(120 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.
No.
This device is a biological indicator used for monitoring sterilizer cycles, not for treating a disease or condition.
No
Explanation: This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components (glass fiber disc, glass ampoule, cap, liner, chemical indicator) and a biological component (spores), indicating it is a physical medical device, not software-only.
Based on the provided information, the STERRAD® CYCLESURE® 24 Biological Indicator is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the STERRAD® Sterilizer cycles." This monitoring is done to assess the effectiveness of the sterilization process, which is a critical step in preventing the transmission of infectious agents. While not directly diagnosing a patient's condition, it is a diagnostic tool used to evaluate the performance of a process that impacts patient safety.
- Device Description: The device contains biological material (bacterial spores) and a growth medium. The principle of operation involves exposing these spores to the sterilization process and then incubating them to see if they grow. This is a classic in vitro method for assessing the effectiveness of a sterilization process.
- Performance Studies: The performance studies described (Evaporation, Bacteriostasis, Growth Promotion, etc.) are all related to the biological and chemical properties of the device and its ability to accurately indicate whether sterilization has occurred. These are typical performance characteristics evaluated for IVDs used in quality control or monitoring.
- Predicate Device: The predicate device is also a biological indicator used for monitoring sterilization cycles, further supporting the classification as an IVD.
While the device doesn't directly analyze a patient sample, it falls under the broader definition of an IVD as it is used in vitro (outside the body) to provide information about the effectiveness of a process (sterilization) that directly impacts patient care and safety. It's a diagnostic tool for the sterilization process itself.
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 STERRAD® Sterilizer cycles.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 10^8 CFU of 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing conducted demonstrated that our modified STERRAD® CYCLESURE® 24 Biological Indicator device is substantially equivalent to the predicate, unmodified STERRAD® CycleSure® Biological Indicator device. The devices share the same intended use, utilize the same technology (hydrogen peroxide as sterilant), exhibit the same performance characteristics and those characteristics have been verified using the same test methods for both devices.
| Validation Study | Results |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| Verification of Minimum Incubation Time (Readout) | Passed |
| Spore Resistance | Passed |
| BI Validation in STERRAD Sterilizers (Dose Response) | Passed |
| Growth Promotion | Passed |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
STERRAD® CycleSure® Biological Indicator, K071014
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 2 8 2011
1102884
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
Kevin Corrigan, RAC Director. Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900
Summary Date: September 27, 2010
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Biological Sterilization Process Indicator |
|---|---|
| Common/Usual Name: | Biological Indicator |
| Product Classification: | II |
| Proprietary Name: | STERRAD® CYCLESURE® 24 Biological Indicator |
2. PREDICATE DEVICES
STERRAD® CycleSure® Biological Indicator, K071014, May 24, 2007
3. INDICATIONS FOR USE
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of STERRAD® Sterilizer cycles.
4. DESCRIPTION OF DEVICE
STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 108 CFU of 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
The testing conducted demonstrated that our modified STERRAD® CYCLESURE® 24 Biological Indicator device is substantially equivalent to the predicate, unmodified STERRAD® CycleSure® Biological Indicator device. The devices share the same intended
1
use, utilize the same technology (hydrogen peroxide as sterilant), exhibit the same performance characteristics and those characteristics have been verified using the same test methods for both devices.
| Validation Study | Results |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| Verification of Minimum Incubation Time (Readout) | Passed |
| Spore Resistance | Passed |
| BI Validation in STERRAD Sterilizers (Dose Response) | Passed |
| Growth Promotion | Passed |
6. DESCRIPTION OF CHANGE:
The following is a list of the specific changes to the predicate STERRAD® CycleSure® Biological Indicator:
- a. Outer vial resin material change (remains molded polypropylene, new vendor)
- b. New supplier for silicon coating process for the Tyvek® cap liner
- Reduced maximum incubation/readout time from 7 days to 3 days C.
- d. Name changed from STERRAD® CycleSure® Biological Indicator to STERRAD® CYCLESURE® 24 Biological Indicator
7. OVERALL PERFORMANCE CONCLUSIONS
The testing conducted demonstrated that the modified STERRAD® CYCLESURE® 24 Biological Indicator device is substantially equivalent to the predicate, unmodified STERRAD® CycleSure® Biological Indicator device.
TYVEK® is a Registered Trademark of Du Pont
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kevin Corrigan Director, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
JAN 28 2011
Re: K102884
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: January 18, 2011 Received: January 19, 2011
Dear Mr. Corrigan:
:
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
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), pleasc 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,
Jams J. Dobbins
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
Device Name: STERRAD® CYCLESURE® 24 Biological Indicator
Indications for Use:
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
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)
Elizabeth H. F.L. Cummins Will
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K102884
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