(84 days)
No
The device description and performance studies focus on biological and chemical indicators, with no mention of AI or ML technologies.
No
The device is a biological indicator used to monitor the effectiveness of sterilization systems, not to directly treat a patient or disease.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose medical conditions in patients.
No
The device description clearly states it is a physical biological indicator consisting of a glass fiber disc, glass ampoule, cap, liner, and chemical indicator. It is a hardware device used for monitoring sterilization processes.
Based on the provided information, the STERRAD® CYCLESURE® 24 Biological Indicator is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended to be used as a "standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles." Monitoring the effectiveness of a sterilization process is a diagnostic function, specifically assessing whether the process has successfully eliminated microorganisms.
- Device Description: The description details a "self-contained standalone biological monitor" containing bacterial spores and growth medium. This setup is designed to determine if viable spores remain after the sterilization process, which is a direct diagnostic test for sterilization efficacy.
- Performance Studies: The studies performed, such as "BI Validation in the STERRAD® Sterilization Systems (Dose Response)" and "Spore Resistance Testing," are focused on evaluating the biological indicator's ability to accurately reflect the sterilization process's effectiveness. This aligns with the testing and validation expected for an IVD used to monitor a critical process like sterilization.
- Predicate Device: The mention of a predicate device with the same name and K number (K103222) strongly suggests that this device is regulated as an IVD. Medical devices with K numbers are typically cleared by regulatory bodies like the FDA, and biological indicators used for sterilization monitoring are commonly classified as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and performance studies clearly indicate that this device is used to perform a diagnostic test (determining the presence or absence of viable microorganisms) outside of the human body to assess the effectiveness of a sterilization process. This fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STERRAD® CYCLESURE® 24 Biological Indicator (PN 14324) is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX® | Standard |
| STERRAD® NX® | Advanced |
| STERRAD® 100NX® | Standard |
| STERRAD® 100NX® | Flex |
| STERRAD® 100NX® | EXPRESS |
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 1x10° 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.
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
Testing was conducted to confirm that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended when used with the STERRRAD® Sterilization Systems. The following tests were performed:
| Studies Performed | Results |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| BI Validation in the STERRAD® Sterilization Systems | |
| (Dose Response) | Passed |
| Verification of Minimum Incubation Time | Passed |
| Growth Promotion | Passed |
| Spore Resistance Testing | Passed |
Performance testing demonstrated that the modified STERRAD® CYCLESURE® 24 Biological Indicator is substantially equivalent to the predicate device (K103222) because they have the same intended use, the same technological characteristics, the same operating principles, and are exposed to the same sterilant (hydrogen peroxide).
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
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 5, 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 880.2800 · STERRAD® CYCLESURE® 24 Biological indicator
-122044
. Ост
4 2012
2. PREDICATE DEVICES
STERRAD® CYCLESURE® 24 Biological Indicator, K103222, 2/25/2011
3. INDICATIONS FOR USE
The STERRAD® CYCLESURE® 24 Biological Indicator (PN 14324) is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX® | Standard |
| STERRAD® NX® | Advanced |
| STERRAD® 100NX® | Standard |
| STERRAD® 100NX® | Flex |
| STERRAD® 100NX® | EXPRESS |
1
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 1x10° 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.
5. SUMMARY OF NONCLINICAL TESTS
Both the modified and predicate devices have the same intended use, the same technological characteristics, the same operating principles, and utilize the same sterilant (hydrogen peroxide).
Testing was conducted to confirm that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended when used with the STERRRAD® Sterilization Systems. The following tests were performed:
| Studies Performed | Results |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| BI Validation in the STERRAD® Sterilization Systems | |
| (Dose Response) | Passed |
| Verification of Minimum Incubation Time | Passed |
| Growth Promotion | Passed |
| Spore Resistance Testing | Passed |
6. DESCRIPTION OF CHANGE
The change of the material grade of the outer vial resin (relative to the predicate device, K103222) is shown in this submission to work as intended with the STERRAD® Sterilization Systems.
7. OVERALL PERFORMANCE CONCLUSIONS
Performance testing demonstrated that the modified STERRAD® CYCLESURE® 24 Biological Indicator is substantially equivalent to the predicate device (K103222) because they have the same intended use, the same technological characteristics, the same operating principles, and are exposed to the same sterilant (hydrogen peroxide).
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal 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
OCT
4
2012
Advanced Sterilization Products Ms. Nancy Chu Manager, Regulatory Affairs 33 Technology Drive Irvine, California 92618
Re: K122044
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 5, 2012 Received: September 6, 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.
3
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.
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
4
Indications for Use
510(k) Number (if known): TBD K122 0 44
Device Name: STERRAD® CYCLESURE® 24 Biological Indicator
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:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX® | Standard |
| Advanced | |
| STERRAD® 100NX® | Flex |
| EXPRESS |
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)
Elicheth F. Olamin-Will-
gn-Off)
Anesthesiology, General Hospital
Anesthesiology, General Hospital Control, Dental Devices
Page 1 of 1
510(k) Number. K122044