(84 days)
Not Found
No
The document describes a computer-controlled sterilization system with software updates, but there is no mention of AI or ML capabilities. The software verification and validation focus on targeted modifications and intended functionality, not on learning or adaptive algorithms.
No.
This device is a sterilizing system for medical devices, not a therapeutic device used to treat patients.
No
Explanation: The device is intended for liquid chemical sterilization of medical devices, not for diagnosing medical conditions.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, trays/containers, and quick connects. While it mentions the processor is computer controlled and continually monitored, and software updates were cleared, the core device is a hardware system for liquid chemical sterilization.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities." This describes a process for disinfecting medical equipment, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the mechanical and chemical aspects of the sterilization process, including the processor, sterilant concentrate, and water treatment system. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The SYSTEM 1E is a medical device used for reprocessing other medical devices to ensure they are safe for reuse. It falls under the category of sterilization or disinfection equipment.
N/A
Intended Use / Indications for Use
The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
-
- The extensive treatment of EPA potable water consists of:
-
- Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
-
- UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. .
-
- The extensive treatment of EPA potable water consists of:
Product codes (comma separated list FDA assigned to the subject device)
MED
Device Description
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Following this initial clearance the FDA was notified of a second qualified supplier of an ultraviolet light water treatment subsystem providing equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Software updates were cleared in K102462 and additions to that file.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light water treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40. peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects ensure thorough circulation of the sterilant solution and rinses.
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 the software modifications do not affect the safety or effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Software Verification/Code Walk-Through | Only targeted modifications were implemented to the device software. | Pass |
| Software Validation | Only targeted modifications were implemented to the device software and modifications work as intended. | 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
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
0
12113520
Image /page/0/Picture/12 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in all capital letters, with a registered trademark symbol to the right of the "S". Below the word is a graphic of several horizontal lines that are slightly curved, resembling waves.
510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Robert Sullivan Senior Director, FDA Regulatory Affairs Tel: 440-392-7695 Fax: 440-357-9198
Submission Date:
November 28, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
1. Device Name
| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
SYSTEM 1E Liquid Chemical Sterilant Processing System K090036 modified by K101409, K102462 and addition to file
3. Description of Device
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Following this initial clearance the FDA was notified of a second qualified supplier of an ultraviolet light water treatment subsystem providing equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Software updates were cleared in K102462 and additions to that file.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40. peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.
2
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects ensure thorough circulation of the sterilant solution and rinses.
4. Intended Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM IE Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
-
- The extensive treatment of EPA potable water consists of:
-
- Pre-filtration through two pre-filters:
- Pre-filter 1 is a gross depth filter that removes approximately 5 micron . or larger particles/contaminants.
- Pre-filter 2 is a surface filter that removes particles/contaminants > . 0.1 micron.
-
- UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered . through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
- The extensive treatment of EPA potable water consists of:
ട്. Description of Safety and Substantial Equivalence
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicates (K090036, K101409 and K102462) except for the modifications to specific components and software described in this submission and corresponding necessary changes to the Operating Manual for consistency. These modifications are intended to improve device usability, reliability, and serviceability without affecting any critical performance parameters. The modifications raise no new concerns of safety and effectiveness when compared to the predicate device.
3
The following table summarizes the verification activities that were performed, with their respective acceptance criteria, to ensure that the software modifications do not affect the safety or effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Software Verification | ||
| /Code Walk-Through | Only targeted modifications were implemented to the device software. | Pass |
| Software Validation | Only targeted modifications were implemented to the device software and modifications work as intended. | Pass |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
FEB 2 1 2012
Re: K113520
Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants / High Level Disinfectants Regulatory Class: II Product Code: MED Dated: January 27, 2012 Received: January 30, 2012
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 mendments, or to devices that have been reclassified in accordance with the provisions of Anchunche, or to actrices 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 approvisions of the Act. The general controls provisions of the Act include controls provided by a registration, listing of devices, good manufacturing practice, requirence to to unitions 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 (1 Mr.), 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.
5
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 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 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/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 I vision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/6 description: The image shows a close-up of a handwritten signature. The signature is in cursive and appears to be written with a dark ink or pen. The signature is somewhat illegible, but it seems to start with a letter that could be a 't' or 'f'. The rest of the signature is difficult to decipher due to the overlapping strokes and the style of the handwriting.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K113520 510(k) Number (if known):
Device Name:
SYSTEM 1E Liquid Chemical Sterilant Processing System
Indications For Use:
The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
-
- The extensive treatment of EPA potable water consists of:
-
- Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
-
- UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. .
-
- The extensive treatment of EPA potable water consists of:
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)/
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113520
Page 1 of 1
February 21, 2012