(451 days)
The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page. At no time will there be patient contact with the subject device.
The Steelco VS Series Steam Sterilizers use saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.
The provided text describes the non-clinical testing performed for the Steelco VS Series Steam Sterilizers (K213545) to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Performance | Ensure performance, labeling, and safety per AAMI ST8:2013 | Labeling complies with section 4.1 of ST8. | Compliance is documented in the labeling, user manual, service manual, and inventory of user interface screens and the ST8 Compliance Test Protocols for the individual models. | Pass |
| Sterilizer design, construction, components, and accessories comply with section 4.2 of ST8. | Compliance is documented in the Machine Hardware Design Specification, risk analysis, FMEA section 3, mechanical aspects, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Sterilizer safety complies with section 4.3 of ST8. | Compliance is documented in the Machine Hardware Design Specification, risk analysis, FMEA section 3, mechanical aspects, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Process monitoring and control devices comply with section 4.4 of ST8. | Compliance is documented in the Design Specification Control and User Interface Hardware, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Biological performance of sterilizers complies with section 4.5 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| Mechanical air removal complies with section 4.6 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| Moisture retention complies with section 4.7 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| General Electrical Safety | Ensure electrical safety in construction and design | Compliance with appropriate provisions of IEC/UL 61010-1 and 61010-2-040. | Compliance is documented in the ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum. | Pass |
| Sterilizer Electrical Safety | Ensure electrical safety in construction and design | Compliance with appropriate provisions of IEC/UL 61010-1 and 61010-2-040. | Compliance is documented in the ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum. | Pass |
| EMC testing | Ensure no interference with nearby machinery and no interference from external EMC issues | Compliance with appropriate provisions of EN IEC 61326 part 1. | Compliance is documented in the EN IEC 61326 pt. 1 compliance report. | Pass |
| Software validation | Ensure software executes designed functions and takes machine to safe state if it fails | Compliance with software validation provisions of ISO 62304. | Compliance is documented in the Software Requirements Specification Functional Specification Control and User Interface System, Risk Analysis, FMEA section 5 for control systems, and software validation. | Pass |
| Pressure Vessel Safety | Ensure pressure vessels are designed and built safely | Compliance with safety requirements of ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) for chamber and jacket, and Section 1 for boiler (if furnished). | Meets requirements of ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) for the chamber and jacket and Section 1 for the boiler (if furnished). See rating plate, section 6.2 of the ST8 Compliance Test Protocols for the individual machines. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size used for the test set" in terms of number of sterilization cycles or units tested. However, it mentions "ST8 Compliance Test Protocols for the individual machines" being documented for various performance criteria. This suggests that testing was conducted for the specific models of sterile, but the exact number of tests or cycles performed is not provided.
Regarding data provenance, the testing was non-clinical (laboratory/engineering testing) and focused on compliance with established standards (e.g., AAMI ST8, IEC/UL 61010, EN IEC 61326, ASME Boiler and Pressure Vessel Code). The document does not specify the country of origin of the testing data, but the manufacturer (Steelco S.P.A.) is based in Italy. The testing described is prospective in nature, as it was conducted to demonstrate compliance of the device before market introduction.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the described study is a non-clinical performance and safety validation study for a steam sterilizer, not an AI or diagnostic imaging device needing expert ground truth for interpretation. The "ground truth" here is defined by established engineering and medical device standards (AAMI ST8, IEC/UL 61010, etc.) and the physical performance of the machine.
4. Adjudication Method for the Test Set
This section is not applicable for a non-clinical performance and safety validation study of a steam sterilizer. The "adjudication" is met by demonstrating compliance with the specified technical standards and their criteria, not through consensus of human evaluators on specific cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted medical devices where human interpretation plays a role. The Steelco VS Series Steam Sterilizers are physical machines for sterilization, and their effectiveness is evaluated through engineering and microbiological performance testing against standards, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The device is a steam sterilizer, a physical machine designed to operate independently to achieve sterilization. It does not involve "algorithms" in the sense of AI-driven interpretation or diagnostic assistance where "human-in-the-loop" performance would be relevant. The software validation mentioned ensures the machine's control software functions correctly and safely.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria of the Steelco VS Series Steam Sterilizers is based on established industry standards and regulatory requirements. Specifically, this includes:
- ANSI/AAMI ST8:2013: For general performance, biological performance, mechanical air removal, and moisture retention.
- IEC/UL 61010-1 and 61010-2-040: For electrical safety.
- EN IEC 61326 part 1: For electromagnetic compatibility (EMC).
- ISO 62304: For software validation.
- ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) and Section 1: For pressure vessel safety.
Compliance with these standards, as evidenced by testing and documentation, serves as the ground truth for the device's acceptable performance, safety, and effectiveness.
8. The Sample Size for the Training Set
This section is not applicable. The Steelco VS Series Steam Sterilizers are physical machines, not an AI model or a system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle standards, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8. There is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 2, 2023
Steelco S.P.A. % Jonathan Wilder President H & W Technology, LLC 301 City Ave. Suite LL3 Bala Cynwyd, PA 19004
Re: K213545
Trade/Device Name: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 16, 2022 Received: January 3, 2023
Dear Jonathan Wilder:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 your device complies with other requirements of the Act or any Federal
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray, III, Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213545
Device Name
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869.
Indications for Use (Describe)
The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page.
At no time will there be patient contact with the subject device.
Please see page 2 for indications for use defining available, preprogrammed cycles.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☐Prescription Use (Part 21 CFR 801 Subpart D) | ☑Over-The-Counter Use (21 CFR 801 Subpart C) |
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Form 3881 continued: Indications for Use K213545
| Cycles | Sterilizationtemperature | Sterilizationtime | Dry time | Maximum recommended load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)each. Refer to Load Table for recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)each. Refer to Load Table for recommended quantities. |
| Prevac -IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray, nonporous items |
| Gravity | 250°F (121°C) | 30 minutes | 30minutes | |
| Gravity | 270°F (132°C) | 15 minutes | 30minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)each. Refer to Load Table for recommended quantities. |
| Gravity | 275°F (135°C) | 15 minutes | 30minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)each. Refer to Load Table for recommended quantities. |
| Gravity -IUSS | 270°F (132°C) | 10 minutes | 1minute | Immediate use - single unwrapped tray, nonporous items |
| Warm-up | 270°F (132°C) | N/A | N/A | N/A |
| Bowie- Dick | 270°F (132°C) | 3.5 minutes | 5 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak test | N/A | N/A | N/A | N/A |
Standard cycles pre-programmed at factory
The maximum loads and dimensions of the sterilizer for each of the sterilizer models are shown in the following table:
Dimensions and Load Capacity
| Internal Chamber Dimensions | Overall dimensions | Number of trays/fabric packs for maximum load |
|---|---|---|
| 26 x 28 x 39" | 37.4 x 94.5 x 50.9" | 9/18 |
| 26 x 28 x 51" | 37.4 x 94.5 x 62.7" | 12/24 |
| 26 x 28 x 69" | 37.4 x 94.5 x 80.4" | 15/30 |
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510(k) Summary for Steelco VS Steam Sterilizers K213545
SUBMITTER: Steelco S.P.A. Via Balegante. 27 31039 Riese Pio X (TV), Italy Phone 011-39-434-5772-911 Fax 011-39-434-5772-900
CONTACT PERSON: Jonathan A. Wilder US Agent Tel: (267) 269-2779 Fax (585) 486-1415 E-mail: jwilder@stericert.com
DATE PREPARED: January 31, 2023
TRADE NAME: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
COMMON NAME: Steam Sterilizer
DEVICE CLASSIFICATION: Class II
DEVICE Steam Sterilizer
PANEL: General Hospital
CLASSIFICATION NAMES: Steam Sterilizer, 21 CFR 880.6880, classification code FLE
PREDICATE DEVICES: AMSCO 600 Steam Sterilizer K183410
DEVICE DESCRIPTION: The Steelco VS Series Steam Sterilizers use saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.
The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).
INTENDED USE/INDICATIONS FOR USE:
At no time will there be patient contact. The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, shown in the table below:
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| Cycles | Sterilizationtemperature | Sterilizationtime | Dry time | Maximum recommended load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | weight 25 lbs (11.3 kg) each. Refer to Load Tablefor recommended quantities. |
| Prevac -IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray,nonporous items |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | weight 25 lbs (11.3 kg) each. Refer to Load Tablefor recommended quantities. |
| Gravity | 275°F (135°C) | 15 minutes | 30 minutes | for recommended quantities. |
| Gravity -IUSS | 270°F (132°C) | 10 minutes | 1 minute | Immediate use - single unwrapped tray,nonporous items |
| Warm-up | 270°F (132°C) | N/A | N/A | N/A |
| Bowie-Dick | 270°F (132°C) | 3.5 minutes | 5 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak test | N/A | N/A | N/A | N/A |
Standard cycles pre-programmed at factory
The maximum loads and dimensions of the sterilizer for each of the sterilizer models are shown in the following table:
Dimensions and Load Capacity
| Internal Chamber Dimensions | Overall dimensions | Number of trays/fabric packs for maximum load | ||
|---|---|---|---|---|
| Width | Height | Depth | ||
| 26 x 28 x 39" | 37.4" | 94.5" | 50.9" | 9/18 |
| 26 x 28 x 51" | 37.4" | 94.5" | 62.7" | 12/24 |
| 26 x 28 x 69" | 37.4" | 94.5" | 80.4" | 15/30 |
Sterilizers are available in single-door (suffix of /1 to the model number) or double-door (suffix of /2 to the model number) configurations with double-door models interlocked to not permit both doors to be open at the same time, and to not allow release of improperly sterilized items to the sterile side of the machine.
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The environment of use will be a healthcare facility's sterile processing department, or wherever else in the facility sterilizers are used.
The Steelco VS Series Sterilizers are compared to the predicate device in the following table.
| Feature | Steelco VS SeriesSteam Sterilizers (K213545) | AMSCO 600 SteamSterilizer(predicate device K183410) | Comparison |
|---|---|---|---|
| Intended Use | The Steelco VS Series SteamSterilizers are designed forsterilization of heat and moisture-stable materials used inhealthcare facilities | The AMSCO 600Steam Sterilizer is designed forsterilization of heat and moisture-stable materials used inhealthcare facilities. | Same |
| CriticalProcessParameters | Time, Chamber Temperature,Pressure | Time, Chamber Temperature,Pressure | Same |
| Control | PLC | Embedded controller | Similar |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated steam | Saturated steam | Same |
| Utilities | Steam, water, electricity,air | Steam, water, electricity,air | Same |
| Chambermaterial | 316 stainless steel | 316L stainless steel | Similar |
| Nominalchamber size | 26" x 28" x 39"26" x 28" x 51"26" x 28" x 69" | 26" x 26" x 39"26" x 26" x 49"26" x 26" x 61" | Similar |
| Feature | Steelco VS Series Steam Sterilizers(K213545) | AMSCO 600 SteamSterilizer(predicate device K183410) | Comparison |
| Door | 316 Stainless Steel28" x 26" Power vertical sliding | 304L Stainless Steel 26" x 26"Power vertical sliding | Similar |
| Chamberpressurerating | 44 PSIG/291°F | 45 PSIG, 300°F | Similar |
| Door seal | Steam activated door seal | Steam activated door seal | Same |
| Externalprocessmonitors | Independent process control andmonitors Printer | Electronic Control Printer | Similar |
| Internalprocessmonitors | Temperature-Dual independent temperatureprobes in chamber drain-Temperature probe in jacketdrain-Temperature probe in coolingwater reservoir tank Pressure-Dual independent pressuretransducers in chamber-Pressure transducerin on-board boiler (if this optionchosen) | Temperature-Dual element RTD located inchamber drain- RTD located in the jacket drain- RTD located in heatexchanger Pressure-Pressure transducer in chamber | Similar |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2013 | Same |
| Accessories | Shelves, loading equipment | BI, CI, Pouches, Trays, Wraps,Tape,Containers, Shelves, LoadingEquipment | Similar |
| Test Cycles | Warm Up, Leak Test, Bowie DickTest | Warm Up, Leak Test, DART(Bowie Dick) Test | Same |
| Cycles | Prevac 270°F (132°C)/4 minutes,fabric packs Prevac 275°F(135°C)/3 minutes, | 270F, Prevac, 4' Full fabric pack270F, Prevac, 4' Full tray270F, Prevac, 4' one fabric pack | Similar |
| Feature | Steelco VS Series Steam Sterilizers(K213545) | AMSCO 600 SteamSterilizer(predicate device K183410) | Comparison |
| double-wrapped instrument traysPrevac - IUSS 270°F (132°C)/4minutes, single unwrapped tray,nonporous items Gravity 250°F(121°C)/30 minutes, double-wrappedinstrument trays Gravity 270°F(132°C) 15 minutes, double-wrappedinstrument trays Gravity 275°F(135°C)/10 minutes, double-wrappedinstrument trays Gravity - IUSS270°F (132°C)/10 minutes, singleunwrapped tray, nonporous items | 270F, Prevac, 4' IUSS275F, Prevac, 3' Full fabric250F, Gravity, 30' Full tray | ||
| Full loads | • 39": 9, 25-lb double wrappedtrays or 18, fabric packs• 51": 12, 25-lbdouble wrapped trays or 24, fabricpacks• 69": 15, 25-lbdouble wrapped trays or 30, fabricpacks | • 39": 9, 25-lbdouble wrapped trays or 12,fabric packs• 51": 12, 25-lbdouble wrapped trays or 16,fabric packs• 63": 15, 25-lbdouble wrapped trays or 20,fabricpacks | Similar |
Technological Characteristics Comparison Table
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The proposed device has the same or similar indications for use as the predicate with similar technological characteristics. The subject devices slightly differ in design, indications, and features from the predicate devices.
SUMMARY OF NON-CLINICAL TESTS:
The Steelco VS Steam Sterilizer non-clinical test was performed according to the standards in the following table. The testing demonstrated that the subject device met the acceptance criteria of these standards.
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| Test | Purpose of theTest | Acceptance Criteria | Result | Conclusion |
|---|---|---|---|---|
| Performance | To ensure that theperformance,labeling, andsafetyrequirementsspecified in AAMIST8:2013 (ST8)are met. | Labeling complieswith section 4.1 ofST8. | Compliance is documentedin the labeling, user manual,service manual, andinventory of user interfacescreens and the ST8Compliance Test Protocolsfor the individual models. | Pass |
| Sterilizer design,construction,components, andaccessories complywith section 4.2 ofST8. | Compliance is documentedin the Machine HardwareDesign Specification, riskanalysis, FMEA section 3,mechanical aspects, ETLconstruction data file, ETLreport IEC 61010-1 and61010-2-040 compliancedata report, ETLcorrigendum, and the ST8Compliance Test Protocolsfor the individual models. | Pass | ||
| Sterilizer safetycomplies withsection 4.3 of ST8. | Compliance is documentedin the Machine HardwareDesign Specification, riskanalysis, FMEA section 3,mechanical aspects, ETLconstruction data file, ETLreport IEC 61010-1 and61010-2-040 compliancedata report, and ETLcorrigendum, and the ST8Compliance Test Protocolsfor the individual models. | Pass | ||
| Process monitoringand control devicescomply with section4.4 of ST8. | Compliance is documentedin the Design SpecificationControl and User InterfaceHardware, ETL constructiondata file, ETL report IEC61010-1 and 61010-2-040compliance data report, ETLcorrigendum, and the ST8Compliance Test Protocolsfor the individual models. | Pass | ||
| Biologicalperformance ofsterilizers complieswith section 4.5 ofST8. | Compliance is documentedin the ST8 Compliance TestProtocols for the individualmachines. | Pass | ||
| Mechanical airremoval complieswith section 4.6 ofST8. | Compliance is documentedin the ST8 Compliance TestProtocols for the individualmachines. | Pass | ||
| Moisture retentioncomplies withsection 4.7 of ST8. | Compliance is documentedin the ST8 Compliance TestProtocols for the individualmachines. | Pass | ||
| Test | Purpose of the | Acceptance Criteria | Result | Conclusion |
| GeneralElectricalSafety | TestTo ensureelectrical safety inthe constructionand design of thesterilizers | Compliance with theappropriateprovisions ofIEC/UL 61010-1 and61010-2-040 | Compliance is documentedin the ETL construction datafile, ETL report IEC 61010-1 and 61010-2-040compliance data report, andETL corrigendum. | Pass |
| SterilizerElectricalSafety | To ensureelectrical safety inthe constructionand design of thesterilizers | Compliance with theappropriateprovisions ofIEC/UL 61010-1 and61010-2-040 | Compliance is documentedin the ETL construction datafile, ETL report IEC 61010-1 and 61010-2-040compliance data report, andETL corrigendum. | Pass |
| EMC testing | To ensure that themachine does notinterfere with theoperation ofnearby machinerynor is interferedwith by externalEMC issues. | Compliance with theappropriateprovisions of ENIEC 61326 part 1. | Compliance is documentedin the EN IEC 61326 pt. 1compliance report. | Pass |
| Softwarevalidation | To ensure that thesoftware executesits designedfunctions and, if itfails, takes themachine to a safestate. | Compliance withsoftware validationprovisions of ISO62304 | Compliance is documentedin the SoftwareRequirements SpecificationFunctional SpecificationControl and User InterfaceSystem, Risk Analysis,FMEA section 5 for controlsystems, and softwarevalidation | Pass |
| PressureVesselSafety | To ensure that thepressure vesselsare designed andbuilt in a safemanner. | Compliance with thesafety requirementsof ASME Boiler andPressure VesselCode, Section VIII(Division 1) for thechamber and jacketand Section 1 for theboiler (if furnished) | Meets requirements ofASME Boiler and PressureVessel Code, Section VIII(Division 1) for the chamberand jacket and Section 1 forthe boiler (if furnished). Seerating plate, section 6.2 ofthe ST8 Compliance TestProtocols for the individualmachines | Pass |
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CONCLUSIONS:
The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K183410, Class II (21 CFR 880.6860), product code FLE.
§ 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).