(266 days)
The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, and other facilities to sterilize reusable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
The Family of Steam Sterilizers B 28 series is validation of fabric packs/textiles for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below)
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
The Family of steam sterilizers B 28 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The B Classic-28 and B Futura-28 models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection
The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document is a 510(k) summary for a medical device (CEFLA S.C.'s Family of Steam Sterilizers B28 series), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness with detailed studies involving human readers or extensive ground truth adjudication. Therefore, many of the requested points from the prompt (like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," "number of experts used to establish the ground truth," etc.) are not applicable to this type of regulatory submission and information.
The acceptance criteria here are based on the performance standards for steam sterilizers, particularly AAMI ST55:2010. The "study" refers to the validation tests performed to ensure compliance with these standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Based on AAMI ST55:2010) | Reported Device Performance |
|---|---|
| Biological Performance (SAL) | |
| - Textile PCD: SAL of 10⁻⁶ reduction (no growth at half cycle with validation loads) | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| - Wrapped instruments and lumen devices (double package): SAL of 10⁻⁶ reduction | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| - Dental handpieces (double package): SAL of 10⁻⁶ reduction | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| Chamber Temperature Stability | |
| - During sterilization holding time: between -0°C and +3°C of the sterilization temperature set point (AAMI ST55:2010, points 4.4.3 / 5.4.3) | Chamber temperatures are always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. Results are in compliance with acceptance criteria. |
| Bowie-Dick Test | |
| - Uniform color change (AAMI ST55:2010, point 5.6.1.1) | After the test run, the Bowie-Dick test indicator showed a uniform color change. |
| Air Leak Test | |
| - Average leak rate: < 1 mmHg (0.13kPa) (AAMI ST55:2010, point 5.6.2) | After the test run, the average leak rate is < 1 mmHg (0.13kPa), which is in compliance with the acceptance criteria. |
| Moisture Retention | |
| - Wrapped instrument test tray: < 0.5% increase | Results are in compliance with the acceptance criteria defined by ANSI / AAMI ST55 for all cycles tested. |
| - Textile test pack: < 2% increase | Results are in compliance with the acceptance criteria defined by ANSI / AAMI ST55 for all cycles tested. |
| Software Validation | |
| - Compliance with IEC 62304 First Edition 2006-05 | Software validation has been performed according to IEC 62304 First Edition 2006-05. (Implies compliance, specific results not detailed). |
| Electrical Safety | |
| - Compliance with IEC 61010-1 and IEC 61010-2-040 | Safety tests have been performed according to IEC 61010-1 and IEC 61010-2-040, demonstrating conformity. (Implies compliance, specific results not detailed). |
| EMC Conformity | |
| - Compliance with IEC 61326-1:2012 | Electromagnetic compatibility tests have been performed according to IEC 61326-1:2012, demonstrating conformity. (Implies compliance, specific results not detailed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "each cycle tested" for biological indicators and moisture retention tests, and "worst case loads" for temperature verification and moisture retention. However, it does not specify the exact number of cycles or loads used for these tests. It indicates the use of "a FDA cleared Bowie-Dick test pack" for that specific test, implying a single test pack per run.
- Data Provenance: The tests were performed to validate the sterilizer's design and sterilization process according to AAMI ST55:2010 requirements. The manufacturer is CEFLA S.C. from Italy. The context suggests these were prospective validation tests conducted by the manufacturer or a certified testing facility as part of the regulatory submission process.
3. 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. The ground truth for sterilizer performance is established by objective scientific/engineering standards like Sterility Assurance Level (SAL), temperature readings, leak rates, and biological indicator growth/no growth, not by expert interpretation of complex data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret medical images or clinical data. Sterilizer validation relies on objective measurements against predefined criteria.
5. 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. This is a submission for a steam sterilizer, which is a physical device, not an AI-powered diagnostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" performance. The device itself (the sterilizer) performs its function autonomously, but its "performance" is verified through engineering and biological tests, not by an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth is derived from objective predefined performance standards and direct measurements:
- Sterility Assurance Level (SAL) of 10⁻⁶ reduction: Verified by biological indicators (which either show growth or no growth after exposure).
- Temperature and pressure readings: Measured by calibrated sensors during cycles.
- Bowie-Dick test results: Visual confirmation of uniform color change on a test indicator.
- Air leak rate: Measured quantitatively.
- Moisture retention: Measured quantitatively as percentage weight increase.
- Compliance with recognized electrical safety (IEC 61010 series), EMC (IEC 61326-1), and software quality (IEC 62304) standards.
8. The sample size for the training set
- Not applicable. This is a physical sterilizer, not a machine learning model that requires a training set. The "training" for such a device would be its mechanical and electrical design and manufacturing process, which are subject to engineering and quality control, not data training.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for it. The integrity and functionality of the device are ensured through its design specifications, manufacturing processes, and adherence to relevant industry standards.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
March 4, 2016
CEFLA S.C. c/o Mr. Maurizio Pantaleoni CEO ISEMED srl Via Altobelli Bonetti 3/a IMOLA (BO), ITALY 40026
Re: K151597
Trade/Device Name: Family of Steam Sterilizer B28 series Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 1. 2016 Received: February 4, 2016
Dear Mr. Pantaleoni,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151597
Device Name Family of Steam sterilizers B28 series
Indications for Use (Describe)
The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, and other facilities to sterilize reusable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
The Family of Steam Sterilizers B 28 series is validation of fabric packs/textiles for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below)
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
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| The Statist Stelling of a arangally in the rollowing finances / Unificiallys . | |||||
|---|---|---|---|---|---|
| B Classic-28 model - 120 VOLT | MOCOM | ANTHOS | STERNWEBER | CASTELLINI | |
| commercial brand commercial brand commercial brand commercial brand | |||||
| B Futura-28 model -120 VOLT | MOCOM | ANTHOS | STERNWEBER | CASTELLINI | |
| commercial brand commercial brand commercial brand commercial brand | |||||
| Table 1 - Different models available for Steam sterilizers |
The steam sterilizers are available in the following models / brandnames :
The full list of codes included in this submission is listed in the table 2 below:
| Code | Model | Commercial Brand Name |
|---|---|---|
| M7A730010 | B Classic-28120 Volt | MOCOM - B Classic-28 |
| M7A770010 | B Futura-28120 Volt | MOCOM - B Futura-28 |
| 7A173010 | B Classic-28120 Volt | STERN WEBER - SW-28 |
| 7A177010 | B Futura-28120 Volt | STERN WEBER - SW-28 PLUS |
| 7A073010 | B Classic-28120 Volt | ANTHOS - A-28 |
| 7A077010 | B Futura-28120 Volt | ANTHOS - A-28 PLUS |
| C7A730010 | B Classic-28120 Volt | CASTELLINI - C-28 |
| C7A770010 | B Futura-28120 Volt | CASTELLINI - C-28 PLUS |
Table 2 – List of codes of steam sterilizers and relation with the commercial brand name
Program description, cycle times, temperature and dry time for each model are described in the tables below:
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B CLASSIC-28 model (B Classic-28; A-28; SW-28; C-28)
Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27.7 litres)
| PROGRAMNAME | CYCLE TYPE | STERILIZATIONTEMPERATUREand TIME | DRYINGTIME (*) | MAXIMUM LOAD () (*) |
|---|---|---|---|---|
| (C1)UNIVERSAL134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9 kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9 kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9 kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C2)UNIVERSAL121 | PREVACUUM(3 steps; -0.8bar each step) | 121°C / 250°F20 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C4) SOLID134 | PREVACUUM(1 step; -0.8bar) | 134°C / 273°F4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray)2.5kg single package metal or polymer instruments(max 0.9kg per tray) |
| (C5)HOLLOW134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray) |
| HELIX/BDTEST | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F3.5 minutes | 1.5 min | Test device only (without another load) |
| VACUUMTEST | Vacuum(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST (****) | / | / |
Table 3 - B-CLASSIC 28 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
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B Futura-28 model (B Futura-28; A-28 PLUS; SW-28 PLUS; C-28 PLUS)
| PROGRAMNAME | CYCLE TYPE | STERILIZATIONTEMPERATUREand TIME | DRYINGTIME (*) | MAXIMUM LOAD () (*) |
|---|---|---|---|---|
| (C1)UNIVERSAL134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9 kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9 kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9 kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C2)UNIVERSAL121 | PREVACUUM(3 steps; -0.8bar each step) | 121°C / 250°F20 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C4) SOLID134 | PREVACUUM(1 step; -0.8bar) | 134°C / 273°F4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray)2.5kg single package metal or polymer instruments(max 0.9kg per tray) |
| (C5)HOLLOW134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray) |
| HELIX/BDTEST | PREVACUUM(3 steps: -0.8bar each step) | 134°C / 273°F3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUMTEST | Vacuum(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST (****) |
Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27.7 litres)
Table 4 - B-FUTURA 28 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
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Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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FAMILY OF STEAM STERILIZERS B 28 SERIES
CEFLA SC 510(K) NOTIFICATION
510(k) Summary - K151597
Family of steam sterilizers B 28 series
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
2.1. General Information
Submitter:
CEFLA SC Via Selice Provinciale, 23/A 40026 - IMOLA (BO) ITALY
Establishment Registration Number: 3006610845
Contact Person in Italy:
Maurizio Pantaleoni ISEMED srl Via Altobelli Bonetti 3/a 40026 Imola (BO) Italy Mob.phone: +39-348 4435155 Telephone: +39-542 683803 Fax: +39-542 698456 Email: regulatory@isemed.eu
February 01, 2016 Summary Preparation Date: 2.2. Names Family of Steam sterilizer B28 series Device Name: Classification Name: Steam Sterilizer Product Code: FLE Regulation number: 880.6880 Class: II
2.3. Predicate Devices
The Family of steam sterilizers B 28 series is substantially equivalent to the following legally marketed predicate device:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| M.O.COM. s.r I | MILLENNIUM series (B² model) | K050263 |
| Tuttnauer USA Co.Ltd | Tuttnauer Pre-Vacuum TabletopAutoclave (Model ELARA-11) | K143311 |
2.4. Intended Use
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The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below).
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
2.5. Device Description
The Family of steam sterilizers B 28 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The B Classic-28 and B Futura-28 models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection
The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.
| The steam sterilizers are available in the following models / brandnames : | ||||
|---|---|---|---|---|
| B Classic-28 model - 120 VOLT | MOCOMcommercial brand | ANTHOScommercial brand | STERNWEBERcommercial brand | CASTELLINIcommercial brand |
| B Futura-28 model -120 VOLT | MOCOMcommercial brand | ANTHOScommercial brand | STERNWEBERcommercial brand | CASTELLINIcommercial brand |
| Table 1 – Different models available for Steam sterilizers |
The full list of codes included in this submission is listed in the table 2 below:
| Code | Model | Commercial Brand Name |
|---|---|---|
| M7A730010 | B Classic-28 | MOCOM - B Classic-28 |
| M7A770010 | B Futura-28 | MOCOM - B Futura-28 |
| 7A173010 | B Classic-28 | STERN WEBER - SW-28 |
| 7A177010 | B Futura-28 | STERN WEBER - SW-28 PLUS |
| 7A073010 | B Classic-28 | ANTHOS - A-28 |
| 7A077010 | B Futura-28 | ANTHOS - A-28 PLUS |
| C7A730010 | B Classic-28 | CASTELLINI - C-28 |
| C7A770010 | B Futura-28 | CASTELLINI - C-28 PLUS |
Table 2 - List of codes of steam sterilizers and relation with the commercial brand name
Program description, cycle times, temperature and dry time for each model are described in the tables below:
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| Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27,7 litres) | ||||
|---|---|---|---|---|
| PROGRAMNAME | CYCLE TYPE | STERILIZATIONTEMPERATUREand TIME | DRYINGTIME (*) | MAXIMUM LOAD () (*) |
| (C1)UNIVERSAL134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9 kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9 kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9 kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C2)UNIVERSAL121 | PREVACUUM(3 steps; -0.8bar each step) | 121°C / 250°F20 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C4) SOLID134 | PREVACUUM(1 step; -0.8bar) | 134°C / 273°F4 minutes | 14.5 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray)2.5kg single package metal or polymer instruments(max 0.9kg per tray) |
| (C5)HOLLOW134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray) |
| HELIX/BDTEST | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F3.5 minutes | 1.5 min | Test device only (without another load) |
| VACUUMTEST | Vacuum(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST (****) | / | / | / | / |
B Classic-28 model (B Classic-28; A-28; SW-28; C-28)
Table 3 - B-CLASSIC 28 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
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| Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27,7 litres) | ||||
|---|---|---|---|---|
| PROGRAMNAME | CYCLE TYPE | STERILIZATIONTEMPERATUREand TIME | DRYINGTIME (*) | MAXIMUM LOAD () (*) |
| (C1)UNIVERSAL134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9 kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9 kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9 kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C2)UNIVERSAL121 | PREVACUUM(3 steps; -0.8bar each step) | 121°C / 250°F20 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments anddental handpieces (max 0.9kg per tray)2.5kg single package metal or polymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metal or polymer instrumentsand dental handpieces (max 0.9kg per tray)1 kg unwrapped porous and fabric textiles0.75 kg single package porous and fabric textiles0.6kg double package porous and fabric textiles |
| (C4) SOLID134 | PREVACUUM(1 step; -0.8bar) | 134°C / 273°F4 minutes | 11.5 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray)2.5kg single package metal or polymer instruments(max 0.9kg per tray) |
| (C5)HOLLOW134 | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F4 minutes | 3 min | 5 kg unwrapped metal or polymer instruments(max 0.9kg per tray) |
| HELIX/BDTEST | PREVACUUM(3 steps; -0.8bar each step) | 134°C / 273°F3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUMTEST | Vacuum(-0.8 bar) | / | / | Empty chamberVacuum -0.8 barTest Time: 27 min |
| VACUUM +HELIX/BDTEST(****) | / | / | / |
B Futura-28 model (B Futura-28; A-28 PLUS; SW-28 PLUS; C-28 PLUS)
Table 4 - B-FUTURA 28 Factory programmed sterilization cycles and parameters
(*) Default drying time, but the drying time can be manually increased
(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .
(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)
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| Features | Subject Device | Predicate Devices | SubstantiallyEquivalent | ||
|---|---|---|---|---|---|
| B FUTURA-28B CLASSIC-28 | MOCOM - MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | |||
| CFR code | 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 | 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 andC2The 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 | The device is intended 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.Typical users of this systemare trained professionalsincluding, but not limited to,dentists, nurses and otherspecific medicalprofessionals.NOTE: The device shall notbe used for the sterilization offluids, liquids orpharmaceutical products. | The ELARA-11 is a table-topautoclave designed forsterilizing medical andsurgical goods, including bothwrapped and unwrapped,solid, hollow, and porousproducts and goods defined ashollow A (e.g., dental handpieces; suction pipes) inophthalmic, dental, medicalclinics; and in first aid rooms.The ELARA-11 is validatedfor use in sterilizing lumeneddevice if no longer than 230mm and no smaller than 3.4mm for sterilization programs2 and 4.The ELARA-11 is validatedfor use in sterilizing fabricpacks/textiles for sterilizationprograms 2 and 4.The ELARA-11 is validatedfor use in sterilizing up to sixdental handpieces forsterilization programs 2 and 4 | equivalent | |
| Construction | |||||
| ChamberVolumeusable | 28 litres(19 litres with tray supportsinserted) | 21 litres(13 litres with tray supportsinserted) | 28.5 litres | equivalent | |
| SterilizationChamberdimensions(Φ x H) | 280 x 450 mm | 250 x 450 mm | 220 x 502mm | equivalent | |
| Subject Device | Predicate Devices | SubstantiallyEquivalent | |||
| Features | B FUTURA-28B CLASSIC-28 | MOCOM – MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | ||
| Design | |||||
| 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 andnon porous heat resistantmaterials / textiles for morethan 100 years.Sterilization temperatures are121°C / 250 °F and 134°C /273 °F. | Sterilization using steam asthe sterilizing agent | same | |
| Mechanismof actionfor steamsterilization | 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 | 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 | 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-vacuumwith post vacuum drying | All cycles are pre-vacuumwith post vacuum drying | equivalent | |
| Device SWcontrolled | Yes | Yes | Yes | same | |
| Builtaccordingto standard | ANSI/AAMI ST55:2010Table-top steam sterilizers | ANSI/AAMI ST55:2003Table-top steam sterilizers | ANSI/AAMI ST55:2010Table-top steam sterilizers | equivalent | |
| 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 1010-2-041: 1995 (1stEdition) | 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) | equivalent | |
| EMCconformity | IEC 61326-1:2012 | IEC 61326-1:2006 | Unknown | equivalent | |
| 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 | pre-heating of the sterilizationchamber | equivalent | |
| SteamGenerator | An external steam generatorproduces steam through adedicated heater | An external steam generatorproduces steam through adedicated heater | steam generator producessteam through a dedicatedheater | equivalent | |
| Subject Device | Predicate Devices | Substant | |||
| Features | B FUTURA-28B CLASSIC-28 | MOCOM - MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | iallyEquivalent | |
| VacuumDevice | Membrane vacuum pumpwith max free air flow of 38litres per minute (B Futura) or20 litres per minute (BClassic) | Membrane vacuum pump withmax free air flow of 20 litresper minute | Vacuum pump | equivalent | |
| Airfiltration | 0.027 µm,efficiency: 99.999%efficiency: 99.97% for 0.3-micron particles | 0.027 µm,efficiency: 99.999%efficiency: 99.97% for 0.3-micron particles | 0.2 µm filter | equivalent | |
| Chamber: | Construction material:Austenitic Stainless Steel.Design Pressure: 2.4 bar /34.8 psi (relative pressure)Design Standard: Conformingto ASME BPVC Section 8,Division 2 | Construction material:Austenitic Stainless Steel.Design Pressure: 2.4 bar /34.8 psi (relative pressure)Design Standard: Conformingto ASME BPVC Section 8,Division 1 | Construction material:Austenitic Stainless Steel.Design Pressure: 2.8 bar / 40psiDesign Standard: Conformingto ASME BPVC Section 8,Division 1 | equivalent | |
| 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 iscontrolled by time,temperature and pressure andare recorded on printout. Theprocess is controlledautomatically through all thephases of the cycle | equivalent | |
| 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:real 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 cyclesDuring the cycle:Sterilization temperatureSterilization timeDry timeChamber temperatureChamber pressureSteam generator pressureTime display: Clock &Time countdownAt the end of the cycle:Cycle outcome (positive ornegative) | equivalent | |
| ProcessMonitors | ✓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 probe inthe reservoir | ✓1 temperature probe inthe chamber✓1 temperature probe inthe heating element✓1 temperature probe inthe steam generator✓1 pressure sensor forsterilization chamber | ✓1 temperature probe in thechamber✓1 temperature probe inthe heating element✓1 temperature probe in thesteam generator✓1 pressure sensor forsterilization chamber | equivalent | |
| Features | Subject DeviceB FUTURA-28B CLASSIC-28 | Predicate Devices | SubstantiallyEquivalent | ||
| Performances | MOCOM – MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | |||
| Biologicalperformance | SAL of 10⁻⁶ reduction(no growth at half cycle withvalidation loadsaccording to AAMIST55:2010) | SAL of 10⁻⁶ reduction(no growth at half cycle withvalidation loadsaccording to AAMIST55:2003) | SAL of 10⁻⁶ reduction(no growth at half cycle withvalidation loads according toAAMI ST55:2010) | same | |
| 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 testpackAAMI ST55:2003 | <0.5% increase in wrappedinstrument test tray<2% increase in textile testpackaccording to AAMIST55:2010 | same | |
| Processequivalenttime (F0) | B FUTURA-28:28.62 (F0 at 121°C - worstcase condition)B CLASSIC-28:27.70 (F0 at 121°C - worstcase condition) | 27.66 (F0 at 121°C – worstcase condition) | Unknown | equivalent | |
| Cycle characteristics | |||||
| Cycle phasescomparison | The cycle is composed by 9phases that are:1) Preheating generator /chamber2) Vacuum / Steam pulses (1or 3 times)3) 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) Pre-heating generator /chamber;2) Vacuum / Steam pulses3) Pressure increasing, withsteam temperature raise up tothe preset conditions (e.g.273 °F);4) Stabilization of thepressure and temperature5) Sterilization process forthe preset time (e.g. 4minutes);6) Chamber pressuredecreasing through steamdischarge;7) Vacuum drying phase;8) Venting phase throughsterile air9) Chamber pressurelevelling up to atmosphericvalue | The cycle is composed by 5phases that are:1) Vacuum stage followedby introduction of saturatedsteam2) Heating stage3) Sterilization Stage4) Exhaust stage - steam inexhausted from chamber5) Dry stage followed byvacuum break until thechamber pressure equalize toatmospheric pressure | equivalent |
2.6. Nonclinical Comparison to predicate devices.
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FAMILY OF STEAM STERILIZERS B 28 SERIES
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FAMILY OF STEAM STERILIZERS B 28 SERIES
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FAMILY OF STEAM STERILIZERS B 28 SERIES
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FAMILY OF STEAM STERILIZERS B 28 SERIES
| Subject Device | Predicate Devices | SubstantiallyEquivalent | ||
|---|---|---|---|---|
| Features | B FUTURA-28B CLASSIC-28 | MOCOM – MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | |
| Availablecycles | • (C1) 134°C universal – 2.1 bar – 4 min cycle• (C2) 121°C universal – 1.1 bar – 20 min cycle• (C4) 134°C solid wrapped – 2.1 bar – 4 min cycle• (C5) 134°C Hollow unwrapped – 2.1 bar – 4 min• User Configurable | • 134°C porous – 2.1 bar - 4 min cycle• 121°C porous – 1.1 bar - 20 min cycle• 134°C hollow - 2.1 bar - 4 min cycle• 121°C hollow - 1.1 bar - 20 min cycle• 134°C wrapped - 2.1 bar - 4 min cycle• 121°C wrapped – 1.1 bar - 20 min cycle• 134°C solid- 2.1 bar - 4 min cycle• 121°C solid-1.1 bar-20 min cycle• 134°C emergency – 2.1 bar - 3 min cycle• User Configurable | 1- Unwrapped -134°C for 4 min - 1min (dry time) – 25min max total cycle time2- Wrapped -134°C for 4min - 20 min (dry time) – 50 min max total cycle time3- Unwrapped/Delicate instruments -121°C for 20 min + 1 min (dry time) - 40min max total cycle time4- Wrapped/Delicate instruments -121°C for 20 minutes + 20min (dry time) - 70min max total cycle time | equivalent |
| Sterilizablematerials /devices | - unwrapped metal or polymer instruments, dental handpieces, porous and fabric textiles- single and double package metal or polymer instruments, dental handpieces, porous and fabric textiles | -Unpackaged porous, solid materials and hollow instruments / dental handpieces-Porous materials in single and double package-Solid and handpieces in single and double package | wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) | equivalent |
| Sterilizationof liquids &pharmaceuticals | NO | NO | NO | same |
| TestPrograms | Vacuum TestHelix / Bowie & Dick TestVacuum Test + Helix / Bowie & Dick Test | Vacuum TestHelix / Bowie & Dick Test | Vacuum TestBowie & Dick Test | equivalent |
| Sterilization cycle specifications | ||||
| Pre vacuum | Yes (single and fractionated) | Yes (single and fractionated) | All cycles are pre- vacuum sterilization cycles | equivalent |
| Vacuumdrying | Yes | Yes | Yes | same |
| Sterilizationtemperatures | 134°C / 273 °F or 121°C / 250 °F | 134°C / 273 °F or 121°C / 250 °F | 134°C / 273 °F or 121°C / 250 °F | same |
| pressure | 31.5 psi or 17 psi | 31.5 psi or 17 psi | 31.5 psi or 17 psi | same |
| Sterilizationtime | 4 min (at 273°F) or 20 min (at 250°F) | 4 min (at 273°F) or 20 min (at 250°F) | 4 min (at 273°F) or 20 min (at 250°F) | same |
| Subject Device | Predicate Devices | SubstantiallyEquivalent | ||
| Features | B FUTURA-28B CLASSIC-28 | MOCOM - MillenniumSeries B² modelK050263 | Tuttnauer Pre-VacuumTabletop AutoclaveELARA-11 K143311 | |
| Single/double wrappedmax load,kg / lbs | 5 kg unwrapped metal orpolymer instruments anddental handpieces (max 0.9kgper tray)2.5kg single package metal orpolymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metalor polymer instruments anddental handpieces (max 0.9kgper tray)1 kg unwrapped porous andfabric textiles0.75 kg single package porousand fabric textiles0.6kg double package porousand fabric textilesMax Nº9 handpiecesMax 6 single sided lumen 118mm x 0,8 or 6 double sidedlumened devices no longerthan 115 mm and no smallerthan 10 mm . | 5 kg unwrapped metal orpolymer instruments anddental handpieces (max 0.9kgper tray)2.5kg single package metal orpolymer instruments anddental handpieces (max 0.9kg per tray)1.5kg double package metalor polymer instruments anddental handpieces (max 0.9kgper tray)1 kg unwrapped porous andfabric textiles0.75 kg single package porousand fabric textiles0.6kg double package porousand fabric textilesMax Nº9 handpiecesMax 6 single sided lumen 118mm x 0,8 or 6 double sidedlumened devices no longerthan 115 mm and no smallerthan 10 mm . | Double wrapped Solid loadshall not exceed 8 KgDouble wrapped porous loadshall not exceed 2 KgMaximum load per tray: 2 kgMax Nº6 handpieces1 lumen device 230 x 3,4 mm | Equivalent |
| 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 the followingparameters are displayed oncontrol panel:- Temperature- Pressure- Process time | same |
| Printouts | A printout / report with all theinformation about the cycle andsterilization result (POSITIVE /NEGATIVE) is available at theend of each cycle. The report isavailable in pdf file format(downloadable via USB key) orcould be printed by the optionalexternal printer. | A printout / report with all theinformation about the cycle andsterilization result (POSITIVE /NEGATIVE) is available at the endof each cycle, when the optionalintegrated printer is available | A printout / report with all theinformation about the cycle andsterilization result (POSITIVE /NEGATIVE) is available at theend of each cycle | Equivalent |
| Recorders | The cycle report can be printedwith the optional printer.Otherwise it can be downloadedthrough Ethernet or wi-ficonnection or through an USBpen . | The cycle report is printed throughthe optional integrated printer,when available | The cycle report is printedthrough the integrated printer,when available | Equivalent |
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FAMILY OF STEAM STERILIZERS B 28 SERIES
2.7.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.
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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°.
- . The biological performances with wrapped instruments and lumen devices (double package) have been verified according to AAMI ST55 (point 5.5.4). All the biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10-9.
- The biological performances with dental handpieces (double package) have been verified according to AAMI ST55 (point 5.5.5). All the biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10-9.
- The Bowie Dick Test cycle has been verified using a FDA cleared Bowie-Dick test pack . according to AAMI ST55 (point 5.6.1.1). After the test run, the Bowie-Dick test indicator showed a uniform color change.
- The Air Leak test has been performed according to AAMI ST55 (point 5.6.2). After the test run, the average leak rate is < 1 mmHg (0,13kPa) which is in compliance with the acceptance criteria defined.
- 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-28 and B Futura 28 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
-
IEC 61010-2-040 Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-040: Particular requirements for sterilizers and washerdisinfectors used to treat medical materials
- . Electromagnetic compatibility tests have been performed according to the following standards demonstrating the conformity of the subject device:
IEC 61326-1 Electrical equipment for measurement, control and laboratory use -EMC requirements - Part 1: General requirements
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FAMILY OF STEAM STERILIZERS B 28 SERIES
2.8.Conclusions
In conclusion, the subject Family of Steam Sterilizers B28 series is substantially equivalent to predicate devices K050263 and K143311. Based on the intended use, technological characteristics, and performance data, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device.
§ 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).