) Bring the pressure toatmospheric level | The cycle is composed by 9phases that are:1) Preheating generator /chamber2) Vacuum / Steam pulses3) Temperature increasethrough pressure raise4) Temperature and pressurestabilization5) Sterilization6) Depressurization ofsterilization chamber(STEAM DISCHARGE)7) Vacuum-drying phase8) Load ventilation withsterile air9) Bring the pressure toatmospheric level | The cycle is composed by 9phases that are:1) Preheating generator /chamber2) Vacuum / Steam pulses3) Temperature increasethrough pressure raise4) Temperature and pressurestabilization5) Sterilization6) Depressurization ofsterilization chamber(STEAM DISCHARGE)7) Vacuum-drying phase8) Load ventilation withsterile air9) Bring the pressure toatmospheric level | Same |
| Features | Subject Device | Predicate Device(K151597) | SubstantiallyEquivalent | |
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | ||
| FUTURA | FUTURA | FUTURA | ||
| • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | ||
| • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | Same | |
| • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46min total cycle | • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46 mintotal cycle | • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46min total cycle | ||
| • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | ||
| • User Configurable | • User Configurable | • User Configurable | ||
| Availablecycles | CLASSIC | CLASSIC | CLASSIC | Same |
| • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | • (C1) 134°C universal - 2.1bar - 4 min cycle – 61 mintotal cycle | ||
| • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | • (C2) 121°C universal – 1.1bar - 20 min cycle - 73 mintotal cycle | Same | |
| • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46 mintotal cycle | • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46 mintotal cycle | • (C4) 134°C solid wrapped –2.1 bar - 4 min cycle – 46min total cycle | ||
| • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | • (C5) 134°C Hollowunwrapped - 2.1 bar – 4 min –50 min total cycle | ||
| • User Configurable | • User Configurable | • User Configurable | ||
| - unwrapped metal or polymerinstruments, dentalhandpieces, porous and fabrictextiles- single and double packagemetal or polymer instruments,dental handpieces, porous andfabric textiles | - unwrapped metal or polymerinstruments, dental handpieces,porous and fabric textiles- single and double packagemetal or polymer instruments,dental handpieces, porous andfabric textiles | - unwrapped metal or polymerinstruments, dental handpieces,porous and fabric textiles- single and double packagemetal or polymer instruments,dental handpieces, porous andfabric textiles | ||
| Sterilizableloads(materials /devices) | ||||
| Sterilizationof liquids &pharmaceuticals | NO | NO | NO | Same |
| Vacuum TestHelix / Bowie & Dick TestVacuum Test + Helix / Bowie& Dick Test | Vacuum TestHelix / Bowie & Dick TestVacuum Test + Helix / Bowie &Dick Test | Vacuum TestHelix / Bowie & Dick TestVacuum Test + Helix / Bowie& Dick Test | ||
| TestPrograms | Same | |||
| Sterilization cycle specifications | ||||
| Yes (single and fractionated)All cycles are pre- vacuumsterilization cycles | Yes (single and fractionated)All cycles are pre- vacuumsterilization cycles | Yes (single and fractionated)All cycles are pre- vacuumsterilization cycles | ||
| Pre vacuum | Same | |||
| Vacuumdrying | Yes | Yes | Yes | Same |
| Sterilizationtemperature | 273 °F or 250 °F(134 °C or 121 °C) | 273 °F or 250 °F(134 °C or 121 °C) | 273 °F or 250 °F(134 °C or 121 °C) | Same |
| Pressure | 2.1bar/31.5psi or 1.1bar/17psi | 2.1bar/31.5psi or 1.1bar/17psi | 2.1bar/31.5psi or 1.1bar/17psi | Same |
| Features | Subject Device | Predicate Device(K151597) | SubstantiallyEquivalent | |
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | ||
| Sterilizationtime | 4 min (at 273°F) or 20 min (at250°F) | 4 min (at 273°F) or 20 min (at250°F) | 4 min (at 273°F) or 20 min (at250°F) | Same |
| Single/double wrappedmax load. kg / lbs | 4 kg unwrapped metal orpolymer instruments anddental handpieces (max 1.33kgper tray) | 4.5 kg unwrapped metal orpolymer instruments and dentalhandpieces (max 1.33kg pertray) | 5 kg unwrapped metal orpolymer instruments anddental handpieces (max 0.9kgper tray) | Equivalent |
| 2 kg single package metal orpolymer instruments anddental handpieces (max 1.33 kgper tray) | 2.25 kg single package metalor polymer instruments anddental handpieces (max 1.33 kgper tray) | 2.5kg single package metal orpolymer instruments anddental handpieces (max 0.9kg per tray) | ||
| 1 kg double package metal orpolymer instruments anddental handpieces (max 0.9kgper tray) | 1.25 kg double package metalor polymer instruments anddental handpieces (max 0.9kgper tray) | 1.5kg double package metalor polymer instruments anddental handpieces (max 0.9kgper tray) | ||
| 0.6 kg unwrapped porous andfabric textiles | 0.75 kg unwrapped porous andfabric textiles | 1 kg unwrapped porous andfabric textiles | ||
| 0.5 kg single package porousand fabric textiles | 0.6 kg single package porousand fabric textiles | 0.75 kg single package porousand fabric textiles | ||
| 0.4 kg double package porousand fabric textiles | 0.5 kg double package porousand fabric textiles | 0.6kg double package porousand fabric textiles | ||
| Max N°9 handpiecesMax 6 single sided lumen 118mm x 0,8 or 6 double sidedlumened devices no longerthan 115 mm and no smallerthan 10 mm. | Max N°9 handpiecesMax 6 single sided lumen 118mm x 0,8 or 6 double sidedlumened devices no longerthan 115 mm and no smallerthan 10 mm. | Max N°9 handpiecesMax 6 single sided lumen 118mm x 0,8 or 6 double sidedlumened devices no longerthan 115 mm and no smallerthan 10 mm. | ||
| IndicatorGauges | During the cycle the followingparameters are displayed oncontrol panel:- Temperature- Pressure- Process time | During the cycle the followingparameters are displayed oncontrol panel:- Temperature- Pressure- Process time | During the cycle thefollowing parameters aredisplayed on control panel:● Temperature● Pressure● Process time | Same |
| Printouts | A printout / report with all theinformation about the cycleand sterilization result(POSITIVE / NEGATIVE) isavailable at the end of eachcycle. The report is availablein pdf file format(downloadable via USB key)or could be printed by theoptional external printer. | A printout / report with all theinformation about the cycleand sterilization result(POSITIVE / NEGATIVE) isavailable at the end of eachcycle. The report is available inpdf file format (downloadablevia USB key) or could beprinted by the optional externalprinter. | A printout / report with all theinformation about the cycleand sterilization result(POSITIVE / NEGATIVE) isavailable at the end of eachcycle. The report is availablein pdf file format(downloadable via USB key)or could be printed by theoptional external printer. | Same |
| Features | Subject Device | Predicate Device(K151597) | SubstantiallyEquivalent | |
| B FUTURA-17B CLASSIC-17 | B FUTURA-22B CLASSIC-22 | B FUTURA-28B CLASSIC-28 | ||
| Recorders | The cycle report can beprinted with the optionalprinter.Otherwise it can bedownloaded through Ethernetor wi-fi connection (only forFUTURA) or through an USBpen (both for FUTURA andCLASSIC) | The cycle report can be printedwith the optional printer.Otherwise it can bedownloaded through Ethernetor wi-fi connection (only forFUTURA) or through an USBpen (both for FUTURA andCLASSIC) | The cycle report can beprinted with the optionalprinter.Otherwise it can bedownloaded through Ethernetor wi-fi connection (only forFUTURA) or through anUSB pen (both for FUTURAand CLASSIC) | Same |
Nonclinical Comparison to Predicate Devices.
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CEFLA SC SERIES 510(K) NOTIFICATION
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CEFLA SC SERIES 510(K) NOTIFICATION
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2.6.Performance Data
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 10t6 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 < 1mmHg (0.13kPa) which is in compliance with the acceptance criteria defined.
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- . The moisture retention test has been performed according to AAMI ST55 (points 5.7.1 / 5.7.2). Due to the different drying time the test has been conducted separately on B Classic-17. B Classic-22. B Futura-17 and B Futura-22 models, using worst case loads and wraps. The results are in compliance with the acceptance criteria defined by ANSI / AAMI ST55 for all the cycles tested.
- Software validation has been performed according to IEC 62304 First Edition . 2006-05.
- Safety tests have been performed according to the following standards ● demonstrating the conformity of the subject device:
-
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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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.
§ 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).