(60 days)
Not Found
No
The document describes a physical test pack for monitoring sterilization cycles and does not mention any computational or data processing components that would suggest the use of AI or ML.
No
This device is a test pack used for routine monitoring and periodic testing of sterilizers, not for treatment or diagnosis of a medical condition in a patient.
No
The device is a test pack used for routine monitoring and periodic testing of STERRAD sterilizers. It evaluates the effectiveness of the sterilization process, rather than diagnosing a medical condition in a patient.
No
The device description clearly outlines physical components (biological indicator, chemical indicator, vials, pouch, silicon mats) that are integral to the device's function, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring and testing the performance of sterilizers, not for diagnosing a disease or condition in a patient using a sample from the human body.
- Device Description: The components described (biological indicator, chemical indicator, vials, pouch, silicon mats) are designed to assess the effectiveness of a sterilization process, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for quality control and performance monitoring of medical device sterilization equipment.
N/A
Intended Use / Indications for Use
The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The STERRAD® Sterilizer CycleSure® Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial (with an orifice) into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle. Two silicon mats are placed in the pouch during use to increase the resistance of the Test Pack, by acting as a reservoir for hydrogen peroxide.
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
hospital-defined loads.
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 STERRAD Sterilizer Test Pack has been evaluated for its resistance in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers.
A comparison of the Test Pack to the biological model developed for each of the STERRAD Sterilizers indicates that the Test Pack is more resistant to the sterilization process than the biological model.
Test Packs containing CycleSure Biological Indictor were exposed to increasing doses of hydrogen peroxide in cach of the STERRAD Sterilization systems using half cycle parameters. The survival curves for the Test Pack were compared to the survival curves for the biological models developed for each of the STERRAD Sterilization systems. It was demonstrated that with all three STERRAD Sterilization systems, the Test Pack configuration more resistant to the sterilization process than the biological model.
Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the data indicate that the chemical indicator responds appropriately when in the Test Pack configuration.
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.
STERRAD® NX Test Pack (K042450)
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 June 9, 2005
510(k) Summary
STERRAD®SterilizerCycleSure® Test Pack Confidential
AUG 1 9 2005
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Joseph M. Ascenzi, PhD, RAC Sr. Manager, Regulatory Affairs Telephone (949) 453-6352 Fax (949) 789-3900
Or
Kevin Corrigan, RAC Director, Regulatory Affairs Telephone (949) 453-6410 Fax (949) 789-3900
Summary Date
June 16, 2005
Common Name
Biological Indicator (Test Pack)
Classification Name
Class II
Officially Marketed Equivalent Device Name(s)
STERRAD® NX Test Pack (K042450)
1
Description of Device
The STERRAD® Sterilizer CycleSure® Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial (with an orifice) into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle. Two silicon mats are placed in the pouch during use to increase the resistance of the Test Pack, by acting as a reservoir for hydrogen peroxide.
Indications for Use:
The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.
Summary of Non-clinical Tests
The STERRAD Sterilizer Test Pack has been evaluated for its resistance in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers.
A comparison of the Test Pack to the biological model developed for each of the STERRAD Sterilizers indicates that the Test Pack is more resistant to the sterilization process than the biological model.
Test Packs containing CycleSure Biological Indictor were exposed to increasing doses of hydrogen peroxide in cach of the STERRAD Sterilization systems using half cycle parameters. The survival curves for the Test Pack were compared to the survival curves
2
for the biological models developed for each of the STERRAD Sterilization systems. It was demonstrated that with all three STERRAD Sterilization systems, the Test Pack configuration more resistant to the sterilization process than the biological model.
Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the data indicate that the chemical indicator responds appropriately when in the Test Pack configuration.
Overall Performance Conclusions
The STERRAD Sterilizer CycleSure Test Pack has the necessary resistance when compared to the biological model to be an appropriate challenge for testing of Sterilization processes in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers. The STERRAD Sterilizer CycleSure Test Pack is substantially equivalent to the predicate devices, the STERRAD NX Test Pack.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three stylized lines.
AUG 1 9 2005
Dr. Joseph M. Ascenzi Sr. Manager, Regulatory Affairs_. . . . . Advanced Sterilization Products 33 Technology Dr. Irvine, California 92618
Re: K051643
R0510+5
Trade/Device Name: Sterrad Sterilizer Cyclesure Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: FRC Dated: August 2, 2005 Received: August 3, 2005
Dear Dr. Ascenzi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard manating to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaonance with the provisions of the Federal Food, Drug, devices that have been recatismed in accessfied of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Costlience Act (Act) that to not requent of the general controls provisions of the Act. The You may, merclore, manot the device, beginements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (see above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contributio may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Court of Fourther in the Federal Register.
4
Page 2 - Dr. Ascenzi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumted on a cademically with other requirements of the Act that FDA has made a decicinnation that Jour Several agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, news, and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of Device as described in your Section 510(K)
This letter will allow you to begin marketing your device as described in your Sec I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket notification. The PDA miding of backandary of the said 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 If you desire specific advice for your de rice on our last note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note Y comact the Office of Comphalico at (210) 276 or Part 807.97). You may obtain "Misbranding by relevelec to promanteriouslities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultive www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chi-Lin, Ph.D.
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
5
Indications for Use
510(k) Number: K051643
Device Name: STERRAD® Sterilizer CycleSure® Test Pack
Indications for Use:
The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.
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)