(497 days)
No
The device is a test pack for monitoring a sterilization cycle, consisting of a biological indicator and a vial. There is no mention of AI/ML in the description, intended use, or performance studies. The studies focus on the resistance of the biological indicator to the sterilization process.
No
This device is a test pack used for routine monitoring and periodic testing of a sterilization cycle, not for diagnosing, treating, or preventing disease.
No
The device is a test pack used for monitoring the sterilization cycle and not for diagnosing any medical condition or disease. It assesses the effectiveness of a sterilization process, not a patient's health.
No
The device description clearly states it consists of a biological indicator and a vial with a cap, which are physical components, not software. The intended use also describes a physical test pack.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring and testing a sterilization cycle (STERRAD® 100NX® DUO Sterilization Cycle). This is a quality control process for a medical device (the sterilizer), not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device consists of a biological indicator and a vial/cap to hold it during sterilization. This is consistent with a sterilization monitoring device.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) from a patient. The "biological indicator" refers to a standardized population of microorganisms used to challenge the sterilization process.
- Performance Studies: The performance studies focus on the resistance of the test pack to the sterilization process and the functionality of the chemical indicator, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.
Product codes
FRC
Device Description
The STERRAD® 100NX® DUO Test Pack consists of a CYCLESURE® 24 Biological Indicator (BI) and a STERRAD® NX® Test Vial with cap for holding the BI during the sterilization cycle.
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
hospital-defined loads
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
The STERRAD® 100NX® DUO Test Pack has been evaluated for its resistance to the DUO Cycle in the STERRAD® 100NX® Sterilizer.
A comparison of the DUO Test Pack to the biological model developed for the DUO Cycle indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.
DUO Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) were exposed to several doses of hydrogen peroxide in a DUO Cycle. These survivor curves were compared to the survivor curves for the biological model developed for the DUO Cycle. The test data showed that the Test Pack configuration was at least as resistant as the biological model.
Additionally, fraction negative data were collected using Test Packs assembled from three lots of CYCLESURE® 24 BI and exposed to increasing volumes of hydrogen peroxide in a DUO Cycle. The results indicated that the Test Pack configuration was at least as resistant as the biological model.
Indicative functionality of the chemical indicator in a DUO Test Pack configuration was evaluated using half-cycle parameters of the DUO Cycle and the response was determined to be appropriate for a chemical indicator.
The subject device and its predicate device have the same intended use which is for routine monitoring of the sterilizer cycle. Additionally, they have the same technological characteristics, the same operating principles and are subjected to the same sterilant (hydrogen peroxide) and therefore, the subject device is substantially equivalent to the predicate.
The Table below lists the tests performed to demonstrate that the DUO Test Pack functions as intended in the STERRAD® 100NX® sterilizer using a DUO Cycle.
| Studies Performed | Results |
|---|---|
| Design Evaluation and Performance Qualification of STERRAD® 100 NX® DUO Test Pack | Passed |
| Functionality Study of the Chemical Indicator Disc of CYCLESURE® 24 BI in Test Pack | Passed |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
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K111391 1 of 3
510(k) Summary
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 Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900
Summary Date: September 10, 2012
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Common/Usual Name: Product Classification: Classification Regulation: Proprietary Name:
Biological Sterilization Process Indicator Biological Indicator (Test Pack) II 21 CFR 880.2800 STERRAD® 100NX® DUO Cycle Test Pack
2. PREDICATE DEVICES
STERRAD® 100NX® Test Pack, K071537 cleared on December 18, 2007
3. INDICATIONS FOR USE
The STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.
SEP 26 2012
1
4. DESCRIPTION OF DEVICE
The STERRAD® 100NX® DUO Test Pack consists of a CYCLESURE® 24 Biological Indicator (BI) and a STERRAD® NX® Test Vial with cap for holding the BI during the sterilization cycle.
5. SUMMARY OF NONCLINICAL TESTS
The STERRAD® 100NX® DUO Test Pack has been evaluated for its resistance to the DUO Cycle in the STERRAD® 100NX® Sterilizer.
A comparison of the DUO Test Pack to the biological model developed for the DUO Cycle indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.
DUO Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) were exposed to several doses of hydrogen peroxide in a DUO Cycle. These survivor curves were compared to the survivor curves for the biological model developed for the DUO Cycle. The test data showed that the Test Pack configuration was at least as resistant as the biological model.
Additionally, fraction negative data were collected using Test Packs assembled from three lots of CYCLESURE® 24 BI and exposed to increasing volumes of hydrogen peroxide in a DUO Cycle. The results indicated that the Test Pack configuration was at least as resistant as the biological model.
Indicative functionality of the chemical indicator in a DUO Test Pack configuration was evaluated using half-cycle parameters of the DUO Cycle and the response was determined to be appropriate for a chemical indicator.
The subject device and its predicate device have the same intended use which is for routine monitoring of the sterilizer cycle. Additionally, they have the same technological characteristics, the same operating principles and are subjected to the same sterilant (hydrogen peroxide) and therefore, the subject device is substantially equivalent to the predicate.
The Table below lists the tests performed to demonstrate that the DUO Test Pack functions as intended in the STERRAD® 100NX® sterilizer using a DUO Cycle.
2
| Studies Performed | Results |
|---|---|
| Design Evaluation and Performance Qualification of | |
| STERRAD® 100 NX® DUO Test Pack | Passed |
| Functionality Study of the Chemical Indicator Disc of | |
| CYCLESURE® 24 BI in Test Pack | Passed |
6. DESCRIPTION OF CHANGE:
- Indications for Use Statement has been revised to incorporate the STERRAD® . 100NX® DUO Test Pack.
- Instructions for Use have been revised to include STERRAD® 100NX® DUO Test . Pack information.
7. OVERALL PERFORMANCE CONCLUSIONS
The performance data shows that the STERRAD® 100NX® DUO Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing the DUO Cycle of the STERRAD® 100NX® Sterilizer and it is substantially equivalent to predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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 33 Technology Drive Irvine, California 92618
SEP 2 6 2012
Re: K111391
Trade/Device Name: STERRAD® 100NX® DUO Cycle Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC 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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
5
Indications for Use
510(k) Number (if known): K111391
STERRAD® 100NX® DUO Cycle Test Pack Device Name:
Indication for Use:
The STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
fu uld.
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices i
K 11 510(k) Number:_