(89 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:
- STERRAD® 100S
- STERRAD® 50
- STERRAD® 200
- STERRAD® NX®
- STERRAD® 100NX® (Standard, Flex and Express Cycles)
- 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).
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 1x10^6 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.
The provided text describes a 510(k) summary for a biological indicator, the STERRAD® CYCLESURE® 24 Biological Indicator. This device is a self-contained biological monitor used to verify the effectiveness of STERRAD® sterilization processes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Evaporation | Pass (meets performance standards) | Passed |
| Verification of Positive BI Color | Pass (correctly indicates positive growth) | Passed |
| Bacteriostasis | Pass (no inhibition of microbial growth by indicator components) | Passed |
| BI Validation in the STERRAD® Sterilization Systems (Dose Response) | Pass (demonstrates appropriate response to varying sterilant exposure in specific systems) | Passed |
| Verification of Minimum Incubation Time | Pass (growth detectable within specified time) | Passed |
| Growth Promotion | Pass (supports growth of target organism) | Passed |
| Spore Resistance Testing | Pass (acceptable resistance to sterilant) | Passed |
Note: The document states "Passed" for all studies, implying that the device met the pre-defined acceptance criteria for each test. The specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but are inherent in the "Passed" designation for regulatory submissions of this type.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the nonclinical tests. The testing methodology for biological indicators typically involves a statistically significant number of replicates, but the exact numbers are not provided in this summary.
Regarding data provenance: The tests were conducted to confirm the performance of the STERRAD® CYCLESURE® 24 Biological Indicator when used with STERRAD® Sterilization Systems. This indicates that the data was generated specifically for the device in question, likely in a controlled laboratory or testing environment. The country of origin of the data is implicitly the country where Advanced Sterilization Products (Irvine, CA, USA) conducted its research and development, but this is not explicitly stated. The studies are prospective in nature, as they are designed to evaluate the performance of a new or modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For a biological indicator, the "ground truth" is established through standardized microbiological and sterilization efficacy testing methods. This does not involve human expert consensus in the same way an image interpretation study would. Instead, the ground truth is determined by:
- Microbiological assays: Confirming the presence and viability of spores.
- Sterilization efficacy: Determining if the sterilization process effectively inactivates the spores under controlled conditions.
- Colorimetric changes: Observing the chemical or biological indicator's color change as designed.
Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context is not directly applicable as it would be for, for example, a diagnostic imaging device. The "experts" would be qualified microbiologists and engineers overseeing the test procedures, rather than a panel of clinicians.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used for studies involving subjective human interpretation, such as medical image reading where discrepancies between readers need to be resolved. This is not applicable to the nonclinical performance testing of a biological indicator, where results are generally objective (e.g., growth/no growth, specific color change, quantitative measurements). The "adjudication" is inherent in the validation protocols and quality control measures of the testing procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable here. This type of study assesses how human performance (e.g., diagnostic accuracy of radiologists) changes with or without the assistance of an AI-powered device. The STERRAD® CYCLESURE® 24 Biological Indicator is a standalone device for monitoring sterilization, not a diagnostic aid for human interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The nonclinical tests listed (Evaporation, Verification of Positive BI Color, Bacteriostasis, BI Validation, Verification of Minimum Incubation Time, Growth Promotion, Spore Resistance Testing) all represent the performance of the biological indicator itself, without human intervention in its function. The device is a "self-contained standalone biological monitor."
7. Type of Ground Truth Used
The ground truth used for evaluating the biological indicator is based on:
- Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to varying levels of sterilant, typically confirmed through incubation and observation of growth.
- Chemical indicator response: The expected color change of the chemical indicator on the cap, confirming exposure to hydrogen peroxide.
- Growth media efficacy: The ability of the nutrient growth medium to support microbial growth.
- Standardized sterilization cycles: The defined parameters of the STERRAD® Sterilization Systems represent the "truth" of the sterilization conditions.
Essentially, the ground truth is established by objective microbiological and physical measurements under controlled conditions.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms. This device is a biological indicator that functions based on microbiological principles, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense. The development of such a device involves extensive R&D and validation, but not statistical machine learning training on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm for this biological indicator, this question is not applicable. The development of the device's performance characteristics is based on established sterilization science, microbiology, and materials science principles, and its effectiveness is validated through the nonclinical studies listed in the summary.
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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).
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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).
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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.
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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
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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
§ 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).