(486 days)
No
The document describes a sterilization system with different cycles and hardware components. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a sterilizer for medical instruments and materials, not a device used for treating patients.
No
Explanation: The STERRAD® 100NX® Sterilizer is explicitly described as a device designed for the "sterilization of both metal and nonmetal medical devices." Its function is to sterilize instruments, not to diagnose medical conditions or analyze medical data.
No
The device description explicitly states it is a "self-contained stand-alone system of hardware and software" and details the hardware components like the sterilization chamber and other instruments.
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 a chemical and plasma process. It does not describe a device that analyzes biological samples.
- 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.)
- Providing diagnostic information
- Using reagents for testing
- Measuring analytes
The STERRAD® 100NX® Sterilizer is a device used to prepare medical instruments for use, ensuring they are free from microorganisms. This falls under the category of a medical device used in the healthcare setting, but not an IVD.
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 safely sterilize medical instruments and materials without leaving toxic residue.
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
- A 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 lbs placed on the bottom shelf,
The STERRAD® 100NX® DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
-
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and a length of 875mm or shorter
-
Accessory devices that are normally connected to a flexible endoscope during use
-
Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 Ibs.
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® 100NX® Sterilizer has three previously cleared cycles (STANDARD, FLEX, EXPRESS) and the new optional additional DUO 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, and printer paper.
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
Not Found
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
Validation Testing: Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores.
Key Results:
- Dose Response with Biological Model (1 x 875 mm Flexible Endoscope): Passed
- Surface Sterilization: Passed
- Mated Surface Sterilization: Passed
- 1 x 875 mm Flexible Endoscope Validation: Passed
- Bacteriostasis Testing in the DUO Cycle: Passed
- In Use Testing – 1 x 875 mm Flexible Endoscopes and Accessories: Passed
- Simulated Use Testing: Passed
- Toxicity Testing of Materials: Passed
- Device Functionality and Material Compatibility: Passed
- Process Reproducibility: Passed
Overall Performance Conclusions: The nonclinical studies demonstrate that the STERRAD® 100NX® DUO Cycle is safe and effective for sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX® DUO Cycle to the predicate devices, the STERRAD® 100NX® Sterilizer FLEX Cycle and the STERRAD® 100S Sterilizer.
Key Metrics
Not Found
Predicate Device(s)
STERRAD® 100NX® Sterilization System [K071385], STERRAD® 100S Sterilization System [K991999, K023290]
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
SEP 1 3 2012
... ... ... ... ..
510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products, Division of Ethicon, Inc. a Johnson & Johnson company 33 Technology Drive Irvine, CA 92618
Contact Person
Nancy Chu Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900
September 10, 2012
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1
Classification Name: Common/Usual Name: Product Classification: Classification Number: Proprietary Name:
Sterilizer, Class II Hydrogen Peroxide Gas Plasma Sterilization System Sterilizer, Class II 21 CFR 880.6860 STERRAD® 100NX® Sterilizer with DUO Cycle
2 PREDICATE DEVICES
STERRAD® 100NX® Sterilization System [K071385] STERRAD® 100S Sterilization System [K991999, K023290]
3 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 safely sterilize medical instruments and materials without leaving toxic residue.
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:
1
-
a 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
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.
The STERRAD® 100NX® DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
-
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and a length of 875mm or shorter
-
Accessory devices that are normally connected to a flexible endoscope during use
-
Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.
2
ិងក្រុង "
DESCRIPTION OF DEVICE ব
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® 100NX® Sterilizer has three previously cleared cycles (STANDARD, FLEX, EXPRESS) and the new optional additional DUO 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, and printer paper.
| CHARACTERISTICS | SUBJECT DEVICE
STERRAD® 100NX®
DUO CYCLE | PREDICATE DEVICES | |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------|
| | | STERRAD® 100S
CYCLE | STERRAD® 100NX® FLEX
CYCLE |
| Base System | STERRAD® 100NX®
Sterilizer | STERRAD® 100S
Sterilizer | STERRAD®
100NX® Sterilizer |
| Hydrogen peroxide, 59% | Yes | Yes | Yes, with
concentration
process |
| Hydrogen peroxide
delivery | STERRAD® 100NX®
Cassette and metered
through Delivery
Module | STERRAD® 100S
cassette | STERRAD®
100NX® Cassette |
| Disposal of hydrogen
peroxide after 10 days of
on-board storage | Hydrogen peroxide
clearance process,
initiated by user | Cassette has to be
ejected by user | Cassette has to be
ejected by user |
| Cycle Time, approximate | 60 minutes | 54 minutes | 42 minutes |
| Load Type | Two flexible
endoscopes with
accessories; 1x875mm
PE/PTFE lumen | No flexible
endoscopes | Two flexible
endoscopes only;
1x850mm
PE/PTFE lumen |
| Load Weight, lbs | 13.2 | Not defined | 21.4 |
5 TABLE 5-1: COMPARISION BETWEEN SUBJECT DEVICE AND . PREDICATES
5
3
SUMMARY OF NONCLINICAL TESTS 6
Validation Testing
Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores. Table 6-1 identifies the validation studies performed and the results obtained.
ក្នុង -
| STUDY | RESULTS |
|---|---|
| Dose Response with Biological Model (1 x 875 mm | |
| Flexible Endoscope | Passed |
| Surface Sterilization | Passed |
| Mated Surface Sterilization | Passed |
| 1 x 875 mm Flexible Endoscope Validation | Passed |
| Bacteriostasis Testing in the DUO Cycle | Passed |
| In Use Testing – 1 x 875 mm Flexible Endoscopes and | |
| Accessories | Passed |
| Simulated Use Testing | Passed |
| Toxicity Testing of Materials | Passed |
| Device Functionality and Material Compatibility | Passed |
| Process Reproducibility | Passed |
TABLE 6-1: VALIDATION STUDIES
7 OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies demonstrate that the STERRAD® 100NX® DUO Cycle is safe and effective for sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX® DUO Cycle to the predicate devices, the STERRAD® 100NX® Sterilizer FLEX Cycle and the STERRAD® 100S Sterilizer.
P. 4 of 4
4
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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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, Division of Ethicon, Incorporated 33 Technology Drive Irvine, CA 92618
SEP
13 2012
Re: K111377
Trade/Device Name: STERRAD 100NX™ Sterilizer with DUO Cycle Regulation Number: 21 CFR §880.6860 Regulation Name: Ethylene Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: September 10, 2012 Received: September 12, 2012
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.
5
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 (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 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 vours.
Wh for
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
X 1113
្រី
Indications for Use
510(k) Number (if known): K111377
STERRAD® 100NX® Sterilizer with DUO 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 safely sterilize medical instruments and materials without leaving toxic residue.
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.
Page 1 of 2
7
រដឹក
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
- A 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 lbs placed on the bottom shelf,
The STERRAD® 100NX® DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
-
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and a length of 875mm or shorter
-
Accessory devices that are normally connected to a flexible endoscope during use
-
Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 Ibs.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
な
Over-The-Counter Use V (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)
Mn
Division Sign-Off) Division Sign-Om)
Division of Anesthesiology, General Hospital ntection Control, Dental Devices
510(k) Number: K 111377