(116 days)
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 Medium Steam Sterilizer Models are as follows: - · 26'' x 371/2' x 42" (Model HC 900)
- 26'' x 37½' x 54'' (Model HC 1200)
The provided text describes a 510(k) premarket notification for a steam sterilizer device, not an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.
However, I can extract the acceptance criteria and performance data for this traditional medical device:
Acceptance Criteria and Device Performance for Amsco® Evolution Medium Steam Sterilizer
The STERIS Corporation performed verification activities to ensure that modifications to their Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) did not affect its safety or effectiveness. The study demonstrates that the device passed all established acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Results of Verification / Validation |
|---|---|---|---|
| Control replacement | Performance testing | Per ST8 | Pass |
| Electrical safety | Per IEC 61010-1 | Pass | |
| 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 |
Note: "Per ST8" refers to AAMI ST8, a recognized standard for hospital steam sterilizers. "Per IEC 61010-1" refers to an international standard for electrical equipment for measurement, control, and laboratory use, which includes safety requirements.
Information Not Applicable or Available in the Provided Document (Pertaining to AI/ML Devices)
This document describes a traditional medical device (steam sterilizer), not an AI/ML device. Therefore, the following information, typically required for AI/ML device studies, is not applicable or found in this submission:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for sterilizers involves functional checks and adherence to standards rather than data sets like those used for AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's performance is objective (e.g., passing a specific test cycle, electrical safety standards met), not based on expert consensus of complex data.
- Adjudication method for the test set: Not applicable. Performance is binary (pass/fail) against objective criteria.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an imaging or diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its function as a sterilizer.
- The type of ground truth used: For this device, ground truth is based on established engineering and safety standards (ST8, IEC 61010-1), and functional performance checks (e.g., proper actuation, no alarms, proper door function after multiple cycles). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
- The sample size for the training set: Not applicable, as this is not an AI/ML device trained on data.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three human profiles facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2018
STERIS Corporation Tony Piotrkowski Sr. Manager. Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K173481
Trade/Device Name: Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) Regulation Number: 21 CFR 880.6880 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: January 11, 2018
Dear Mr. Tony 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 (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K173481
Device Name
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisturestable 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 Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amsco Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 5-3 for recommendedquantities. |
| PrevacGravity | 270°F (132°C)250°F (121°C) | 4 minutes30 minutes | 5 minutes15 minutes | Single Fabric PackFabric Packs. Refer toTable 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 for recommendedquantities. |
| DARTWarm-UpDART | 270°F (132°C)270°F (132°C) | 3 minutes3 1/2 minutes | 1 minute1 minute | N/ABowie-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.
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The Amsco Evolution Medium Steam Fluse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle
| 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 5-3 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 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 5-3 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 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) | 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
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The following table lists STERIS's recommended loads by sterilizer size: Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 37 ½" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |
The following table is a guideline for liquid cycle processing: Table 5-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37½" x 42" (Model HC 900) .
- 26" x 37½" x 54" (Model HC – 1200)
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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/6/Picture/0 description: The image shows the STERIS logo. The word STERIS is in large, bold, sans-serif font. Below the word STERIS is an image of several horizontal wavy lines in blue. The lines are stacked on top of each other and appear to represent water.
510(k) Summary For Amsco Evolution Medium 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: K173481
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
Trade Name: Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)
| 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 Medium Steam Sterilizer (Models HC-900 and HC-1200), K091136.
3. Description of Device
The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 Medium Steam Sterilizer Models are as follows:
- · 26'' x 371/2' x 42" (Model HC 900)
- 26'' x 37½' x 54'' (Model HC 1200)
4. Intended Use
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 6-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 6-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 6-3 for recommendedquantities. |
| DARTWarm-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 Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
*The liquid cycle is for non-patient contact use only.
{9}------------------------------------------------
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-2):
| Cycles | SterilizeTemperature | SterilizeTime | 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 6-3 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 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 | 30 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. |
| Table 6-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) | ||||
|---|---|---|---|---|
| Sterilizer factory-programmed sterilization cycles and cycle values |
{10}------------------------------------------------
K173481 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| DARTWarm-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 InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 37 1/2" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |
Table 6-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
| Table 6-4. Amsco Evolution Medium Steam |
|---|
| Sterilizer Liquid Cycle* Guideline |
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37½" x 42" (Model HC - 900)
- 26" x 37½" x 54" (Model HC 1200) ●
5. Description of Safety and Substantial Equivalence
The Evolution Medium 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.
{11}------------------------------------------------
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 Medium Steam Sterilizers.
| DeviceModification | Verification /ValidationActivity | AcceptanceCriteria | Results ofVerification/Validation |
|---|---|---|---|
| Control replacement | Performance testingElectrical safety | Per ST8Per IEC 61010-1 | Pass |
| Software modifications | Software validation | Software shall be appropriatelyverified and validated | Pass |
| Vacuum pumpreplacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriatelyverified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracketmodification | Door operation check | Proper function aftermultiple 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 (K091136), Class II (21 CFR 880.6880), product code FLE.
§ 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).