(105 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the biological and chemical properties of a sterilization indicator, with no mention of AI or ML technologies.
No
The device is a biological indicator used for monitoring sterilization processes, not for treating patients.
No
This device is a biological indicator used to monitor the effectiveness of a sterilization process, not to diagnose a disease or condition in a patient.
No
The device description clearly states it is a physical biological indicator consisting of a glass fiber disc, glass ampoule, cap, liner, and chemical indicator. It is a hardware device used for monitoring sterilization processes.
Based on the provided information, the STERRAD CYCLESURE 24 Biological Indicator is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is for "frequent monitoring of the following STERRAD Sterilization Systems". While it's monitoring a sterilization process, the mechanism involves a biological indicator (spores) and a growth medium to assess the effectiveness of that process. This falls under the umbrella of testing or monitoring a process that directly impacts the safety of medical devices used on patients.
- Device Description: The description details a "self-contained stand-alone biological monitor" that uses a biological agent (spores) and a growth medium. This is a classic setup for a biological indicator used in sterilization monitoring, which is a type of in vitro test.
- Mechanism: The device works by exposing the spores to the sterilization process and then incubating them in a growth medium to see if they survive. This is an in vitro test to determine the effectiveness of the sterilization.
While it doesn't directly test a patient sample, it is used to evaluate the performance of a process (sterilization) that is critical for patient safety in a healthcare setting. This type of monitoring device is typically classified as an IVD.
N/A
Intended Use / 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
- 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).
Product codes (comma separated list FDA assigned to the subject device)
FRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Stability
Description: Verification of spore population for 9 month labeled product shelf life. Results: Passed
Description: Verification of resistance characteristics (D-value, survival time, and kill time) for 9 month labeled product shelf life. Results: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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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) |
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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.
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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:
STERRAD
CYCLESURE 24 BI |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use /
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:
• STERRAD 100S
• STERRAD 50
• STERRAD 200
• STERRAD NX
• STERRAD 100NX (Standard, Flex and
Express Cycles)
o 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). | Same as predicate |
Table 1: Comparison between Modified and Predicate Devices
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| | Predicate Device:
STERRAD CYCLESURE 24 BI
(K123017) | Modified Device:
STERRAD
CYCLESURE 24 BI |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Technological
Characteristics | The STERRAD CYCLESURE 24 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. | 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 second
Survival Time: calculated based on D-value
Kill 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 red
to golden yellow or bronze to indicate exposure
to hydrogen peroxide | Same as predicate |
| Shelf-life | 6 months | 9 months |
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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 labeled | |
| product shelf life | Passed | |
| Stability | Verification of resistance characteristics (D-value, | |
| survival time, and kill time) for 9 month labeled | ||
| product 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.