(206 days)
No
The device description and performance studies focus on biological and chemical indicators for sterilization monitoring, with no mention of AI or ML.
No
The device is a test pack used for monitoring the effectiveness of sterilizer cycles and does not directly treat or diagnose a medical condition in a patient.
No
This device is designed to monitor the efficacy of sterilizer cycles and provides an indication of whether the sterilization process was successful, rather than diagnosing a disease or condition in a patient.
No
The device description clearly outlines physical components such as a plastic tray, paper strip, latex tubing, and a chemical indicator strip, indicating it is a hardware-based device.
Based on the provided information, the STERRAD® BI Test Pack is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states it's for "frequent monitoring of the STERRAD® Sterilizer cycles." This monitoring involves assessing the effectiveness of the sterilization process.
- Device Description: The device contains a "biological sterilization process indicator" (spores) and a "chemical process indicator." These components are used to evaluate the outcome of the sterilization process.
- Mechanism: The biological indicator uses a known quantity of bacterial spores (Bacillus subtilis var. niger) to determine if the sterilization process was sufficient to kill them. This is a classic method for assessing sterilization efficacy. The chemical indicator provides a visual confirmation of exposure to the sterilization agent.
- Performance Studies: The performance studies mention "Survival and Kill Performance Data," which directly relates to the ability of the sterilization process to kill microorganisms.
While the device itself doesn't directly diagnose a disease in a patient, it is used in vitro (outside the body) to assess the effectiveness of a process (sterilization) that is critical for preventing the transmission of infectious agents. The results of the test (whether the spores are killed or not) provide information about the performance of the sterilizer, which is a key aspect of ensuring patient safety in a healthcare setting.
Therefore, it fits the definition of an In Vitro Diagnostic device as it is used to provide information about a process that impacts patient health, performed on a sample (the spores) outside of the body.
N/A
Intended Use / Indications for Use
The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.
Product codes
FRC
Device Description
The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 10° Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.
The narrow opening and channels leading to the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.
The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
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
Testing was conducted to show that the Survival and Kill Performance Data generated for the STERRAD 50 and STERRAD 100S Sterilizers was accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ADVANCED STERILIZATION PRODUCTS®
a Johnson Johnson company REGULATORY AFFAIRS DEPARTMENT
993775
510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Kevin Corrigan, R.A.C. Director of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900
Submission Date
November 5, 1999
Trade Name
STERRAD® BI Test Pack
Common Name
Biological Indicator (Challenge Pack)
Classification Name Class II
Legally Marketed Equivalent Device Name(s)
STERRAD® BI Test Pack, K921909, October 1, 1993 as modified in K991675, June 15, 1999.
DIVISION OF ETHICON, INC. + 33 TECHNOLOGY DRIVE · IRVINE, CA 92618 · (949) 581-5799 FAX (949) 789-3900
1
Description of Device
The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 10° Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.
The narrow opening and channels leading to the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.
The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
Statement of Intended Use
The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.
Description of Modification
The modification to the STERRAD® BI Test Pack involves labeling only.
With the continued evolution of the STERRAD Sterilization System, new models of the sterilizer have been developed. The STERRAD BI Test Pack was originally cleared for use in the STERRAD 100 Sterilizer. In January of 1999, ASP received marketing clearance (K981625) for the STERRAD 50 Sterilizer and ASP currently has a 510(k) notification pending for another new sterilizer model, the STERRAD 100S Sterilizer. These two new sterilizers utilize a modification of the original STERRAD process. Consequently, new performance data (Survival and Kill characteristics) were needed for the STERRAD BI Test Pack in these new sterilizers.
This premarket notification modifies the Performance Certification of the STERRAD BI Test Pack to add the performance characteristics of the test pack in the STERRAD 50 and STERRAD 100S Sterilizers.
2
Summary of Nonclinical Tests
Testing was conducted to show that the Survival and Kill Performance Data generated for the STERRAD 50 and STERRAD 100S Sterilizers was accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines, possibly representing movement or progress. The logo is presented in black and white.
JUN - 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kevin Corrigan, R.A.C. Director, Regulatory Affairs Advanced Sterilization Products Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618
K993775 Re : STERRAD® BI Test Pack Trade Name: Regulatory Class: II FRC Product Code: Dated: March 10, 2000 Received: March 13, 2000
Dear Mr. Corrigan:
We have reviewed your Section 510(k) notification of intent to we have reviewed freferenced above and we have determined the market the device ially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been Medical Device imendance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Intras, 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back us your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with SubbeanClarly Squaring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (UP) / regarions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif bac. abbamasy action. In addition. In addition, FDA regaration may ther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any premazion you might have under sections 531 through 542 of
4
Page 2 - Mr. Corrigan
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510 m, providence of your device to a legally rinding of bubbandedice results in a classification for your marketed predication wour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Jourision of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, Suzar unner
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ED STERILIZATION PRODUCTS® ADVANC
1031400111001 como REGULATORY AFFAIRS DEPARTMENT
Indications for Use
To Be Assigned 510(k) Number:
STERRAD®BI Test Pack Device Name
Indications For Use:
The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Optional Format 1-2-96)
DIVISION OF ETHICON, INC. . 33 TECHNOLOGY DRIVE . IRVINE, CA 92618 . (949) 581-5799 FAX (949) 789-3900
Lain S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev
510(k) Number K993275