(105 days)
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent montoring of the following STERRAD Sterlization Systems and has been validated for use in health care facilities:
- . STERRAD 100S
- o STERRAD 50
- . STERRAD 200
- o STERRAD NX®
- . STERRAD 100NX® (Standard, Flex and Express Cycles)
- For STERRAD 100NX DUO Cycle in the United States, the STERRAD CYCLESURE 24 Biological 0 Indicator should only be used in a test pack configuration (REF 20243).
The STERRAD CYCLESURE 24 Biological Indicator (BI) 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 1x106 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 document describes a 510(k) premarket notification for the STERRAD® CYCLESURE® 24 Biological Indicator. The primary modification being sought is an extension of the labeled shelf life from 6 months to 9 months. The information provided focuses on demonstrating that this shelf life extension does not impact the device's performance or safety.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specifications Maintained) | Reported Device Performance |
|---|---|
| Spore Population | Passed |
| Resistance Characteristics (D-value) | Passed |
| Resistance Characteristics (Survival Time) | Passed |
| Resistance Characteristics (Kill Time) | Passed |
| Positive BI color test | Passed |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for the stability studies. It mentions "Stability studies were conducted" in the plural, implying multiple tests were performed.
The data provenance is not specified in terms of country of origin, but it is explicitly prospective as the studies were conducted to verify the device's stability over an extended shelf life.
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 to this submission. The device is a biological indicator designed to monitor sterilization processes, and its performance is evaluated against predefined biological and chemical metrics (spore population, D-value, color change), not against expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
This question is not applicable, as the evaluation is based on objective scientific measurements and laboratory testing, not human interpretation requiring adjudication.
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. The device is a biological indicator, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its design and biological components, and it functions standalone in the sense that it indicates sterilization failure or success without human intervention beyond observing the color change or culture results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established by well-defined scientific and microbiological specifications. These include:
- Minimum viable spore population: 1 x 10⁶ Geobacillus stearothermophilus spores/BI (as per the device description).
- Resistance characteristics: D-value at 2.5 mg/L of hydrogen peroxide (≥ ~1 second), calculated survival time, and a kill time of 60 seconds.
- Positive BI color test: The indicator should demonstrate the expected color change (from red to golden yellow or bronze) when exposed to hydrogen peroxide.
These are objective, quantitative measures for a biological indicator.
8. The sample size for the training set
This question is not applicable. The device is not an AI/ML model that requires a "training set." Its performance is based on its inherent physical and biological properties.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Advanced Sterilization Products Ms. Sun Choi Regulatory Affairs Specialist IV 33 Technology Dr. Irvine, CA 92618
Re: K151971
Trade/Device Name: STERRAD® CYCLESURE® 24 Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: October 13, 2015 Received: October 14, 2015
Dear Ms. Choi:
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.
{1}------------------------------------------------
Page 2 - Ms. Choi
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K151971
Device Name STERRAD® CYCLESURE® 24 Biological Indicator
Indications for Use (Describe)
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent montoring of the following STERRAD Sterlization Systems and has been validated for use in health care facilities:
- . STERRAD 100S
- o STERRAD 50
- . STERRAD 200
- o STERRAD NX®
- . STERRAD 100NX® (Standard, Flex and Express Cycles)
- For STERRAD 100NX DUO Cycle in the United States, the STERRAD CYCLESURE 24 Biological 0 Indicator should only be used in a test pack configuration (REF 20243).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
20
{3}------------------------------------------------
510(k) Summary
I. SUBMITTER
Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618
Contact Person: Sun Choi Regulatory Affairs Specialist IV Telephone: (949) 453-6378 Fax: (949) 798-3900
Date Prepared: July 13, 2015
II. DEVICE
Name of Device: STERRAD® CYCLESURE® 24 Biological Indicator Common or Usual Name: Biological Indicator Classification Name: Biological Sterilization Process Indicator (21 CFR 880.2800) Regulatory Class: II Product Code: FRC
III. PREDICATE DEVICE
STERRAD CYCLESURE 24 Biological Indicator K123017
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The STERRAD CYCLESURE 24 Biological Indicator (BI) 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 1x106 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.
{4}------------------------------------------------
V. 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 has been validated for use in health care facilities:
- STERRAD 100S
- STERRAD 50
- o STERRAD 200
- STERRAD NX® ●
- STERRAD 100NX® (Standard, Flex and Express Cycles) ●
- For STERRAD 100NX DUO Cycle in the United States, the STERRAD O CYCLESURE 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed modification is to extend the labeled shelf life of the STERRAD CYCLESURE 24 BI. The intended use/indications for use, technological characteristics, design, materials, and principles of operation have not changed. Refer to Table 1 for comparison between modified and predicate devices for the STERRAD CYCLESURE 24 BI.
| Predicate Device:STERRAD CYCLESURE 24 BI(K123017) | Modified Device:STERRADCYCLESURE 24 BI | |
|---|---|---|
| Intended Use /Indications for Use | The STERRAD CYCLESURE 24 BiologicalIndicator is intended to be used as a standardmethod for frequent monitoring of the followingSTERRAD Sterilization Systems:• STERRAD 100S• STERRAD 50• STERRAD 200• STERRAD NX• STERRAD 100NX (Standard, Flex andExpress Cycles)o For STERRAD 100NX DUO Cycle inthe United States, the STERRADCYCLESURE 24 Biological Indicatorshould only be used in a test packconfiguration (REF 20243). | Same as predicate |
Table 1: Comparison between Modified and Predicate Devices
{5}------------------------------------------------
| Predicate Device:STERRAD CYCLESURE 24 BI(K123017) | Modified Device:STERRADCYCLESURE 24 BI | |
|---|---|---|
| TechnologicalCharacteristics | The STERRAD CYCLESURE 24 BI is a self-contained stand- alone biological monitorintended for the routine monitoring of theSTERRAD Sterilization Process. It consists ofa glass fiber disc containing a minimum of1x10⁶ Geobacillus stearothermophilus spores, aglass ampoule containing nutrient growthmedium, a cap and liner closing the vial and achemical indicator on top of the cap. The capcontains two small circular openings that allowfor diffusion of hydrogen peroxide vapor intothe vial. The relatively small size of the circularopenings serves as a restriction to this diffusion. | Same as predicate |
| Organism | Geobacillus stearothermophilus ATCC 7953 | Same as predicate |
| Viable Spore Population | Minimum of 1 x 10⁶ spores/BI | Same as predicate |
| Carrier Material | Glass Fiber | Same as predicate |
| Resistance Characteristics | D-value at 2.5 mg/L of hydrogen peroxide:≥ ~ 1 secondSurvival Time: calculated based on D-valueKill Time: 60 seconds | Same as predicate |
| Incubation Temperature | 55 - 60 °C | Same as predicate |
| Incubation Time | 24 hours to 3 days (72 hours) | Same as predicate |
| Chemical Indicator | A throughput indicator, changes color from redto golden yellow or bronze to indicate exposureto hydrogen peroxide | Same as predicate |
| Shelf-life | 6 months | 9 months |
{6}------------------------------------------------
VII. PERFORMANCE DATA
The modified and predicate devices have the same intended use/indications for use, technological characteristics, design, materials, and principles of operation. The proposed modification is to extend the labeled shelf life of the STERRAD CYCLESURE 24 BI from 6 months to 9 months. Stability studies were conducted to demonstrate that the specifications (D-value, survival time, kill time, spore population, and positive BI color test) are maintained throughout the proposed labeled shelf life of the modified device. Refer to Table 2 for the summary of stability studies.
| Study Type | Description | Results |
|---|---|---|
| Stability | Verification of spore population for 9 month labeledproduct shelf life | Passed |
| Stability | Verification of resistance characteristics (D-value,survival time, and kill time) for 9 month labeledproduct shelf life | Passed |
Table 2: Summary of Performance Testing
VIII. CONCLUSIONS
Stability study results demonstrate that the specifications (D-value, survival time, kill time, spore population, and positive BI color test) are maintained throughout the proposed labeled shelf life (9 months) of the STERRAD CYCLESURE 24 BI. Modified and predicate devices have the same intended use/indications for use, technological characteristics, design, materials, and principles of operation.
Therefore, Advanced Sterilization Products considers the modified device with the extended shelf life to be substantially equivalent to its predicate device.
§ 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).