(116 days)
The STERRAD® CYCLESURE® 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.
This document describes the validation of the STERRAD® CYCLESURE® 24 Biological Indicator. However, it does not involve an AI device, therefore many of the requested categories are not applicable.
Here's the information extracted from the provided text, with clarification regarding the inapplicability of AI-specific questions:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states "Performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX™ Express Cycle." Specific quantitative acceptance criteria are not detailed in the provided text. The performance data is presented qualitatively as "Passed" for each study.
| Study Performed | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Evaporation | Not explicitly stated | Passed |
| Verification of positive BI color | Not explicitly stated | Passed |
| Bacteriostasis | Not explicitly stated | Passed |
| BI validation in STERRAD® 100NX™ Express Cycle (Dose Response) | Not explicitly stated | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test.
- Data Provenance: The testing was conducted by Advanced Sterilization Products, a division of Ethicon, Inc. The data is from nonclinical laboratory tests rather than human patient data, therefore country of origin and retrospective/prospective distinctions are not applicable in the typical sense for medical imaging or AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is a biological indicator for sterilization. Its "ground truth" is determined by microbiological and chemical validation methods, not by expert interpretation of images or clinical data.
4. Adjudication method for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data, typically in studies involving human interpretation or clinical outcomes. This device's performance is assessed through laboratory testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable. This is not an AI device, and an MRMC study is not relevant to its validation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is not an AI algorithm. The device, a biological indicator, operates independently of human interpretation for its primary function (indicating sterilization efficacy), though humans read the results. The "standalone" concept for an AI algorithm doesn't apply here.
7. The type of ground truth used:
The ground truth for a biological indicator is established through:
- Microbiological assays: Verification of spore kill (or survival) based on established protocols for sterilization efficacy testing (e.g., D-value, Z-value determinations for sterilization resistance).
- Chemical indicator changes: Visual color changes indicating exposure to sterilant.
- Growth medium changes: Observation of growth/no-growth in sterile culture, indicating spore survival or kill.
The document refers to "BI validation in STERRAD® 100NX™ Express Cycle (Dose Response)" which implies methods to determine logarithmic reduction of spores, a standard ground truth for biological indicator performance.
8. The sample size for the training set:
This question is not applicable. This is not an AI device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
This question is not applicable, as there is no "training set" for this device.
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510(k) Summary
K103222 FEB 2 5 2011
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products, Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Ms. Yogi Shah Project Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900
Summary Date: October 28, 2010
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Biological Sterilization Process Indicator Common/Usual Name: Biological Indicator Product Classification: II Classification Regulation: 21CFR880.2200 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® 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 |
{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
Testing was previously submitted in support of the substantial equivalence of the modified STERRAD® CYCLESURE® 24 Biological Indicator to the predicate STERRAD® CycleSure® Biological Indicator device. Both devices have same intended use, same technological characteristics, same operating principles, and utilize the same sterilant (hydrogen peroxide).
Additional testing was conducted to confirm that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended when used with the STERRAD® 100NX" Express Cycle.
| Study Performed | Results |
|---|---|
| Evaporation | Passed |
| Verification of positive BI color | Passed |
| Bacteriostasis | Passed |
| BI validation in STERRAD® 100NX™ Express Cycle (DoseResponse) | Passed |
6. DESCRIPTION OF CHANGE:
The following changes (relative to the predicate device, K071014) were reported in K102884 and incorporated into the STERRAD® CycleSure® 24 Biological Indicator that is shown in this submission to work as intended with the STERRAD® 100NX™ Express Cycle:
- a. Outer vial resin material changed (remains molded polypropylene from the same vendor)
- b. New supplier (and new process) for the silicon coating process for the Tyvek® cap liner
- c. Maximum readout time reduced from 7 days to 3 days
- d. Name changed from STERRAD® CycleSure® Biological Indicator to STERRAD® CYCLESURE® 24 Biological Indicator
- e. Additional changes to the Instructions for Use for clarity
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In addition, Intended Use statement revised adding sterilizer models and their related cycles for clarity for this submission.
7. OVERALL PERFORMANCE CONCLUSIONS
Performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX™ Express Cycle.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Yogi Shah Project Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
FEB 2 5 2011
Re: K103222
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: February 10, 2011 Received: February 14, 2011
Dear Ms. Shah:
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 that developmation 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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Page 2- Ms. Shah
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 Fequirement 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 53) -542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), a
please go to 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, (2) CER D . . 007 CE) . . 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 tollulu free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jums J. Rabadad
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): K103222
Device Name: STERRAD® CYCLESURE® 24 Biological Indicator
Indication for Use:
The STERRAD® CYCLESURE® 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 (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)
Elishath to. Willian
(Division Sign-Off) Division of Anesther plogy, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K103222
§ 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).