(555 days)
Not Found
No
The document describes a sterilization system based on chemical and physical processes (hydrogen peroxide vapor and plasma). There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the sterilization process itself and its effectiveness on different materials and device types.
No.
This device is designed for sterilization of medical devices, not for diagnosing, treating, or preventing disease in patients.
No
Explanation: The device is described as a sterilizer designed to sterilize medical instruments and devices, not to diagnose medical conditions.
No
The device description explicitly states that the STERRAD® 100NX™ Sterilizer is a "self-contained stand-alone system of hardware and software". It also details the hardware components, such as the sterilization chamber, instruments, and frame.
Based on the provided text, the STERRAD® 100NX™ Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization of both metal and nonmetal medical devices at low temperatures." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The device description details a system for sterilizing instruments using hydrogen peroxide gas plasma. This aligns with a sterilization process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use.
N/A
Intended Use / Indications for Use
The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD® sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Standard cycle:
-
Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Flex Scope cycle: -
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**
Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load.
*A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
The STERRAD® 100NX™ EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
-
It can sterilize instrument surfaces and instruments having diffusionrestricted spaces, such as the hinged portion of forceps and scissors
-
It can sterilize rigid and semi-rigid endoscopes without lumens
Product codes
MLR
Device Description
The STERRAD® 100NX™ Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas-plasma using electrical energy. The STERRAD® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.
The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation Testing: Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores.
Key results from validation studies:
- Dose Response with Anodized Aluminum Surfaces: Passed
- Surface Sterilization: Passed
- Mated Surface Sterilization: Passed
- Bacteriostasis Testing in the EXPRESS Cycle: Passed
- In Use Testing - General Medical Devices: Passed
- Simulated Use Testing: Passed
- Toxicity Testing of Materials: Passed
- Chemical Indicator Functionality: Passed
- CycleSure Biological Indicator Qualification: Passed
- Bacteriostasis Testing of CycleSure Biological Indicator: Passed
- Device Functionality and Material Compatibility: Passed
- Process Reproducibility: Passed
Overall Performance Conclusions: The nonclinical studies demonstrate that the STERRAD® 100NX™ EXPRESS Cycle is safe and effective for surface sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX™ EXPRESS Cycle to the predicate devices, the STERRAD® 100NX™ Sterilizer, and the STERRAD® 200 Sterilizer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).
0
K092622
510(k) Notification
510(k) Summary
MAR - 4 2011
Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Nancy Chu Regulatory Affairs Manager Tel: (949) 453-6435 Fax: (949) 789-3900 Email: nchu@its.jnj.com
April 15, 2010
1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle
2.0 PREDICATE DEVICES
STERRAD® 100NX™ Sterilization System [K071385] STERRAD® 200 Sterilization System [K030429]
3.0 INDICATIONS FOR USE
The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD® sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NXTM Sterilizer Standard cycle:
-
Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
1
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Flex Scope cycle:
-
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**
Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The l x 850 mm flexible endoscopes were validated without any additional load.
- A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load,
The STERRAD® 100NX™ EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
-
It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors
-
It can sterilize rigid and semi-rigid endoscopes without lumens
Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 Ibs placed on the bottom shelf.
4.0 DESCRIPTION OF DEVICE
The STERRAD® 100NX™ Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas-plasma using electrical energy. The STERRAD® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.
The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.
SUMMARY OF NONCLINICAL TESTS 5.0
5.1 Validation Testing
Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores. Table 8-1 on the following page identifies the validation studies performed and the results obtained.
2
Table 8-1: Validation Studies
| Study | Results |
|---|---|
| Dose Response with Anodized Aluminum Surfaces | Passed |
| Surface Sterilization | Passed |
| Mated Surface Sterilization | Passed |
| Bacteriostasis Testing in the EXPRESS Cycle | Passed |
| In Use Testing - General Medical Devices | Passed |
| Simulated Use Testing | Passed |
| Toxicity Testing of Materials | Passed |
| Chemical Indicator Functionality | Passed |
| CycleSure Biological Indicator Qualification | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | Passed |
| Device Functionality and Material Compatibility | Passed |
| Process Reproducibility | Passed |
OVERALL PERFORMANCE CONCLUSIONS 6.0
The nonclinical studies demonstrate that the STERRAD® 100NX™ EXPRESS Cycle is safe and effective for surface sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX™ EXPRESS Cycle to the predicate devices, the STERRAD® 100NX™ Sterilizer, and the STERRAD® 200 Sterilizer.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 330 Technology Drive Irvine, California 92618
MAR - 4 2011
Re: K092622
Trade/Device Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR . Dated: March 1, 2011 Received: March 2, 2011
Dear Ms. Chu:
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.
4
Page 2- Ms. Chu
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 (OS) 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 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.
Sincerely yours,
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
5
Indications for Use
510(k) Number (if known): K092622
STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Device Name:
Indications for Use:
The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Standard cycle:
-
Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Flex Scope cycle: -
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**
Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load.
*A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
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The STERRAD® 100NX™ EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
-
It can sterilize instrument surfaces and instruments having diffusionrestricted spaces, such as the hinged portion of forceps and scissors
-
It can sterilize rigid and semi-rigid endoscopes without lumens
The validation studies for EXPRESS Cycle were performed using a validation load Note: consisting of a single instrument tray weighing 10.7 Ibs placed on the bottom shelf.
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)
Elizth. B. Clain-Wall
Jivision Sign-Off) ·············································································································································································· Tection Control, Dental Devices
10(k) Number: K092622
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