(141 days)
Not Found
No
The document describes a standard steam sterilizer with various pre-programmed cycles and validation against established standards. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is noted as being performed according to FDA guidance for software in medical devices, not specifically for AI/ML.
No
The device is a sterilizer for heat and moisture-stable materials used in healthcare facilities, not a device intended for direct therapeutic treatment of patients.
No
The device is a steam sterilizer designed to sterilize heat and moisture-stable materials, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly indicates it is a physical steam sterilizer with specific chamber sizes and configurations, not solely software. While software is mentioned for cycle operation validation, it is a component of a larger hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly stated as "sterilization of heat and moisture-stable materials used in healthcare facilities." This describes a process for making medical devices or materials sterile, not a test performed on biological samples to diagnose a condition or provide information about a patient's health.
- Device Description: The description details a steam sterilizer with different cycle types (Prevacum, Gravity, Liquid, SFPP, Leak Test, DART). This aligns with a sterilization device, not an IVD.
- Performance Studies: The performance studies focus on demonstrating the effectiveness of the sterilization process (achieving a sterility assurance level, moisture retention, etc.) using biological indicators and test packs. This is typical for a sterilization device validation, not an IVD validation which would involve clinical samples and metrics like sensitivity and specificity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other characteristics typically associated with IVD devices.
In summary, the device's purpose is to sterilize materials, which is a process performed on medical devices or other items, not a diagnostic test performed on a patient's sample.
N/A
Intended Use / Indications for Use
The Amsco Chimeron Small Steam Sterilizer models 16, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum (Models 16, 16C and 20, 20C) - are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Chimeron Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
Cycles: Prevac, Gravity, Liquid, DART Warm-Up, DART, Leak Test
For details on Sterilize Temperature, Sterilize Time, Dry Time, and Recommended Load for each cycle, refer to Table 4-1 in the document.
The Amsco Chimeron Small Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2):
Cycles: SFPP, Prevac, Gravity, Liquid, DART Warm-Up, DART, Leak Test
For details on Sterilize Temperature, Sterilize Time, Dry Time, and Recommended Load for each cycle, refer to Table 4-2 in the document.
The liquid cycle is for non-patient contact use only.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Amsco Chimeron Small Steam Sterilizer models 16, 16CS. 16S. 20, 20C. 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum (Models 16, 16C and 20, 20C) are equipped with Prevacuum. . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20CS) – are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Chimeron Small Steam Sterilizer Models are as follows:
- 16" x 16" x 26" (Models 16, 16C, 16CS, and 16S)
- 20" x 20" x 38" (Models 20, 20C, 20CS, and 20S)
General Sterilizer Features:
- Operating Principle: Steam is the sterilizing agent.
- Sterilization Cycles Offered: Prevac, Gravity, SFPP (Models 16CS, 16S, 20CS, and 20S Only), Liquid
- Chamber Sizes: 16" x 16" x 26", 16" x 16" x 38"
- Chamber Door: Type 316L stainless steel Vertical Sliding (26"x26")
- Shell Assembly: Type 316L stainless steel ASME certified
- Control Technology: Embedded Controller, Touch Screen, 320 x 240 Pixel Display, Ink on Paper Printer
- Process Monitors: Chamber Transducer, Dual Element Chamber Drain Sensor
- Safety Devices: Pressure Relief Valve, Chamber Float Switch, Emergency Stop Switch
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
healthcare facilities
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)
Verification studies were performed to demonstrate the effectiveness and safety of the sterilizer. The studies validated that the sterilizer performs as intended and meets the requirements of ANSI/AAMI ST8:2008.
- Empty chamber testing was performed as described in Section 5.4.2.5 of ANSI/AAMI-ST8 for the Prevac, Gravity, Liquid and SFPP cycles. These cycles demonstrated that the sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Sections 4.4.2 of ANSI/AAMI-ST8.
- All SFPP cycles were validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All SFPP cycles were validated using full load instrument trays, described in 5.5.4.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All GRAVITY cycles were validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All GRAVITY cycles were validated using full load instrument trays, described in 5.5.4.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All Immediate Use (Short or Abbreviated) GRAVITY cycles were validated using both a single, nonporous instrument weighing no more than 100g in an otherwise empty, unwrapped instrument tray and a full, non-porous load of unwrapped instrument trays as described in 5.5.5.1.2 of ANSI/AAMI-ST8. and were qualified according to Section 5.5.5 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 using half-cycle cycle analysis.
- All PREVAC cycles were validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles were validated using full load instrument trays, described in 5.5.4.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All Immediate Use (Short or Abbreviated) PREVAC cycles were validated using both a single, nonporous instrument weighing no more than 100g in an otherwise empty, unwrapped instrument tray and a full, non-porous load of unwrapped instrument trays, described in 5.5.5.1.2 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.5 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 using half-cycle cycle analysis.
- All LIQUID cycles were validated using three 1,000 ml flasks, described in Section 5.5.3.1 of the ANSI/AAMI-ST8, and were qualified according to Section 5.5.3 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
- The DART cycle was validated using the Bowie-Dick Test Pack, as described in 5.6.1.1 of the ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet. The DART cycle uses the same dynamic air removal routines as the 270°F Prevac cycle.
- The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL) of at least 10^-6.
Fo value of at least 12.
Moisture retention: less than 3% increase in presterilization test pack weight (SFPP and Gravity using fabric test pack, PREVAC cycles).
Moisture retention: less than 20% increase in presterilization weight of the towel (SFPP and Gravity with full load instrument trays, PREVAC cycles).
Water loss not exceeding 50 ml (LIQUID cycles).
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
K 111223
ﺎ
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION SUMMARY Amsco Chimeron Small Steam Sterilizer
Device Name
SEP 20 2011
| Trade Name: | Amsco Chimeron Small Steam Sterilizer |
|---|---|
| Models: | 16, 16C, 16CS, 16S, 20, 20C, 20CS, and 20S |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880) |
| Product Code FLE |
2. Predicate Device
K030789, Amsco Century Small Steam Sterilizer, product code [FLE] cleared March 26th, 2003.
3. Description of Device
The Amsco Chimeron Small Steam Sterilizer models 16, 16CS. 16S. 20, 20C. 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum (Models 16, 16C and 20, 20C) are equipped with Prevacuum. . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- . Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20CS) – are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Chimeron Small Steam Sterilizer Models are as follows:
- · 16" x 16" x 26" (Models 16, 16C, 16CS, and 16S)
- · 20" x 20" x 38" (Models 20, 20C, 20CS, and 20S)
Intended Use 4.
The Amsco Chimeron Small Steam Sterilizer Models 16, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configurations:
- Models 16, 16C, 20, 20C: . Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
12
1
- . Models 16CS, 16S, 20CS, and 20S: . Steam Flush Pressure-Pulse (SFPP) – equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Chimeron Small Prevacuum Steam Sterilizers (Models 16, 16C, 20, and 20C) are equipped with the following factory-validated sterilization cycles (Table 5-1):
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Factory
Default | Recommended Load |
|------------------------------|--------------------------|-------------------|------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F
(132°C) | 4 minutes | 20 minutes | Yes | Fabric Packs. Refer to
Table 5-3 for
recommended
quantities. |
| Prevac | 270°F
(132°C) | 4 minutes | 30 minutes | Yes | Double wrapped
instrument trays,
maximum weight 25
lbs (11.3 kg) each.
Refer to Table 5-3 for
recommended
quantities. |
| Prevac | 270°F
(132°C) | 4 minutes | 5 minutes | No | Single Fabric Pack |
| Prevac | 275°F
(135°C) | 3 minutes | 30 minutes | Yes | Double wrapped
instrument trays,
maximum weight 25
lbs (11.3 kg) each.
Refer to Table 5-3 for
recommended
quantities. |
| Prevac
(Immediate
Use) | 270°F
(132°C) | 4 minutes | 1 minutes | Yes | Unwrapped instrument
tray with a single
instrument or multiple
unwrapped instrument
trays, maximum
weight 25 lbs (11.3 kg)
each. Refer to Table
5-3 for recommended
quantities. |
| Gravity | 250°F
(121°C) | 30 minutes | 15 minutes | No | Fabric Packs. Refer to
Table 5-3 for
recommended
quantities. |
| Gravity | 270°F
(132°C) | 15 minutes | 30 minutes | No | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. |
| Gravity | 250°F
(121°C) | 30 minutes | 30 minutes | No | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. |
| Gravity | 270°F
(132°C) | 25 minutes | 15 minutes | No | Fabric Packs. Refer to Table 5-3 for recommended quantities. |
| Gravity
(Immediate Use) | 270°F
(132°C) | 3 minutes | 1 minutes | Yes | Unwrapped instrument tray with a single instrument or multiple unwrapped instrument trays, non-porous load, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. |
| Gravity
(Immediate Use) | 270°F
(132°C) | 10 minutes | 1 minutes | Yes | Unwrapped instrument tray with a single instrument or multiple unwrapped instrument trays, non-porous load, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. |
| Liquid | 250°F
(121°C) | 45 minutes | N/A | No | Validated with 3 1000ml bottles. Refer to Table 5-4 for recommended full load quantities. |
| DART Warm-Up | 270°F
(132°C) | 3 minutes | 1 minute | Yes | N/A |
| DART | 270°F
(132°C) | 3 ½
minutes | 1 minute | Yes | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | Yes | N/A |
Table 5-1
2
. . .
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
3
*The liquid cycle is for non-patient contact use only.
The Amsco Chimeron Small Steam Flush Pressure-Pulse (SFPP) Sterilizers (Models 16CS, 16S, 20CS, and 20S) are equipped with the following factoryvalidated sterilization cycles (Table 5-2):
Table 5-2
.
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Factory Default | Recommended Load |
|---|---|---|---|---|---|
| SFPP | 270°F | ||||
| (132°C) | 4 minutes | 30 minutes | Yes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| SFPP | 270°F | ||||
| (132°C) | 4 minutes | 20 minutes | Yes | Fabric Packs. | |
| Refer to Table 5-3 for recommended quantities. | |||||
| SFPP | 275°F | ||||
| (135°C) | 3 minutes | 30 minutes | Yes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| SFPP | 270°F | ||||
| (132°C) | 4 minutes | 5 minutes | No | Single Fabric Pack | |
| Prevac | 270°F | ||||
| (132°C) | 4 minutes | 20 minutes | No | Fabric Packs. | |
| Refer to Table 5-3 for recommended quantities | |||||
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Factory Default | Recommended Load |
| Prevac | 270°F | ||||
| (132°C) | 4 minutes | 30 minutes | No | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| Prevac | 270°F | ||||
| (132°C) | 4 minutes | 5 minutes | No | Single Fabric Pack | |
| Prevac | 275°F | ||||
| (135°C) | 3 minutes | 30 minutes | No | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| Prevac | |||||
| (Immediate Use) | 270°F | ||||
| (132°C) | 4 minutes | 1 minutes | No | Unwrapped instrument tray with a single instrument or multiple unwrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| Gravity | 250°F | ||||
| (121°C) | 30 minutes | 15 minutes | No | Fabric Packs. Refer to Table 5-3 for recommended quantities. | |
| Gravity | 270°F | ||||
| (132°C) | 15 minutes | 30 minutes | No | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 for recommended quantities. | |
| Cycles | Sterilize | ||||
| Temperature | Sterilize | ||||
| Time | Dry Time | Factory | |||
| Default | Recommended | ||||
| Load | |||||
| Gravity | 250°F | ||||
| (121°C) | 30 minutes | 30 minutes | No | Double wrapped | |
| instrument trays, | |||||
| maximum weight | |||||
| 25 lbs (11.3 kg). | |||||
| each. Refer to | |||||
| Table 5-3 for | |||||
| recommended | |||||
| quantities. | |||||
| Gravity | 270°F | ||||
| (132°C) | 25 minutes | 15 minutes | No | Fabric Packs. | |
| Refer to Table 5-3 | |||||
| for recommended | |||||
| quantities. | |||||
| Gravity | |||||
| (Immediate | |||||
| Use) | 270°F | ||||
| (132°C) | 3 minutes | 1 minutes | Yes | Unwrapped | |
| instrument tray | |||||
| with a single | |||||
| instrument or | |||||
| multiple | |||||
| unwrapped | |||||
| instrument trays, | |||||
| non-porous load, | |||||
| maximum weight | |||||
| 25 lbs (11.3 kg) | |||||
| each. Refer to | |||||
| Table 5-3 for | |||||
| recommended | |||||
| quantities. | |||||
| Gravity | |||||
| (Immediate | |||||
| Use) | 270°F | ||||
| (132°C) | 10 minutes | 1 minutes | Yes | Unwrapped | |
| instrument tray | |||||
| with a single | |||||
| instrument or | |||||
| multiple | |||||
| unwrapped | |||||
| instrument trays, | |||||
| non-porous load, | |||||
| maximum weight | |||||
| 25 lbs (11.3 kg) | |||||
| each. Refer to | |||||
| Table 5-3 for | |||||
| recommended | |||||
| quantities | |||||
| Cycles | Sterilize | ||||
| Temperature | Sterilize | ||||
| Time | Dry Time | Factory | |||
| Default | Recommended | ||||
| Load | |||||
| Liquid | 250°F | ||||
| (121°C) | 45 | ||||
| minutes | N/A | No | Validated with 3 | ||
| 1000ml bottles. | |||||
| Refer to Table 5-4 | |||||
| for recommended | |||||
| full load | |||||
| quantities. | |||||
| DART | |||||
| Warm-Up | 270°F | ||||
| (132°C) | 3 minutes | 1 minute | Yes | N/A | |
| DART | 270°F | ||||
| (132°C) | 3 ½ | ||||
| minutes | 1 minute | Yes | Bowie-Dick Test | ||
| Pack, DART Test | |||||
| Pack | |||||
| Leak Test | N/A | N/A | N/A | Yes | N/A |
4
:
5
人
6
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
Table 5-3 Amsco Chimeron Small Steam Sterilizers recommended loads per sterilizer size
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 16" x 16" x 26" | 2 | 4 |
| 20" x 20" x 38" | 3 | 6 |
The following table is a guideline for liquid cycle processing:
Table 5-4 Amsco Chimeron Small Steam Sterilizers Liquid Cycle Guideline
| Sterilizer
Size | Number of
Containers
for full
load | Number of
Containers
for validation | Volume of Liquid In
One Container | Minimum Recommended
Sterilize, Time at 250°F
(121°C) |
|--------------------|---------------------------------------------|-------------------------------------------|--------------------------------------|------------------------------------------------------------|
| 16" x 16"
x 26" | 15 | 3 | 1000 ml | 45 minutes |
| 20" x 20"
x 38" | 32 | 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
of 12
7
5. Description of Safety and Substantial Equivalence
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-1.
| Table 5-1 |
|---|
| Summary of the Proposed and predicate Devices |
| Technological Characteristics |
| General Sterilizer
Features | Amsco Chimeron Small
Steam Sterilizer
(All Models Included unless Specified) | Amsco Century Small
Steam Sterilizer
(K030789) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A steam sterilizer intended for
sterilization of non-porous and porous,
heat- and moisture-stable materials in
healthcare facilities. | A steam sterilizer intended for
sterilization of non-porous and porous,
heat- and moisture-stable materials in
healthcare facilities. |
| Operating Principle | Steam is the sterilizing agent. | Steam is the sterilizing agent. |
| Sterilization Cycles
Offered | Prevac
Gravity
SFPP (Models 16CS, 16S, 20CS, and 20S
Only)
Liquid | Prevac
Gravity |
| Chamber Sizes | 16" x 16" x 26"
16" x 16" x 38" | 16" x 16" x 26"
16" x 16" x 38" |
| Chamber Door | Type 316L stainless steel
Vertical Sliding (26"x26") | Type 316L stainless steel
Vertical Sliding (26"x26") |
| Shell Assembly | Type 316L stainless steel
ASME certified | Type 316L stainless steel
ASME certified |
| Control Technology | Embedded Controller
Touch Screen
320 x 240 Pixel Display
Ink on Paper Printer | Embedded Controller
Touch Screen
320 x 240 Pixel Display
Ink on Paper Printer |
| Process Monitors | Chamber Transducer
Dual Element Chamber Drain Sensor | Chamber Transducer
Single Element Chamber Drain Sensor |
| Safety Devices | Pressure Relief Valve
Chamber Float Switch
Emergency Stop Switch | Pressure Relief Valve
Chamber Float Switch
Emergency Stop Switch |
8
Effectiveness
Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° probability of survival. STERIS validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Amsco Chimeron Steam Sterilizers have been validated to meet the requirements of ANSVAAMI ST8:2008, December 2008.
The results of the Amsco Chimeron Steam Sterilizer verification studies demonstrate that the sterilizers perform as intended. The results are summarized as follows:
- Empty chamber testing was performed as described in Section 5.4.2.5 of . ANSVAAMI-ST8. for the Prevac. Gravity. Liquid and SFPP cycles. These cycles demonstrated that the sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Sections 4.4.2 of ANSVAAMI-ST8.
- AII SFPP cycles were validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All SFPP cycles were validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, and were qualified according to Section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All GRAVITY cycles were validated using the fabric test pack, described in . Section 5.5.2.1 of ANSUAAMI-ST8, and were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All GRAVITY cycles were validated using full load instrument trays, described . in 5.5.4.1 of ANSVAAMI-ST8, and were qualified according to Section 5.5.4
9
ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All Immediate Use (Short or Abbreviated) GRAVITY cycles were validated . using both a single, nonporous instrument weighing no more than 100g in an otherwise empty, unwrapped instrument tray and a full, non-porous load of unwrapped instrument trays as described in 5.5.5.1.2 of ANSVAAMI-ST8. and were qualified according to Section 5.5.5 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th using half-cycle cvcle analysis.
- All PREVAC cycles were validated using the fabric test pack, described in . Section 5.5.2.1 of ANSVAAMI-ST8, and were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles were validated using full load instrument trays, described . in 5.5.4.1 of ANSVAAMI-ST8, and were qualified according to Section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All Immediate Use (Short or Abbreviated) PREVAC cycles were validated . using both a single, nonporous instrument weighing no more than 100g in an otherwise empty, unwrapped instrument tray and a full, non-porous load of unwrapped instrument trays, described in 5.5.5.1.2 of ANSVAAMI-ST8, and were qualified according to Section 5.5.5 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis.
- All LIQUID cycles were validated using three 1,000 ml flasks, described in . Section 5.5.3.1 of the ANSVAAMI-ST8, and were qualified according to Section 5.5.3 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
- The DART cycle was validated using the Bowie-Dick Test Pack, as described in . 5.6.1.1 of the ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSVAAMI-ST8, and demonstrated a uniform color change throughout the test sheet. The DART cycle uses the same dynamic air removal routines as the 270°F Prevac cycle.
- The software validation for the cycle operation was performed according to t FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05). "
10
Safety :
STERIS sterilizers including the Amsco Chimeron Steam Sterilizers have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Amsco Chimeron Steam Sterilizers comply with the following requirements:
- ANSI/UL 61010-1 2nd Edition (7/22/2005) "Safety Requirements for . Electrical Equipment for Measurement, Control and Laboratory Use - Part 1 General Requirements.
- CAN/CSA C22.2 No. 61010-1 2nd Edition (7/12/2004) "Safety . Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 1 General Requirements".
- UL 61010A-2-041 1st Edition (3/27/2002) "Particular Requirements for . Autoclaves Using Steam for Treatment of Medical Materials and for · Laboratory Processes"
- CAN/CSA C22.2 No 1010.2.041 (R2004) "Particular Requirements for ● Autoclaves Using Steam for Treatment of Medical Materials and for Laboratory Processes".
- ASME Boiler Pressure Vessel Code, Section VIII (Division 1) (7/1/2007) ●
Hazards - Failure of Performance
Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.
To avoid failure, the user must ensure that the materials, instruments and devices to be sterilized are thoroughly cleaned, the manufacturer's instructions for use are followed, the cycle to be used for each type of sterilizer load has been validated, the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.
The technology designed into STERIS steam sterilizers including the Amsco Chimeron Steam Sterilizers provide control safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
11
Conclusion
The Amsco Chimeron Small Steam Sterilizer has been validated to meet the requirements of ANSVAAMI ST8:2008, December 4, 2008.
The results of the Amsco Chimeron Small Steam Sterilizer validation studies demonstrate that the sterilizer performs as intended.
Based on the information provided in this premarket notification, it can be concluded that the Amsco Chimeron Small Steam Sterilizer is substantially equivalent to the predicate device and is safe and effective when used as intended.
12
Image /page/12/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert F. Sullivan Senior Director FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
NOV 1 7 2011
Re: K111223
Trade/Device Name: Amsco Chimeron Small Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 24, 2011 Received: August 25, 2011
Dear Mr. Sullivan:
This letter corrects our substantially equivalent letter of September 20, 2011.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
13
Page 2- Mr. Sullivan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
Indications for Use
K 111223 510(k) Number (if known):
Device Name:
Amsco Chimeron Small Steam Sterilizer
Indications For Use:
The Amsco Chimeron Small Steam Sterilizer models 16, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- . Prevacuum (Models 16, 16C and 20, 20C) - are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are ● equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Chimeron Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 4-3 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 4-3 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 4-3 for recommended quantities. |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| Prevac | ||||
| (Immediate | ||||
| Use) | 270°F (132°C) | 4 minutes | 1 minutes | Unwrapped instrument tray |
| with a single instrument or | ||||
| multiple unwrapped | ||||
| instrument trays, maximum | ||||
| weight 25 lbs (11.3 kg) | ||||
| each. Refer to Table 4-3 | ||||
| for recommended | ||||
| quantities. | ||||
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to |
| Table 4-3 for recommended | ||||
| quantities. | ||||
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument |
| trays, maximum weight 25 | ||||
| lbs (11.3 kg) each. Refer to | ||||
| Table 4-3 for recommended | ||||
| quantities. | ||||
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument |
| trays, maximum weight 25 | ||||
| lbs (11.3 kg) each. Refer to | ||||
| Table 4-3 for recommended | ||||
| quantities. | ||||
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to |
| Table 4-3 for recommended | ||||
| quantities. | ||||
| Gravity | ||||
| (Immediate | ||||
| Use) | 270°F (132°C) | 3 minutes | 1 minutes | Unwrapped instrument tray |
| with a single instrument or | ||||
| multiple unwrapped | ||||
| instrument trays, non- | ||||
| porous load, maximum | ||||
| weight 25 lbs (11.3 kg) | ||||
| each. Refer to Table 4-3 | ||||
| for recommended | ||||
| quantities. | ||||
| Gravity | ||||
| (Immediate | ||||
| Use) | 270°F (132°C) | 10 minutes | 1 minutes | Unwrapped instrument tray |
| with a single instrument or | ||||
| multiple unwrapped | ||||
| instrument trays, non- | ||||
| porous load, maximum | ||||
| weight 25 lbs (11.3 kg) | ||||
| each. Refer to Table 4-3 | ||||
| for recommended | ||||
| quantities. | ||||
| Cycles | Sterilize | |||
| Temperature | Sterilize | |||
| Time | Dry Timer | Recommended Load | ||
| Liquid | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml |
| bottles. Refer to Table 4-4 | ||||
| for recommended full load | ||||
| quantities. | ||||
| DART | ||||
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, |
| DART Test Pack | ||||
| Leak Test | N/A | N/A | N/A | N/A |
Table 4-1.
Amsco Chimeron Small Prevacuum Steam Sterilizer Models 16, 16, 20, 20C factoryvalidated sterilization cvcles and cvcle values
P. 1 46
15
.
.
·
16
*The liquid cycle is for non-patient contact use only.
The Amsco Chimeron Small Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2):
| Table 4-2. |
|---|
| Amsco Chimeron Small Steam Flush Pressure-Pulse (SFPP)Sterilizer Models 16S, |
| 16CS, 20S, 20CS factory-validated sterilization cycles and cycle values |
| Cycles > >>Sterilize: >>>Sterilize: >>>Dry Time >> Recommended Load >> |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 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 4-3 | ||||
| for recommended | ||||
| quantities. | ||||
| SFPP | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to |
| Table 4-3 for | ||||
| recommended quantities. | ||||
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped |
| instrument trays, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Refer to | ||||
| Table 4-3 for | ||||
| recommended quantities. | ||||
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to |
| Table 4-3 for | ||||
| recommended quantities. | ||||
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| 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 4-3 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 4-3 for recommended quantities. |
| Prevac (Immediate Use) | 270°F (132°C) | 4 minutes | 1 minutes | Unwrapped instrument tray with a single instrument or multiple unwrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Cycles | Sterilize | |||
| Temperature | Sterilize | |||
| Time | Dry Time | Recommended Load | ||
| Gravity | ||||
| (Immediate | ||||
| Use) | 270°F (132°C) | 3 minutes | 1 minutes | Unwrapped instrument |
| tray with a single | ||||
| instrument or multiple | ||||
| unwrapped instrument | ||||
| trays, non-porous load, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Refer to | ||||
| Table 4-3 for | ||||
| recommended quantities. | ||||
| Gravity | ||||
| (Immediate | ||||
| Use) | 270°F (132°C) | 10 minutes | 1 minutes | Unwrapped instrument |
| tray with a single | ||||
| instrument or multiple | ||||
| unwrapped instrument | ||||
| trays, non-porous load, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Refer to | ||||
| Table 4-3 for | ||||
| recommended quantities. | ||||
| Liquid | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml |
| bottles. Refer to Table 4-4 | ||||
| for recommended full load | ||||
| quantities. | ||||
| DART | ||||
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minutė | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, |
| DART Test Pack | ||||
| Leak Test | N/A | N/A | N/A | N/A |
17
·
18
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 16" x 16" x 26" | 2 | 4 |
| 20" x 20" x 38" | 3 | 6 |
p. 50f 6
・
19
The following table is a guideline for liquid cycle processing:
Table 4-4 Amsco Chimeron Small Steam Sterilizer Liquid Cycle Guideline
| Sterilizer
Size | Number of
Containers
for full
load | Number of
Containers
for validation | Volume of Liquid
In One Container | Minimum Recommended
Sterilize Time at 250°F
(121°C) |
|--------------------|---------------------------------------------|-------------------------------------------|--------------------------------------|-----------------------------------------------------------|
| 16" x 16"
x 26" | 15 | 3 | 1000 ml | 45 minutes |
| 20" x 20"
x 38" | 32 | 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The Amsco Chimeron Small Steam Sterilizer is offered in the following chamber sizes:
- 16" x 16" x 26" (Models 16, 16C, 16CS, and 16S) .
- 20" x 20" x 38" (Models 20, 20C, 20CS, and 20S) ●
Prescription Use _ (Part 21 CFR 801 Subpart D) . AND/OR
Over-The-Counter Use __ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eluhut S. Clavijo-Willian
Division Sign-Off) vision of Anesthesiology, General Hospital tection Control, Dental Devices
510(k) Number: K111233
p. 6 of 6