(489 days)
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction, with no mention of AI or ML in the description or performance studies.
No
This device is a chemical indicator tape used to differentiate between processed and unprocessed sterilization loads, not to treat a condition or disease.
No
The device is a chemical indicator tape used to differentiate between processed and unprocessed sterilization loads, not to diagnose a medical condition in a patient.
No
The device is a chemical indicator tape, which is a physical product that changes color based on exposure to a chemical agent (hydrogen peroxide). It is not software.
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 process indicator for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces its function as a process indicator that changes color upon exposure to hydrogen peroxide, a sterilizing agent.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status.
The device is clearly described as a process indicator for sterilization, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
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® DUO 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. Product shelf-life was presented in the STERRAD® SEALSURE® Chemical Indicator Tape, EXPRESS cycle 510(k) submission (K103219) and was not repeated nor presented in this submission since the product's design has not changed.
| STUDY | RESULTS |
|---|---|
| Chemical Indicator Functionality | Passed |
| Tape Adhesion Strength | Passed |
| End Point / Post Processing Color Stability | Passed |
| Biocompatibility | Passed |
| Shelf life | Passed |
The nonclinical studies demonstrate that the STERRAD® SEALSURE® Chemical Indicator Tape is as safe and as effective for differentiating processed from unprocessed packages when used with the STERRAD® 100NX® DUO Cycle, and within the indications for use for the indicator and tape, thus establishing that the STERRAD® SEALSURE® Chemical Indicator Tape is substantially equivalent to the predicate device, the STERRAD® SEALSURE® Chemical Indicator Tape (K103219, cleared 4/1/2011).
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
KIII 519
OCT
143
Э 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® SEALSURE® Chemical Indicator Tape
2. PREDICATE DEVICES
STERRAD® SEALSURE® Chemical Indicator Tape (K103219)
1
p²δ3
3. INDICATIONS FOR USE
STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
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® DUO Cycle and the results show that the STERRAD® SEALSURE® Chemical Indicator Tape performs as a through-put process indicator by responding to hydrogen peroxide Product shelf-life was presented in the STERRAD® SEALSURE® exposure. Chemical Indicator Tape, EXPRESS cycle 510(k) submission (K103219) and was not repeated nor presented in this submission since the product's design has not changed.
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 when used with the STERRAD® 100NX® DUO Cycle, and within the indications for use for the indicator and tape, thus establishing that the STERRAD® SEALSURE® Chemical Indicator Tape is substantially equivalent to the predicate device, the STERRAD® SEALSURE® Chemical Indicator Tape (K103219, cleared 4/1/2011).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
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: K111519
Trade/Device Name: Sterrad® Sealsure® Chemical Indicator Tape (PN 14202) 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.
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
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
5
Indications for Use
510(k) Number (if known): K111519
Device Name:
STERRAD® SEALSURE® Chemical Indicator Tape
Indications for Use
Indications for Ose
STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) intended for use by healthcare providers to secure non-woven (150 11110 1:2609) mrans to be sterilized in the STERRAD® Sterilization Systems.
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX® | Standard |
| STERRAD® NX® | Advanced |
| STERRAD®100NX® | Flex |
| STERRAD®100NX® | EXPRESS |
| STERRAD®100NX® | DUO |
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)
| (Division/Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K111519 |
Page 1 of 1(Posted November 13, 2003)