(151 days)
STERRAD® Chemical Indicator Strip (K921910)
Not Found
No
The device is a chemical indicator strip that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational or algorithmic processing.
No
The device is a chemical indicator strip used to differentiate processed from unprocessed medical device packages in sterilization systems, rather than for direct therapeutic use on a patient.
No
The device, a chemical indicator strip, differentiates between processed and unprocessed packages by a color change due to exposure to hydrogen peroxide. It does not diagnose any medical condition or disease.
No
The device is a physical chemical indicator strip that changes color based on exposure to hydrogen peroxide, indicating a chemical reaction, not a software function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the STERRAD® Chemical Indicator Strip is a "Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages)" and is for use with medical device packages to be sterilized. This indicates its purpose is to monitor the sterilization process itself, not to diagnose a condition or analyze a biological sample from a human body.
- Device Description: The description explains that the indicator functions by a chemical reaction to hydrogen peroxide exposure, resulting in a color change. This is a process monitoring function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Measuring analytes in a biological sample
Therefore, the STERRAD® Chemical Indicator Strip is a device used to monitor a sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD®100NX™ | Flex |
| EXPRESS |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
STERRAD® Chemical Indicator Strip is a through-put process indicator strip to be used with STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® Chemical Indicator Strip functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The yellow (or lighter) chemical indicator bar indicates that the load has been exposed to 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
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)
Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX™ EXPRESS Cycle and the results show that the Chemical Indicator Strip performs as a through-put process indicator by responding as expected to hydrogen peroxide exposure.
| Study | Result |
|---|---|
| Chemical Indicator Functionality | Passed |
| End Point / Post Processing Color Stability | Passed |
| Shelf life | Passed |
| Biocompatibility | 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.
STERRAD® Chemical Indicator Strip (K921910)
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
510(k) Summary
APR - 1 2011
Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618
Contact Person
Nancy Chu Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900
Date: October 29, 2010
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Indicator, Physical/Chemical Sterilization Process |
|---|---|
| Common/Usual Name: | Chemical Sterilization Process Indicator |
| Product Classification: | 2 |
| Proprietary Name: | STERRAD® Chemical Indicator Strip |
2. PREDICATE DEVICE
STERRAD® Chemical Indicator Strip (K921910)
3. INDICATIONS FOR USE
The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD®100NX™ | Flex |
| EXPRESS | |
1
4. DESCRIPTION OF DEVICE
STERRAD® Chemical Indicator Strip is a through-put process indicator strip to be used with STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® Chemical Indicator Strip functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The yellow (or lighter) chemical indicator bar indicates that the load has been exposed to hydrogen peroxide.
5. SUMMARY OF NONCLINICAL TESTS
Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX™ EXPRESS Cycle and the results show that the Chemical Indicator Strip performs as a through-put process indicator by responding as expected to hydrogen peroxide exposure.
| Study | Result |
|---|---|
| Chemical Indicator Functionality | Passed |
| End Point / Post Processing Color Stability | Passed |
| Shelf life | Passed |
| Biocompatibility | Passed |
6. OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies demonstrate that the STERRAD® Chemical indicator Strip is as safe and as effective as the predicate for differentiating processed from unprocessed packages within the indications for use for the chemical indicator thus establishing that the modified STERRAD® Chemical Indicator Strip is substantially equivalent to the predicate device, the STERRAD® Chemical Indicator Strip (K921910).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618
APR - 1 2011
Re: K103218
Trade Name: STERRAD® Chemical Indicator Strip Regulation Number: 21 CFR §880.2800 Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: March 15, 2011 Received: March 16, 2011
Dear Ms. Chu:
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.
3
Page 2- Ms. Chu
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
James J. Robel
for Z
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103218
Device Name: STERRAD® Chemical Indicator Strip
The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50. | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| STERRAD® NX™ | Advanced |
| STERRAD®100NX™ | Standard |
| STERRAD®100NX™ | Flex |
| STERRAD®100NX™ | EXPRESS |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (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)
Edith A. S. Clunie. Will
(Division Sign-Off) ിvision of Anesthesiology, General Hospital :nfection Control, Dental Devices
Page 1 of 1
(Posted November 13, 2003)
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