(89 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization monitoring, with no mention of AI or ML.
No
The device is a biological indicator used to monitor the effectiveness of sterilization systems, not to provide therapeutic treatment.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose a condition or disease in a patient.
No
The device description clearly outlines physical components like a glass fiber disc, glass ampoule, cap, liner, and chemical indicator, indicating it is a hardware device.
Based on the provided information, the STERRAD® CYCLESURE® 24 Biological Indicator is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it is for "frequent monitoring of the following STERRAD® Sterilization Systems and Cycles." This monitoring involves assessing the effectiveness of the sterilization process.
- Device Description: The device contains biological material (bacterial spores) and a growth medium. The process involves exposing the spores to the sterilization process and then incubating them in the growth medium to determine if the spores were killed. This is a test performed in vitro (outside of a living organism) to evaluate a process (sterilization).
- Performance Studies: The performance studies focus on the biological indicator's ability to accurately reflect the sterilization process (e.g., Dose Response, Growth Promotion, Spore Resistance Testing). These are tests to validate the performance of the in vitro diagnostic device.
While it doesn't directly diagnose a disease in a patient, it is used to monitor and validate a process (sterilization) that is critical for preventing the transmission of infectious agents, which falls under the scope of IVDs. It's a quality control tool for a medical process.
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)
0 For STERRAD® 100NX® DUO Cycle in the United States, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 |
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.
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
DEC 2 6 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: November 14, 2012
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Biological Sterilization Process Indicator |
|---|---|
| Common/Usual Name: | Biological Indicator |
| Product Classification: | II |
| Product Code: | FRC |
| Classification Regulation: | 21 CFR 880.2800 |
| Proprietary Name: | STERRAD® CYCLESURE® 24 Biological Indicator |
2. PREDICATE DEVICES
STERRAD® CYCLESURE® 24 Biological Indicator, K111375, 9/14/2012
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)
0 For STERRAD® 100NX® DUO Cycle in the United States, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
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 | Passed |
| (Dose Response) | |
| 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, K111375) 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 (K111375) 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/0 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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 26, 2012
Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive IRVINE CA 92618
Re: K123017
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: November 28, 2012 Received: November 29, 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
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,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
K123017 510(k) Number (if known): TBD
Device Name: STERRAD® CYCLESURE® 24 Biological Indicator
Indication for Use:
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as standard method for frequent monitoring of the following STERRAD® a 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)
Elizabeth F. Claverie
2012.12.19 20:42:14 -05'00'
KI23012
Page 1 of 1
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthestology, Dental Devices
510(k) Number,
18