(260 days)
Not Found
No
The summary describes a steam sterilizer with pre-programmed cycles and standard validation methods. There is no mention of AI, ML, or any technology that would suggest adaptive learning or data-driven decision making beyond the pre-defined cycles.
No.
Explanation: The device is a steam sterilizer designed to sterilize medical materials. While it is used in healthcare settings and helps prevent infections, it does not directly treat or diagnose a disease or condition in a patient, making it a medical device but not a therapeutic one.
No
The device is a steam sterilizer, designed to sterilize medical instruments and materials, not to diagnose diseases or medical conditions.
No
The device description clearly indicates it is a physical steam sterilizer with specific chamber sizes and hardware components. While it mentions software validation, the core device is a piece of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 focuses on the physical characteristics of a steam sterilizer, including chamber size and cycle types (Prevacum, Gravity, Liquid, Leak Test, DART). These are features of a sterilization device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the effectiveness of the sterilization process (achieving a certain sterility assurance level, moisture retention, etc.), which is relevant to a sterilizer, not an IVD.
Therefore, the AMSCO Chimeron Medium Steam Sterilizers are medical devices used for sterilization, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The AMSCO Chimeron Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table A-1):
Product codes
FLE
Device Description
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
The chamber sizes of the proposed AMSCO Chimeron Medium Steam Sterilizer Models are as follows:
· 26" x 26" x 39" (Models 39SL and 39CSL)
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)
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 degree 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 ANSI/AAMI 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 ANSI/AAMI-ST8, for the Prevac, Gravity, and Liquid 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 GRAVITY 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 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 ANSVAAMI-ST8, and were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10 d 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 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 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 ANSVAAMI-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 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 LIOUID 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 liquid cycle is for non-patient contact use only.
- 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.)
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
STERIS®
510(k) Summary For AMSCO Chimeron Medium Steam Sterilizer K112403
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Tim Stuthers Director, Regulatory Affairs Telephone: (440) 392-7222 Fax No: (440) 357-9198
Summary Date:
December 29th, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
Device Name 1.
| Trade Name: | AMSCO Chimeron Medium Steam Sterilizer |
|---|---|
| Models: | 39SL and 39CSL |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880) |
| Product Code FLE |
2. Predicate Device
K020747, AMSCO Century Medium Steam Sterilizer, product code [FLE] cleared May 17th, 2002.
Description of Device 3.
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
The chamber sizes of the proposed AMSCO Chimeron Medium Steam Sterilizer Models are as follows:
· 26" x 26" x 39" (Models 39SL and 39CSL)
Intended Use 4.
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
The AMSCO Chimeron Medium Prevacuum Steam Sterilizers are equipped with the following factory-validated sterilization cycles (Table B-1):
2
Table B-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 B-2 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 B-2 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 B-2 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
B-2 for recommended
quantities. |
| Gravity | 250°F
(121°C) | 30
minutes | 15
minutes | No | Fabric Packs. Refer to
Table B-2 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 B-2 for
recommended |
| 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 B-2 for
recommended
quantities. |
| Gravity | 270°F
(132°C) | 25
minutes | 15
minutes | No | Fabric Packs. Refer to
Table B-2 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 B-2 for
recommended
quantities. |
| Gravity
(Immediate
Use) | 270°F
(132°C) | 10
minutes | 1 minutes | Yes | Unwrapped instrument
tray with a single
instrument or multiple
uniwrapped instrument
trays, non-porous load,
maximum weight 25
lbs (11.3 kg) each.
Refer to Table. B-2 for
recommended
quantities. |
| Liquid* | 250°F
(121°C) | 45
minutes | N/A | No | Validated with 3
1000ml bottles. Refer
to Table B-3 for
recommended full load
quantities. |
| DART Warm-
Up
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 |
. .
.
.
3
·
3
. :
.
*The liquid cycle is for non-patient contact use only.
.
.
・
·
.
4
Table B-2 lists STERIS' full loads by sterilizer size:
Table B-2 AMSCO Chimeron Medium Steam Sterilizer full load per sterilizer size
| :
| Accessful of Concessfore & Manager & Particle Particle Particle Particle Particle Particle Particle Particle Particle Particle Particle Particle Pro
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -444
1
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1
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All condiction in
. |
Table B-3 is a guideline for liquid cycle processing. The liquid cycle is for nonpatient contact use only.
Table B-3 AMSCO Chimeron Medium 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) |
|---|---|---|---|---|
| 26" x 26" x 39" | 80 | 3 | 1000 ml | 45 minutes |
Description of Safety and Substantial Equivalence ഗ്
···
A summary of the technological characteristics of the device subject of this r summary of the venire of the predicate devices is included in Table B-4.
5
5
Table B-4 Summary of the Proposed and Predicate Device Technological Characteristics
and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the
::
| General Sterilizer
Features | AMSCO Chimeron Medium
Steam Sterilizer
(K112403) | AMSCO Century Medium
Steam Sterilizer
(K020747) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Liquid | Prevac
Gravity
Liquid
SFPP |
| Chamber Sizes | 26" x 26" x 39" | 26" x 26" x 39"
26" x 26" x 49"
26" x 26" x 61" |
| Chamber Door | Type 316L stainless steel
Hinge or Horizontal Sliding | Type 316L stainless steel
Hinge or Horizontal Sliding |
| 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
Dual Element Chamber Drain Sensor |
| Safety Devices | Pressure Relief Valve
Chamber Float Switch
Emergency Stop Switch on Powered,
Sliding Door Units | Pressure Relief Valve
Chamber Float Switch
Emergency Stop Switch on Powered,
Sliding Door Units |
б
. .
·
.
6
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 ANSI/AAMI 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 ● ANSI/AAMI-ST8, for the Prevac, Gravity, and Liquid 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 GRAVITY 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 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 ANSVAAMI-ST8, and were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10 d 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 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 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 ANSVAAMI-ST8, and were qualified according to Section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at
7
least 106 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 LIOUID 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 liquid cycle is for non-patient contact use only.
- 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). "
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)
8
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.
Conclusion
The AMSCO Chimeron Medium Steam Sterilizer has been validated to meet the requirements of ANSVAAMI ST8: 2008, December 4, 2008.
The results of the AMSCO Chimeron Medium 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 Medium Steam Sterilizer is substantially equivalent to the predicate device and is safe and effective when used as intended.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Public Health Service
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
MAY - 8 2012
Re: K112403
Trade/Device Name: AMSCO Chimeron Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: April 26, 2012 Received: April 27, 2012
Dear Mr. Sullivan:
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. 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.
10
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.goy/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,
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
11
Indications for Use
510(k) Number (if known): K112403
Device Name:
AMSCO Chimeron Medium Steam Sterilizer
Indications For Use:
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- · Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The AMSCO Chimeron Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table A-1):
| AMSCO Chimeron Medium Prevaccum Steam Sterilizer factory validated sterilization cycles and cycle values | ||||
|---|---|---|---|---|
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to |
| Table A-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 A-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 A-2 for recommended | ||||
| quantities. |
| Table A-1 | 1 |
|---|---|
| ----------- | --- |
AMSCO Chimeron Medium Prevacuum Steam Sterilizer factory-validated sterilization
12
| 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 A-2
for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table A-2 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 A-2 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 A-2 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table A-2 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 A-2
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 A-2
for recommended
quantities. |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml bottles. Refer to Table A-3 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 |
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
13
*The liquid cycle is for non-patient contact use only.
.
.
.
:
:
.
. . . . .
:
· .
and the same of the same
.
The following table lists STERIS' full loads by sterilizer size:
| Table A-2 | ||||
|---|---|---|---|---|
| AMSCO Chimeron Medium Steam | ||||
| Sterilizer full load per sterilizer size |
. .
.
:
1
గా
:
.
:
. . . . . . . .
:
.
:
.
| 12008 1112007 19618 18000
A P W A W W A A L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L
| And Children Color | ||||
|---|---|---|---|---|
| 1 |
14
The following table is a guideline for liquid cycle processing:
| Table A-3 |
|---|
| AMSCO Chimeron Medium 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) |
|-----------------|---------------------------------------------|-------------------------------------------|-----------------------------------------|--------------------------------------------------------------|
| 26" x 26" x 39" | 80 | 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The AMSCO Chimeron Medium Steam Sterilizer is offered in the following chamber sizes:
26" x 26" x 39" (Models 39SL and 39CSL) ●
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)
4
Suan Rummerfer Ecn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112403