(102 days)
Not Found
No
The summary describes a steam sterilizer with pre-programmed cycles and standard performance testing, with no mention of AI or ML capabilities.
No.
The device is a sterilizer for materials used in healthcare facilities, not a device intended to treat a disease or condition in a patient.
No
This device is a sterilizer designed to sterilize heat and moisture-stable materials used in healthcare facilities, not to diagnose a condition. While it has a "DART" (Bowie-Dick) cycle and "Leak Test" cycle, these are for testing the sterilizer's performance, not for diagnosing a patient.
No
The device description clearly indicates it is a physical steam sterilizer with specific chamber sizes and hardware components (vacuum pump, printer, valves, switches, door). While it mentions "Software modifications" and "Software validation" in the performance studies, this refers to the software controlling the hardware, not a standalone software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is designed for "sterilization of heat and moisture-stable materials used in healthcare facilities." This describes a process for making medical instruments and materials safe for use, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of the sterilizer (chamber size, configurations) and the types of sterilization cycles it performs. This aligns with a sterilization device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis
- Reagents, assays, or other components used in laboratory testing
The device is a steam sterilizer, which is a type of medical device used to prepare instruments and materials for use in patient care by eliminating microorganisms. This is distinct from an IVD, which is used to perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Amsco Evolution Series Steam Sterilizer Models HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are 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, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amso Evolution Series Prevacum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 5-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | 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) | 15 minutes | 45 minutes | 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 | 45 minutes | 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 | Fabric Packs. Refer to
Table 5-3 for recommended
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 |
- The liquid cycle is for non-patient contact use only.
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | 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 | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table
5-3 for recommended
quantities. |
| SFPP | 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. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, 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 | Refer to Table 5-4 for
recommended quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
Table 5-2. Amso Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and ycle values
*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 Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are 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, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Floorloader Steam Sterilizer Models are as follows:
- 26" x 61" x 49" (Model HC 2000) .
- 26'' x 61'' x 72'' (Model HC 3000)
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)
| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|---|---|---|---|
| Control replacement | Performance testing
Electrical safety | Per ST8
Per IEC 61010-1 | Pass |
| Door gasket replacement | Door operation check | Proper function and no
alarms after multiple cycles | Pass |
| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|---|---|---|---|
| Software modifications | Software validation | Software shall be appropriately
verified and validated | Pass |
| Vacuum pump
replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately
verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket
modification | Door operation check | Proper function after
multiple cycles | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K173493
Trade/Device Name: Amsco Evolution Floorloader Steam Sterilizer HC-2000 And HC-3000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017
Dear Anthony Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Amsco Evolution Floorloader Steam Sterilizer (HC-2000 and HC-3000)
Indications for Use (Describe)
The Amsco Evolution Series Steam Sterilizer Models HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are 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, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amso Evolution Series Prevacum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 5-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | 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) | 15 minutes | 45 minutes | 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 | 45 minutes | 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 | Fabric Packs. Refer to
Table 5-3 for recommended
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 |
- The liquid cycle is for non-patient contact use only.
3
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | 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 | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table
5-3 for recommended
quantities. |
| SFPP | 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. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, 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 | Refer to Table 5-4 for
recommended quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
Table 5-2. Amso Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and ycle values
*The liquid cycle is for non-patient contact use only.
4
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-------------------------|-----------------------------|--------------|
| 26" x 61" x 49" HC-2000 | 15 | 40 |
| 26" x 61" x 72" HC-3000 | 25 | 60 |
Table 5-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| Number of | Volume of Liquid In One | Minimum Recommended |
|---|---|---|
| Containers | Container | Sterilize Time at 250°F (121°C) |
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- Model HC 2000 26" x 61" x 49" .
- . Model HC – 3000 26" x 61" x 72"
5
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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6
Image /page/6/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue.
510(k) Summary For Amsco Evolution Floorloader Steam Sterilizer
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Tony Piotrkowski Senior Manager, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 e-mail: tony_piotrkowski@steris.com
Submission Date: February 12, 2018
Premarket Notification Number: K173493
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
7
Device Name 1.
Trade Name: Amsco Evolution Floorloader Steam Sterilizer HC-2000 And HC-3000
| Device Class: | Class II |
|---|---|
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
2. Predicate Device
AMSCO Evolution Floorloader Steam Sterilizer (Models HC-2000 and HC-3000), K092490.
3. Description of Device
The Amsco Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are 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, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Floorloader Steam Sterilizer Models are as follows:
- 26" x 61" x 49" (Model HC 2000) .
- 26'' x 61'' x 72'' (Model HC 3000)
4. Intended Use
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are 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, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
8
The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):
| 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 6-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 for recommended
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 |
| Cycles | Sterilize
Temperature | Sterilize Time | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and Fabric
Packs. Refer to Table 6-3 for
recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 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 6-3 for
recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table
6-3 for recommended
quantities. |
| SFPP | 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 6-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 for
recommended 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 6-1. Amsco Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
*The liquid cycle is for non-patient contact use only.
9
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-2):
Table 6-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cvcle values
*The liquid cycle is for non-patient contact use only.
10
The following table lists STERIS's recommended loads by sterilizer size:
Table 6-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-------------------------|-----------------------------|--------------|
| 26" x 61" x 49" HC-2000 | 15 | 40 |
| 26" x 61" x 72" HC-3000 | 25 | 60 |
The following table is a guideline for liquid cycle processing:
Table 6-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| Number of | Volume of Liquid In One | Minimum Recommended |
|---|---|---|
| Containers | Container | Sterilize Time at 250°F (121°C) |
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- Model HC 2000 26" x 61" x 49" ●
- Model HC 3000 226' x 61" x 72" ●
ട്. Description of Safety and Substantial Equivalence
The Evolution Floorloader Sterilizers are the same as the predicate devices except for the specific modifications described in this submission. There are no differences in the indications for use or technology (including features, materials, and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the described modifications, and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure that these modifications do not affect the safety or effectiveness of the Evolution Floorloader Steam Sterilizers.
| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|-------------------------|------------------------------------------|--------------------------------------------------------|-------------------------------------------|
| Control replacement | Performance testing
Electrical safety | Per ST8
Per IEC 61010-1 | Pass |
| Door gasket replacement | Door operation check | Proper function and no
alarms after multiple cycles | Pass |
11
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173493 Amsco Evolution Floorloader Steam Sterilizer
| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|---------------------------------------|------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| Software modifications | Software validation | Software shall be appropriately
verified and validated | Pass |
| Vacuum pump
replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately
verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket
modification | Door operation check | Proper function after
multiple cycles | Pass |
6. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device (K092490), Class II (21 CFR 880.6880), product code FLE.