(487 days)
Not Found
No
The device description and performance studies focus on a biological indicator for sterilization monitoring, with no mention of AI or ML technologies. The change is limited to labeling for a new sterilization cycle.
No
This device is a biological indicator used to monitor the effectiveness of sterilization systems, not to directly treat a medical condition or ailment.
No
The device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components like a glass fiber disc, glass ampoule, cap, and liner, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of sterilization cycles in STERRAD® Sterilization Systems. This is a quality control measure for a sterilization process, not a test performed on a biological sample from a patient to diagnose a condition or provide information about a patient's health.
- Device Description: The device contains bacterial spores and growth medium. While it involves biological components, its function is to indicate whether a sterilization process has successfully killed the spores, not to analyze a patient sample.
- Lack of IVD Characteristics: The description does not mention analyzing patient samples, diagnosing diseases, or providing information about a patient's health status.
Therefore, the STERRAD® CYCLESURE® 24 Biological Indicator is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
- STERRAD® 100S .
- STERRAD® 50 .
- STERRAD® 200 .
- STERRAD® NX® .
- STERRAD® 100NX® (Standard, Flex and Express Cycles) .
- o For STERRAD® 100NX® DUO Cycle. the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
Product codes
FRC
Device Description
The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of lx10° Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion. There are no changes to the STERRAD® CYCLESURE® 24 Biological Indicator from the device cleared in K102884. The change is to the labeling to add the STERRRAD® 100NX® DUO Cycle to the CYCLESURE® 24 Biological Indicator Indications for Use Statement.
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
Study Type: N/A
Sample Size: N/A
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: The performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX® DUO Cycle by meeting the same performance criteria as the predicate devices.
Studies Performed and Results:
Evaporation - Passed
Verification of Positive BI Color - Passed
Bacteriostasis - Passed
BI Validation in the STERRAD® Sterilization Systems (Dose Response) - 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).
0
510(k) Summary
SEP 14 2012
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 II 21 CFR 880.2200
STERRAD® CYCLESURE® 24 Biological indicator
2. PREDICATE DEVICES
- STERRAD® CYCLESURE® 24 Biological Indicator, K102884, 1/28/2011 .
- STERRAD® CYCLESURE® 24 Biological Indicator for use in STERRAD® EXPRESS Cycle, K103222, 2/25/2011
1
3. INDICATIONS FOR USE
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
- STERRAD® 100S .
- STERRAD® 50 .
- STERRAD® 200 .
- STERRAD® NX® .
- STERRAD® 100NX® (Standard, Flex and Express Cycles) .
- o For STERRAD® 100NX® DUO Cycle. the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
4. DESCRIPTION OF DEVICE
The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of lx10° Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion. There are no changes to the STERRAD® CYCLESURE® 24 Biological Indicator from the device cleared in K102884. The change is to the labeling to add the STERRRAD® 100NX® DUO Cycle to the CYCLESURE® 24 Biological Indicator Indications for Use Statement.
5. SUMMARY OF NONCLINICAL TESTS
Testing conducted for this submission is to confirm that STERRAD® CYCLESURE® 24 Biological Indicator performs as its intended use in a newly developed STERRAD® 100NX® DUO Cycle.
The STERRAD® CYCLESURE® 24 Biological Indicator, the subject device of this submission, remains the same since receiving clearance on January 28, 2011 (K102884). A subsequent submission (K103222) added the STERRAD® 100NX® EXPRESS Cycle to the Indications for Use statement. The only change to the predicate devices is a newly developed STERRAD® 100NX® DUO Cycle added to the Indications for Use statement.
2
Recently cleared predicate devices (K102884 and K103222) and the subject device of this submission, have the same intended use, the same technological characteristics, the same operating principles, and utilize the same sterilant (hydrogen peroxide).
This submission is intended to support the DUO Cycle for use in the STERRAD® 100NX® Sterilizer. Therefore, only following performance data related to the DUO Cycle are included in this submission.
| Studies Performed | Results |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| BI Validation in the STERRAD® Sterilization Systems | |
| (Dose Response) | Passed |
6. DESCRIPTION OF CHANGE
A newly developed STERRAD® 100NX® DUO Cycle is added to the Indications for Use statement.
7. OVERALL PERFORMANCE CONCLUSIONS
The performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX® DUO Cycle by meeting the same performance criteria as the predicate devices.
The STERRAD® CYCLESURE® 24 Biological Indicator is substantially equivalent to predicate devices (K102884 and K103222) because they have the same intended use, the same technological characteristics, the same operating principles and use the same sterilant (Hydrogen Peroxide).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 14 2012
Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
Re: Ki11375
Trade/Device Name: Sterrad® Cyclesure® 24 Biological Indicator 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
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 yours,
F. Roodman
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): K111375
STERRAD® CYCLESURE® 24 Biological Indicator Device Name:
Indication for Use:
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
- STERRAD® 100S .
- STERRAD® 50
- STERRAD® 200 .
- STERRAD® NX®
- STERRAD® 100NX® (Standard, Flex and Express Cycles) .
- o For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
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)
Ropiy Gangulim
sion Sign-Orr)
Ion of Anestheslology, General Hospital
Ion of Anestheslology, General Infection Control,
510(k) Number: K111375
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