(451 days)
Not Found
No
The description focuses on standard steam sterilization processes and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a steam sterilizer intended for sterilizing heat and moisture-stable materials used in healthcare facilities, not for direct patient treatment or diagnosis.
No
The device is a sterilizer designed to process medical instruments, not to diagnose or detect medical conditions in patients. It removes air and exposes items to steam to achieve sterility.
No
The device is a steam sterilizer, which is a piece of hardware designed to sterilize medical equipment using steam. While it includes software for control and operation, it is fundamentally a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the sterilization of heat and moisture-stable materials used in healthcare facilities. This is a process to make medical devices and instruments sterile, not to perform diagnostic tests on biological samples.
- Device Description: The description details a steam sterilizer that uses heat and steam to kill microorganisms on medical equipment. This is a sterilization process, not a diagnostic test.
- No mention of biological samples: There is no mention of the device being used with blood, urine, tissue, or any other biological sample, which is a key characteristic of IVDs.
- No mention of diagnostic testing: The text does not describe any process of analyzing samples to diagnose a condition or disease.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
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 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles.
Product codes (comma separated list FDA assigned to the subject device)
FLE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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).
The environment of use will be a healthcare facility's sterile processing department, or wherever else in the facility sterilizers are used.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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.
| Test | Purpose of the Test | Acceptance Criteria | Result | Conclusion |
|---|---|---|---|---|
| Performance | To ensure that the performance, labeling, and safety requirements specified in AAMI ST8:2013 (ST8) are met. | 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 | To ensure electrical safety in the construction and design of the sterilizers | Compliance with the 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 | To ensure electrical safety in the construction and design of the sterilizers | Compliance with the 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 | To ensure that the machine does not interfere with the operation of nearby machinery nor is interfered with by external EMC issues. | Compliance with the appropriate provisions of EN IEC 61326 part 1. | Compliance is documented in the EN IEC 61326 pt. 1 compliance report. | Pass |
| Software validation | To ensure that the software executes its designed functions and, if it fails, takes the machine to a safe state. | 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 | To ensure that the pressure vessels are designed and built in a safe manner. | Compliance with the safety 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) | 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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
1
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
2
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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3
Form 3881 continued: Indications for Use K213545
| Cycles | Sterilization
temperature | Sterilization
time | Dry time | Maximum recommended load |
|-------------------|------------------------------|-----------------------|---------------|---------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30
minutes | 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 | 30
minutes | 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 | 30
minutes | |
| Gravity | 270°F (132°C) | 15 minutes | 30
minutes | 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 | 30
minutes | 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 | 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 |
|---|---|---|
| 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 |
4
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:
5
| Cycles | Sterilization
temperature | Sterilization
time | 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 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 | 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 Table
for 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.
6
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 Series
Steam Sterilizers (K213545) | AMSCO 600 Steam
Sterilizer
(predicate device K183410) | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Steelco VS Series Steam
Sterilizers are designed for
sterilization of heat and moisture-stable materials used in
healthcare facilities | The AMSCO 600
Steam Sterilizer is designed for
sterilization of heat and moisture-stable materials used in
healthcare facilities. | Same |
| Critical
Process
Parameters | 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 |
| Chamber
material | 316 stainless steel | 316L stainless steel | Similar |
| Nominal
chamber 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 Steam
Sterilizer
(predicate device K183410) | Comparison |
| Door | 316 Stainless Steel
28" x 26" Power vertical sliding | 304L Stainless Steel 26" x 26"
Power vertical sliding | Similar |
| Chamber
pressure
rating | 44 PSIG/291°F | 45 PSIG, 300°F | Similar |
| Door seal | Steam activated door seal | Steam activated door seal | Same |
| External
process
monitors | Independent process control and
monitors Printer | Electronic Control Printer | Similar |
| Internal
process
monitors | Temperature
-Dual independent temperature
probes in chamber drain
-Temperature probe in jacket
drain
-Temperature probe in cooling
water reservoir tank Pressure
-Dual independent pressure
transducers in chamber
-Pressure transducer
in on-board boiler (if this option
chosen) | Temperature
-Dual element RTD located in
chamber drain
- RTD located in the jacket drain
- RTD located in heat
exchanger 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, Loading
Equipment | Similar |
| Test Cycles | Warm Up, Leak Test, Bowie Dick
Test | 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 pack
270F, Prevac, 4' Full tray
270F, Prevac, 4' one fabric pack | Similar |
| Feature | Steelco VS Series Steam Sterilizers
(K213545) | AMSCO 600 Steam
Sterilizer
(predicate device K183410) | Comparison |
| | double-wrapped instrument trays
Prevac - IUSS 270°F (132°C)/4
minutes, single unwrapped tray,
nonporous items Gravity 250°F
(121°C)/30 minutes, double-wrapped
instrument trays Gravity 270°F
(132°C) 15 minutes, double-wrapped
instrument trays Gravity 275°F
(135°C)/10 minutes, double-wrapped
instrument trays Gravity - IUSS
270°F (132°C)/10 minutes, single
unwrapped tray, nonporous items | 270F, Prevac, 4' IUSS
275F, Prevac, 3' Full fabric
250F, Gravity, 30' Full tray | |
| Full loads | • 39": 9, 25-lb double wrapped
trays or 18, fabric packs
• 51": 12, 25-lb
double wrapped trays or 24, fabric
packs
• 69": 15, 25-lb
double wrapped trays or 30, fabric
packs | • 39": 9, 25-lb
double wrapped trays or 12,
fabric packs
• 51": 12, 25-lb
double wrapped trays or 16,
fabric packs
• 63": 15, 25-lb
double wrapped trays or 20,
fabric
packs | Similar |
Technological Characteristics Comparison Table
7
8
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.
9
| Test | Purpose of the
Test | Acceptance Criteria | Result | Conclusion |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Performance | To ensure that the
performance,
labeling, and
safety
requirements
specified in AAMI
ST8:2013 (ST8)
are met. | 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 |
| Test | Purpose of the | Acceptance Criteria | Result | Conclusion |
| General
Electrical
Safety | Test
To ensure
electrical safety in
the construction
and design of the
sterilizers | Compliance with the
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 | To ensure
electrical safety in
the construction
and design of the
sterilizers | Compliance with the
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 | To ensure that the
machine does not
interfere with the
operation of
nearby machinery
nor is interfered
with by external
EMC issues. | Compliance with the
appropriate
provisions of EN
IEC 61326 part 1. | Compliance is documented
in the EN IEC 61326 pt. 1
compliance report. | Pass |
| Software
validation | To ensure that the
software executes
its designed
functions and, if it
fails, takes the
machine to a safe
state. | 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 | To ensure that the
pressure vessels
are designed and
built in a safe
manner. | Compliance with the
safety 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) | 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 |
10
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.