(120 days)
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
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.
The provided 510(k) summary describes a biological indicator, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) do not apply to this submission.
However, I can still extract the acceptance criteria and performance data for the biological indicator and address the relevant points from your request.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding numerical performance metrics for each criterion in the manner typically seen for AI/ML device performance. Instead, it lists validation studies that were conducted and reports a "Passed" status for each. This indicates that the device met the internal specifications or established thresholds for each validation study.
| Validation Study | Acceptance Criteria (Implied / Qualitative) | Reported Device Performance |
|---|---|---|
| Evaporation | Device resists evaporation to an acceptable degree (specific threshold not provided). | Passed |
| Verification of Positive BI Color | The biological indicator consistently displays a positive color change when growth occurs. | Passed |
| Bacteriostasis | Device does not inhibit the growth of microorganisms when they are present and should grow. | Passed |
| Verification of Minimum Incubation Time | Spore growth (and indicator change) is accurately detected within the specified minimum incubation time. | Passed |
| Spore Resistance | Geobacillus stearothermophilus spores exhibit expected resistance to the sterilant. | Passed |
| BI Validation in STERRAD Sterilizers | The biological indicator accurately reflects the efficacy of STERRAD sterilizer cycles (Dose Response). | Passed |
| Growth Promotion | The growth medium effectively promotes the growth of microorganisms (spores) when viable. | Passed |
Study Details (as applicable to a biological indicator)
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of BIs) used for each validation study. The data provenance is internal to Advanced Sterilization Products, Division of Ethicon, Inc., and the studies appear to be prospective validation tests conducted by the manufacturer to demonstrate the device's performance. No country of origin for "data" in the context of clinical populations is relevant here as it's a lab-based performance validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device where expert interpretation determines ground truth for a test set. The "ground truth" for a biological indicator is based on microbiological growth or non-growth under controlled conditions, which are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or diagnosis in AI studies. For a biological indicator, the outcome (growth or no growth, color change) is a direct, observable, and quantifiable result of a controlled microbiological experiment.
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
Not applicable. This is not an AI/ML device, so no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone biological indicator, not an algorithm. Its "standalone performance" is its ability to accurately indicate the presence or absence of sterilizing conditions based on microbial viability. The validation studies listed (e.g., Evaporation, Growth Promotion, Spore Resistance) represent its standalone performance characteristics.
7. The type of ground truth used
The ground truth used for these validation studies is microbiological growth/viability or physical/chemical property verification. For instance:
- For "Verification of Positive BI Color" and "Growth Promotion," the ground truth is the actual presence and growth of viable Geobacillus stearothermophilus spores.
- For "Spore Resistance" and "BI Validation in STERRAD Sterilizers," the ground truth is the known exposure to sterilant and the expected survival/kill rate of the spores.
- For "Evaporation" and "Bacteriostasis," the ground truth relates to the integrity and functional properties of the device under test conditions.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
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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
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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
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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.
. *
:
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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), 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
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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
Page 1 of 1
§ 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).