(101 days)
Not Found
No
The document describes a steam sterilizer with various sterilization cycles and physical specifications. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is a steam sterilizer designed for sterilizing materials in healthcare facilities, not for treating patients.
No
The device is a sterilizer designed for processing medical materials, not for diagnosing medical conditions. Its function is to perform sterilization cycles (e.g., Prevacuum, Gravity, Liquid, Leak Test, DART), which are treatments, not diagnostic tests.
No
The device description clearly describes a physical steam sterilizer with specific chamber sizes and cycle types, indicating it is a hardware device with integrated software for control.
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 is a process for making medical devices and materials safe for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of a steam sterilizer, including chamber size and sterilization cycles. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The device is clearly a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 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 5-1):
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 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 26" x 42" (Model HC 800) ●
- 26" x 26" x 54" (Model HC 1000) .
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)
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.
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Results of Verification / Validation |
|---|---|---|---|
| Control replacement | Performance testing Electrical safety | Per ST8 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 |
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
February 22, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K173490
Trade/Device Name: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017
Dear Anthony Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 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. Amso Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|----------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and
Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 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) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table 5-3 for recommended
quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | $3 \frac{1}{2}$
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.
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
3
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factoryprogrammed 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 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 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 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.
4
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 26" x 26" x 49" | 12 | 16 |
| 26" x 26" x 61" | 15 | 20 |
Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. 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 Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26'' x 26' x 49'' (Model HC 800)
- 26" x 26" x 61" (Model HC 1000)
5
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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6
Image /page/6/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in a bold, sans-serif font at the top of the logo, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines that are stacked on top of each other.
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: K173490
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
7
Device Name 1.
Amsco® Evolution Medium Steam Sterilizer (Models HC-800 and Trade Name: HC-1000)
| 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-800 and HC-1000), K091731.
3. Description of Device
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 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 26" x 42" (Model HC 800) ●
- 26" x 26" x 54" (Model HC 1000) .
4. Intended Use
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 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 | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each and
Fabric Packs. Refer to
Table 6-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 for
recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Refer to
Table 6-3 for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 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) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 for recommended
quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 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. |
| 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 |
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):
Table 6-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cvcles and cvcle values
10
K173490 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
*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 | 16 |
| 26" x 37 ½" x 54" | 15 | 20 |
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 Cvcle* 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 26" x 49" (Model HC - 800)
- 26" x 26" x 61" (Model HC = 1000) .
5. Discussion of Technology Comparison and Verification Activities
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.
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.
11
| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|---------------------------------------|------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| Control replacement | Performance testing
Electrical safety | Per ST8
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 |
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 (K091731), Class II (21 CFR 880.6880), product code FLE.