(489 days)
Not Found
No
The device description and performance studies focus on a chemical reaction resulting in a color change, with no mention of AI or ML.
No
The device is a chemical indicator strip used to differentiate processed from unprocessed packages in sterilization systems, rather than directly treating a medical condition or ailment.
No
This device is a chemical indicator strip used to verify that a sterilization process has occurred, not to diagnose a medical condition in a patient.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "process indicator" to differentiate processed from unprocessed packages in a sterilization system. It's used to monitor the sterilization process itself, not to diagnose a condition or analyze a biological sample from a patient.
- Device Description: The description explains it functions by a chemical reaction to indicate exposure to hydrogen peroxide, a sterilizing agent. This is a quality control measure for the sterilization process, not a diagnostic test.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue). This device interacts with medical device packages and the sterilization environment, not biological samples.
- No Patient Information: The description lacks any mention of patient age range, anatomical site, or intended user in a clinical diagnostic context.
This device falls under the category of a sterilization process indicator, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
The STERRAD® Chemical Indicator Strip (PN 14100) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
Product codes
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
Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX® DUO 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. Product shelf-life was presented in the STERRAD® Chemical Indicator Strip, EXPRESS cycle 510(k) (K103218) and was not repeated for this submission since the product's design has not changed.
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
510(k) Summary
OCT 3 2012
Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618
Contact Person
Nancy Chu Manager. Regulatory Affairs (949) 453-6435 Telephone (949) 789-3900 Fax
Date: September 10, 2012
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Common/Usual Name: Product Classification: Proprietary Name:
Sterilization Process Indicator Chemical Sterilization Process Indicator II STERRAD® Chemical Indicator Strip
2. PREDICATE DEVICE
STERRAD® Chemical Indicator Strip (K103218)
3. INDICATIONS FOR USE
The STERRAD® Chemical Indicator Strip (PN 14100) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
1
KIII 218
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® DUO 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. Product shelf-life was presented in the STERRAD® Chemical Indicator Strip, EXPRESS cycle 510(k) (K103218) and was not repeated for this submission since the product's design has not changed.
| 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, when used with the STERRAD® 100NX DUO Cycle, for differentiating processed from unprocessed packages within the indications for use for the chemical indicator thus establishing that the STERRAD® Chemical Indicator Strip is substantially equivalent to the predicate device, the STERRAD® Chemical Indicator Strip (K103128).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
3 2012
Advanced Sterilization Products
Ms. Nancy Chu
Manager, Regulatory Affairs
33 Technology Drive
Irvine, California 92618
Re: K111518 Trade/Device Name: Sterrad® Chemical Indicator Strip (PN 14100) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: September 21, 2012 Received: September 24, 2012
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,
For
Elizabeth
Stuttard
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): K111518
Device Name:
STERRAD® Chemical Indicator Strip
Indications for Use:
The STERRAD® Chemical Indicator Strip (PN 14100) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
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)
Signature
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division Control Dental Devices Division of Anesthoolors 277
Infection Control, Dental Devices
111518
510(k) Number;
Page 1 of 1
(Posted November 13, 2003)