(44 days)
Not Found
No
The device description and performance studies focus on biological and chemical processes for sterilization monitoring, with no mention of AI or ML.
No
The device is a biological indicator used for monitoring sterilization cycles, not for treating or diagnosing any medical condition.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components like a glass fiber disc, glass ampoule, cap, liner, and chemical indicator, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a sterilization process (STERRAD® Sterilizer cycles). It is not intended to diagnose a disease, condition, or state of health in a human or animal.
- Device Description: The device contains bacterial spores and growth medium. Its function is to determine if the sterilization process successfully killed the spores. This is a quality control measure for the sterilization equipment, not a diagnostic test performed on a biological sample from a patient.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) from a patient, which is a core characteristic of IVD devices.
Therefore, the STERRAD® CycleSure® Biological Indicator is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STERRAD ® CycleSure® Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The STERRAD® CycleSure® 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 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.
The STERRAD® CycleSure® Biological Indicator is identical in design (with exception of fill volume) and performance specifications (with exception of incubation time) to the predicate device.
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
Not Found
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)
The studies were conducted to confirm the performance and quality characteristics of the modified culture media to evaluate suitability of the media for use in the STERRAD® CycleSure® Biological Indicator.
The growth media was tested for the color reversion after the growth and it was determined that color did not revert and yellow (positive) color was stable for up to seven days of incubation time. This test result confirms performance characteristic of the growth media.
The Bacteriostatis test was conducted to evaluate growth promotion and bactriostatic effect of pH indicator. Test data demonstrated that growth media was not bacteriostatic and met the specifications of performance characteristics.
The Fill Volume Determination study was conducted to determine if the growth media maintains enough volume to support positive growth and test data met the specifications.
The study was performed to determine the culture media reformulation can meet the reduced incubation time of 24 hours and test data confirms the 24 hours incubation time.
The design verification was done to confirm that the culture media consistently support growth of the Geobacillus stearothermophilus organism. Test data also confirms the growth support of the indicator organism.
The accelerated stability study was performed to evaluate the initial shelf life of the culture media to use in the STERRAD® CycleSure® Biological Indicator. The test result supports eighteen months of shelf life.
The performance and quality testing results of the media formulation has shown to promote growth, no color reversion, was not bacteriostatic and meet the 24 hours incubation time.
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.
Not Found
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
Advanced Sterilization Products Confidential
510(K) Summary
STERRAD® CycleSure®Biological Indicator
1. Sponsor:
MAY 2 4 2007
Advanced Sterilization Products, Inc. 33. Technology Drive Irvine, CA. 92618
Contact Person:
Yogi Shah Advanced Sterilization Products, Inc. 33. Technology Drive Irvine, CA. 92618 Phone: 949-789-8548 Fax: 949-789-3900 E: mail: yshah6@aspus.inj.com
Summary Date: March 27, 2007
2. Device Name
- Proprietary Name: STERRAD® CycleSure® Biological Indicator a.
- Device Common/Usual Name: Biological indicator b.
- Device Classification Name: Biological Sterilization Process Indicators C.
3. Identification of Predicate Device:
STERRAD® CycleSure®Biological STERRAD® CycleSure® Biological Indicator, K031226, May 2, 2003 and Indicator, K994055, February 13, 2002
4. Device Description:
The STERRAD® CycleSure® 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 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.
The STERRAD® CycleSure® Biological Indicator is identical in design (with exception of fill volume) and performance specifications (with exception of incubation time) to the predicate device.
1
Indication For Use: 5.
The STERRAD ® CycleSure® Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles
The Indication For Use is identical for the predicate device and proposed device.
Description of Modification 6.
The culture media has been modified to achieve 24 hours incubation time (read out time) and the labeling for the device was modified to reflect the reduce incubation time of 24 hours. Additionally, growth media fill volume has been modified.
7. Performance Test Data
The studies were conducted to confirm the performance and quality characteristics of the modified culture media to evaluate suitability of the media for use in the STERRAD® CycleSure® Biological Indicator.
The growth media was tested for the color reversion after the growth and it was determined that color did not revert and yellow (positive) color was stable for up to seven days of incubation time. This test result confirms performance characteristic of the growth media.
The Bacteriostatis test was conducted to evaluate growth promotion and bactriostatic effect of pH indicator. Test data demonstrated that growth media was not bacteriostatic and met the specifications of performance characteristics.
The Fill Volume Determination study was conducted to determine if the growth media maintains enough volume to support positive growth and test data met the specifications.
The study was performed to determine the culture media reformulation can meet the reduced incubation time of 24 hours and test data confirms the 24 hours incubation time.
The design verification was done to confirm that the culture media consistently support growth of the Geobacillus stearothermophilus organism. Test data also confirms the growth support of the indicator organism.
The accelerated stability study was performed to evaluate the initial shelf life of the culture media to use in the STERRAD® CycleSure® Biological Indicator. The test result supports eighteen months of shelf life.
The performance and quality testing results of the media formulation has shown to promote growth, no color reversion, was not bacteriostatic and meet the 24 hours incubation time.
2
Substantial Equivalence 8.
The modified STERRAD® CycleSure® Biological Indicator have the following similarities to the predicate device:
- have the same indicated use
- use same operating principles ■
- incorporate same design (with exception of culture media formulation and fill volume) .
- 트 have the same shelf life
- have same performance characteristics (with exception of incubation time) 트
- . are packaged using the same materials and process
In addition, the test result indicates that proposed STERRAD® CycleSure® Biological Indicator is substantially equivalent to currently marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the symbol.
Public Health Service
MAY 2 4 2007
ood and Drug Administration 200 Corporate Boulevard ockville MD 20850
Mr. Yogi Shah Project Manager, Regulatory Affairs Advanced Sterilization Products, Incorporated 33 Technology Drive Irvine, California 92618
Re: K071014
Trade/Device Name: Sterrad® CycleSure® Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: May 8, 2007 Received: May 9, 2007
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. 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 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); 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,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
HFZ-401 DMC
cc:
5
ADVANCED STERILIZATION PRODUCTS®
common Johnson company
REGULATORY AFFAIRS DEPARTMENT
Indications for Use
510(k) Number: To be assigned
Device Name: STERRAD® CycleSure®Biological Indicator
Indications For Use:
The STERRAD® CycleSure® 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 (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) | Page 1 of 1 |
|---|---|
| (Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices | |
| 410(k) Number | K071014 |
PAGE 3
DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • IRVINE, CA 92618 • (949) 581-5799 • FAX (949) 789-3900