(107 days)
Not Found
No
The document describes a standard steam sterilizer with pre-programmed cycles based on time and temperature, and does not mention any AI or ML capabilities.
No
This device is a steam sterilizer designed to sterilize heat and moisture-stable materials and instruments used in healthcare facilities. Its function is to prepare medical equipment for use, not to treat patients directly.
No
This device is a steam sterilizer, designed to sterilize medical instruments and materials, not to diagnose medical conditions. Its function is to kill microorganisms, which is a treatment or preparation function, not a diagnostic one.
No
The device description clearly outlines a physical steam sterilizer that uses saturated steam to sterilize heat-stable healthcare products. It describes hardware components and processes like air removal, steam exposure, and drying.
Based on the provided information, the AMSCO 600 Steam Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization of heat and moisture-stable materials used in healthcare facilities." This is a process for making medical devices and materials sterile, not for performing diagnostic tests on biological samples.
- Device Description: The description details the process of using steam to sterilize items by removing air, exposing to steam, and drying. This is a physical sterilization process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, treatment, or prevention of disease based on in vitro examination of specimens.
- Intended User/Care Setting: The users are technicians in sterile processing departments or surgical suites, focused on sterilizing instruments and materials.
- Performance Studies: The performance studies focus on the sterilizer's ability to meet sterilization standards (ANSI/AAMI ST8) and safety standards (electrical, pressure vessel, etc.). They do not involve evaluating diagnostic accuracy or performance with biological samples.
In summary, the AMSCO 600 Steam Sterilizer is a medical device used for sterilization, which is a process to prepare other medical devices for use. It does not fit the definition of an In Vitro Diagnostic device.
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) | 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 minute | 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 Test
Pack |
| Leak Test | N/A | N/A | N/A | N/A |
Product codes
FLE
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.
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).
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
The AMSCO 600 Steam Sterilizer nonclinical test was performed according to the standards described below in Table 4. The testing demonstrated that subject device met the acceptance criteria described in these standards.
| Test | Result | Conclusion |
|---|---|---|
| Performance | Meets requirements of ANSI/AAMI ST8 | PASS |
| General Electrical | ||
| Safety | Meets requirements of IEC 61010-1 | PASS |
| Sterilizer Electrical | ||
| Safety | Meets requirements of IEC 61010-2-40 | PASS |
| Electromagnetic | ||
| Compatibility | Meets requirements of FCC 47 CFR Part 15 - | |
| Subpart B | PASS | |
| Pressure Vessel | ||
| Safety | Meets requirements of ASME Boiler Pressure | |
| Vessel Code, Section VIII (Division 1) | PASS |
Key Metrics
Not Found
Predicate Device(s)
K112403 AMSCO Chimeron Steam Sterilizer
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
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March 27, 2019
STERIS Corporation Anthony Piotrkowski Director of Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K183410
Trade/Device Name: AMSCO 600 Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 1, 2019 Received: March 4, 2019
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183410
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) | 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 minute | 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 Test
Pack |
| 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 |
|---|---|---|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |
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Expiration Date: 06/30/2020
See PRA Statement below.
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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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510(k) Summary For AMSCO 600 Steam Sterilizer
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: March 1, 2019
Premarket Notification Number: K183410
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION 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 |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
2. Predicate Device
K112403 AMSCO Chimeron Steam Sterilizer (later renamed AMSCO 400)
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).
Intended Use/Indications for Use 4.
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factory-
6
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION AMSCO 600 Steam Sterilizer
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) | 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
Test Pack |
| 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 |
|---------------------|-----------------------------|--------------|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |
7
5. Technological Characteristics
Table 3. Technological Characteristics Comparison Table for AMSCO 600 and AMSCO Chimeron
| Feature | AMSCO 600 Steam Sterilizer
(K183410) | AMSCO Chimeron Steam
Sterilizer
(Predicate Device/K112403) | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended
Use | The AMSCO 600 Steam Sterilizer
is designed for sterilization of heat
and moisture-stable materials used
in healthcare facilities. | The AMSCO Chimeron Medium
Steam Sterilizer (Models 39SL and
39CSL) are 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 | Proposed offered in
additional sizes, all
validated per
ANSI/AAMI ST8 |
| Door | 304L Stainless Steel
26" x 26" Power vertical sliding | 316L Stainless Steel
26" x 26" Power vertical sliding | Both stainless steel,
same operation |
| 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 |
| Feature | AMSCO 600 Steam Sterilizer
(K183410) | AMSCO Chimeron Steam
Sterilizer
(Predicate Device/K112403) | Comparison |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 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 ST8:2006 | Proposed sterilizer
meets current
revision of the
sterilizer standard |
| Accessories | BI, CI, Pouches, Trays, Wraps,
Tape, Containers, Shelves,
Loading Equipment | BI, CI, Pouches, Trays, Wraps,
Tape, Containers, Shelves,
Loading Equipment | Same |
8
| Test Cycles | Warm Up, Leak Test, DART
(Bowie Dick) Test | Warm Up, Leak Test, DART
(Bowie Dick) Test | Same |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 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, 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
250F, Gravity, 30' Full fabric
270F, Gravity, 15' Full tray
270F, Gravity, 25' Full fabric
270F, Gravity, 3' IUSS
270F, Gravity, 10' IUSS
250F, Liquid, 45', 80-1L bottles | All cycles available
on the proposed
sterilizer were also
available on the
predicate |
| 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 | 4, 25-lb double wrapped trays or
12, fabric packs | Proposed sterilizer
can sterilize larger
loads – maximum
load configurations
validated per
ANSI/AAMI ST8 |
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION AMSCO 600 Steam Sterilizer
The proposed device has the same intended use and similar indications for use as the predicate with similar technological characteristics. The subject device slightly differ in their design and indications and features to the predicate device.
Summary of Nonclinical Tests 6.
The AMSCO 600 Steam Sterilizer nonclinical test was performed according to the standards described below in Table 4. The testing demonstrated that subject device met the acceptance criteria described in these standards.
| Test | Result | Conclusion |
|---|---|---|
| Performance | Meets requirements of ANSI/AAMI ST8 | PASS |
| General Electrical | ||
| Safety | Meets requirements of IEC 61010-1 | PASS |
| Sterilizer Electrical | ||
| Safety | Meets requirements of IEC 61010-2-40 | PASS |
| Electromagnetic | ||
| Compatibility | Meets requirements of FCC 47 CFR Part 15 - | |
| Subpart B | PASS | |
| Pressure Vessel | ||
| Safety | Meets requirements of ASME Boiler Pressure | |
| Vessel Code, Section VIII (Division 1) | PASS |
Table 4: Non-Clinical Testing of AMSCO 600 Steam Sterilizer
7. 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 or better than the legally marketed predicate device K112403, Class II (21 CFR 880.6860), product code FLE.