Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a steam sterilizer with various pre-programmed cycles and validation against established standards. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

No
This device is a sterilizer for medical instruments and materials, not a device used for treating patients.

Diagnostic

No

The device is a steam sterilizer, used for sterilizing materials in healthcare facilities. Its function is to kill microorganisms, not to diagnose a disease or condition. The "diagnostic" aspect mentioned in the device's cycles (e.g., Leak Test, DART) refers to testing the sterilizer's function, not diagnosing a patient.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components (steam sterilizer models with specific chamber sizes) and the performance studies validate the effectiveness of the physical sterilization process, not just software functionality. While software is mentioned for cycle operation, it is part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "sterilization of heat and moisture-stable materials used in healthcare facilities." This describes a process for making medical devices or materials sterile, not for performing diagnostic tests on biological samples.
Device Description: The description details a steam sterilizer with different cycle types (Prevacum, Gravity, Liquid, SFPP, Leak Test, DART). These are all related to the sterilization process.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment. The performance studies focus on the effectiveness of the sterilization process (sterility assurance level, kill of biological indicators), not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.

Therefore, the Amsco Evolution Medium Steam Sterilizer is a medical device used for sterilization, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

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 4-3 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 4-3 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 4-3 for recommended
quantities

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
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.
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 Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2)

| 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 | 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. |

Product codes (comma separated list FDA assigned to the subject device)

80 FLE

Device Description

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 37½" x 42" (Model HC 900)
. 26" x 37½" x 54" (Model HC - 1200)

The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 37½" x 42" (Model HC 900)
· 26" x 371/2" x 54" (Model HC 1200)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 106 probability of survival. STERIS validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Amsco Evolution Steam Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8, Fourth Edition, November 2001.

The results of the Amsco Evolution Steam Sterilizer verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:

Empty chamber testing performed as described in Section 5.4.2.5 of . ANSI/AAMI-ST8, for the Prevac, Gravity, Liquid and SFPP cycles. These cycles demonstrated that the sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. The stcrilizer meets the requirements of Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8.
All SFPP cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an « Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All SFPP cycles validated using full load instrument trays, described in 5.5.4.1 ● of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All GRAVITY cycles validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All GRAVITY cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All PREVAC cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
All PREVAC cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All LIQUID cycles validated using three 1,000 ml flasks, described in Section 5.5.3.1 of the ANSI/AAMI-ST8, and were qualified according to Section 5.5.3 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. The liquid cycle is for non-patient contact use only.
The DART cycle validated using the Bowie-Dick Test Pack, as described in o 5.6.1.1 of the ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet.
The software validation for the cycle operation was performed according to . FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)."

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.

K082435

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

Regulation Number and Section

§ 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).

Summary

0

STERIS®

JUN 2 9 2009

510(k) Summary For Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone:(440) 392-7695 Fax No: (440) 357-9198

Summary Date:

June 17, 2009

STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600

1

1. Device Name

Trade Name:	Amsco Evolution Medium Steam Sterilizer
Models:	HC-900 and HC-1200
Common/Usual Name:	Steam Sterilizer
Classification Name:	Steam Sterilizer (21 CFR 880.6880)
Product Code 80 FLE

2. Predicate Device

K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008.

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 37½" 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.

2

:

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |----------------------|---------------- | Prevac | 270°F (132°C) | Prevac | 270°F (132°C) | Gravity | 250°F (121°C) | Liquid* | 250°F (121°C) | Prevac | 275°F (135°C) | Gravity | 270°F (132°C) | Gravity | 250°F (121°C) | Gravity | 270°F (132°C) | DART Warm-Up
DART | 270°F (132°C) | 3 minutes | DART | 270°F (132°C) DART Test Pack | Leak Test | N/A | Cycles | Sterilize Temperature | SFPP | 270°F (132°C) maximum weight 25 lbs (11.3 kg) | SFPP | 275°F (135°C) maximum weight 25 lbs (11.3 kg) | Prevac | 270°F (132°C) maximum weight 25 lbs (11.3 kg) | Gravity | 250°F (121°C) | SFPP | 270°F (132°C) | Prevac | 275°F (135°C) maximum weight 25 lbs (11.3 kg) | Gravity | 270°F (132°C) maximum weight 25 lbs (11.3 kg) |
----------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 4 minutes | 5 minutes | Single Fabric Pack |
| 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| 45 minutes | N/A | Refer to Table 4-4 for recommended quantities. |
| 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| 1 minute | N/A |
| 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,
|
| N/A | N/A | N/A |
| Sterilize Time | Dry Time | Recommended Load |
| 4 minutes | 30 minutes | Double wrapped instrument trays,
each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| 3 minutes | 30 minutes | Double wrapped instrument trays,
each. Refer to Table 4-3 for recommended quantities. |
| 4 minutes | 30 minutes | Double wrapped instrument trays,
each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| 4 minutes | 5 minutes | Single Fabric Pack |
| 3 minutes | 30 minutes | Double wrapped instrument trays,
each. Refer to Table 4-3 for recommended quantities. |
| 15 minutes | 30 minutes | Double wrapped instrument trays,
each. Refer to Table 4-3 for recommended quantities |

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

*The liquid cycle is for non-patient contact use only.

3

The Amsco Evolution Medium 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 Evolution Medium Steam Flush Pressure-Pulse (SFPP)
Sterilizer factory-programmed sterilization cycles and cycle values
A LIE LA LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE

4

STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|----------|---------------------------------------------------|
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 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.

The following table lists STERIS's recommended loads by sterilizer size:

Sterilizer recommended loads per sterilizer size
Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 37 ½" x 42"	12	18
26" x 37 ½" x 54"	16	30

Table 4-3. Amsco Evolution Medium Steam

The following table is a guideline for liquid cycle processing:

Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline

| | 120000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
1403147271-2-
(1100 0 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 | A S M B |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 1000 ml | 45 minutes |
| i
1 | 1 | |

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 371/2" x 54" (Model HC 1200)

ട്. Description of Safety and Substantial Equivalence

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5.

5

| General Sterilizer
Features | Amsco Evolution Medium Steam
Sterilizer (Models HC-900 and HC-
1200) | Amsco Evolution Medium Steam
Sterilizer (K082435)
(Models HC-600 and HC-1500) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A steam sterilizer intended for
sterilization of non-porous and porous,
heat- and moisture-stable materials in
healthcare facilities. | A steam sterilizer intended for
sterilization of non-porous and porous,
heat- and moisture-stable materials in
healthcare facilities. |
| Operating Principle | Steam is the sterilizing agent. | Steam is the sterilizing agent. |
| Sterilization Cycles
Offered | Prevac
Gravity
SFPP
Liquid | Prevac
Gravity
SFPP
Liquid |
| Chamber Sizes | 26" x 26" x 39"
26" x 37.5" x 60" | 26" x 37.5" x 42"
26" x 37.5" x 54" |
| Chamber Door | Type 316L stainless steel
Vertical Sliding (26"x26")
Hinged or Horizontal Sliding
(26"x37½") | Type 316L stainless steel
Vertical Sliding (26"x26")
Hinged or Horizontal Sliding
(26"x37½") |
| Shell Assembly | Type 316L stainless steel
ASME certified | Type 316L stainless steel
ASME certified |
| Control Technology | Unity Controller
Touch Screen
8.4" Display
Ink on Paper Printer | Unity Controller
Touch Screen
8.4" Display
Ink on Paper Printer |
| Process Monitors | Chamber Transducer
Dual Element Chamber Drain Sensor | Chamber Transducer
Dual Element Chamber Drain Sensor |
| Safety Devices | Pressure Relief Valve
Chamber Float Switch
Control Lockout Switch | Pressure Relief Valve
Chamber Float Switch
Control Lockout Switch |

Table 5-5. Summary of the Proposed and predicate Devices

Effectiveness

Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 106 probability of survival. STERIS validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Amsco Evolution Steam Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8, Fourth Edition, November 2001.

The results of the Amsco Evolution Steam Sterilizer verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:

6

Empty chamber testing performed as described in Section 5.4.2.5 of . ANSI/AAMI-ST8, for the Prevac, Gravity, Liquid and SFPP cycles. These cycles demonstrated that the sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. The stcrilizer meets the requirements of Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8.
All SFPP cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an « Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All SFPP cycles validated using full load instrument trays, described in 5.5.4.1 ● of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All GRAVITY cycles validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All GRAVITY cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All PREVAC cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
All PREVAC cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All LIQUID cycles validated using three 1,000 ml flasks, described in Section � 5.5.3.1 of the ANSI/AAMI-ST8, and were qualified according to Section 5.5.3 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce

7

an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. The liquid cycle is for non-patient contact use only.

The DART cycle validated using the Bowie-Dick Test Pack, as described in o 5.6.1.1 of the ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet.
The software validation for the cycle operation was performed according to . FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)."

Safety

STERIS sterilizers including the Amsco Evolution Steam Sterilizer have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Amsco Evolution Steam Sterilizer complies with the following requirements:

. Underwriters Laboratory (UL) Electrical Safety Code 61010-1 certified by Intertek Testing Services (ITS).
. Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services.
American Society of Mechanical Engineers (ASME), Section VIII, Division 1 ● for unfired pressure vessels.

Hazards -- Failure of Performance

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

To avoid failure, the user must ensure that the materials, instruments and devices to be sterilized are thoroughly cleaned, the manufacturer's instructions for use are followed, the cycle to be used for each type of sterilizer load has been validated, the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

The technology designed into STERIS steam sterilizers including the Amsco Evolution Steam Sterilizer provide pc controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

8

User Information

STERIS conducts in-house training and has developed a series of user training videos that provide helpful information about the appropriate use of steam sterilizers. STERIS further provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed Operator Manual and other labeling. STERIS also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in healthcare facilities.

9

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is facing to the right.

JUN 29 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor Ohio 44060

... ... ... .. .. .. ..

Re: K091136

Trade/Device Name: Amsco Evolution Medium Steam Sterilization (Models HC-900 and HC-1200)

Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 17, 2009 Received: June 18, 2009

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

10

Page 2- Mr. Sullivan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Penner

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K091136

Device Name:

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

Indications For 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.

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

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 4-3 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 4-3 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 4-3 for recommended
quantities

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:

12

STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
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.
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 Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2)

| 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 | 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. |

Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP)
Sterilizer factory-programmed sterilization cycles and cycle values

. .

13

STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

: ..

. '

· ..

.

| 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 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 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 | 30 minutes | Double wrapped instrument trays, 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 | Refer to Table 4-4 for recommended quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 1/2 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
26" x 37 ½" x 42"	12	18
26" x 37 ½" x 54"	16	30

Table 4-3. Amsco Evolution Medium Steam Sterilizer recom 1 Parti .

·

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The following table is a guideline for liquid cycle processing:

Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline

| Number of
Containers | Volume of Liquid In One
Container | Minimum Recommended
Sterilize 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 371/2" x 42" (Model HC 900) .
26" x 371/2' x 54" (Model HC 1200) .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy
(Division-Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091131