(151 days)
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational or learning components.
No.
The device is a chemical indicator tape used to confirm that sterilization loads have been processed, not to treat a patient.
No
Explanation: The device is a chemical indicator tape designed to show if a load has been exposed to hydrogen peroxide during sterilization, differentiating between processed and unprocessed loads. It does not diagnose medical conditions in patients.
No
The device is a physical chemical indicator tape that changes color, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure sterilization packs and wraps and to differentiate between processed and unprocessed loads in a sterilization system. This is a quality control/process monitoring function for sterilization, not a diagnostic test performed on a biological sample.
- Device Description: The description reinforces its function as a process indicator that changes color upon exposure to hydrogen peroxide, a sterilizing agent.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
- Performance Studies: The performance studies focus on the indicator's functionality in response to hydrogen peroxide, tape adhesion, color stability, biocompatibility, and shelf life – all related to its role in the sterilization process, not diagnostic performance.
In summary, the STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator used in sterilization, not a device for diagnosing conditions based on biological samples.
N/A
Intended Use / Indications for Use
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD® 100NX™ | Flex |
| EXPRESS |
The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
Product codes
JOJ
Device Description
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems.
The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
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
healthcare providers
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 STERRAD® SEALSURE® Chemical Indicator Tape in the STERRAD® 100NX™ EXPRESS Cycle and the results show that the STERRAD® SEALSURE® Chemical Indicator Tape performs as a through-put process indicator by responding to hydrogen peroxide exposure.
| STUDY | RESULTS |
|---|---|
| Chemical Indicator Functionality | Passed |
| Tape Adhesion Strength | Passed |
| End Point / Post Processing Color Stability | Passed |
| Biocompatibility | Passed |
| Shelf life | Passed |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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: | II |
| Proprietary Name: | STERRAD® SEALSURE® Chemical Indicator Tape |
2. PREDICATE DEVICES
1
3. INDICATIONS FOR USE
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD® 100NX™ | Flex |
| EXPRESS |
The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
4. DESCRIPTION OF DEVICE
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems.
The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
5. SUMMARY OF NONCLINICAL TESTS
Performance testing was conducted to demonstrate the functionality of STERRAD® SEALSURE® Chemical Indicator Tape in the STERRAD® 100NX™ EXPRESS Cycle and the results show that the STERRAD® SEALSURE® Chemical Indicator Tape performs as a through-put process indicator by responding to hydrogen peroxide exposure.
2
| STUDY | RESULTS |
|---|---|
| Chemical Indicator Functionality | Passed |
| Tape Adhesion Strength | Passed |
| End Point / Post Processing Color Stability | Passed |
| Biocompatibility | Passed |
| Shelf life | Passed |
6. OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies demonstrate that the STERRAD® SEALSURE® Chemical Indicator Tape is as safe and as effective for differentiating processed from unprocessed packages, and within the indications for use for the indicator and tape thus establishing that the modified STERRAD® SEALSURE® Chemical Indicator Tape is substantially equivalent to the predicate device, the STERRAD® SealSure® Chemical Indicator Tape (K022441, K040742).
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-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: K103219
Trade Name: STERRAD® SEALSURE™ Chemical Indicator Tape 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.
4
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 D
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
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Indications for Use
510(k) Number (if known): K103219
Device Name: STERRAD® SEALSURE® Chemical Indicator Tape
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator [(Class 1 Process Indicator (ISO 11140-1)] intended for use by healthcare providers to secure nonwoven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems.
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD®100NX™ | Flex |
| EXPRESS |
The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
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 M. S. Clumir Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
(Posted November 13, 2003)
KI 03219 510(k) Number: