(84 days)
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 |
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.
Here's a breakdown of the acceptance criteria and study information for the STERRAD® CYCLESURE® 24 Biological Indicator, based on the provided 510(k) summary:
Device: STERRAD® CYCLESURE® 24 Biological Indicator
1. Acceptance Criteria and Reported Device Performance:
The document describes several studies performed to confirm the biological indicator performs as intended. The acceptance criteria for these tests are implicitly "Passed," indicating that the device met the required performance standards.
| Study Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Evaporation | Passed | Passed |
| Verification of Positive BI Color | Passed | Passed |
| Bacteriostasis | Passed | Passed |
| BI Validation in STERRAD® Systems (Dose Response) | Passed | Passed |
| Verification of Minimum Incubation Time | Passed | Passed |
| Growth Promotion | Passed | Passed |
| Spore Resistance Testing | Passed | Passed |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each test. It mentions that "Testing was conducted" and "Performance testing demonstrated," but no specific numbers of biological indicators tested are provided.
The data provenance is implied to be prospective testing conducted by the applicant (Advanced Sterilization Products) as part of their submission for clearance of the modified device. The country of origin for the data is not specified, but the applicant's address is in Irvine, CA, USA.
3. Number and Qualifications of Experts for Ground Truth:
This information is not applicable to this type of device (biological indicator) and study. Biological indicators are designed to provide a direct readout (growth or no growth of spores) to indicate sterility. There is no human interpretation of images or complex data involved that would require expert consensus.
4. Adjudication Method:
Not applicable. See point 3. The results of the biological indicator (growth or no growth) are objective and do not require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output with and without AI assistance to assess changes in accuracy or efficiency. A biological indicator functions as a direct sterility monitor and does not involve human interpretation in the same way.
6. Standalone Performance Study (Algorithm Only):
Yes, a standalone performance study was done in the sense that the biological indicator itself (the "algorithm" in this context) was tested independently to verify its function. The listed studies (Evaporation, Verification of Positive BI Color, Bacteriostasis, BI Validation, Minimum Incubation Time, Growth Promotion, Spore Resistance Testing) all assess the intrinsic performance of the biological indicator without human intervention or interpretation beyond observing the final growth result.
7. Type of Ground Truth Used:
The ground truth used for this device is based on microbiological principles and refers to the known outcome of spore killing under specific sterilization conditions.
- Positive Controls: Unsterilized or partially sterilized biological indicators are expected to show spore growth.
- Negative Controls: Properly sterilized biological indicators are expected to show no spore growth.
- D-value and Z-value parameters: For spore resistance testing, the ground truth relates to the known resistance of Geobacillus stearothermophilus spores to hydrogen peroxide under defined conditions.
- Growth Promotion: The ground truth is the ability of the medium to support the growth of the target microorganism.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that learns from a training set. It is a physical biological indicator.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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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).
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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
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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
§ 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).