(103 days)
No
The description details a steam sterilizer with pre-programmed cycles and an automated loading/unloading system that can be initiated by a barcode reader. There is no mention of adaptive learning, pattern recognition, or any other characteristics typically associated with AI/ML. The device operates based on fixed parameters and pre-defined logic.
No
Explanation: The device is a sterilizer for medical instruments, designed to prevent disease transmission, not to treat a disease or condition.
No
The device is a steam sterilizer, used to sterilize medical instruments and materials, not to diagnose medical conditions.
No
The device is a steam sterilizer and an automated loading/unloading system, which are clearly hardware devices. While there is mention of software validation, the core function and description are of physical equipment.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to sterilize heat and moisture-stable materials used in healthcare facilities, such as fabric packs and instrument trays. This is a process to render medical devices sterile for patient use.
- Device Description: The device description details a steam sterilizer that uses saturated steam to kill microorganisms on medical instruments and materials.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of biological specimens.
The device is a medical device used for the sterilization of other medical devices, which is a crucial step in preventing the spread of infection in healthcare settings.
N/A
Intended Use / Indications for Use
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
| Cycles | Sterilize
Temperature | Sterilize Time | Dry Time | Maximum Recommended Load |
|:---|:---|:---|:---|:---|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each and Fabric Packs. Refer to
Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3
kg) each . Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Prevac-IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single
unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak
Test | N/A | N/A | N/A | N/A |
The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.
Product codes
FLE, PEC
Device Description
The AMSCO 600 Steam Sterilizer uses 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).
The ALUS is used with the AMSCO 600 Steam Sterilizer’s existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.
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
technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite
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
| Test | Criterion | Results |
|---|---|---|
| Sterilizer | ||
| performance | Meets ST 8 requirements: | |
| Temperature distribution: - 0 to + 6 °F | ||
| Air removal – CI pass, 270 -276 °F | ||
| Moisture retention - ≤ 20% mass increase | ||
| Biological performance – F0 ≥ 12, BI pass | 0 to + 4.3 °F | |
| CI pass, 271 - 273 °F | ||
| ≤ 16 % mass increase | ||
| F0 ≥ 87, BI pass | ||
| Electrical safety | Meets IEC 61010-1:2012, IEC 61010-2-040:2016 and | |
| IEC 61326-1:2012 requirements for electrical safety | Conforms with: | |
| IEC 61010-1:2012 | ||
| IEC 61010-2-040:2016 | ||
| IEC 61326-1:2012 | ||
| Software validation | Meets documented software specifications | |
| ALUS Function | Meets documented performance specifications |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 25, 2021
Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K211500
Trade/Device Name: AMSCO 600 Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 2, 2021 Received: June 3, 2021
Dear Anthony Piotrkowski:
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 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
1
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 mediation-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, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AMSCO 600 Steam Sterilizer
Indications for Use (Describe)
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
| Cycles | Sterilize
Temperature | Sterilize Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|----------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each and Fabric Packs. Refer to
Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3
kg) each . Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Prevac-
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single
unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak
Test | N/A | N/A | N/A | N/A |
Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cvcle values
3
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 26" x 51" | 12 | 16 |
| 26" x 26" x 63" | 15 | 20 |
ize
The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For AMSCO 600 Steam Sterilizer K211500
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Tony Piotrkowski Contact: Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com
Summary Date: August 23, 2021
Premarket Notification Number: K211500
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer
Device Name 1.
| Trade Name: | AMSCO 600 Steam Sterilizer |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Sterilizer Automated Loading System | |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE, PEC |
2. Predicate Device
K183410 AMSCO 600 Steam Sterilizer
3. Description of Device
The AMSCO 600 Steam Sterilizer uses 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).
The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer
load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.
4. Intended Use/Indications for Use
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factoryprogrammed cycles (Table 1):
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg) each
and Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg) each.
Refer to Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg) each.
Refer to Table 2 for recommended
quantities. |
| Prevac-
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg) each.
Refer to Table 2 for recommended
quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak Test | N/A | N/A | N/A | N/A |
Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values
Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 26" x 51" | 12 | 16 |
| 26" x 26" x 63" | 15 | 20 |
7
The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.
5. Technological Characteristics Comparison
| Feature | AMSCO 600 Steam Sterilizer
(Modified Device) | AMSCO 600 Steam Sterilizer
(Predicate Device/K183410) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The AMSCO 600 Steam Sterilizer
is 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 | Embedded Controller | Embedded Controller | Same |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated Steam | Saturated Steam | Same |
| Utilities | Steam, Water, Electricity, Air | Steam, Water, Electricity, Air | Same |
| Chamber
Material | 316L Stainless Steel | 316L Stainless Steel | Same |
| Nominal
Chamber
Size | • 26" w x 26" h x 39" d
• 26" w x 26" h x 49" d
• 26" w x 26" h x 61" d | • 26" w x 26" h x 39" d
• 26" w x 26" h x 49" d
• 26" w x 26" h x 61" d | Same |
| Door | 304L Stainless Steel
26" x 26" Power vertical sliding | 304L Stainless Steel
26" x 26" Power vertical sliding | Same |
| Chamber
Pressure
Rating | 45 psig, 300°F | 45 psig, 300°F | Same |
| Door Seal | Steam activated door seal | Steam activated door seal | Same |
| External
Process
Monitors | • Electronic Control
• Printer | • Electronic Control
• Printer | Same |
| Internal
Process
Monitors | Temperature
-Dual element RTD located in
chamber drain
- RTD located in the jacket drain
- RTD located in heat exchanger
Pressure
-Pressure transducer in chamber | Temperature
-Dual element RTD located in
chamber drain
- RTD located in the jacket drain
- RTD located in heat exchanger
Pressure
-Pressure transducer in chamber | Same |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2013 | Same |
| Accessories | BI, CI, Pouches, Trays, Wraps,
Tape, Containers, Shelves,
Loading Equipment, automated
loading system | BI, CI, Pouches, Trays, Wraps,
Tape, Containers, Shelves,
Loading Equipment | Added automated
loading system.
Software validation
demonstrates
proper performance |
| Test Cycles | Warm Up, Leak Test, DART
(Bowie Dick) Test | Warm Up, Leak Test, DART
(Bowie Dick) Test | Same |
| Feature | AMSCO 600 Steam Sterilizer
(Modified Device) | AMSCO 600 Steam Sterilizer
(Predicate Device/K183410) | Comparison |
| Cycles | 270F, Prevac, 4' Full fabric pack
270F, Prevac, 4' Full tray
270F, Prevac, 4' One fabric pack
270F, Prevac, 4' IUSS
275F, Prevac, 3' Full fabric
250F, Gravity, 30' Full tray
270F, Prevac, 10' Full tray | 270F, Prevac, 4' Full fabric pack
270F, Prevac, 4' Full tray
270F, Prevac, 4' One fabric pack
270F, Prevac, 4' IUSS
275F, Prevac, 3' Full fabric
250F, Gravity, 30' Full tray | Added 10-minute
270F, prevacuum
cycle. Testing
performer per
AAMI ST8
demonstrates
proper performance |
| Full Loads | • 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 | • 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 | Same |
Table 5-1. Device Comparison Table for AMSCO 600 Modified and Predicate
8
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer
The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are addition a 10-minute, 270 °F (132 °C) prevacuum, steam sterilization cycle and addition of an automated loading and unloading system (ALUS). Sterilizer automated loading systems are described under FDA product code PEC so the resulting product will be under product codes FLE and PEC. Other design modifications since the last clearance have been made to improve manufacturability, allow for sale outside the United States and add convenience features to sterilizer.
Summary of Nonclinical Tests 6.
| Test | Criterion | Results | ||
|---|---|---|---|---|
| Sterilizer | ||||
| performance | Meets ST 8 requirements: | |||
| Temperature distribution: - 0 to + 6 °F | ||||
| Air removal – CI pass, 270 -276 °F | ||||
| Moisture retention - ≤ 20% mass increase | ||||
| Biological performance – F0 ≥ 12, BI pass | 0 to + 4.3 °F | |||
| CI pass, 271 - 273 °F | ||||
| ≤ 16 % mass increase | ||||
| F0 ≥ 87, BI pass | ||||
| Electrical safety | Meets IEC 61010-1:2012, IEC 61010-2-040:2016 and | |||
| IEC 61326-1:2012 requirements for electrical safety | Conforms with: | |||
| IEC 61010-1:2012 | ||||
| IEC 61010-2-040:2016 | ||||
| IEC 61326-1:2012 | ||||
| Software validation | Meets documented software specifications | Software meets specifications | ||
| ALUS Function | Meets documented performance specifications | Properly loads and unloads |
6. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject 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.