(79 days)
No
The document describes a liquid chemical sterilization system with automated, computer-controlled processes and water treatment. There is no mention of AI or ML in the intended use, device description, or performance studies. The software modifications mentioned are described as minor and not altering cycle parameters, which is not indicative of AI/ML implementation.
No.
This device is designed for sterilization of medical instruments, not for direct therapeutic treatment of patients.
No
This device is a sterilization system that uses liquid chemicals to sterilize medical devices. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, trays, containers, and quick connects. While it mentions software control and monitoring, it is an integral part of a larger hardware system designed for liquid chemical sterilization. The performance studies also include hardware-related testing.
Based on the provided text, the SYSTEM 1E Liquid Chemical Sterilant Processing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the liquid chemical sterilization of medical devices (critical and semi-critical heat-sensitive devices). This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a system for sterilizing medical instruments using a chemical process and treated water. It does not mention any components or functions related to 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.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or kits for laboratory testing
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 equipment, not in vitro diagnostics.
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
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 IE Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.
The device was originally cleared under K090036. Following the 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. Minor revisions to software that did not alter cycle parameters were cleared under K102462 and K113520.
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 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.
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 SYSTEM IE Quick Connects, if required, facilitate delivery of the liquid chemical sterilant use-solution and rinse water to internal channels.
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 limited hardware and software modifications do not affect the safety or effectiveness of the SYSTEM IE Liquid Chemical Sterilant Processing System.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility testing | The described modifications to specific o-rings did not alter the biocompatibility profile of the device | Pass |
| SYSTEM 1E Processor Performance | The modifications do not affect the performance of the S1E Diagnostic and Liquid Chemical Sterilization Cycles | Pass |
| Software Verification Code Walk-Through | Only the targeted modifications were implemented to the device software | Pass |
| Software Validation | Only the targeted modifications were implemented to the device software | Pass |
| Machine Validation | The targeted modifications do not affect the performance of the device | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090036, K101409, K102462, K113520
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the text "K 131078" on the top, followed by the word "STERIS" with a registered trademark symbol. Below the word "STERIS" is a graphic of several horizontal lines that are wavy. The text and graphic are centered in the image.
JUL 5 2013
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:
Marcia L. Benedict Senior Director, Regulatory Affairs Tel: 440-392-7063 Fax: 440-357-9198
June 11, 2013 Submission Date:
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, K101409, K102462, and K113520)
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 IE Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.
The device was originally cleared under K090036. Following the 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. Minor revisions to software that did not alter cycle parameters were cleared under K102462 and K113520.
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 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 SYSTEM IE Quick Connects, if required, facilitate delivery of the liquid chemical sterilant use-solution and rinse water to internal channels.
4. Intended Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical 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 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:
ડ. Description of Safety and Substantial Equivalence
The SYSTEM IE Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modifications described in this submission. 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.
3
The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure that these limited hardware and software modifications do not affect the safety or effectiveness of the SYSTEM IE Liquid Chemical Sterilant Processing System.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility testing | The described modifications to specific o-rings did not alter the biocompatibility profile of the device | Pass |
| SYSTEM 1E Processor Performance | The modifications do not affect the performance of the S1E Diagnostic and Liquid Chemical Sterilization Cycles | Pass |
| Software Verification Code Walk-Through | Only the targeted modifications were implemented to the device software | Pass |
| Software Validation | Only the targeted modifications were implemented to the device software | Pass |
| Machine Validation | The targeted modifications do not affect the performance of the device | Pass |
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a sans-serif style, and the letters are evenly spaced.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2013
STERIS Corporation Ms. Marcia L. Benedict Senior Director, Regulatory Affairs 5960 Heisley Road Mentor OH 44060
Re: K131078
Trade/Device Name: SYSTEM IE 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: June 11, 2013 Received: June 12, 2013
Dear Ms. Benedict:
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.
5
Page 2 - Ms. Benedict
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 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.
Image /page/5/Picture/7 description: The image shows the text "Sincerely yours," at the top. Below this, there is a signature and the name "Tejashri Purohit-Sheth, M.D." The text "Clinical Deputy Director" is below the name, followed by "DAGRID". The word "FOR" is at the bottom right.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
6
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of SYSTEM 1E Liquid Chemical Sterilant Processing System
2017/08/2017 11:57
Indications for Use
510(k) Number (if known): K131078
Device Name:
. . . . . . . . . . . . . . . . . . . . .
SYSTEM IE Liquid Chemical Sterilant Processing System
יו יוני יוצרים בייני מיני מוקדות מידעת מידעים מידע איינו איינו איינו איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער איינער
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.
-
Prescription Use ・・ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (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) izabeth F. C. 2 3 2013.06.28 21:5
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page I of I