(71 days)
Not Found
No
The document describes a standard steam sterilizer with predefined cycles and validation based on established standards, with no mention of AI or ML.
No
This device is a sterilizer for heat and moisture-stabile materials used in healthcare, not a device for treating patients.
No
The device is a steam sterilizer, which is used for the terminal sterilization of materials, not for diagnosing diseases or conditions.
No
The device description clearly indicates it is a physical steam sterilizer with specific dimensions and configurations, not solely software. While it mentions software validation, this is for the control of the hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "sterilization of heat and moisture-stabile materials used in healthcare facilities." This describes a process for making medical devices or materials sterile, not for performing tests on biological samples to diagnose conditions.
- Device Description: It is described as a "Class II medical device as defined by 21 CFR 880.6880," which is the regulation for Sterilizers, Steam. This classification is for devices used to sterilize other medical devices, not for IVDs.
- Performance Studies: The performance studies focus on demonstrating the effectiveness of the sterilization process (killing biological indicators, achieving a certain sterility assurance level, etc.). This is consistent with a sterilizer, not an IVD which would focus on analytical performance metrics like sensitivity, specificity, etc.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
Therefore, the Amsco Century Medium Steam Sterilizer 26" x 26" is a medical device intended for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amsco Century Medium Steam Sterilizer 26" x 26" is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and is available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie- Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Leak Test and DART (Bowie-Dick) cycles.
Product codes
FLE
Device Description
The Amsco Century Medium Steam Sterilizer 26" x 26" is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Medium Steam Sterilizer 26" x 26" is offered in the following configurations:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm) .
- 26" x 26" x 49" (660 mm x 660 mm x 1245 mm) .
- 26" x 26" x 61" (660 mm x 660 mm x 1520 mm) .
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 is demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 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). Prior to release, the Amsco Century Medium Steam Sterilizer 26" x 26" will be validated to meet the requirements of ANSI/AAMI ST8, Third Edition, January, 1994.
The results of the Amsco Century Medium Steam Sterilizer 26" x 26" verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:
- All SFPP cycles verified using the fabric test pack, described in Section 5.5.1.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSU/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, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All WRAP/SFPP cycles verified using full load instrument trays, described in 5.5.3.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.3 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 verified using the fabric test pack, described in Section 5.5.1.1 of t ANSI/AAMI-ST8, were qualified according to Section 5.5.1 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, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All PREVAC cycles verified using the fabric test pack, described in Section 5.5.1.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.1 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, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles verified using full load instrument trays, described in 5.5.3.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.3 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 LIQUID cycles verified using three 1,000 ml flasks, described in Section 5.5.2.1 of the t ANSI/AAMI-ST8, were qualified according to Section 5.5.2 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 verified 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 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 (5/29/98). "
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
510(k) SUMMARY
Submitter Information
Lori Haller, Manager, Regulatory Affairs STERIS Corporation 2424 West 23rd Street Erie, Pennsylvania 16506 (814) 870-8559 Date Summary Prepared: May 8, 2002
Introduction
The Amsco Century Medium Steam Sterilizer 26" x 26" is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Medium Steam Sterilizer 26' x 26" is substantially equivalent with the predicate device Amsco Century Medium Steam Sterilizer, K010865, cleared May 31, 2001.
The Amsco Century Medium Prevacuum Steam Sterilizer 26" x 26" is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-A):
| CYCLES | STERILIZE
TEMPERATURE | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|---------|--------------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg) each.
Fabric Packs. Refer to Table 2 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 2 for recommended quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 3 for recommended quantities. |
Tablo 1-4
The Amsco Century Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-B):
Table 1-B
| CYCLES | STERILIZE
TEMPERATURE | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOADS |
|-----------|--------------------------|-------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 20
minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Wrap/SFPP | 270°F (132°C) | 4 minutes | 20
minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg)
each. Non-Porous Goods only. Refer
to Table 2 for recommended
quantities. |
1
| Prevac | 270°F (132°C) | 4 minutes | 20
minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg)
each. Fabric Packs. Refer to Table 2
for recommended quantities. |
|---------|---------------|------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Gravity | 250°F (121°C) | 30 minutes | 15
minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
The following table lists STERIS's recommended loads by sterilizer size:
| Table 2 | · I A L M H M H H | |
|---|---|---|
| STARI | WRAPPED INSTRUMENT TRAYS | મ છે. વિદ્યાર તા |
| 16" x 26" " | ||
| Submit College of Art Leading And Article Comments And All All All All All All All All Province And Province And Provention Comments of Camper Comments of Camper Comments of | ||
| 26" x 26" - | Complete Collection Colline and Child Child Annual Child A for contrasted on Microsoft of Since And Property Property of Property of |
The following table is a guideline for the liquid cycle processing:
Table 3
| NUMBER OF CONTAINERS | VOLUME OF LIQUID IN
ONE CONTAINER | MINIMUM RECOMMENDED
STERILIZE TIME AT 250°F
(121°C) |
|----------------------|--------------------------------------|-----------------------------------------------------------|
| 3 | 1000 mL | 45 minutes |
Effectiveness
Effectiveness of sterilizer function and exposure time recommendations is 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 cveles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). Prior to release, the Amsco Century Medium Steam Sterilizer 26" x 26" will be validated to meet the requirements of ANSI/AAMI ST8, Third Edition, January, 1994.
The results of the Amseo Century Medium Steam Sterilizer 26" x 26" verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:
- All SFPP cycles verified using the fabric test pack, described in Section 5.5.1.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSU/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, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All WRAP/SFPP cycles verified using full load instrument trays, described in 5.5.3.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.3 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.
2
- All GRAVITY cycles verified using the fabric test pack, described in Section 5.5.1.1 of t ANSI/AAMI-ST8, were qualified according to Section 5.5.1 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, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
- All PREVAC cycles verified using the fabric test pack, described in Section 5.5.1.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 104 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles verified using full load instrument trays, described in 5.5.3.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.3 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 using balf-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 LIQUID cycles verified using three 1,000 ml flasks, described in Section 5.5.2.1 of the t ANSI/AAMI-ST8, were qualified according to Section 5.5.2 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 verified 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 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 (5/29/98). "
Safety
STERIS sterilizers including the Amsco Century Medium Steam Sterilizer 26" x 26" have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Arnsco Century Medium Steam Sterilizer 26" x 26" complies with the following requirements:
- Underwriters Laboratory (UL) Electromedical Code 3101 as certified by Intertek Testing . Services (ITS).
- Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by . Intertek Testing Services.
- . American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels.
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.
3
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.
Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incidence of sterilizer malfunction or sterilization process failure is relatively rare. Further, there are no known reports in the literature of patient infections that have resulted from steam sterilizer failures. The technology designed into STERIS steam sterilizers including the Amsco Century Medium Steam Sterilizer 26" x 26" provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
User Information
STERIS conducts in-house training and has developed a series of user training videos that provide helpful information about the appropriate use of steam sterilizers. STERIS further provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed Operator Manual and other labeling. STERIS also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image within the circle appears to be a stylized representation of a human figure or a symbol related to health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2003
Ms. Lori Haller Manager, Regulatory Affairs Steris Corporation 2424 West 23rd Street Erie, Pennsylvania 16506
Re: K020747
Trade/Device Name: Amsco Century Medium Sterilizer 26 Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: March 5, 2002 Received: March 7, 2002
Dear Ms. Haller:
This letter corrects our substantially equivalent letter of May 17, 2002 regarding the product code.
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Ms. Haller
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runres
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT DEVICE NAME: AMSCO CENTURY MEDIUM STEAM STERILIZER 26" X 26"
INDICATIONS FOR USE:
The Amsco Century Medium Steam Sterilizer 26" x 26" is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and is available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-. Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, WRAP/SFPP, Prevacuum, . Gravity, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Century Medium Prevacum Sterilizer 26" x 26" is equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 1-A):
| CYCLES | STERILIZE
TEMPERATURE | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOAD |
|---------|--------------------------|-------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg)
each. Fabric Packs. Refer to Table 2
for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 3 for recommended
quantities. |
Table 1-A
The Amsco Century Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-B):
| Table 1-B
CYCLES | STERILIZE
TEMPERATURE | STERILIZE
TIME | DRY
TIME | RECOMMENDED LOADS |
|---------------------|--------------------------|-------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 20
minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Wrap/SFPP | 270°F (132°C) | 4 minutes | 20
minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg)
each. Non-Porous Goods only.
Refer to Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 20
minutes | Double-wrapped Instrument Trays,
maximum weight of 17 lbs (7.7 kg)
each. Fabric Packs. Refer to Table
2 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15
minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
7
The following table lists STERIS recommended loads by sterilizer size:
Table 2
| STERILIZER SIZE | WRAPPED INSTRUMENT TRAYS | FABRIC PACKS |
|---|---|---|
| 26" x 26" x 39" | ||
| 26" x 26" x 49" | ||
| womany and survey and served and service and many and mores. | ||
| 26" x 26" x 61" | 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 |
The following table is the guideline for liquid cycle processing:
Table 3
| NUMBER OF CONTAINERS | VOLUME OF LIQUID IN
ONE CONTAINER | MINIMUM RECOMMENDED
STERILIZE TIME AT 250°F
(121°C) |
|----------------------|--------------------------------------|-----------------------------------------------------------|
| 3 | 1000 mL | 45 minutes |
The Amsoo Century Medium Steam Sterilizer 26" x 26" is offered in the following configurations:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm) .
- 26" x 26" x 49" (660 mm x 660 mm x 1245 mm) .
- 26" x 26" x 61" (660 mm x 660 mm x 1520 mm) .
(Please Do Not Write Below This Line - Continue on Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
John Lovell
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K020747