(85 days)
Not Found
No
The document describes steam sterilizers and their operational cycles. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on standard sterilization processes and software validation.
No
The device is a sterilizer designed for heat and moisture-stable materials used in healthcare facilities, not a device for treating or diagnosing medical conditions.
No
The device is designed for the 'sterilization of heat and moisture-stable materials', which is a treatment or preparation function, not a diagnostic one.
No
The device is described as a steam sterilizer, which is a physical piece of equipment used for sterilization. While it mentions software validation, the core device is 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 describes a process for making medical devices or materials safe for use, not a test performed on biological samples to diagnose a condition.
- Device Description: The description focuses on the sterilizer's function and modifications compared to predicate devices, not on analyzing biological samples.
- 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.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The device is a sterilizer, which is a medical device used to prepare other medical devices for use. It does not perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Amsco 400 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 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 400 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 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) 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
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The AMSCO 400 Steam 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 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.
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)
Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design, is summarized below.
Test: Software validation per IEC 62304
Result: All safety and functional tests pass
Conclusion: 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 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
October 28, 2021
STERIS Corporation % Anthoy Piotrkowski Director, Regulatory Affairs STERIS Corporation 5960 Heislev Rd Mentor, OH 44060
Re: K212424
Trade/Device Name: AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 24, 2021 Received: September 27, 2021
Dear Anthoy Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212424/S001 Device Name
Amsco 400 Small Steam Sterilizer
Indications for Use (Describe)
The Amsco 400 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 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 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
Table 4-1.
Amsco 400 Small Prevacuum Steam Sterilizer Models 16, 16, 20, 20C factory-validated sterlization 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 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. |
| 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. |
3
| 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 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 400 Small Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 4-2):
Table 4-2.
Amsco 400 Small Steam Flush Pressure-Pulse (SFPP)Sterilizer Models 16S, 16CS, 20S, factory-validated sterilization cycles and cycle values
| 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. |
| 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. |
4
| 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 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 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 |
The following table is a guideline for liquid cycle processing:
Table 4-4 Amsco 400 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 400 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) .
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
X
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
5
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
6
Indications for Use
510(k) Number (if known) K212424/S001 Device Name
AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL)
Indications for Use (Describe)
The AMSCO 400 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 400 Medium Prevacuum Steam Sterilizers are equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 4.5):
Table 4.5.
AMSCO 400 Medium Prevacuum 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 4.6 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
4.6 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 4.6 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 A-2 for
recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4.6 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 4.6 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 4.6 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4.6 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
4.6 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
4.6 for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml bottles. Refer to Table 4.7 for
recommended full load quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| 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 |
7
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS' full loads by sterilizer size:
Table 4.6
AMSCO 400 Medium Steam Sterilizer full load per sterilizer size
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 26" x 39" | 4 | 12 |
The following table is a guideline for liquid cycle processing:
Table 4.7 AMSCO 400 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 400 Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (Models 39SL and 39CSL) ●
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
BF SC Publishing Services (301) 443-6740
8
Indications for Use
510(k) Number (if known) K212424/S001 Device Name
AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60CH, 36CSL, 48CSL and 60CSL)
Indications for Use (Describe)
The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) 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 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.8):
Table 4.8.
Amsco 400 Medium Prevacuum 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 4.9 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 4.9
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 4.9 for recommended
quantities. |
| Gravity | 250°F
(121°C) | 30
minutes | 15 minutes | Fabric Packs. Refer to Table 4.9 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 4.9 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 4.9 for recommended
quantities. |
| Gravity | 270°F
(132°C) | 25
minutes | 15 minutes | Fabric Packs. Refer to Table 4.9 for recommended
quantities. |
| Liquid* | 250°F
(121°C) | 45
minutes | N/A | Validated with 3 1000ml bottles. Refer to Table 4.10 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 |
- The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Table 4.9 | ||||||
|---|---|---|---|---|---|---|
| Amsco 400 Medium Steam Sterilizer recommended loads per sterilizer size |
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 37.5" x 36" | 9 | 18 |
9
| 26" x 37.5" x 48" | 12 | 30 |
|---|---|---|
| 26" x 37.5" x 60" | 15 | 36 |
The following table is a guideline for liquid cycle processing:
Table 4.10 AMSCO 400 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 37.5" x 36" | 112 | 3 | 1000 ml | 45 minutes |
| 26" x 37.5" x 48" | 154 | 3 | 1000 ml | 45 minutes |
| 26" x 37.5" x 60" | 196 | 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37.5" x 36" (Models 36H, 36CH, 36CH, 36CSL, 36CSL) ●
- 26" x 37.5" x 48" (Models 48H, 48CH, 48CH, 48CSL) ●
- 26" x 37.5" x 60" (Models 60H, 48CH, 48CH, 48CSL) ●
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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Image /page/10/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in large, bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water waves.
K212424/S001 510(k) Summary For AMSCO 400 Small Steam Sterilizers
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Email:
Summary Date: August 3, 2021
11
Device Name 1.
| Trade Name: | AMSCO 400 Small Steam Sterilizer (cleared as
AMSCO Chimeron Small Steam Sterilizer) |
|------------------------|----------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
2. Predicate Devices
K111223 - AMSCO Chimeron Small Steam Sterilizer (renamed AMSCO 400 before commercialization)
The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.
3. Description of Devices
The AMSCO 400 Steam 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 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.
4. Intended Use / Indications for Use
The Amsco 400 Small Steam Sterilizer models 16, 16CS, 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.
12
The Amsco 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
Table 4-1.
Amsco 400 Small Prevacuum Steam Sterilizer Models 16, 16, 20, 20C 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 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| 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.
13
The Amsco 400 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 400 Small Steam Flush Pressure-Pulse (SFPP)Sterilizer Models 16S, 16CS, 20S, 20CS factory-validated sterilization cycles and cycle values
14
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Table 4-3 | |
|---|---|
| ----------- | -- |
Amsco 400 Small Steam Sterilizer 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:
| 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 |
Table 4-4 Amsco 400 Small Steam Sterilizer Liquid* Cycle Guideline
*The liquid cycle is for non-patient contact use only.
The Amsco 400 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) ●
5. Summary of Nonclinical Tests
The modified sterilizers have the same indications for use, intended use and same technological characteristics as the predicate devices. Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design, is summarized below.
| Test | Result | Conclusion |
|---|---|---|
| Software validation per IEC 62304 | All safety and functional tests pass | PASS |
15
6. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Small Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K111223, Class II (21 CFR 880.6880), product code FLE.
16
K212424/S001 510(k) Summary For AMSCO 400 Medium 26" x 26" Steam Sterilizers
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 tony_piotrkowski@steris.com Email:
Summary Date: August 3, 2021
17
Device Name 6.
| Trade Name: | AMSCO 400 Medium26" x 26" Steam Sterilizer |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
7. Predicate Devices
K112403 - Chimeron Medium 26" x 26" Steam Sterilizer (renamed AMSCO 400 before commercialization)
The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.
8. Description of Devices
The AMSCO 400 Steam 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 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.
9. Intended Use / Indications for Use
The AMSCO 400 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 400 Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.5):
18
Table 4.5.
AMSCO 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cycle values
| AMSCO 400 Medium Prevacuum 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 4.6 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 4.6 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 4.6 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 A-2 for | ||||
| recommended quantities. | ||||
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4.6 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 4.6 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 4.6 for | ||||
| recommended quantities. | ||||
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4.6 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 4.6 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 4.6 for recommended quantities. | ||||
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml bottles. Refer to Table 4.7 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 |
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS' full loads by sterilizer size:
| Table 4.6 | ||
|---|---|---|
| AMSCO 400 Medium Steam Sterilizer full load per sterilizer size | ||
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
| 26" x 26" x 39" | 4 | 12 |
19
The following table is a guideline for liquid cycle processing:
Table 4.7 AMSCO 400 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 400 Medium Steam Sterilizer is offered in the following chamber sizes:
- 26' x 26' x 39" (Models 39SL and 39CSL) ●
10. Summary of Nonclinical Tests
The modified sterilizers have the same indications for use, intended use and same technological characteristics as the predicate devices. Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design, is summarized below.
| Test | Result | Conclusion |
|---|---|---|
| Software validation per IEC 62304 | All safety and functional tests pass | PASS |
6. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Medium 26" x 26" Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K112403, Class II (21 CFR 880.6880), product code FLE.
20
K212424/S001 510(k) Summary For AMSCO 400 Medium Steam Sterilizers
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Email: tony_piotrkowski@steris.com
Summary Date: August 3, 2021
21
Device Name 11.
| Trade Name: | AMSCO 400 Medium Steam Sterilizer |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
12. Predicate Devices
K112055 - AMSCO 400 Medium Steam Sterilizer (renamed AMSCO 400 before commercialization)
The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.
13. Description of Devices
The AMSCO 400 Steam 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 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.
14. Intended Use / Indications for Use
The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) 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 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.8):
22
Table 4.8.
Amsco 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cvcle values
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 4.9 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 4.9 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 4.9 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4.9 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 4.9 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 4.9 for recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4.9 for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Validated with 3 1000ml bottles. Refer to Table 4.10 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 |
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
Table 4.9
Amsco 400 Medium Steam Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 37.5" x 36" | 9 | 18 |
| 26" x 37.5" x 48" | 12 | 30 |
| 26" x 37.5" x 60" | 15 | 36 |
The following table is a guideline for liquid cycle processing:
23
Table 4.10
AMSCO 400 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 37.5" x 36" | 112 | 3 | 1000 ml | 45 minutes |
| 26" x 37.5" x 48" | 154 | 3 | 1000 ml | 45 minutes |
| 26" x 37.5" x 60" | 196 | 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37.5" x 36" (Models 36H, 36CH, 36SL, 36CSL)
- 26" x 37.5" x 48" (Models 48H, 48CH, 48CH, 48CSL) ●
- 26" x 37.5" x 60" (Models 60H, 48CH, 48CH, 48CSL)
15. Summary of Nonclinical Tests
The modified sterilizers have the same indications for use, intended use and same technological characteristics as the predicate devices. Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design, is summarized below.
| Test | Result | Conclusion |
|---|---|---|
| Software validation per IEC 62304 | All safety and functional tests pass | PASS |
6. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Medium Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K112055, Class II (21 CFR 880.6880), product code FLE.